Cleared Traditional

ADVIA IMS (K001344) - FDA 510(k) Clearance

Class I Chemistry device.

K001344 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
60d
Days
Class 1
Risk

K001344 is an FDA 510(k) clearance for the ADVIA IMS. Classified as Colorimetry, Cholinesterase (product code DIH), Class I - General Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on June 26, 2000 after a review of 60 days - a notably fast clearance cycle.

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: 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 Bayer Corp. devices

Submission Details

510(k) Number K001344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2000
Decision Date June 26, 2000
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 88d · This submission: 60d
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 25
Devices cleared under the same product code (DIH) and FDA review panel - the closest regulatory comparables to K001344.
SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
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IL TEST CHOLINESTERASE
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KODAK EKTACHEM DT SLIDES (CHE)
K913198 · Eastman Kodak Company · Aug 1991
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K912217 · Eastman Kodak Company · Jul 1991
CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE
K885272 · Sigma Chemical Co. · Mar 1989