Cleared Traditional

STREP A QUICK (K850831) - FDA 510(k) Clearance

Class I Microbiology device.

K850831 · Abbott Laboratories · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
38d
Days
Class 1
Risk

K850831 is an FDA 510(k) clearance for the STREP A QUICK. 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 38 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

Submission Details

510(k) Number K850831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1985
Decision Date April 08, 1985
Days to Decision 38 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
64d faster than avg
Panel avg: 102d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 28
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K850831.
PHADIRECT STREP A TEST
K854150 · Pharmacia, Inc. · Oct 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
DIRECTIGEN GROUP A STREP TEST KIT
K843713 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1985
PHARMACIA STREP A DIRECT SWAB TEST
K844107 · Pharmacia, Inc. · Nov 1984
PATHO DX LATEX AGGLUTINATION STREP A
K842383 · Diagnostic Products Corp. · Jul 1984