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Enzyme Immunoassay Anti-Sci-70 Antibody Test Kit

by Helix Diagnostics, Inc.

510(k) K951798

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK951798 Date17 Jul 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
LJM
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.

This device is an enzyme immunoassay test kit designed to detect anti-Scl-70 antibodies in serum samples. It falls under the category of antinuclear antibody tests, specifically targeting the Scl-70 antigen, and is used for diagnostic purposes in immunology.

The kit is intended for in vitro diagnostic use and is supplied as a manual or automated assay system. It has received FDA 510(k) clearance under the classification of Class II medical devices (K951798, LJM) and is regulated under the regulation number 866.5100. The device is not described as single-use or reusable, nor are MRI safety or sterility details provided in the specifications.

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