Cleared Traditional

K811374 - BI-CRP LATEX TEST

K811374 is the FDA 510(k) clearance for BI-CRP LATEX TEST by Biologics Intl., Inc.. It is a Class 2 Microbiology device (product code DCN) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K811374 · Biologics Intl., Inc. · Microbiology device
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Jun 1981
Decision
28d
Days
Class 2
Risk

K811374 is an FDA 510(k) clearance for the BI-CRP LATEX TEST. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Biologics Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5270 - the FDA microbiology 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 Biologics Intl., Inc. devices

Submission Details

510(k) Number K811374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1981
Decision Date June 12, 1981
Days to Decision 28 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 102d · 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 Microbiology 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 K811374.
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
CRP SLIDE
K810862 · Syn-Kit, Inc. · Apr 1981
ANTISERUM TO HUMAN C-REACTIVE PROTEINS
K790716 · Kent Laboratories, Inc. · Aug 1979
LAS-R HUMAN CRP TEST
K771535 · Hyland Therapeutic Div., Travenol Laboratories · Sep 1977