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Reaads IgM Anti-Prothrombin Semi-Quantitative Test Kit

by Corgenix, Inc.

510(k) K001398

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 NumberK001398 Date30 Mar 2001ClearedStatusActive

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  • Withdrawn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
DHC
Device Class
Class II
Regulation
21 CFR Part 866.5820
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Reaads IgM Anti-Prothrombin Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) designed for the in vitro diagnostic detection and semi-quantitation of IgM anti-prothrombin antibodies. It is intended for use in human serum or citrated plasma samples from individuals with systemic lupus erythematosus and lupus-like disorders, such as antiphospholipid syndrome.

This test kit is supplied for in vitro diagnostic use and has received FDA 510(k) clearance under K001398. It is classified as a System, Test, Systemic Lupus Erythematosus device under regulation number 866.5820.

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