Cholestech LDX High-Sensitivity C-Reactive Protein (HS-CRP)

• • Terminated Z-1178-2013 FDA Class II ·initiated 6 Mar 2013

  The Alere Cholestech LDX hsCRP cassette (PN 12-807) may have increased imprecision relative to the performance data in the package insert, which may cause differences in quantitative results for hsCRP compared to a reference method or repeat testing on the same patient sample.

• • Terminated Z-2457-2008 FDA Unclassified (pre-2012) ·initiated 9 Aug 2006

  Test results are high, outside of control material upper limit specification. Results could be as high as 15%.

Full name

Choletech Ldx High-Sensitivity C-Reactive Protein (Hs-Crp)

510(k) Number

K040579 ↗

FDA Product Code

DCK

Device Class

Class II

Regulation

21 CFR Part 866.5270

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Cholestech Corp. →

• What clinical conditions is the Cholestech LDX HS-CRP test used to evaluate, and how does it help in diagnosis?

  The Cholestech LDX High-Sensitivity C-Reactive Protein (HS-CRP) test quantifies levels of HS-CRP in whole blood or serum to serve as a marker for inflammation, infection, tissue injury, and related conditions. Elevated HS-CRP levels can help clinicians assess risk for cardiovascular events, monitor chronic inflammatory diseases, and evaluate responses to treatment. It is particularly useful for identifying low-grade systemic inflammation where traditional CRP tests may not be sensitive enough.

• Is the Cholestech LDX HS-CRP test designed for use in any specific setting, and what type of sample does it require?

  The test is intended for single-use in clinical laboratory settings and is also classified as a point-of-care diagnostic tool, meaning it can be used outside traditional lab environments for rapid results. It is designed to work with whole blood or serum samples, providing flexibility for different clinical workflows. No additional sterilization is required, as it is supplied as a ready-to-use system.

• How is the Cholestech LDX HS-CRP test regulated, and what does this mean for its use in clinical practice?

  The Cholestech LDX HS-CRP has received FDA 510(k) clearance under regulation 866.5270, indicating it is deemed substantially equivalent to a legally marketed device. It is also regulated under the In Vitro Diagnostic Device Directive (IVDD), ensuring compliance with both U.S. and European standards. This regulatory pathway confirms its safety, performance, and intended use as a quantitative diagnostic tool for HS-CRP measurement in clinical settings.

• What does the term 'single-use' mean for the Cholestech LDX HS-CRP test, and how does this impact its handling?

  The 'single-use' designation means the test is designed for one-time use per device, ensuring patient safety and accuracy by preventing cross-contamination or degradation of reagents. Clinicians should treat each test as sterile and disposable, adhering to standard single-use protocols for in vitro diagnostics. This also simplifies storage and inventory management, as unused tests can be stored until needed without concerns about expiration or reuse.