← Product Code [GTZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/GTZ) · K961423 # OSOM STREP A TEST (K961423) _Wyntek Diagnostics, Inc. · GTZ · Oct 11, 1996 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GTZ/K961423 ## Device Facts - **Applicant:** Wyntek Diagnostics, Inc. - **Product Code:** [GTZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/GTZ.md) - **Decision Date:** Oct 11, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.3740 - **Device Class:** Class 1 - **Review Panel:** Microbiology ## 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). ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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: 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- {1} # 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** -28- --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GTZ/K961423](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GTZ/K961423) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com