Cleared Special

K001133 - VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & C...

K001133 is the FDA 510(k) clearance for VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & C... by Ortho-Clinical Diagnostics, Inc.. It is a Class 2 Chemistry device (product code KHS) cleared through the Special 510(k) pathway after a 14-day FDA review.

K001133 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
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Apr 2000
Decision
14d
Days
Class 2
Risk

K001133 is an FDA 510(k) clearance for the VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2. 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 24, 2000 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ortho-Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K001133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2000
Decision Date April 24, 2000
Days to Decision 14 days
Submission Type Special
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
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 65
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K001133.
ANALYST PANELS + ANALYTICAL TEST ROTOR
K010864 · Hemagen Diagnostics, Inc. · May 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
K010206 · Dade Behring, Inc. · Mar 2001
CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
K002354 · Diagnostic Chemicals , Ltd. · Sep 2000
CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50
K990754 · Diagnostic Chemicals , Ltd. · Apr 1999
CARBON DIOXIDE-SL ASSAY, CAT # 253-01
K983019 · Diagnostic Chemicals , Ltd. · Sep 1998
RAICHEM CO2 REAGENT
K982056 · Reagents Applications, Inc. · Jun 1998