Cleared Traditional

K952647 - IL TEST LIPASE

K952647 is the FDA 510(k) clearance for IL TEST LIPASE by Instrumentation Laboratory CO. It is a Class 1 Chemistry device (product code CHI) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K952647 · Instrumentation Laboratory CO · Chemistry device
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Optimized for regulatory review, auditing and printing
Jul 1995
Decision
41d
Days
Class 1
Risk

K952647 is an FDA 510(k) clearance for the IL TEST LIPASE. Classified as Lipase-esterase, Enzymatic, Photometric, Lipase (product code CHI), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on July 20, 1995 after a review of 41 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K952647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1995
Decision Date July 20, 1995
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 88d · This submission: 41d
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 11
Devices cleared under the same product code (CHI) and FDA review panel - the closest regulatory comparables to K952647.
SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT
K970905 · Beckman Instruments, Inc. · Jun 1997
CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS
K952180 · Beckman Instruments, Inc. · Aug 1995
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
COLORIMETRIC CHLORIDE PRODUCT #4314125
K900827 · American Research Products Co. · May 1990