Cleared Traditional

K942114 - ROCHE TDM CALIBRATION VERIFICATION TEST...

K942114 is the FDA 510(k) clearance for ROCHE TDM CALIBRATION VERIFICATION TEST... by Roche Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code DIF) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K942114 · Roche Diagnostic Systems, Inc. · Chemistry device
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Sep 1994
Decision
122d
Days
Class 1
Risk

K942114 is an FDA 510(k) clearance for the ROCHE 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 September 2, 1994 after a review of 122 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K942114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1994
Decision Date September 02, 1994
Days to Decision 122 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
34d slower than avg
Panel avg: 88d · This submission: 122d
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
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K936166 · Medical Analysis Systems, Inc. · Jul 1994
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