Cleared Traditional

K831465 - CRP-CHECK

K831465 is an FDA 510(k) clearance for CRP-CHECK, manufactured by Diagnostic Technology, Inc.. The device is a Class 2 Immunology device with product code DCN cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K831465 · Diagnostic Technology, Inc. · Immunology device
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Jun 1983
Decision
33d
Days
Class 2
Risk

K831465 is an FDA 510(k) clearance for the CRP-CHECK. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Diagnostic Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 33 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 Diagnostic Technology, Inc. devices

FDA 510(k) Submission Details - K831465

510(k) Number K831465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1983
Decision Date June 08, 1983
Days to Decision 33 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
71d faster than avg
Panel avg: 104d · This submission: 33d
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 40
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K831465.
CPR SLIDE EIKEN
K854819 · Syn-Kit, Inc. · Feb 1986
LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS)
K855057 · Behring Diagnostics, Inc. · Feb 1986
CRP SLIDE TEST KIT
K840699 · Difco Laboratories, Inc. · Mar 1984
SERO/TEX CRP TEST
K821388 · Texas Immunology, Inc. · Jul 1982
EMIT C-REACTIVE PROTEIN ASSAY
K821413 · Syva Co. · May 1982
IMMUNEX CRP
K812881 · Armkel, LLC · Oct 1981