← Back to catalogue

Ontrak Testcup 502, Model 3016641

FDA 510(k)

Class II (US FDA 510(k))

510(k) K001417

by Roche Diagnostics Corp.

Identifiers

510(k) Number
K001417 FDA 510(k)
FDA Product Code
DKZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3100 FDA 510(k)
Regulation Number
862.3100 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Ontrak Testcup 502, Model 3016641 is an enzyme immunoassay device used for the detection of amphetamines. It functions as a diagnostic tool within the field of clinical toxicology.

This device is manufactured by Roche Diagnostics Corp. and received FDA 510(k) clearance on June 29, 2000, under regulation number 862.3100. It is classified as a Class II device subject to special controls.

Frequently asked questions

What is the primary purpose of the Ontrak Testcup 502?

The Ontrak Testcup 502 is a diagnostic tool designed for use in clinical toxicology settings to detect the presence of amphetamines using enzyme immunoassay technology.

Who is the manufacturer of this device?

This device is manufactured by Roche Diagnostics Corp., located in Indianapolis, Indiana.

What is the regulatory status of the Ontrak Testcup 502?

The device received FDA 510(k) clearance on June 29, 2000, under regulation number 862.3100. It is classified as a Class II device subject to special controls.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K001417 FDA 510 (k) - ONTRAK TESTCUP 502, Ontrak Testcup 502, Model 3016641 510(k) K001417 - FDA.report, ONTRAK TESTCUP 502, MODEL 3016641 (K001417) — FDA 510(k) | Innolitics, PDF K001417 - Ontrak Testcup 502, Model 3016641

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA 510(k) K001417 24 fields · synced Sep 25, 2026