Cleared Abbreviated

K063057 - IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP

K063057 is an FDA 510(k) clearance for IMMULITE/IMMULITE 1000, manufactured by Diagnostic Products Corporation. The device is a Class 2 Chemistry device with product code NQD cleared through the Abbreviated 510(k) pathway after a 78-day FDA review.

K063057 · Diagnostic Products Corporation · Chemistry device
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Dec 2006
Decision
78d
Days
Class 2
Risk

K063057 is an FDA 510(k) clearance for the IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP. Classified as Cardiac C-reactive Protein, Antigen, Antiserum, And Control (product code NQD), Class II - Special Controls.

Submitted by Diagnostic Products Corporation (Los Angeles, US). The FDA issued a Cleared decision on December 22, 2006 after a review of 78 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Diagnostic Products Corporation devices

FDA 510(k) Submission Details - K063057

510(k) Number K063057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2006
Decision Date December 22, 2006
Days to Decision 78 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 88d · This submission: 78d
Pathway characteristics
Standards-based clearance path.

NQD Device Classification - Class 2, Special Controls

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 17
Devices cleared under the same product code (NQD) and FDA review panel - the closest regulatory comparables to K063057.
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT
K071002 · Beckman Coulter, Inc. · Jun 2007
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
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK
K060369 · Dade Behring, Inc. · May 2006
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS
K053603 · Roche Diagnostics Corp. · Feb 2006