Cleared Traditional

K992658 - OSOM ULTRA STREP A TEST, MODEL 147

K992658 is an FDA 510(k) clearance for OSOM ULTRA STREP A TEST, manufactured by Wyntek Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code GTY cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K992658 · Wyntek Diagnostics, Inc. · Microbiology device
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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.

FDA 510(k) Submission Details - K992658

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 102d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

GTY Device Classification - Class 1, General Controls

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 41
Devices cleared under the same product code (GTY) and FDA review panel - the closest regulatory comparables to K992658.
QUICKVUE DIPSTICK STREP A
K011097 · Quidel Corp. · May 2001
ACON STREP A RAPID TEST STRIP
K010582 · Acon Laboratories Co. · May 2001
SAS STREP A TEST
K993456 · Sa Scientific, Inc. · Mar 2000
STREP B OIA
K991828 · Biostar, Inc. · Aug 1999
UNI-GOLD STREP A TEST KIT
K982373 · Trinity Biotech, Plc · Feb 1999
BIOSTREP A-DIRECT STREP A ANTIGEN TEST
K983386 · Princeton BioMeditech Corp. · Nov 1998
K992658 · OSOM ULTRA STREP A TEST, MODEL 147
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