Cleared Special

K072440 - VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)

K072440 is an FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS: CA SLIDES (M..., manufactured by Ortho-Clinical Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CJY cleared through the Special 510(k) pathway after a 21-day FDA review.

K072440 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
21d
Days
Class 2
Risk

K072440 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MO.... Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on September 20, 2007 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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 - K072440

510(k) Number K072440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2007
Decision Date September 20, 2007
Days to Decision 21 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
68d faster than avg
Panel avg: 89d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

CJY Device Classification - Class 2, Special Controls

Product Code CJY Azo Dye, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 - CJY Azo Dye, Calcium

All 46
Devices cleared under the same product code (CJY) and FDA review panel - the closest regulatory comparables to K072440.
S-TEST CA
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K051757 · Diagnostic Chemicals , Ltd. · Nov 2005
K072440 · VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)
Download PDF FDA Summary Ortho-Clinical Diagno…