Cleared Traditional

K961423 - OSOM STREP A TEST

K961423 is an FDA 510(k) clearance for OSOM STREP A TEST, manufactured by Wyntek Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K961423 · Wyntek Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
182d
Days
Class 1
Risk

K961423 is an FDA 510(k) clearance for the OSOM STREP A TEST. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Wyntek Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 11, 1996 after a review of 182 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

FDA 510(k) Submission Details - K961423

510(k) Number K961423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1996
Decision Date October 11, 1996
Days to Decision 182 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 102d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

GTZ Device Classification - Class 1, General Controls

Product Code GTZ Antisera, 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 - GTZ Antisera, All Groups, Streptococcus Spp.

All 87
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K961423.
BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI
K991726 · Binax, Inc. · Aug 1999
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
K971522 · Abbott Laboratories · Mar 1998
STREPTOLEX-STAT
K962296 · Unipath , Ltd. · Dec 1996
CARDS Q.S. STREP A
K955108 · Quidel Corp. · Apr 1996
BINAX STREP A TEST
K960712 · Binax, Inc. · Mar 1996
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)
K952819 · Abbott Laboratories · Jan 1996