Cleared Traditional

K990399 - ONTRAK TESTCUP M2K

K990399 is the FDA 510(k) clearance for ONTRAK TESTCUP M2K by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K990399 · Roche Diagnostics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
65d
Days
Class 2
Risk

K990399 is an FDA 510(k) clearance for the ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 15, 1999 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K990399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1999
Decision Date April 15, 1999
Days to Decision 65 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 87d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 96
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K990399.
CEDIA DAU AMPHASSURE ASSAY
K994380 · Microgenics Corp. · May 2000
URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A
K000460 · Dade Behring, Inc. · Apr 2000
IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5
K992632 · Diagnostic Products Corp. · Jan 2000
ONTRAK TESTCUP-ER M2K
K990418 · Roche Diagnostics Corp. · Apr 1999
ONTRAK TESTCUP-5 M2K
K990337 · Roche Diagnostics Corp. · Feb 1999
MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES
K983699 · Roche Diagnostic Systems, Inc. · Dec 1998