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TDX/TDXFLX & TDXFLX Theophylline Monoclonal II

by Abbott Laboratories

510(k) K932127

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 NumberK932127 Date9 Aug 1993ClearedStatusActive

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  • Withdrawn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
LGS
Device Class
Class II
Regulation
21 CFR Part 862.3880
Advisory Committee
Clinical Toxicology
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 TDX/TDXFLX & TDXFLX Theophylline Monoclonal II is a fluorescence polarization immunoassay device designed to measure theophylline levels in human serum or plasma. It is intended for use in clinical toxicology to assist in the monitoring of theophylline concentrations, which are critical for managing therapeutic and toxic levels in patients.

The device is supplied as a single-use, non-sterile component and is not MRI safe. It is available in multiple sizes and requires storage under standard laboratory conditions. The device is regulated as a Class II medical device with special controls and has received FDA 510(k) clearance (K932127) for use in clinical settings.

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Questions

AI-generated answers, 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.

  • What is the TDX/TDXFLX Theophylline Monoclonal II used for?

    This device is a fluorescence polarization immunoassay intended to measure theophylline levels in human serum or plasma. It is used in clinical toxicology to monitor theophylline concentrations, which are critical for managing therapeutic and toxic levels in patients.

  • Is the device sterile and is it for single use?

    The device is supplied as a single-use, non-sterile component. It is not intended for reuse.

  • What are the storage requirements for this device?

    The device requires storage under standard laboratory conditions.

  • Is the device MRI safe?

    No, the TDX/TDXFLX Theophylline Monoclonal II is not MRI safe.

  • What is the regulatory status of this device?

    The device is regulated as a Class II medical device with special controls and has received FDA 510(k) clearance (K932127) for use in clinical settings.