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K Number
K990581
Device Name
DIRECT HDL-CHOLESTEROL REAGENT
Manufacturer
KAMIYA BIOMEDICAL CO.
Date Cleared
1999-06-18

(115 days)

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

The K-ASSAY Direct HDL-Cholesterol reagent is intended for the quantitative in vitro determination of HDL-cholesterol in serum or plasma which is used in the diagnosis and treatment of lipid disorders.

The K-ASSAY Direct HDL-Cholesterol calibrator is intended to be used for the calibration of the K-ASSAY Direct HDL-Cholesterol assay.

Device Description

K-Assay Direct HDL-Cholesterol Reagent K-Assay Direct HDL-Cholesterol Calibrator

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "K-Assay Direct HDL-Cholesterol Reagent and Calibrator". This type of document does not contain the detailed information about acceptance criteria or specific study results that you are requesting.

Here's why and what information is typically missing:

Why this document doesn't have the requested information:

  • 510(k) Clearance: A 510(k) clearance primarily focuses on demonstrating "substantial equivalence" to a predicate device already on the market. It's not a pre-market approval (PMA) and doesn't require the same depth of clinical study data to be submitted or publicly summarized in the clearance letter itself.
  • Regulatory Focus: The letter confirms that the device can be marketed because it meets the regulatory requirements for substantial equivalence. It refers to the "indications for use" but doesn't detail the specific performance studies that underpinned those claims.
  • Proprietary Information: Detailed study results, acceptance criteria, and ground truth methodologies are often considered proprietary by the manufacturer and are submitted to the FDA confidentially. They are rarely fully disclosed in the public 510(k) clearance letter.

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

  1. A table of acceptance criteria and the reported device performance: This document only states the device's intended use for quantitative determination of HDL-cholesterol. It does not provide performance metrics like accuracy, precision, sensitivity, specificity, or the acceptance criteria for these.
  2. Sample size used for the test set and the data provenance: Not mentioned.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
  4. Adjudication method for the test set: Not mentioned.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable for an in vitro diagnostic reagent like this. MRMC studies are typically for imaging devices where human interpretation is involved.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for an in vitro diagnostic reagent. Its performance is inherent to the chemical assay itself.
  7. The type of ground truth used: Not mentioned. For a diagnostic assay, the "ground truth" would likely be established by a reference method for HDL-cholesterol.
  8. The sample size for the training set: Not mentioned. In the context of an in vitro diagnostic reagent, there isn't typically a "training set" in the same way an AI algorithm has one. Performance is established through validation studies.
  9. How the ground truth for the training set was established: Not mentioned.

In summary, the provided FDA 510(k) clearance letter confirms the regulatory status of the device but does not contain the detailed technical and scientific performance data or study design information you are looking for. To find such information, one would typically need to consult the device's Instructions For Use (IFU), peer-reviewed publications by the manufacturer, or the more detailed (and often redacted) 510(k) summary filed with the FDA, if available, though even that rarely contains all the detail requested.

§ 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.