Cleared Traditional

K042015 - ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE

K042015 is an FDA 510(k) clearance for ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY A..., manufactured by Bayer Healthcare, Diagnostics Division. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K042015 · Bayer Healthcare, Diagnostics Division · Chemistry device
Download Printable Device Report (PDF)
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Sep 2004
Decision
64d
Days
Class 2
Risk

K042015 is an FDA 510(k) clearance for the ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Bayer Healthcare, Diagnostics Division (Tarrytown, US). The FDA issued a Cleared decision on September 29, 2004 after a review of 64 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, Diagnostics Division devices

FDA 510(k) Submission Details - K042015

510(k) Number K042015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2004
Decision Date September 29, 2004
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, 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 - CGA Glucose Oxidase, Glucose

All 333
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K042015.
ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100
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K041427 · Arkray, Inc. · Nov 2004
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K041478 · Becton Dickinson · Oct 2004
GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
K033055 · Diamond Diagnostics, Inc. · Jan 2004
RANDOX RX DAYTONA
K024014 · Randox Laboratories, Ltd. · Dec 2003
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K031472 · Lifescan, Inc. · Aug 2003