Cleared Traditional

K874027 - LIPASE UV [TOYO]

K874027 is an FDA 510(k) clearance for LIPASE UV [TOYO], manufactured by Advocacy International, Ltd.. The device is a Class 1 Chemistry device with product code CHI cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K874027 · Advocacy International, Ltd. · Chemistry device
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May 1988
Decision
238d
Days
Class 1
Risk

K874027 is an FDA 510(k) clearance for the LIPASE UV [TOYO]. Classified as Lipase-esterase, Enzymatic, Photometric, Lipase (product code CHI), Class I - General Controls.

Submitted by Advocacy International, Ltd. (Washington, US). The FDA issued a Cleared decision on May 27, 1988 after a review of 238 days - an extended review 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: 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 Advocacy International, Ltd. devices

FDA 510(k) Submission Details - K874027

510(k) Number K874027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1987
Decision Date May 27, 1988
Days to Decision 238 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 88d · This submission: 238d
Pathway characteristics
Predicate-based equivalence.

CHI Device Classification - Class 1, General Controls

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 17
Devices cleared under the same product code (CHI) and FDA review panel - the closest regulatory comparables to K874027.
MILES LIPASE SERA-PAK METHOD
K920337 · Heraeus Kulzer, Inc. · Mar 1992
COLORIMETRIC CHLORIDE PRODUCT #4314125
K900827 · American Research Products Co. · May 1990
ABBOTT A-GENT LIPASE REAGENT
K884596 · Abbott Laboratories · Dec 1988
KODAK EKTACHEM DT SLIDES (LIPA)
K875173 · Eastman Kodak Company · Feb 1988
WAKO(TM) AUTOKIT LIPASE
K874640 · Wako Chemicals USA, Inc. · Dec 1987
ENZLIPASE, ENZYMATIC LIPASE KIT
K862312 · Nuclear Diagnostics, Inc. · Sep 1986