Cleared Traditional

K880049 - CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBS...

K880049 is the FDA 510(k) clearance for CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBS... by Sclavo, Inc.. It is a Class 1 Chemistry device (product code DIH) cleared through the Traditional 510(k) pathway after a 387-day FDA review.

K880049 · Sclavo, Inc. · Chemistry device
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Jan 1989
Decision
387d
Days
Class 1
Risk

K880049 is an FDA 510(k) clearance for the CHOLINESTERASE - BUTYRYTHIOCHOLINE 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 387 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

Submission Details

510(k) Number K880049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1988
Decision Date January 27, 1989
Days to Decision 387 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
299d slower than avg
Panel avg: 88d · This submission: 387d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 17
Devices cleared under the same product code (DIH) and FDA review panel - the closest regulatory comparables to K880049.
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K912217 · Eastman Kodak Company · Jul 1991
CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE
K885272 · Sigma Chemical Co. · Mar 1989
ATYPICAL CHOLINESTERASE
K873496 · Sclavo, Inc. · Jan 1989
CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE
K880199 · 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