Cleared Traditional

K790796 - LIPASE REAGENT SET

K790796 is the FDA 510(k) clearance for LIPASE REAGENT SET by Alta Diagnostics, Inc.. It is a Class 1 Chemistry device (product code CET) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K790796 · Alta Diagnostics, Inc. · Chemistry device
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Jul 1979
Decision
84d
Days
Class 1
Risk

K790796 is an FDA 510(k) clearance for the LIPASE REAGENT SET. Classified as Olive Oil Emulsion (turbidimetric), Lipase (product code CET), Class I - General Controls.

Submitted by Alta Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 17, 1979 after a review of 84 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 Alta Diagnostics, Inc. devices

Submission Details

510(k) Number K790796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1979
Decision Date July 17, 1979
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 88d · This submission: 84d
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 11
Devices cleared under the same product code (CET) and FDA review panel - the closest regulatory comparables to K790796.
LIPASE
K812794 · Pointe Scientific, Inc., · Oct 1981
LIPASE TEST KIT
K792289 · Mallinckrodt Critical Care · Dec 1979
HARLECO BRAND CLINICARD LIPASE TEST SET
K791922 · Dade, Baxter Travenol Diagnostics, Inc. · Nov 1979
ACA LIPASE ANALYTICAL TEST PACK
K770364 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1977