Cleared Traditional

K062981 - I-CHROMA CRP TEST

K062981 is an FDA 510(k) clearance for I-CHROMA CRP TEST, manufactured by Boditech Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code DCN cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K062981 · Boditech Diagnostics, Inc. · Chemistry device
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Jul 2007
Decision
287d
Days
Class 2
Risk

K062981 is an FDA 510(k) clearance for the I-CHROMA CRP TEST. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Boditech Diagnostics, Inc. (East Stroudsburg, US). The FDA issued a Cleared decision on July 13, 2007 after a review of 287 days - an extended review cycle.

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 Boditech Diagnostics, Inc. devices

FDA 510(k) Submission Details - K062981

510(k) Number K062981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date July 13, 2007
Days to Decision 287 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
199d slower than avg
Panel avg: 88d · This submission: 287d
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 Chemistry 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 K062981.
C-REACTIVE PROTEIN (LATEX)
K083444 · Roche Diagnostics Corp. · Mar 2009
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