Cleared Special

K001769 - VITROS CHEMISTRY PRODUCTS CREA DT SLIDES

Also marketed or referenced as:
VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT

K001769 is the FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS CREA DT SLIDES by Ortho-Clinical Diagnostics. It is a Class 2 Chemistry device (product code CGX) cleared through the Special 510(k) pathway after a 9-day FDA review.

K001769 · Ortho-Clinical Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
9d
Days
Class 2
Risk

K001769 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS CREA DT SLIDES. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on June 21, 2000 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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 devices

Submission Details

510(k) Number K001769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2000
Decision Date June 21, 2000
Days to Decision 9 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
79d faster than avg
Panel avg: 88d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - CGX Alkaline Picrate, Colorimetry, Creatinine

All 110
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K001769.
SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
K071280 · Beckman Coulter, Inc. · Jun 2007
SYNCHRON SYSTEMS CREATININE REAGENT
K071283 · Beckman Coulter, Inc. · Jun 2007
SYNCHRON SYSTEMS CREATININE (CREA) REAGENT
K060935 · Beckman Coulter, Inc. · Apr 2006
CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17
K000055 · Diagnostic Chemicals , Ltd. · Feb 2000
CREA
K981799 · Abbott Laboratories · Jul 1998
CREATININE (CREA)
K981240 · Abbott Laboratories · May 1998