Cleared Traditional

CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 (K020603) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K020603 · Good Biotech Corp. · Chemistry device
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Jun 2002
Decision
108d
Days
Class 2
Risk

K020603 is an FDA 510(k) clearance for the CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Good Biotech Corp. (Taichung, TW). The FDA issued a Cleared decision on June 13, 2002 after a review of 108 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 Good Biotech Corp. devices

Submission Details

510(k) Number K020603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2002
Decision Date June 13, 2002
Days to Decision 108 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 88d · This submission: 108d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DCN System, Test, C-reactive Protein

All 69
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