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Fiax Test Kit for Theophylline Quant.

by Intl. Diagnostic Technology 510(k)

Active United States

510(k) K801642

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801642 Date27 Aug 1980ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

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, 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.

The Fiax Test Kit for Theophylline Quantification is an enzyme immunoassay device designed for the quantitative measurement of theophylline in biological samples. Theophylline is a medication used to treat respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD), and accurate quantification is critical for therapeutic monitoring to avoid toxicity or subtherapeutic levels.

This kit is intended for use in clinical toxicology settings and has received FDA 510(k) clearance under product code KLS (Regulation 862.3880). Supplied as a single-use diagnostic tool, the device is classified as Class II and was reviewed by the Toxicology Advisory Committee. No third-party review was conducted, and the clearance was granted as substantially equivalent to a predicate device. Storage and handling conditions are not specified in the regulatory data.

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