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Ontrak Testcup-Er

by Roche Diagnostic Systems, Inc. 510(k)

Active United States

510(k) K983388

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983388 Date18 Nov 1998ClearedStatusActive

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  • Withdrawn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 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DIO
Device Class
Class II
Regulation
21 CFR Part 862.3250
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Ontrak Testcup-Er is an Enzyme Immunoassay device for detecting Cocaine And Cocaine Metabolites. It is classified as a device in the Clinical Toxicology medical specialty.

The device is supplied with a product code of DIO and is regulated under regulation number 862.3250. It has been authorized with an FDA 510K clearance, with a decision date of 1998-11-18 and a k-number of K983388.

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