Cleared Traditional

K880144 - STANBIO SYPHILIS RPR TEST, NO. 1170

K880144 is an FDA 510(k) clearance for STANBIO SYPHILIS RPR TEST, manufactured by Stanbio Laboratory. The device is a Class 2 Microbiology device with product code GMQ cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K880144 · Stanbio Laboratory · Microbiology device
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May 1988
Decision
131d
Days
Class 2
Risk

K880144 is an FDA 510(k) clearance for the STANBIO SYPHILIS RPR TEST, NO. 1170. Classified as Antigens, Nontreponemal, All (product code GMQ), Class II - Special Controls.

Submitted by Stanbio Laboratory (San Antonio, US). The FDA issued a Cleared decision on May 23, 1988 after a review of 131 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K880144

510(k) Number K880144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1988
Decision Date May 23, 1988
Days to Decision 131 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
29d slower than avg
Panel avg: 102d · This submission: 131d
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 30
Devices cleared under the same product code (GMQ) and FDA review panel - the closest regulatory comparables to K880144.
BIOKIT RPR
K910541 · Biokit USA, Inc. · Oct 1991
CROMATEST SYPHILIS DIAGNOSTIC
K904496 · Biotrax, Inc. · Jul 1991
VISUWELL(R) REAGIN TEST (MODIFICATION)
K900338 · Adi Diagnostics, Inc. · Apr 1990
TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA
K880165 · Ampcor, Inc. · Mar 1988
RPR TEST FOR SYPHILIS IN SERUM OR PLASMA
K880477 · Ampcor, Inc. · Mar 1988
RSR CARD TEST
K871252 · Advanced Polymer Systems, Inc. · Aug 1987
K880144 · STANBIO SYPHILIS RPR TEST, NO. 1170
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