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Immunomatrix Theophylline Assay System

by Immunomatrix

510(k) K911060

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 NumberK911060 Date8 May 1991ClearedStatusActive

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  • Withdrawn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)

Full name
Immunomatrix Theophyline Assay System
510(k) Number
FDA Product Code
KLS
Device Class
Class II
Regulation
21 CFR Part 862.3880
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Immunomatrix Theophylline Assay System is an enzyme immunoassay device intended to measure theophylline concentrations in serum. It is classified under clinical toxicology and functions as a diagnostic tool for monitoring theophylline levels, a drug used to stimulate the cardiovascular, respiratory, and central nervous systems.

The device is supplied as a test system and is intended for use in clinical laboratory settings. It is regulated under product code KLS and device class 2, with an FDA 510(k) authorization (K911060) indicating substantial equivalence. The system is designed for single-use applications and should be stored according to manufacturer specifications. MRI safety and reusability details are not specified in the available data.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Immunomatrix Theophylline Assay System used for?

    It is an enzyme immunoassay device designed to measure theophylline concentrations in serum. Theophylline is a drug used to stimulate the cardiovascular, respiratory, and central nervous systems, and this system helps monitor its levels in clinical toxicology settings.

  • How is the device supplied and where is it intended to be used?

    The device is supplied as a complete test system and is intended for use in clinical laboratory settings. It is not described for point-of-care or home use, and its setup is optimized for professional laboratory environments.

  • Is the assay system single-use or reusable?

    The device is designed for single-use applications. Reusability details are not specified in the available data, so each test should be treated as a one-time use to ensure accuracy and prevent cross-contamination.

  • What are the storage requirements for this assay system?

    The device should be stored according to the manufacturer’s specifications. While exact temperature or humidity conditions are not detailed in the registry data, proper storage typically involves keeping immunoassay components in a cool, dry place away from direct light until use.

  • What regulatory classification does this device hold?

    The system is regulated under FDA product code KLS and device class 2. It received FDA 510(k) authorization (K911060) with a substantial equivalence decision, indicating it was found to be as safe and effective as a legally marketed predicate device.