Cleared Traditional

K040030 - BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114

K040030 is an FDA 510(k) clearance for BIOCHECK CARDIAC-1 CRP RAPID TEST, manufactured by Biocheck, Inc.. The device is a Class 2 Immunology device with product code DCN cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K040030 · Biocheck, Inc. · Immunology device
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Jun 2004
Decision
161d
Days
Class 2
Risk

K040030 is an FDA 510(k) clearance for the BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Biocheck, Inc. (Northridge, US). The FDA issued a Cleared decision on June 16, 2004 after a review of 161 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biocheck, Inc. devices

FDA 510(k) Submission Details - K040030

510(k) Number K040030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2004
Decision Date June 16, 2004
Days to Decision 161 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 105d · This submission: 161d
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 47
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K040030.
S-TEST C-REACTIVE PROTEIN (CRP)
K083040 · Alfa Wassermann Diagnostic Technologies, Inc. · Jan 2009
ROCHE-CREACTIVE PROTEIN (LATEX)
K073277 · Roche Diagnostics Corp. · Mar 2008
DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH
K061825 · Dade Behring, Inc. · Sep 2006
TINA-QUANT CRP (LATEX)
K032336 · Roche Diagnostics Corp. · Aug 2003
C-REACTIVE PROTEIN (CRP)
K030899 · Abbott Laboratories · Jul 2003
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT
K021572 · Beckman Coulter, Inc. · Jul 2002