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K Number
K972853
Device Name
CHOLESTEROL RAPID LIQUID REAGENT
Manufacturer
REAGENTS APPLICATIONS, INC.
Date Cleared
1997-09-24

(89 days)

Product Code
CHH
Regulation Number
862.1175
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This reagent is intended for the rapid quantitative in-vitro measurement of total serum or plasma cholesterol concentration, utilizing manual or automated analyzers. The determination of serum plasma is one of the important tools in the diagnosis and classification of lipemia. Other conditions, such as hepatic and thyroid diseases, influence cholesterol levels.

Device Description

Cholestero! Rapid |Liquid Reagent

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "RAICHEM Cholesterol Rapid Liquid Reagent." It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the format requested.

The letter primarily:

  • Confirms that the device is substantially equivalent to legally marketed predicate devices.
  • States that the device can be marketed subject to general controls of the Federal Food, Drug, and Cosmetic Act.
  • Provides information about applicable regulations and contact details for further inquiries.

The "Indications for Use" section (page 2 of the document) describes what the reagent is intended for: "rapid quantitative in-vitro measurement of total serum or plasma cholesterol concentration, utilizing manual or automated analyzers." It also mentions that cholesterol determination is important for diagnosing and classifying lipemia and that other conditions influence cholesterol levels.

However, the document does not include any of the following requested information:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number of experts used to establish ground truth or their qualifications.
  4. Adjudication method for the test set.
  5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
  6. Information on a standalone algorithm performance study.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How the ground truth for the training set was established.

Therefore,Based on the provided text, I cannot provide the requested information regarding the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter and details the regulatory approval but does not include the specifics of performance studies or acceptance criteria.

§ 862.1175 Cholesterol (total) test system.

(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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.