Cleared Traditional

K990337 - ONTRAK TESTCUP-5 M2K

K990337 is the FDA 510(k) clearance for ONTRAK TESTCUP-5 M2K by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K990337 · Roche Diagnostics Corp. · Toxicology device
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Optimized for regulatory review, auditing and printing
Feb 1999
Decision
20d
Days
Class 2
Risk

K990337 is an FDA 510(k) clearance for the ONTRAK TESTCUP-5 M2K. 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 February 23, 1999 after a review of 20 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 K990337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1999
Decision Date February 23, 1999
Days to Decision 20 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
67d faster than avg
Panel avg: 87d · This submission: 20d
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 K990337.
IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5
K992632 · Diagnostic Products Corp. · Jan 2000
ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8
K990399 · Roche Diagnostics Corp. · Apr 1999
ONTRAK TESTCUP-ER M2K
K990418 · Roche Diagnostics Corp. · Apr 1999
MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES
K983699 · Roche Diagnostic Systems, Inc. · Dec 1998
ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON
K973075 · Roche Diagnostic Systems, Inc. · Oct 1997
ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION
K972891 · Roche Diagnostic Systems, Inc. · Oct 1997