Cleared Traditional

K855057 - LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS)

K855057 is the FDA 510(k) clearance for LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS) by Behring Diagnostics, Inc.. It is a Class 2 Immunology device (product code DCN) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K855057 · Behring Diagnostics, Inc. · Immunology device
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Feb 1986
Decision
70d
Days
Class 2
Risk

K855057 is an FDA 510(k) clearance for the LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS). Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on February 26, 1986 after a review of 70 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

Submission Details

510(k) Number K855057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1985
Decision Date February 26, 1986
Days to Decision 70 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
34d faster than avg
Panel avg: 104d · This submission: 70d
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 37
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K855057.
WAKO(TM) CRP
K882374 · Wako Chemicals USA, Inc. · Jul 1988
KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK
K880728 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1988
CPR SLIDE EIKEN
K854819 · Syn-Kit, Inc. · Feb 1986
CRP SLIDE TEST KIT
K840699 · Difco Laboratories, Inc. · Mar 1984
EMIT C-REACTIVE PROTEIN ASSAY
K821413 · Syva Co. · May 1982
IMMUNEX CRP
K812881 · Armkel, LLC · Oct 1981