Cleared Special

K001769 - VITROS CHEMISTRY PRODUCTS CREA DT SLIDES

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

K001769 is an FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS CREA DT SLIDES, manufactured by Ortho-Clinical Diagnostics. The device is a Class 2 Chemistry device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K001769

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
80d faster than avg
Panel avg: 89d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

CGX Device Classification - Class 2, Special Controls

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 157
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K001769.
ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR
K023407 · Elan Diagnostics · Feb 2003
APPRAISE URINE MICROALBUMIN COLLECTION KIT
K002156 · Osborn Group, Inc. · Dec 2000
CREATININE
K003247 · Jas Diagnostics, Inc. · Dec 2000
CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17
K000055 · Diagnostic Chemicals , Ltd. · Feb 2000
CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02
K991109 · A.P. Total Care, Inc. · May 1999
DUAL VIAL CREATININE REAGENT
K983937 · Intersect Systems, Inc. · Jan 1999
K001769 · VITROS CHEMISTRY PRODUCTS CREA DT SLIDES
Download PDF FDA Summary Ortho-Clinical Diagno…