Cleared Traditional

K862440 - PARAMAX LIPASE REAGENT

K862440 is the FDA 510(k) clearance for PARAMAX LIPASE REAGENT by American Dade. It is a Class 1 Chemistry device (product code CET) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K862440 · American Dade · Chemistry device
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Aug 1986
Decision
39d
Days
Class 1
Risk

K862440 is an FDA 510(k) clearance for the PARAMAX LIPASE REAGENT. Classified as Olive Oil Emulsion (turbidimetric), Lipase (product code CET), Class I - General Controls.

Submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on August 4, 1986 after a review of 39 days - a notably fast clearance cycle.

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: 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 American Dade devices

Submission Details

510(k) Number K862440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1986
Decision Date August 04, 1986
Days to Decision 39 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
49d faster than avg
Panel avg: 88d · This submission: 39d
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.

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 K862440.
MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST
K901858 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1990
LIPASE SR LIQUID STABLE REAGENT SET
K885078 · Medical Analysis Systems, Inc. · Mar 1989
BECKMAN EPSILON(TM) LIPASE TEST KIT
K864438 · Beckman Instruments, Inc. · Mar 1987
ENZYGNOST LIPASE TEST
K844240 · Behring Diagnostics, Inc. · Feb 1985
LIPASE
K812794 · Pointe Scientific, Inc., · Oct 1981
LIPASE TEST KIT
K792289 · Mallinckrodt Critical Care · Dec 1979