Cleared Traditional

K896272 - QUANTEX CRP PLUS (LATEX

K896272 is the FDA 510(k) clearance for QUANTEX CRP PLUS (LATEX by Biokit USA, Inc.. It is a Class 2 Immunology device (product code DCN) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K896272 · Biokit USA, Inc. · Immunology device
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Nov 1989
Decision
9d
Days
Class 2
Risk

K896272 is an FDA 510(k) clearance for the QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Biokit USA, Inc. (Barcelona, ES). The FDA issued a Cleared decision on November 8, 1989 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - the FDA immunology 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 Biokit USA, Inc. devices

Submission Details

510(k) Number K896272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1989
Decision Date November 08, 1989
Days to Decision 9 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 104d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCN System, Test, C-reactive Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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 Immunology devices follow this clearance model.

Regulatory Peers - DCN System, Test, C-reactive Protein

All 38
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K896272.
SYNCHRON C-REACTIVE PROTEIN REAGENT
K910535 · Beckman Instruments, Inc. · Apr 1991
RAPITEX (R) CRP NEW
K903853 · Behring Diagnostics, Inc. · Aug 1990
RAICHEM(TM) SPIA(TM) CRP REAGENT
K902593 · Reagents Applications, Inc. · Jun 1990
QM300 PCR ANTIBODY PACK
K885001 · Kallestad Diag, A Div. of Erbamont, Inc. · Dec 1988
DU PONT DIMENSION C-REACTIVE PROTEIN METHOD
K883515 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1988
WAKO(TM) CRP
K882374 · Wako Chemicals USA, Inc. · Jul 1988