Cleared Special

K073277 - ROCHE-CREACTIVE PROTEIN (LATEX)

K073277 is an FDA 510(k) clearance for ROCHE-CREACTIVE PROTEIN (LATEX), manufactured by Roche Diagnostics Corp.. The device is a Class 2 Immunology device with product code DCN cleared through the Special 510(k) pathway after a 106-day FDA review.

K073277 · Roche Diagnostics Corp. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
106d
Days
Class 2
Risk

K073277 is an FDA 510(k) clearance for the ROCHE-CREACTIVE PROTEIN (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 March 6, 2008 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - the FDA immunology device 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. Standard predicate reliance. 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 - K073277

510(k) Number K073277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2007
Decision Date March 06, 2008
Days to Decision 106 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 105d · This submission: 106d
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 Immunology 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 K073277.
PATHFAST HSCRP
K083412 · Mitsubishi Kagaku Iatron · Mar 2009
S-TEST C-REACTIVE PROTEIN (CRP)
K083040 · Alfa Wassermann Diagnostic Technologies, Inc. · Jan 2009
ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS
K072658 · Siemens Medical Solutions Diagnostics · Apr 2008
I-CHROMA CRP TEST
K062981 · Boditech Diagnostics, Inc. · Jul 2007
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
K073277 · ROCHE-CREACTIVE PROTEIN (LATEX)
Download PDF FDA Summary Roche Diagnostics Cor…