Cleared Special

K081411 - VITROS CHEMISTRY PRODUCT NA+ SLIDES

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

K081411 is the FDA 510(k) clearance for VITROS CHEMISTRY PRODUCT NA+ SLIDES by Ortho-Clinical Diagnostics, Inc.. It is a Class 2 Chemistry device (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)
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.

View all Ortho-Clinical Diagnostics, Inc. devices

Submission Details

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
47d faster than avg
Panel avg: 88d · This submission: 41d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 108
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K081411.
EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520
K100829 · Medica Corp. · Jan 2011
EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
K100673 · Medica Corp. · Apr 2010
VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927
K091861 · Ortho-Clinical Diagnostics, Inc. · Sep 2009
TECO ISE REAGENT SET FOR CX SYSTEM
K052724 · Teco Diagnostics · Dec 2005
ISE INDIRECT NA, K, CL FOR GEN.2
K053165 · Roche Diagnostics Corp. · Dec 2005
ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
K051646 · Pointe Scientific, Inc., · Oct 2005