Cleared Traditional

K001344 - ADVIA IMS

K001344 is an FDA 510(k) clearance for ADVIA IMS, manufactured by Bayer Corp.. The device is a Class 1 Chemistry device with product code DIH cleared through the Traditional 510(k) pathway after a 60-day FDA review.

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

FDA 510(k) Submission Details - K001344

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 88d · This submission: 60d
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 K001344.
WIENER LAB COLINESTERASA AA
K023992 · Wiener Laboratories Saic · Feb 2003
ADVIA 1650 CHOLINESTERASE ASSAY
K013750 · Bayer Diagnostics Corp. · Jan 2002
CARESIDE CHOLINESTERASE
K002792 · Careside, Inc. · Nov 2000
TEST-MATE CHE CHOLINESTERASE TEST SYSTEM
K961656 · Eqm Research, Inc. · Nov 1996
IL TEST CHOLINESTERASE
K943367 · Instrumentation Laboratory CO · Feb 1996
CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05
K955498 · Diagnostic Chemicals , Ltd. · Jan 1996