Cleared Traditional

K842541 - RAPID PLASMA REAGIN CARD TEST

K842541 is an FDA 510(k) clearance for RAPID PLASMA REAGIN CARD TEST, manufactured by Clinical Sciences, Inc.. The device is a Class 2 Microbiology device with product code GMQ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K842541 · Clinical Sciences, Inc. · Microbiology device
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Jul 1984
Decision
24d
Days
Class 2
Risk

K842541 is an FDA 510(k) clearance for the RAPID PLASMA REAGIN CARD TEST. Classified as Antigens, Nontreponemal, All (product code GMQ), Class II - Special Controls.

Submitted by Clinical Sciences, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1984 after a review of 24 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 Clinical Sciences, Inc. devices

FDA 510(k) Submission Details - K842541

510(k) Number K842541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1984
Decision Date July 26, 1984
Days to Decision 24 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
78d faster than avg
Panel avg: 102d · This submission: 24d
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 21
Devices cleared under the same product code (GMQ) and FDA review panel - the closest regulatory comparables to K842541.
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
AUTOGROUPER 16C SYS AUTOMATED REAG
K834149 · Technicon Instruments Corp. · Mar 1984
TRUST RPR CARD TEST #65144
K832479 · Emd Chemicals, Inc. · Sep 1983
TRUST RPR TITRATION CARD TEST #65145
K832480 · Emd Chemicals, Inc. · Sep 1983