Cleared Traditional

SYNCHRON C-REACTIVE PROTEIN REAGENT (K910535) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K910535 · Beckman Instruments, Inc. · Immunology device
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Apr 1991
Decision
63d
Days
Class 2
Risk

K910535 is an FDA 510(k) clearance for the SYNCHRON C-REACTIVE PROTEIN REAGENT. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on April 12, 1991 after a review of 63 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K910535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1991
Decision Date April 12, 1991
Days to Decision 63 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
41d faster than avg
Panel avg: 104d · This submission: 63d
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 23
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K910535.
CRP
K991372 · Abbott Laboratories · Jun 1999
REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE
K990825 · Dade Behring, Inc. · Apr 1999
OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT
K954537 · Olympus America, Inc. · Feb 1996
RAPITEX (R) CRP NEW
K903853 · Behring Diagnostics, Inc. · Aug 1990
DU PONT DIMENSION C-REACTIVE PROTEIN METHOD
K883515 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1988
LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS)
K855057 · Behring Diagnostics, Inc. · Feb 1986