Cleared Traditional

K880199 - CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE

K880199 is an FDA 510(k) clearance for CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE, manufactured by Sclavo, Inc.. The device is a Class 1 Chemistry device with product code DIH cleared through the Traditional 510(k) pathway after a 380-day FDA review.

K880199 · Sclavo, Inc. · Chemistry device
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Jan 1989
Decision
380d
Days
Class 1
Risk

K880199 is an FDA 510(k) clearance for the CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE. Classified as Colorimetry, Cholinesterase (product code DIH), Class I - General Controls.

Submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on January 27, 1989 after a review of 380 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sclavo, Inc. devices

FDA 510(k) Submission Details - K880199

510(k) Number K880199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1988
Decision Date January 27, 1989
Days to Decision 380 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
292d slower than avg
Panel avg: 88d · This submission: 380d
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 K880199.
CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE
K885272 · Sigma Chemical Co. · Mar 1989
ATYPICAL CHOLINESTERASE
K873496 · Sclavo, Inc. · Jan 1989
CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE
K880049 · Sclavo, Inc. · Jan 1989
DU PONT DIMENSION PSEUDOCHOLINESTERASE METHOD
K883890 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1988
CHOLINESTERASE (BTC) REAGENT
K863203 · Sigma Diagnostics, Inc. · Sep 1986
CHOLINESTERASE (PTC) REAGENT
K863202 · Sigma Diagnostics, Inc. · Sep 1986