OSOM STREP A TEST

K961423 · Wyntek Diagnostics, Inc. · GTZ · Oct 11, 1996 · Microbiology

Device Facts

• Record ID: K961423
• Device Name: OSOM STREP A TEST
• Applicant: Wyntek Diagnostics, Inc.
• Product Code: GTZ · Microbiology
• Decision Date: Oct 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3740
• Device Class: Class 1

Indications for 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.

Device Story

OSOM Strep A Test; immunochromatographic dipstick assay; detects Group A Streptococcal antigen. Input: throat swab or culture colony. Principle: antibody-coated membrane; blue test line indicates positive result if antigen present. Used in clinical settings; performed by healthcare professionals. Provides rapid qualitative results in minutes; facilitates immediate clinical decision-making regarding antibiotic therapy; eliminates 18-24 hour wait time associated with traditional culture methods.

Clinical Evidence

No clinical data provided in document.

Technological Characteristics

Immunochromatographic dipstick technology; antibody-coated membrane; colorimetric detection (blue test line).

Indications for Use

Indicated for qualitative detection of Group A Streptococcal antigen in throat swabs or confirmation of presumptive Group A Streptococcal colonies from culture.

Regulatory Classification

Identification

Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identify Streptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Streptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.

Reference Devices

• Sheep blood agar medium culture and serological grouping

Submission Summary (Full Text)

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K961423

Wyntek
Diagnostics

OCT 11 1996

Wyntek
pstics

6146
Nancy Ridge Drive
Suite 101
San Diego California 92121 USA

# 8. 510 (k) Summary

## Submitter:

Wyntek Diagnostics, Inc.
6146 Nancy Ridge Dr. Ste. 101
San Diego, CA 92121
Tel: [phone]
Fax: [phone]

## 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.

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# 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 can be obtained in minutes using OSOM Strep A test. Culture methods to obtain comparable results require 18-24 hours or longer.

Applicant Signed: **Shu-Ching Cheng** Date: **April 11, 1996**

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