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K Number
K992365
Device Name
AIA-PACK FOLATE ASSAY
Manufacturer
TOSOH MEDICS, INC.
Date Cleared
1999-08-10

(26 days)

Product Code
CGN
Regulation Number
862.1295
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

AIA-PACK FOLATE is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on TOSOH AIA System analyzers.

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the "AIA-PACK FOLATE Assay". This type of document declares a device substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not inherently contain the detailed study information, acceptance criteria, or performance data that would typically be found in the manufacturer's 510(k) submission itself.

Therefore,Based on the text provided, I cannot provide descriptions for the following points as they are not contained within the FDA clearance letter:

  • A table of acceptance criteria and the reported device performance
  • Sample sizes used for the test set and data provenance
  • Number of experts and their qualifications for ground truth
  • Adjudication method for the test set
  • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
  • Whether a standalone (algorithm only) performance study was done
  • The type of ground truth used
  • Sample size for the training set
  • How ground truth for the training set was established

However, I can provide the following information from the document:

The device is the AIA-PACK FOLATE Assay, intended for "IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on TOSOH AIA System analyzers."

The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the manufacturer's submission (K992365), which would have included data demonstrating this equivalence, but this specific data is not present in the provided FDA clearance letter.

§ 862.1295 Folic acid test system.

(a)
Identification. A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.(b)
Classification. Class II.