The FDA reviewed Beckman Coulter's submission for their Access Vitamin B12 assay. The FDA determined the Access Vitamin B12 assay is substantially equivalent to a legally marketed predicate device. The Access Vitamin B12 assay is a chemiluminescent immunoassay for quantitative measurement of vitamin B12 levels in human serum and plasma, and is intended for use in diagnosing and treating anemias caused by gastrointestinal malabsorption. The FDA cleared the Access Vitamin B12 assay for marketing subject to general controls.
The FDA reviewed Beckman Coulter's submission for their Access Vitamin B12 assay. The FDA determined the Access Vitamin B12 assay is substantially equivalent to a legally marketed predicate device. The Access Vitamin B12 assay is a chemiluminescent immunoassay for quantitative measurement of vitamin B12 levels in human serum and plasma, and is intended for use in diagnosing and treating anemias caused by gastrointestinal malabsorption. The FDA cleared the Access Vitamin B12 assay for marketing subject to general controls.
The FDA reviewed Beckman Coulter's submission for their Access Vitamin B12 assay. The FDA determined the Access Vitamin B12 assay is substantially equivalent to a legally marketed predicate device. The Access Vitamin B12 assay is a chemiluminescent immunoassay for quantitative measurement of vitamin B12 levels in human serum and plasma, and is intended for use in diagnosing and treating anemias caused by gastrointestinal malabsorption. The FDA cleared the Access Vitamin B12 assay for marketing subject to general controls.
The FDA reviewed Beckman Coulter's submission for their Access Vitamin B12 assay. The FDA determined the Access Vitamin B12 assay is substantially equivalent to a legally marketed predicate device. The Access Vitamin B12 assay is a chemiluminescent immunoassay for quantitative measurement of vitamin B12 levels in human serum and plasma, and is intended for use in diagnosing and treating anemias caused by gastrointestinal malabsorption. The FDA cleared the Access Vitamin B12 assay for marketing subject to general controls.
Re: K223289 Trade/Device Name: Access Vitamin B12 Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: Class II Product Code: CDD Dated: October 25, 2022 Received: October 25, 2022
Dear Kuljeet Kaur:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting- combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531- 542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting- mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical- devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Digitally signed by Paula Paula Caposino -S Caposino -S Date: 2022.12.23 12:57:41 -05'00'
Paula Caposino, Ph.D.
Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: 06/30/2023 Indications for Use See PRA Statement below.
510(k) Number (if known)
k223289
Device Name Access Vitamin B12
Indications for Use (Describe)
The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF Access Vitamin B12 510(k) Summary
510k Number: k223289 Date Prepared: December 23, 2022
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92
Submitted By: Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Device Description: The Access Vitamin B12 assay is a competitive binding immunoenzymatic assay. The Access Vitamin B12 reagent kit is in a liquid ready-to-use format designed for optimal performance on Beckman Coulter’s immunoassay analyzers. Each reagent kit contains two reagent packs. Other items needed to run the assay include substrate, calibrators, and wash buffer.
Intended Use:
The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay
for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
Page 1 of 4 Comparison of Technological Characteristics to the Predicate System Predicate Access Vitamin B12 on Access Vitamin B12 on DxI 9000 Attribute/Characteristic Access Immunoassay System Access Immunoassay Analyzer Analyte Measured Access Vitamin B12 Same Standardization USP Reference Material Same Intended Use/ Indications The Access Vitamin B12 assay is a Same for Use paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
Solid Phase Paramagnetic particles coated with goat Same
anti-mouse IgG; mouse monoclonal anti- intrinsic factor Conjugate Intrinsic factor-alkaline phosphatase Same Technology Two-step competitive Same Format Chemiluminescent Same Method Automated Same Calibration Utilizes a stored calibration curve Same Sample Type Serum or plasma Same Reagent Pack formulation Access Reagent Pack formulation and Same and packaging packaging. Stability Stable at 2 to 10°C for 14 days after initial Same use Substrate Access Substrate Lumi-Phos PRO Substrate Measuring Range 50 – 1,500 pg/mL (37 – 1,107 pmol/L) 68 - 1,500 pg/mL (50 - 1,107 pmol/L) Instrument Access Immunoassay System DxI 9000 Access Immunoassay Analyzer
Summary of Studies:
Method Comparison: A method comparison study was completed to compare the Access Vitamin B12 assay on the DxI 9000 Access Immunoassay Analyzer to the Access Vitamin B12 assay on the Access Immunoassay System using a protocol based on CLSI EP09c-A3. The results of the method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope of 1.00 ± 0.14 and supports the equivalence of the Access Vitamin B12 assay on DxI 9000 Access Immunoassay Analyzer to the Access Vitamin B12 assay on the Access instrument.
Concentration Correlation Range* Slope Intercept Coefficient N Slope Intercept (pg/mL) 95% CI 95% CI R2 122 70 - 1248 1.00 0.96 - 1.02 6.1 -0.16 - 15 0.97 *Range is Access values
Page 2 of 4 Imprecision: The imprecision study was run on three DxI 9000 Access Immunoassay Analyzers, three reagent lots, and three calibrator lots. Six (6) serum samples, with varying Vitamin B12 concentrations, were assayed in duplicate with two runs per day, over 21 days. The assay was design to meet the requirements of imprecision of SD ≤ 12 pg/mL for values ≤ 100 pg/mL and CV ≤ 12.0 % for values > 100 pg/mL. The observed within-laboratory (total) % CV was between 2.7% and 7.7% for Vitamin B12 concentrations > 100 pg/mL. The within- laboratory (total) SD was between 6 – 9 for Vitamin B12 concentrations ≤ 100 pg/mL. The results from a representative lot are as follows:
Linearity: A verification study was performed to determine the linearity of the Access Vitamin B12 assay on the DxI 9000 Access Immunoassay Analyzer based on CLSI EP06-ED2. The results of this study met the acceptance criterion and indicate that the Access Vitamin B12 assay is linear on the DxI 9000 Immunoassay System throughout the analytical measuring interval (68 - 1,500 pg/mL (50 - 1,107 pmol/L).
LoB/LoD: Verification studies were performed to determine the Limit of Blank (LoB) and Limit of Detection (LoD) of the Access Vitamin B12 assay using a protocol based on CLSI EP17- A2. The claimed LoB is 50 pg/mL (37 pmol/L). The assay is designed to meet the requirements for LoD ≤ 68 pg/mL (≤ 50 pmol/L). The results data demonstrate the LoB estimate of the vitamin B12 assay on DxI 9000 is 35 pg/mL (26 pmol/L). The observed LoD of the Vitamin B12 assay on DxI 9000 immunoassay analyzer is 49 pg/mL (36 pmol/L).
LoQ: Verification studies were performed to determine the Limit of Quantitation (LoQ) of the Access Vitamin B12 assay using a protocol based on CLSI EP17- A2 The assay is designed to meet the requirements for LoQ ≤ 68 pg/mL (≤ 50 pmol/L). The results data demonstrate the 20% CV LoQ estimate for the Access Vitamin B12 assay is 42 pg/mL. The results demonstrate the LoQ at 20% within laboratory (total) CV estimate of the Access Vitamin B12 assay to be 68 pg/mL. The maximum observed LoQ estimate for the Access Vitamin B12 assay on the DxI 9000 immunoassay system is less than the reported LoD value (49 pg/mL).
Page 3 of 4 Following the CLSI EP17-A2 recommendation that the LoQ must be greater than or equal to LoD, the LoQ observed value is reported as 49 pg/mL.
Other claims: The claims for the analytical specificity, reference intervals, matrix comparison are being transferred from file k955436.
Substantial Equivalence Comparison Conclusion
Beckman Coulter’s Access Vitamin B12 Assay on the DxI 9000 Access Immunoassay Analyzer is substantially equivalent to the Access Vitamin B12 Assay on the Access Immunoassay System as demonstrated through the information and data provided in this submission. The performance testing presented in this submission provides evidence that the device is safe and effective in its intended use.
