Cleared Traditional

K822662 - REAGIN ANTIGEN SUSPENSION

K822662 is the FDA 510(k) clearance for REAGIN ANTIGEN SUSPENSION by Oxoid U.S.A., Inc.. It is a Class 2 Microbiology device (product code GMQ) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K822662 · Oxoid U.S.A., Inc. · Microbiology device
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Sep 1982
Decision
18d
Days
Class 2
Risk

K822662 is an FDA 510(k) clearance for the REAGIN ANTIGEN SUSPENSION. Classified as Antigens, Nontreponemal, All (product code GMQ), Class II - Special Controls.

Submitted by Oxoid U.S.A., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 21, 1982 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3820 - 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 Oxoid U.S.A., Inc. devices

Submission Details

510(k) Number K822662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1982
Decision Date September 21, 1982
Days to Decision 18 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
84d faster than avg
Panel avg: 102d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GMQ Antigens, Nontreponemal, All
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - GMQ Antigens, Nontreponemal, All

All 13
Devices cleared under the same product code (GMQ) and FDA review panel - the closest regulatory comparables to K822662.
TRUST RPR CARD TEST #65144
K832479 · Emd Chemicals, Inc. · Sep 1983
TRUST RPR TITRATION CARD TEST #65145
K832480 · Emd Chemicals, Inc. · Sep 1983
RAPID REAGIN CARD TEST
K822661 · Oxoid U.S.A., Inc. · Sep 1982
TREP CARD EIKEN
K820567 · Syn-Kit, Inc. · Apr 1982
VDRL CARBON ANTIGEN
K812894 · Oxoid U.S.A., Inc. · Nov 1981
DADE RPR CARD TEST
K811152 · American Dade · May 1981