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K Number
K993606
Device Name
K-ASSAY APO A1/B CALIBRATOR SET
Manufacturer
KAMIYA BIOMEDICAL CO.
Date Cleared
1999-11-26

(32 days)

Product Code
JIX
Regulation Number
862.1150
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 Apo A1/B Calibrator Set is intended to be used for the calibration of the K-ASSAY APO A1/B immunoturbidimetric assay for quantitating APO A1/B in serum samples.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "K-ASSAY Apo A1/B Calibrator Set." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It provides "INDICATIONS FOR USE STATEMENT" (page 2) which clarifies the intended purpose of the device: "The K-ASSAY Apo A1/B Calibrator Set is intended to be used for the calibration of the K-ASSAY APO A1/B immunoturbidimetric assay for quantitating APO A1/B in serum samples."

The document does not include any of the following 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.
  6. Information on a standalone algorithm performance study.
  7. The type of ground truth used.
  8. The sample size for the training set.
  9. How the ground truth for the training set was established.

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.