Cleared Traditional

ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K) (K990409) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K990409 · 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

K990409 is an FDA 510(k) clearance for the ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K). Classified as Gas Chromatography, Morphine (product code DMY), 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 862.3640 - 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 K990409 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
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 DMY Gas Chromatography, Morphine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3640
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.