Cleared Traditional

K053603 - C-REACTIVE PROTEIN (LATEX) HIGH SENSITI...

K053603 is the FDA 510(k) clearance for C-REACTIVE PROTEIN (LATEX) HIGH SENSITI... by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code NQD) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K053603 · Roche Diagnostics Corp. · Chemistry device
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Feb 2006
Decision
48d
Days
Class 2
Risk

K053603 is an FDA 510(k) clearance for the C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTR.... Classified as Cardiac C-reactive Protein, Antigen, Antiserum, And Control (product code NQD), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 9, 2006 after a review of 48 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. 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K053603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2005
Decision Date February 09, 2006
Days to Decision 48 days
Submission Type Traditional
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
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NQD Cardiac C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
Definition In Vitro Diagnostic Test To Measure C-reactive Protein For The Purpose Of Making Cardiac Risk Assessments.
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 - NQD Cardiac C-reactive Protein, Antigen, Antiserum, And Control

All 16
Devices cleared under the same product code (NQD) and FDA review panel - the closest regulatory comparables to K053603.
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK
K062924 · Dade Behring, Inc. · Dec 2006
DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH
K061802 · Dade Behring, Inc. · Sep 2006
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK
K060369 · Dade Behring, Inc. · May 2006
DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE
K053109 · Dade Behring, Inc. · Dec 2005
OLYMPUS CRP LATEX REAGENT, OSR6199
K051564 · Olympus America, Inc. · Aug 2005
TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)
K042485 · Roche Diagnostics Corp. · Oct 2004