Cleared Traditional

K885272 - CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE

K885272 is an FDA 510(k) clearance for CHOLINESTERASE REAGENT, manufactured by Sigma Chemical Co.. The device is a Class 1 Chemistry device with product code DIH cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K885272 · Sigma Chemical Co. · Chemistry device
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Mar 1989
Decision
96d
Days
Class 1
Risk

K885272 is an FDA 510(k) clearance for the CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE. Classified as Colorimetry, Cholinesterase (product code DIH), Class I - General Controls.

Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on March 28, 1989 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3240 - 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 Sigma Chemical Co. devices

FDA 510(k) Submission Details - K885272

510(k) Number K885272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1988
Decision Date March 28, 1989
Days to Decision 96 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
8d slower than avg
Panel avg: 88d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

DIH Device Classification - Class 1, General Controls

Product Code DIH Colorimetry, Cholinesterase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3240
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 - DIH Colorimetry, Cholinesterase

All 23
Devices cleared under the same product code (DIH) and FDA review panel - the closest regulatory comparables to K885272.
KODAK EKTACHEM DT SLIDES (CHE)
K913198 · Eastman Kodak Company · Aug 1991
CHOLINESTERASE TEST KIT
K912148 · Crestat Diagnostics, Inc. · Aug 1991
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K912217 · Eastman Kodak Company · Jul 1991
ATYPICAL CHOLINESTERASE
K873496 · Sclavo, Inc. · Jan 1989
CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE
K880049 · Sclavo, Inc. · Jan 1989
CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE
K880199 · Sclavo, Inc. · Jan 1989