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AIA-PACK Folate Assay

by Tosoh Medics, Inc. 2 variants

510(k) K964349

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK964349 Date27 Nov 1996ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0672-2019 FDA Class II initiated 30 Nov 2018

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CGN
Device Class
Class II
Regulation
21 CFR Part 862.1295
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The AIA-PACK Folate Assay is an in vitro diagnostic device classified as a radioimmunoassay for folic acid, designed for the quantitative measurement of folate levels in human serum. It operates on the principle of competitive immunoassay, enabling precise detection of folate concentrations to support clinical assessments of nutritional status, hematological disorders, or pregnancy-related conditions. This assay is intended for use exclusively on Tosoh AIA System analyzers, ensuring compatibility and standardized results.

This assay is supplied as a single-use reagent kit, requiring no additional sterilization. It is intended for use in clinical chemistry laboratories and has been cleared by the FDA under 510(k) as substantially equivalent to predicate devices. The device is regulated under 21 CFR 862.1295 and is categorized under the CGN product code. Storage conditions and shelf life are specified in the accompanying documentation, though exact details are not provided in the regulatory data.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the AIA-PACK Folate Assay used for?

    The AIA-PACK Folate Assay is an in vitro diagnostic device that uses competitive radioimmunoassay technology to quantitatively measure folate levels in human serum. This measurement helps clinicians assess nutritional status, diagnose hematological disorders, and evaluate conditions related to pregnancy, such as neural tube defects in fetuses.

  • How is the AIA-PACK Folate Assay supplied and prepared for use?

    The AIA-PACK Folate Assay is supplied as a single-use reagent kit. It is pre-packaged and does not require additional sterilization before use. The kit is designed to be compatible only with Tosoh AIA System analyzers, ensuring accurate and standardized results.

  • Is the AIA-PACK Folate Assay sterile and intended for single-use?

    Yes, the AIA-PACK Folate Assay is supplied as a single-use reagent kit and does not require further sterilization. The design ensures that each kit is intended for one-time use, reducing the risk of contamination and ensuring reliable performance.

  • What storage conditions and shelf life should be followed for the AIA-PACK Folate Assay?

    While the exact storage conditions and shelf life are detailed in the accompanying documentation provided by Tosoh Medics, the kit is typically stored under controlled conditions to maintain its integrity. Always refer to the manufacturer’s instructions for precise storage guidelines to ensure optimal performance and validity of results.

  • Which analyzers are compatible with the AIA-PACK Folate Assay?

    The AIA-PACK Folate Assay is exclusively designed for use on Tosoh AIA System analyzers. This compatibility ensures that the assay operates correctly and delivers consistent, reliable results within the intended clinical chemistry workflow.