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K Number
K053157
Device Name
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
Manufacturer
DADE BEHRING, INC.
Date Cleared
2005-12-09

(25 days)

Product Code
LBS
Regulation Number
862.1475
Type
Special
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The AHDL method for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure high density lipoprotein cholesterol (HDL-C) in human serum and plasma. HDL-C measurements are used as an aid in the diagnostics of lipid disorders.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the Dimension® Automated HDL Cholesterol (AHDL) device, indicating substantial equivalence to predicate devices. It does not contain a detailed study report with specific acceptance criteria or reported device performance metrics in the format requested.

The letter confirms the device is an in vitro diagnostic intended to quantitatively measure high-density lipoprotein cholesterol (HDL-C) in human serum and plasma, used as an aid in the diagnostics of lipid disorders.

Therefore, I cannot extract the following information from the provided text:

  • A table of acceptance criteria and the reported device performance
  • Sample size used for the test set and the data provenance
  • Number of experts used to establish the ground truth for the test set and the qualifications of those experts
  • Adjudication method for the test set
  • If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
  • If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
  • The type of ground truth used
  • The sample size for the training set
  • How the ground truth for the training set was established

This letter represents the FDA's decision regarding the device's clearance, not the detailed study results that led to that decision. Such information would typically be found in the manufacturer's 510(k) submission itself.

§ 862.1475 Lipoprotein test system.

(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.