Cleared Traditional

K903853 - RAPITEX (R) CRP NEW

K903853 is an FDA 510(k) clearance for RAPITEX CRP NEW, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DCN cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K903853 · Behring Diagnostics, Inc. · Immunology device
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Aug 1990
Decision
9d
Days
Class 2
Risk

K903853 is an FDA 510(k) clearance for the RAPITEX (R) CRP NEW. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on August 30, 1990 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 Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K903853

510(k) Number K903853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1990
Decision Date August 30, 1990
Days to Decision 9 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 105d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCN Device Classification - Class 2, Special Controls

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 48
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K903853.
SPQ CRP CONTROL LEVEL II
K935075 · Incstar Corp. · Jan 1994
EYE SPOT CRP TEST
K932180 · J.S. Medical Assoc. · Aug 1993
SYNCHRON C-REACTIVE PROTEIN REAGENT
K910535 · Beckman Instruments, Inc. · Apr 1991
RAICHEM(TM) SPIA(TM) CRP REAGENT
K902593 · Reagents Applications, Inc. · Jun 1990
V-TREND TARGET CRP TEST
K892231 · Texas Immunology, Inc. · Apr 1989
QM300 PCR ANTIBODY PACK
K885001 · Kallestad Diag, A Div. of Erbamont, Inc. · Dec 1988