Cleared Traditional

K071002 - IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SEN...

K071002 is the FDA 510(k) clearance for IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SEN... by Beckman Coulter, Inc.. It is a Class 2 Chemistry device (product code NQD) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K071002 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
73d
Days
Class 2
Risk

K071002 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (C.... Classified as Cardiac C-reactive Protein, Antigen, Antiserum, And Control (product code NQD), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on June 21, 2007 after a review of 73 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K071002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2007
Decision Date June 21, 2007
Days to Decision 73 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
15d faster than avg
Panel avg: 88d · This submission: 73d
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 K071002.
CardioPhase® hsCRP
K212559 · Siemens Healthcare Diagnostics Products GmbH · Dec 2022
CRP Vario
K173833 · SENTINEL CH. SpA · Sep 2018
ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS
K081294 · Siemens Healthcare Diagnostics, Inc. · Jul 2008
SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT
K070626 · Beckman Coulter, Inc. · May 2007
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