Cleared Traditional

K910686 - RHEUMAJET CRP

K910686 is the FDA 510(k) clearance for RHEUMAJET CRP by Biokit USA, Inc.. It is a Class 2 Immunology device (product code DCN) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K910686 · Biokit USA, Inc. · Immunology device
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Mar 1991
Decision
28d
Days
Class 2
Risk

K910686 is an FDA 510(k) clearance for the RHEUMAJET CRP. 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 March 19, 1991 after a review of 28 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 K910686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1991
Decision Date March 19, 1991
Days to Decision 28 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 104d · This submission: 28d
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 K910686.
OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT
K954537 · Olympus America, Inc. · Feb 1996
SPQ CRP CONTROL LEVEL II
K935075 · Incstar Corp. · Jan 1994
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