Cleared Traditional

K852806 - QUIDEL QUEST STREP GROUP A TEST

K852806 is the FDA 510(k) clearance for QUIDEL QUEST STREP GROUP A TEST by Quidel Corp.. It is a Class 1 Immunology device (product code GTZ) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K852806 · Quidel Corp. · Immunology device
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Jul 1985
Decision
27d
Days
Class 1
Risk

K852806 is an FDA 510(k) clearance for the QUIDEL QUEST STREP GROUP A TEST. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Quidel Corp. (La Jolla, US). The FDA issued a Cleared decision on July 30, 1985 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3740 - the FDA immunology 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 Quidel Corp. devices

Submission Details

510(k) Number K852806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1985
Decision Date July 30, 1985
Days to Decision 27 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 104d · This submission: 27d
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 47
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K852806.
OXOID STREPTOCOCAL GROUPING KIT
K854929 · Oxoid U.S.A., Inc. · Mar 1986
ABBOTT STREP A P.S.D.
K852266 · Abbott Laboratories · Dec 1985
PHADIRECT STREP A TEST
K854150 · Pharmacia, Inc. · Oct 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