Cleared Abbreviated

K033643 - CO2 CALIBRATOR/DILUENT

K033643 is an FDA 510(k) clearance for CO2 CALIBRATOR/DILUENT, manufactured by Bayer Healthcare, Diagnostics Division. The device is a Class 2 Chemistry device with product code JIT cleared through the Abbreviated 510(k) pathway after a 49-day FDA review.

K033643 · Bayer Healthcare, Diagnostics Division · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
49d
Days
Class 2
Risk

K033643 is an FDA 510(k) clearance for the CO2 CALIBRATOR/DILUENT. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Bayer Healthcare, Diagnostics Division (Tarrytown, US). The FDA issued a Cleared decision on January 8, 2004 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Bayer Healthcare, Diagnostics Division devices

FDA 510(k) Submission Details - K033643

510(k) Number K033643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2003
Decision Date January 08, 2004
Days to Decision 49 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Standards-based clearance path.

JIT Device Classification - Class 2, Special Controls

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIT Calibrator, Secondary

All 187
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K033643.
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ABBOTT ARCHITECT ESTRADIOL CALIBRATORS
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OLYMPUS PREALBUMIN CALIBRATOR, ODR3029
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K031924 · Ortho-Clinical Diagnostics · Aug 2003