Cleared Special

K032336 - TINA-QUANT CRP (LATEX)

K032336 is an FDA 510(k) clearance for TINA-QUANT CRP (LATEX), manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with product code DCN cleared through the Special 510(k) pathway after a 7-day FDA review.

K032336 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
7d
Days
Class 2
Risk

K032336 is an FDA 510(k) clearance for the TINA-QUANT CRP (LATEX). Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 5, 2003 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5270 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K032336

510(k) Number K032336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2003
Decision Date August 05, 2003
Days to Decision 7 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 88d · This submission: 7d
Pathway characteristics
Modification to existing cleared device.

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 62
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K032336.
DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH
K061825 · Dade Behring, Inc. · Sep 2006
DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511
K050713 · Good Biotech Corp. · Jun 2005
BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114
K040030 · Biocheck, Inc. · Jun 2004
C-REACTIVE PROTEIN (CRP)
K030899 · Abbott Laboratories · Jul 2003
PAROS CRP
K022690 · Horiba, Ltd. · Dec 2002
CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET
K021757 · Good Biotech Corp. · Jul 2002
K032336 · TINA-QUANT CRP (LATEX)
Download PDF FDA Summary Roche Diagnostics Cor…