Cleared Special

VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927 (K091861) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K091861 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
76d
Days
Class 2
Risk

K091861 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KI.... 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 September 3, 2009 after a review of 76 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 K091861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2009
Decision Date September 03, 2009
Days to Decision 76 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 88d · This submission: 76d
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 161
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K091861.
ABL90 FLEX PLUS System
K252475 · Radiometer Medicals Aps · May 2026
i-STAT CG8+ cartridge with the i-STAT 1 System
K230275 · Abbott Point of Care, Inc. · Oct 2023
A-LYTE® Integrated Multisensor (IMT Na K Cl)
K222438 · Siemens Healthcare Diagnostics, Inc. · Jul 2023
ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
K220977 · Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · Jul 2023
GLP systems Track
K213486 · Abbott Laboratories · Mar 2022
Stat Profile Prime Plus Analyzer System
K200403 · Nova Biomedical Corporation · Apr 2020