Cleared Traditional

K843741 - RPR TEST REDITEST

K843741 is an FDA 510(k) clearance for RPR TEST REDITEST, manufactured by Biokit USA, Inc.. The device is a Class 2 Microbiology device with product code GMP cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K843741 · Biokit USA, Inc. · Microbiology device
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Oct 1984
Decision
30d
Days
Class 2
Risk

K843741 is an FDA 510(k) clearance for the RPR TEST REDITEST. Classified as Antisera, Control For Nontreponemal Tests (product code GMP), Class II - Special Controls.

Submitted by Biokit USA, Inc. (Barcelona, Spain, US). The FDA issued a Cleared decision on October 25, 1984 after a review of 30 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 - K843741

510(k) Number K843741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1984
Decision Date October 25, 1984
Days to Decision 30 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
72d faster than avg
Panel avg: 102d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GMP Device Classification - Class 2, Special Controls

Product Code GMP Antisera, Control For Nontreponemal Tests
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 - GMP Antisera, Control For Nontreponemal Tests

All 8
Devices cleared under the same product code (GMP) and FDA review panel - the closest regulatory comparables to K843741.
VISUWELL REAGIN TEST 960 TEST KIT
K885298 · Allelix Diagnostics, Inc. · Mar 1989
V-TREND RPRL CARD TEST
K875180 · Texas Immunology, Inc. · Feb 1988
VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010
K851504 · Ncs Diagnostics, Inc. · Aug 1985
BECKMAN R.PR CONTROL SERUM SET
K812425 · Beckman Instruments, Inc. · Sep 1981
CONTROL SERUMS FOR NONTREPONEMAL TEST
K810119 · Hillside Acres, Inc. · Feb 1981
K843741 · RPR TEST REDITEST
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