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Vw
61s
Nancy
Ridge
Dre
Suite 102
San Diego
Caltorna
ial
Usa
KI4WIY23
OCT 11 095
@ 619.452 3198,
@ 619.452.3258
540 (k) Summary
Submitter :
Wyntek Diagnostics, Inc.
6146 Nancy Ridge Dr. Ste. 101
San Diego, CA 92121
Tel: 619-452-3198
Fax: 619-452-3258
Contact Person:
Shu-Ching Cheng
Product Name:
Proprietary Name: OSOM™ Strep A Test
Common Name: Rapid Immunoassay for Group A Streptococcal
Antigen Test Kit
Classification Name: Antigens, All Groups, Streptococcus spp.
Intended Use:
OSOM Strep A Test is an immunochromatographic
assay for the qualitative detection of Group A Streptococcal
antigen from throat swabs or confirmation of presumptive Group
‘A Streptococcal colonies from culture.
Description:
OSOM Strep A Test uses color immunochromatographic
dip stick technology with antibodies coated on the membrane. If
group A Streptococcus is present in the swab sample, a blue test
line will appear to indicate a positive result.
27 Substantial Equivalence:
The OSOM Strep A Test is substantially equivalent to results
obtained through isolation of Group A Streptococcus colonies on
sheep blood agar medium followed by a serological grouping of
presumptive Group A Streptococcus. Serotyping is used to confirm
identity of presumptive Group A Streptococcus isolates.
These techniques and OSOM Strep A are substantially equivalent
in that:
a. Both are intended for use in the detection of Group A
Streptococcus,
b. Both are in vitro tests.
The tests differ in that:
a. OSOM Strep A can detect non-viable as well as viable
organisms.
b. Results cab be obtained in minutes using OSOM Strep A test.
Culture methods to obtain comparable results require 18-24
hours or longer.
Applicant Signed: Ging Cty ee Date: __ Gari, 44k
Shu-Ching Cheng
