Cleared Traditional

K850256 - CONFIRM IMMUNOASSAY FOR DETECTTION STRE...

K850256 is an FDA 510(k) clearance for CONFIRM IMMUNOASSAY FOR DETECTTION STRE..., manufactured by Abbott Laboratories. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K850256 · Abbott Laboratories · Microbiology device
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Apr 1985
Decision
76d
Days
Class 1
Risk

K850256 is an FDA 510(k) clearance for the CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 8, 1985 after a review of 76 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K850256

510(k) Number K850256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1985
Decision Date April 08, 1985
Days to Decision 76 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
26d faster than avg
Panel avg: 102d · This submission: 76d
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 81
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K850256.
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
STREP A QUICK
K850831 · Abbott Laboratories · Apr 1985
VENTRESCREEN STREP A TEST
K844855 · Ventrex Laboratories, Inc. · Jan 1985
RESPIRALEX LATEX AGGLUTINATION TEST
K844399 · Orion Diagnostica, Inc. · Jan 1985