Cleared Traditional

K040579 - CHOLETECH LDX HIGH-SENSITIVITY C-REACTI...

K040579 is an FDA 510(k) clearance for CHOLETECH LDX HIGH-SENSITIVITY C-REACTI..., manufactured by Cholestech Corp.. The device is a Class 2 Chemistry device with product code DCK cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K040579 · Cholestech Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
106d
Days
Class 2
Risk

K040579 is an FDA 510(k) clearance for the CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP). Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Cholestech Corp. (Hayward, US). The FDA issued a Cleared decision on June 18, 2004 after a review of 106 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Cholestech Corp. devices

FDA 510(k) Submission Details - K040579

510(k) Number K040579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2004
Decision Date June 18, 2004
Days to Decision 106 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
18d slower than avg
Panel avg: 88d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCK Device Classification - Class 2, Special Controls

Product Code DCK C-reactive Protein, Antigen, Antiserum, And Control
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 - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 94
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K040579.
NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT
K052591 · Clinical Data, Inc. · Feb 2006
WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
K041155 · Stanbio Laboratory · Oct 2004
N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET
K040241 · Genzyme Corp. · Jun 2004
QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2
K032663 · Instrumentation Laboratory CO · Dec 2003
WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET
K024280 · Wako Chemicals USA, Inc. · Jun 2003
VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
K030626 · Ortho-Clinical Diagnostics, Inc. · Mar 2003