Cleared Traditional

K052163 - ADVIA IMS GLUCOSE ASSAY

K052163 is an FDA 510(k) clearance for ADVIA IMS GLUCOSE ASSAY, manufactured by Bayer Healthcare, LLC. The device is a Class 2 Chemistry device with product code CFR cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K052163 · Bayer Healthcare, LLC · Chemistry device
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Oct 2005
Decision
63d
Days
Class 2
Risk

K052163 is an FDA 510(k) clearance for the ADVIA IMS GLUCOSE ASSAY. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Bayer Healthcare, LLC (Tarrytown, US). The FDA issued a Cleared decision on October 11, 2005 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 Healthcare, LLC devices

FDA 510(k) Submission Details - K052163

510(k) Number K052163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2005
Decision Date October 11, 2005
Days to Decision 63 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
25d faster than avg
Panel avg: 88d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFR Device Classification - Class 2, Special Controls

Product Code CFR Hexokinase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CFR Hexokinase, Glucose

All 127
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K052163.
GLUCOSE
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ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)
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K041052 · Hemagen Diagnostics, Inc. · Jun 2004
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
K031135 · Dade Behring, Inc. · Jun 2003
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K024281 · Wako Chemicals USA, Inc. · Feb 2003