Cleared Traditional

K033007 - BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM

K033007 is an FDA 510(k) clearance for BAYER ADVIA DIGOXIN ASSAY FOR THE INTEG..., manufactured by Bayer Diagnostics Corp.. The device is a Class 2 Chemistry device with product code KXT cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K033007 · Bayer Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
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Nov 2003
Decision
49d
Days
Class 2
Risk

K033007 is an FDA 510(k) clearance for the BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on November 14, 2003 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3320 - 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 Diagnostics Corp. devices

FDA 510(k) Submission Details - K033007

510(k) Number K033007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2003
Decision Date November 14, 2003
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXT Device Classification - Class 2, Special Controls

Product Code KXT Enzyme Immunoassay, Digoxin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
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 - KXT Enzyme Immunoassay, Digoxin

All 78
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K033007.
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K011920 · Syva Co., Dade Behring, Inc. · Jul 2001