Cleared Traditional

K921249 - WAKO AUTOKIT LIPASE-COLOR

K921249 is an FDA 510(k) clearance for WAKO AUTOKIT LIPASE-COLOR, manufactured by Wako Chemicals USA, Inc.. The device is a Class 1 Chemistry device with product code CHI cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K921249 · Wako Chemicals USA, Inc. · Chemistry device
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Jul 1992
Decision
127d
Days
Class 1
Risk

K921249 is an FDA 510(k) clearance for the WAKO AUTOKIT LIPASE-COLOR. Classified as Lipase-esterase, Enzymatic, Photometric, Lipase (product code CHI), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on July 21, 1992 after a review of 127 days - within the typical 510(k) review window.

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 Wako Chemicals USA, Inc. devices

FDA 510(k) Submission Details - K921249

510(k) Number K921249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1992
Decision Date July 21, 1992
Days to Decision 127 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 88d · This submission: 127d
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 16
Devices cleared under the same product code (CHI) and FDA review panel - the closest regulatory comparables to K921249.
LIPASE FLEX REAGENT CARTRIDGE
K952816 · Dupont Medical Products · Jul 1995
LIPASE-PS ASSAY PROCEDURE NO. 805
K941085 · Sigma Diagnostics, Inc. · May 1994
ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY
K923917 · Nuclear Diagnostics, Inc. · Feb 1994
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