LogoFDA 510(k) Search
K Number
K971902
Device Name
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
Manufacturer
ROCHE DIAGNOSTIC SYSTEMS, INC.
Date Cleared
1997-06-16

(24 days)

Product Code
LBS
Regulation Number
862.1475
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
Predicate For
K973369
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. The Roche UNIMATE HDL Direct reagent is an in vitro diagnostic test for the quantitative determination of High Density Lipoprotein Cholesterol (HDL CHOL) in serum.
  2. The Roche Calibrator HDL Direct is intended for use as calibrator in quantitative High Density Lipoprotein Cholesterol (HDL CHOL) assays.
Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for an in vitro diagnostic device (Roche UNIMATE HDL Direct Reagent and Roche Calibrator HDL Direct). It does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a summary of safety and effectiveness.

Therefore, I cannot extract the requested information regarding:

  • Acceptance criteria and reported device performance table: This information is not present in the document.
  • Sample size and data provenance for the test set: Not available.
  • Number and qualifications of experts for ground truth: Not available.
  • Adjudication method for the test set: Not available.
  • MRMC comparative effectiveness study and effect size: Not available.
  • Standalone algorithm performance: Not applicable as this is a reagent/calibrator, not an algorithm.
  • Type of ground truth used: Not available.
  • Sample size for the training set: Not applicable/available.
  • How ground truth for the training set was established: Not applicable/available.

This document serves as notification that the device has been found substantially equivalent to a predicate device and can be marketed, but it does not provide the underlying study details.

§ 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.