Cleared Traditional

K880477 - RPR TEST FOR SYPHILIS IN SERUM OR PLASMA

K880477 is an FDA 510(k) clearance for RPR TEST FOR SYPHILIS IN SERUM OR PLASMA, manufactured by Ampcor, Inc.. The device is a Class 2 Microbiology device with product code GMQ cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K880477 · Ampcor, Inc. · Microbiology device
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Mar 1988
Decision
55d
Days
Class 2
Risk

K880477 is an FDA 510(k) clearance for the RPR TEST FOR SYPHILIS IN SERUM OR PLASMA. Classified as Antigens, Nontreponemal, All (product code GMQ), Class II - Special Controls.

Submitted by Ampcor, Inc. (Bridgeport, US). The FDA issued a Cleared decision on March 30, 1988 after a review of 55 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.

FDA 510(k) Submission Details - K880477

510(k) Number K880477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1988
Decision Date March 30, 1988
Days to Decision 55 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
47d faster than avg
Panel avg: 102d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GMQ Device Classification - Class 2, Special Controls

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 31
Devices cleared under the same product code (GMQ) and FDA review panel - the closest regulatory comparables to K880477.
VISUWELL(R) REAGIN TEST (MODIFICATION)
K900338 · Adi Diagnostics, Inc. · Apr 1990
STANBIO SYPHILIS RPR TEST, NO. 1170
K880144 · Stanbio Laboratory · May 1988
TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA
K880165 · Ampcor, Inc. · Mar 1988
RSR CARD TEST
K871252 · Advanced Polymer Systems, Inc. · Aug 1987
SYPHILIS SEROLOGICAL REAGENTS
K871226 · New Horizons Diagnostics Co. · May 1987
OCEAN SCIENTIFIC VDRL TEST
K864731 · Ocean Scientific, Inc. · Mar 1987
K880477 · RPR TEST FOR SYPHILIS IN SERUM OR PLASMA
Download PDF Ampcor, Inc.