Cleared Traditional

K864438 - BECKMAN EPSILON(TM) LIPASE TEST KIT

K864438 is an FDA 510(k) clearance for BECKMAN EPSILON(TM) LIPASE TEST KIT, manufactured by Beckman Instruments, Inc.. The device is a Class 1 Chemistry device with product code CET cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K864438 · Beckman Instruments, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1987
Decision
120d
Days
Class 1
Risk

K864438 is an FDA 510(k) clearance for the BECKMAN EPSILON(TM) LIPASE TEST KIT. Classified as Olive Oil Emulsion (turbidimetric), Lipase (product code CET), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on March 12, 1987 after a review of 120 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K864438

510(k) Number K864438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1986
Decision Date March 12, 1987
Days to Decision 120 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 88d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

CET Device Classification - Class 1, General Controls

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.

Regulatory Peers - CET Olive Oil Emulsion (turbidimetric), Lipase

All 10
Devices cleared under the same product code (CET) and FDA review panel - the closest regulatory comparables to K864438.
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K862440 · American Dade · Aug 1986
ENZYGNOST LIPASE TEST
K844240 · Behring Diagnostics, Inc. · Feb 1985
LIPASE
K812794 · Pointe Scientific, Inc., · Oct 1981