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K Number
K993345
Device Name
K-ASSAY APO AI
Manufacturer
KAMIYA BIOMEDICAL CO.
Date Cleared
1999-10-25

(20 days)

Product Code
DER
Regulation Number
866.5580
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The K-ASSAY Apo Al Assay is intended to be used for the quantitative determination of Apo Al in human serum by immunoturbidimetric assay. Apolipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. FOR IN VITRO DIAGNOSTIC USE.

Device Description

Not Found

AI/ML Overview

This FDA 510(k) clearance letter (K993345) for the K-ASSAY Apo AI Assay primarily focuses on establishing substantial equivalence to a predicate device. It does not contain the detailed information required to describe the acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical study report or a detailed 510(k) summary.

Specifically, the document does NOT provide:

  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, their qualifications, or adjudication methods for establishing ground truth.
  4. Information about multi-reader multi-case (MRMC) studies or standalone algorithm performance.
  5. Type of ground truth used.
  6. Sample size for the training set or how its ground truth was established.

The letter states the device is "intended to be used for the quantitative determination of Apo Al in human serum by immunoturbidimetric assay" and that "Apolipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases." This describes the intended use and clinical utility, but not performance metrics or study details.

To obtain the requested information, one would typically need to consult the complete 510(k) submission summary, which sometimes contains a more detailed description of the analytical and clinical studies performed to support the substantial equivalence claim. This particular clearance letter is a high-level official communication, not a scientific publication detailing study methodology and results.

§ 866.5580

Alpha -1-lipoprotein immunological test system.(a)
Identification. Analpha -1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha- 1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement ofalpha- 1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).(b)
Classification. Class II (performance standards).