Cleared Traditional

K983387 - ONTRAK TESTCUP AND TESTSTIK CONTROLS

K983387 is the FDA 510(k) clearance for ONTRAK TESTCUP AND TESTSTIK CONTROLS by Roche Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code DIF) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K983387 · Roche Diagnostic Systems, Inc. · Chemistry device
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Oct 1998
Decision
14d
Days
Class 1
Risk

K983387 is an FDA 510(k) clearance for the ONTRAK TESTCUP AND TESTSTIK CONTROLS. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on October 9, 1998 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3280 - the FDA in vitro diagnostics and chemistry 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 Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K983387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1998
Decision Date October 09, 1998
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DIF Drug Mixture Control Materials

All 131
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K983387.
RANDOX HUMAN ASSSAYED DRUG CONTROL
K012319 · Randox Laboratories, Ltd. · Aug 2001
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K990377 · Roche Diagnostics Corp. · Feb 1999
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K983709 · Beckman Coulter, Inc. · Oct 1998
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3
K983127 · Medical Analysis Systems, Inc. · Sep 1998
VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III
K982649 · Ortho-Clinical Diagnostics, Inc. · Aug 1998
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3
K982024 · Medical Analysis Systems, Inc. · Jun 1998