Cleared Traditional

ABBOTT A-GENT LIPASE REAGENT (K884596) - FDA 510(k) Clearance

Class I Chemistry device.

K884596 · Abbott Laboratories · Chemistry device
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Dec 1988
Decision
33d
Days
Class 1
Risk

K884596 is an FDA 510(k) clearance for the ABBOTT A-GENT LIPASE REAGENT. Classified as Lipase-esterase, Enzymatic, Photometric, Lipase (product code CHI), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 6, 1988 after a review of 33 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 Abbott Laboratories devices

Submission Details

510(k) Number K884596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1988
Decision Date December 06, 1988
Days to Decision 33 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
55d faster than avg
Panel avg: 88d · This submission: 33d
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 10
Devices cleared under the same product code (CHI) and FDA review panel - the closest regulatory comparables to K884596.
LIPASE-PS ASSAY PROCEDURE NO. 805
K941085 · Sigma Diagnostics, Inc. · May 1994
WAKO AUTOKIT LIPASE-COLOR
K921249 · Wako Chemicals USA, Inc. · Jul 1992
MILES LIPASE SERA-PAK METHOD
K920337 · Heraeus Kulzer, Inc. · Mar 1992
KODAK EKTACHEM DT SLIDES (LIPA)
K875173 · Eastman Kodak Company · Feb 1988
WAKO(TM) AUTOKIT LIPASE
K874640 · Wako Chemicals USA, Inc. · Dec 1987
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K845027 · Eastman Kodak Company · Jan 1985