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ENA Profile ELISA Test System

by Trinity Biotech USA 510(k)

Active United States

510(k) K993839

Overview

The ENA Profile ELISA Test System is an Extractable Antinuclear Antibody, Antigen And Control device, designed for the qualitative detection of specific antinuclear antibodies (ANAs) in serum specimens. It simultaneously identifies antibodies to Smith (Sm), Sm/RNP, SS-A (Ro), SS-B (La), Scl-70, and Jo-1 antigens via enzyme-linked immunosorbent assay (ELISA) technology.

This in vitro diagnostic device is supplied as a single-use system for use in clinical immunology laboratories. It requires no special storage conditions beyond refrigeration (2–8°C) and is intended for professional use only. The system carries FDA 510(k) clearance (K993839) under product code LLL and regulation 866.5100, classified as a Class II device under the Traditional 510(k) pathway.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK993839 Date12 Jan 2000ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
LLL
Device Class
Class II
Regulation
21 CFR Part 866.5100
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What specific antinuclear antibodies (ANAs) does the ENA Profile ELISA Test System detect, and how does it perform this detection?

    The ENA Profile ELISA Test System detects antibodies to six specific antigens: Smith (Sm), Sm/RNP, SS-A (Ro), SS-B (La), Scl-70, and Jo-1. Detection is performed simultaneously via enzyme-linked immunosorbent assay (ELISA) technology, which allows for qualitative identification of these antibodies in serum specimens.

  • Is the ENA Profile ELISA Test System intended for single-use or repeated use, and what storage requirements apply?

    The ENA Profile ELISA Test System is designed for single-use only in clinical immunology laboratories. It requires standard refrigeration storage (2–8°C) and does not need any additional preservation measures beyond this.

  • What regulatory pathway was used for FDA clearance of this device, and how is it classified?

    The ENA Profile ELISA Test System received FDA clearance under the Traditional 510(k) pathway and is classified as a Class II device. It was determined to be substantially equivalent to a predicate device, with clearance assigned under product code LLL and regulation 866.5100, reflecting its use in immunology testing.

  • Who is the intended user of the ENA Profile ELISA Test System, and where would it typically be used?

    The system is intended for professional use only in clinical immunology laboratories. It is not designed for point-of-care or home testing and requires trained personnel to operate the ELISA-based assay for detecting specific ANAs in serum specimens.