Cleared Traditional

K940457 - LIPASE REAGENT SYSTEM (FDA 510(k) Clearance)

Class I Chemistry device.

K940457 · Medical Diagnostic Technologies, Inc. · Chemistry device
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Jun 1994
Decision
121d
Days
Class 1
Risk

K940457 is an FDA 510(k) clearance for the LIPASE REAGENT SYSTEM. Classified as Olive Oil Emulsion (turbidimetric), Lipase (product code CET), Class I - General Controls.

Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on June 2, 1994 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1465 - 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.

View all Medical Diagnostic Technologies, Inc. devices

Submission Details

510(k) Number K940457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1994
Decision Date June 02, 1994
Days to Decision 121 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
33d slower than avg
Panel avg: 88d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CET Olive Oil Emulsion (turbidimetric), Lipase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1465
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.