Cleared Traditional

K011963 - ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY

K011963 is an FDA 510(k) clearance for ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY, manufactured by Bayer Corp.. The device is a Class 2 Chemistry device with product code CFR cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K011963 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
151d
Days
Class 2
Risk

K011963 is an FDA 510(k) clearance for the ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on November 20, 2001 after a review of 151 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Bayer Corp. devices

FDA 510(k) Submission Details - K011963

510(k) Number K011963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2001
Decision Date November 20, 2001
Days to Decision 151 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
63d slower than avg
Panel avg: 88d · This submission: 151d
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 136
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K011963.
WAKO L-TYPE GLUCOSE 2
K024281 · Wako Chemicals USA, Inc. · Feb 2003
GLUCOSE-SL-C ASSAY, MODEL 257-30
K023739 · Diagnostic Chemicals , Ltd. · Jan 2003
POLY-CHEM GLUCOSE
K020852 · Polymedco, Inc. · Jul 2002
RAICHEM GLUCOSE UV REAGENT
K012668 · Hemagen Diagnostics, Inc. · Oct 2001
GLUCOSE (HEXOKINASE)
K011900 · Jas Diagnostics, Inc. · Jul 2001
MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
K002199 · Pointe Scientific, Inc., · Nov 2000