Cleared Special

K081411 - VITROS CHEMISTRY PRODUCT NA+ SLIDES

Also marketed or referenced as:
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2

K081411 is an FDA 510(k) clearance for VITROS CHEMISTRY PRODUCT NA+ SLIDES, manufactured by Ortho-Clinical Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JGS cleared through the Special 510(k) pathway after a 41-day FDA review.

K081411 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
41d
Days
Class 2
Risk

K081411 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCT NA+ SLIDES. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on June 30, 2008 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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 - K081411

510(k) Number K081411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2008
Decision Date June 30, 2008
Days to Decision 41 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
48d faster than avg
Panel avg: 89d · This submission: 41d
Pathway characteristics
Modification to existing cleared device.

JGS Device Classification - Class 2, Special Controls

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
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 - JGS Electrode, Ion Specific, Sodium

All 159
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K081411.
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K081411 · VITROS CHEMISTRY PRODUCT NA+ SLIDES
Download PDF FDA Summary Ortho-Clinical Diagno…