Cleared Traditional

ONTRAK TESTCUP-ER

K983388 · Roche Diagnostic Systems, Inc. · Toxicology
Nov 1998
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K983388 is an FDA 510(k) clearance for the ONTRAK TESTCUP-ER, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on November 18, 1998, 54 days after receiving the submission on September 25, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K983388 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1998
Decision Date November 18, 1998
Days to Decision 54 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

Similar Devices — DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 144
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
K213211 · Carolina Liquid Chemistries Corp. · Jan 2022
DRI Cocaine Metabolite Assay
K211973 · Microgenics Corporation · Sep 2021
Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
K191638 · Medtest DX · Mar 2020
DRI Cocaine Metabolite Assay
K181499 · Microgenics Corporation · Jul 2018
Emit II Plus Cocaine Metabolite Assay
K170293 · Siemens Healthcare Diagnostics, Inc. · Oct 2017
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
K163570 · Carolina Liquid Chemistries Corporation · Aug 2017