Cleared Traditional

K880165 - TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA

K880165 is an FDA 510(k) clearance for TRUST RPR TEST FOR SYPHILIS IN SERUM OR..., 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 77-day FDA review.

K880165 · Ampcor, Inc. · Microbiology device
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Mar 1988
Decision
77d
Days
Class 2
Risk

K880165 is an FDA 510(k) clearance for the TRUST 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 77 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 Ampcor, Inc. devices

FDA 510(k) Submission Details - K880165

510(k) Number K880165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1988
Decision Date March 30, 1988
Days to Decision 77 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 102d · This submission: 77d
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 22
Devices cleared under the same product code (GMQ) and FDA review panel - the closest regulatory comparables to K880165.
RPR CARD TEST KIT
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STANBIO SYPHILIS RPR TEST, NO. 1170
K880144 · Stanbio Laboratory · May 1988
SYPH-TRUST
K863368 · I.A.F. Production, Inc. · Dec 1986
RAPID PLASMA REAGIN CARD TEST
K842541 · Clinical Sciences, Inc. · Jul 1984
AUTOGROUPER 16C SYS AUTOMATED REAG
K834149 · Technicon Instruments Corp. · Mar 1984