Skip to content

ANA Antisera Control Kit

by Lipogen, Inc.

510(k) K894659

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK894659 Date21 Sep 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

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  • Withdrawn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
DHN
Device Class
Class II
Regulation
21 CFR Part 866.5100
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The ANA Antisera Control Kit is an Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control as classified under FDA regulation 866.5100. This kit serves as a reference standard for validating and calibrating immunofluorescent assays used to detect antinuclear antibodies (ANA) in clinical immunology testing. It provides predefined control sera to ensure assay accuracy and reproducibility in diagnostic workflows.

Supplied as a single-use reagent, the kit is intended for use in laboratory settings where ANA testing is performed. It is regulated under FDA 510(k) clearance (K894659) and falls under Device Class II. The kit is not sterile and requires proper storage as specified in accompanying documentation. No additional regulatory status beyond the stated 510(k) clearance is implied.

Other devices from Lipogen, Inc.

See all devices from Lipogen, Inc. →

Questions

AI-generated answers, 19 Sep 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 ANA Antisera Control Kit used for in a clinical immunology lab?

    The ANA Antisera Control Kit is designed as a reference standard to validate and calibrate indirect immunofluorescent assays for detecting antinuclear antibodies (ANA). It provides predefined control sera, ensuring the accuracy and reproducibility of ANA testing results in laboratory workflows.

  • Is the ANA Antisera Control Kit intended for single-use or repeated use?

    The kit is explicitly supplied as a single-use reagent, meaning each kit should be used once and then discarded. This is standard practice for control materials to maintain consistency and prevent cross-contamination.

  • How should the ANA Antisera Control Kit be stored according to the manufacturer’s specifications?

    While the exact storage instructions are detailed in the accompanying documentation, the kit is not sterile and requires adherence to proper storage conditions as outlined by Lipogen, Inc. to preserve its integrity and performance.

  • What regulatory pathway was followed for the FDA clearance of this device?

    The ANA Antisera Control Kit received FDA clearance through a traditional 510(k) pathway, classified as substantially equivalent (SESE) under the Immunology advisory committee (IM). The clearance number is K894659, and it falls under Device Class II.

  • Does the kit come with any specific instructions regarding sterility or handling precautions?

    The kit is explicitly stated as *not sterile*, so standard laboratory aseptic techniques should be followed during handling. Since it is a reagent for immunofluorescent assays, proper contamination control is critical to ensure reliable test results.