Cleared Traditional

K910541 - BIOKIT RPR

K910541 is an FDA 510(k) clearance for BIOKIT RPR, manufactured by Biokit USA, Inc.. The device is a Class 2 Microbiology device with product code GMQ cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K910541 · Biokit USA, Inc. · Microbiology device
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Oct 1991
Decision
256d
Days
Class 2
Risk

K910541 is an FDA 510(k) clearance for the BIOKIT RPR. Classified as Antigens, Nontreponemal, All (product code GMQ), Class II - Special Controls.

Submitted by Biokit USA, Inc. (Barcelona, ES). The FDA issued a Cleared decision on October 18, 1991 after a review of 256 days - an extended review 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: 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.

View all Biokit USA, Inc. devices

FDA 510(k) Submission Details - K910541

510(k) Number K910541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1991
Decision Date October 18, 1991
Days to Decision 256 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 102d · This submission: 256d
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 K910541.
TRUST
K954994 · Guardian Scientific, Corp. · Oct 1996
RPR CARD TEST KIT
K955136 · Remel, L.P. · Jul 1996
VISUWELL REAGIN II
K952802 · Biomira Diagnostics, Inc. · May 1996
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