Cleared Traditional

VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES (K093611) - FDA 510(k) Clearance

Also marketed or referenced as:
VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093611 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Apr 2010
Decision
143d
Days
Class 2
Risk

K093611 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on April 15, 2010 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - 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 Ortho-Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K093611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2009
Decision Date April 15, 2010
Days to Decision 143 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 88d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHS Enzymatic, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
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 - KHS Enzymatic, Carbon-dioxide

All 85
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K093611.
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE
K061238 · Dade Behring, Inc. · May 2006
CARBON DIOXIDE
K060295 · Abbott Laboratories · May 2006
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
K010206 · Dade Behring, Inc. · Mar 2001
CO2
K981840 · Abbott Laboratories · Jun 1998
BOEHRINGER MANNHEIM BICARBONATE ASSAY
K933461 · Boehringer Mannheim Corp. · Dec 1994
BICARBONATE
K891991 · Boehringer Mannheim Corp. · Jun 1989