Skip to content

TheraTest Kit (Modification) LJM

by Theratest Laboratories, Inc.

510(k) K955481

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955481 Date6 Mar 1996ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Theratest Kit (Modification)
510(k) Number
FDA product code
LJM
Device class
Class II
Regulation
21 CFR Part 866.5100
Advisory committee
Immunology
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 TheraTest Kit (Modification) is an Antinuclear Antibody (Enzyme-Labeled) Test Kit, designed for the detection of antinuclear antibodies (ANA) using enzyme-linked immunosorbent assay (ELISA) technology. It includes antigens, enzyme-labeled reagents, and controls to facilitate serological testing for autoimmune conditions. This device falls under the classification of in vitro diagnostic (IVD) reagents, specifically for immunology applications, and is intended for laboratory use in identifying ANA markers in patient samples.

Supplied as a kit, the TheraTest Kit (Modification) is intended for use in physicians’ office laboratories, hospital laboratories, reference laboratories, and research settings. The device is classified as a Class II medical device under FDA regulations (21 CFR 866.5100) and was granted FDA 510(k) clearance (K955481) in 1996 for modifications to an existing product. It is not specified as single-use or reusable, but typical ELISA-based kits of this nature are generally intended for single-use per batch of reagents. No MRI safety or sterility specifications are provided in the available data.

Devices cleared under K955481

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K955481
UDI-DISize and differences
EL-ANA Profiles: anti-Jo-1 104-901
THERATEST LABORATORIES, INC.
104-901 / 104-90100854473003163 —On the market

Similar devices

Other devices filed under FDA product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls).

Other devices from Theratest Laboratories, Inc.

See all devices from Theratest Laboratories, Inc. →