Cleared Traditional

LIPASE-PS ASSAY PROCEDURE NO. 805 (K941085) - FDA 510(k) Clearance

Class I Chemistry device.

K941085 · Sigma Diagnostics, Inc. · Chemistry device
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May 1994
Decision
70d
Days
Class 1
Risk

K941085 is an FDA 510(k) clearance for the LIPASE-PS ASSAY PROCEDURE NO. 805. Classified as Lipase-esterase, Enzymatic, Photometric, Lipase (product code CHI), Class I - General Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on May 17, 1994 after a review of 70 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K941085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1994
Decision Date May 17, 1994
Days to Decision 70 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
18d faster than avg
Panel avg: 88d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHI Lipase-esterase, Enzymatic, Photometric, 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 - CHI Lipase-esterase, Enzymatic, Photometric, Lipase

All 19
Devices cleared under the same product code (CHI) and FDA review panel - the closest regulatory comparables to K941085.
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IL TEST LIPASE
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ABBOTT A-GENT LIPASE REAGENT
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KODAK EKTACHEM DT SLIDES (LIPA)
K875173 · Eastman Kodak Company · Feb 1988
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K845027 · Eastman Kodak Company · Jan 1985