Cleared Traditional

K964355 - ONTRAK TESTCUP 5 (MODIFICATION)

K964355 · Roche Diagnostic Systems, Inc. · Toxicology device
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Dec 1996
Decision
42d
Days
-
Risk

K964355 is an FDA 510(k) clearance for the ONTRAK TESTCUP 5 (MODIFICATION). Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on December 13, 1996 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel. 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

FDA 510(k) Submission Details - K964355

510(k) Number K964355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1996
Decision Date December 13, 1996
Days to Decision 42 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 87d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

LCM Device Classification - Class 0,

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

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