Cleared Traditional

K850772 - BACTIGEN GROUP B STREPTOCOCCUS TEST

K850772 is an FDA 510(k) clearance for BACTIGEN GROUP B STREPTOCOCCUS TEST, manufactured by Armkel, LLC. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K850772 · Armkel, LLC · Microbiology device
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May 1985
Decision
93d
Days
Class 1
Risk

K850772 is an FDA 510(k) clearance for the BACTIGEN GROUP B STREPTOCOCCUS TEST. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on May 29, 1985 after a review of 93 days - within the typical 510(k) review window.

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 Armkel, LLC devices

FDA 510(k) Submission Details - K850772

510(k) Number K850772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1985
Decision Date May 29, 1985
Days to Decision 93 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 102d · This submission: 93d
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 89
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K850772.
CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.
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RAPID DIRECT STREP A LATEX AGGLUTINATION TEST
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PATHO DX LATEX AGGLUTINATION STREP B KIT
K845022 · Diagnostic Products Corp. · May 1985
CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES
K850256 · Abbott Laboratories · Apr 1985
STREP A QUICK
K850831 · Abbott Laboratories · Apr 1985