Cleared Traditional

K851132 - LATEX AGGLUTINATION TEST

K851132 is an FDA 510(k) clearance for LATEX AGGLUTINATION TEST, manufactured by New Horizons Diagnostics Co.. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K851132 · New Horizons Diagnostics Co. · Microbiology device
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Jul 1985
Decision
106d
Days
Class 1
Risk

K851132 is an FDA 510(k) clearance for the LATEX AGGLUTINATION TEST. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by New Horizons Diagnostics Co. (Columbia, US). The FDA issued a Cleared decision on July 5, 1985 after a review of 106 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 New Horizons Diagnostics Co. devices

FDA 510(k) Submission Details - K851132

510(k) Number K851132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1985
Decision Date July 05, 1985
Days to Decision 106 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 102d · This submission: 106d
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 90
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K851132.
CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.
K853073 · Marion Laboratories, Inc. · Aug 1985
QUIDEL QUEST STREP GROUP A TEST
K852806 · Quidel Corp. · Jul 1985
RAPID DIRECT STREP A LATEX AGGLUTINATION TEST
K852841 · Smithkline Diagnostics, Inc. · Jul 1985
BACTIGEN GROUP B STREPTOCOCCUS TEST
K850772 · Armkel, LLC · May 1985
PATHO DX LATEX AGGLUTINATION STREP B KIT
K845022 · Diagnostic Products Corp. · May 1985
CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES
K850256 · Abbott Laboratories · Apr 1985