Cleared Traditional

OSOM ULTRA STREP A TEST, MODEL 147 (K992658) - FDA 510(k) Clearance

Class I Microbiology device.

K992658 · Wyntek Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
162d
Days
Class 1
Risk

K992658 is an FDA 510(k) clearance for the OSOM ULTRA STREP A TEST, MODEL 147. Classified as Antigens, All Groups, Streptococcus Spp. (product code GTY), Class I - General Controls.

Submitted by Wyntek Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on January 18, 2000 after a review of 162 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Wyntek Diagnostics, Inc. devices

Submission Details

510(k) Number K992658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1999
Decision Date January 18, 2000
Days to Decision 162 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 102d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTY Antigens, All Groups, Streptococcus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GTY Antigens, All Groups, Streptococcus Spp.

All 43
Devices cleared under the same product code (GTY) and FDA review panel - the closest regulatory comparables to K992658.
AllTest Strep A Rapid Test
K260342 · Hangzhou AllTest Biotech Co., Ltd. · Apr 2026
Flowflex® Plus Strep A Rapid Test Cassette
K251697 · ACON Laboratories, Inc. · Nov 2025
Healgen Strep A Rapid Test Strip (Throat Swab)
K212623 · Healgen Scientific, LLC · Mar 2022
ABBOTT STREP A CONTROLS
K922490 · Abbott Laboratories · Jul 1992
KODAK SURECELL(TM) STREP A CONTROL FLUID SET
K904589 · Eastman Kodak Company · Jan 1991
ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL
K864752 · Abbott Laboratories · Feb 1987