Cleared Traditional

K021757 - CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET

K021757 is an FDA 510(k) clearance for CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, manufactured by Good Biotech Corp.. The device is a Class 2 Immunology device with product code DCN cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K021757 · Good Biotech Corp. · Immunology device
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Optimized for regulatory review, auditing and printing
Jul 2002
Decision
61d
Days
Class 2
Risk

K021757 is an FDA 510(k) clearance for the CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET. 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 July 29, 2002 after a review of 61 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 Good Biotech Corp. devices

FDA 510(k) Submission Details - K021757

510(k) Number K021757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2002
Decision Date July 29, 2002
Days to Decision 61 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
44d faster than avg
Panel avg: 105d · This submission: 61d
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 K021757.
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
BAYER ADVIA IMS SYSTEM
K012337 · Bayer Corp. · Dec 2001
CRP HS TEST SYSTEM
K003400 · Roche Diagnostics Corp. · May 2001