Cleared Traditional

DELTATEST (R) LIPASE II (K893718) - FDA 510(k) Clearance

Class I Chemistry device.

K893718 · Electro-Nucleonics, Inc. · Chemistry device
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Sep 1989
Decision
134d
Days
Class 1
Risk

K893718 is an FDA 510(k) clearance for the DELTATEST (R) LIPASE II. Classified as Olive Oil Emulsion (turbidimetric), Lipase (product code CET), Class I - General Controls.

Submitted by Electro-Nucleonics, Inc. (Columbia, US). The FDA issued a Cleared decision on September 28, 1989 after a review of 134 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 Electro-Nucleonics, Inc. devices

Submission Details

510(k) Number K893718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1989
Decision Date September 28, 1989
Days to Decision 134 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 88d · This submission: 134d
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.