Cleared Traditional

K021194 - RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM

K021194 is an FDA 510(k) clearance for RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM, manufactured by Hemagen Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code DCK cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K021194 · Hemagen Diagnostics, Inc. · Chemistry device
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Jul 2002
Decision
105d
Days
Class 2
Risk

K021194 is an FDA 510(k) clearance for the RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on July 29, 2002 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5270 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Hemagen Diagnostics, Inc. devices

FDA 510(k) Submission Details - K021194

510(k) Number K021194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2002
Decision Date July 29, 2002
Days to Decision 105 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 88d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCK Device Classification - Class 2, Special Controls

Product Code DCK C-reactive Protein, Antigen, Antiserum, And Control
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 Chemistry devices follow this clearance model.

Regulatory Peers - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 105
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K021194.
K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR
K023828 · Kamiya Biomedical Co. · Feb 2003
HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
K023269 · Instrumentation Laboratory CO · Dec 2002
K-ASSAY HS-CRP CONTROLS
K022486 · Kamiya Biomedical Co. · Aug 2002
RDI HS CRP KIT
K021609 · Reference Diagnostics, Inc. · Jun 2002
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT
K010597 · Beckman Coulter, Inc. · May 2001
K-ASSAY HS-CRP CONTROLS
K011079 · Kamiya Biomedical Co. · May 2001