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Anaton

by Armkel, LLC 510(k)

Active United States

510(k) K801046

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801046 Date14 May 1980ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

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 Anaton is an Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Device Class II), designed for use in immunofluorescence assays to detect and confirm the presence of antinuclear antibodies (ANA) in patient sera. It serves as a reference standard to validate assay performance, ensuring accuracy in diagnostic testing for autoimmune conditions such as systemic lupus erythematosus (SLE) and other connective tissue diseases.

Supplied as a non-sterile, single-use reagent, the Anaton is intended for laboratory use only and requires refrigeration between 2°C and 8°C. It is regulated under FDA 510(k) clearance (K801046) and falls under the DHN product code for diagnostic controls. Compliance with 21 CFR 866.5100 ensures its suitability for clinical immunology applications, with no MRI safety considerations applicable.

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