Cleared Special

K001133 - VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2

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

K001133 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K001133

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
75d faster than avg
Panel avg: 89d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

KHS Device Classification - Class 2, Special Controls

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 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
CARESIDE CO2, TOTAL
K992475 · Careside, Inc. · Sep 1999
CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01
K991108 · A.P. Total Care, Inc. · May 1999
CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50
K990754 · Diagnostic Chemicals , Ltd. · Apr 1999
K001133 · VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
Download PDF FDA Summary Ortho-Clinical Diagno…