Cleared Traditional

K962165 - COBAS-FP TDM CALIBRATION VERIFICATION T...

K962165 is the FDA 510(k) clearance for COBAS-FP TDM CALIBRATION VERIFICATION T... by Roche Diagnostic Systems, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K962165 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jun 1996
Decision
22d
Days
Class 1
Risk

K962165 is an FDA 510(k) clearance for the COBAS-FP TDM CALIBRATION VERIFICATION TEST SET. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on June 26, 1996 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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 Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K962165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1996
Decision Date June 26, 1996
Days to Decision 22 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
65d faster than avg
Panel avg: 87d · This submission: 22d
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 K962165.
LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL
K970666 · Bio-Rad · Mar 1997
CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1
K965157 · Boehringer Mannheim Corp. · Jan 1997
ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL
K964422 · Roche Diagnostic Systems, Inc. · Nov 1996
U-DOA CONTROLS
K961724 · Medical Diagnostic Technologies, Inc. · Jun 1996
LYPHOCHEK BENZO/TCA CONTROL-SET B
K955153 · Bio-Rad · Feb 1996
ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL
K954799 · Roche Diagnostic Systems, Inc. · Dec 1995