Cleared Traditional

K140248 - S TEST REAGENT CARTRIDGE CARBON DIOXIDE...

K140248 is an FDA 510(k) clearance for S TEST REAGENT CARTRIDGE CARBON DIOXIDE..., manufactured by Hitachi Chemical Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code KHS cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K140248 · Hitachi Chemical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
40d
Days
Class 2
Risk

K140248 is an FDA 510(k) clearance for the S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2). Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Hitachi Chemical Diagnostics, Inc. (Los Angeles, US). The FDA issued a Cleared decision on March 11, 2014 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hitachi Chemical Diagnostics, Inc. devices

FDA 510(k) Submission Details - K140248

510(k) Number K140248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2014
Decision Date March 11, 2014
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 88d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHS Device Classification - Class 2, Special Controls

Product Code KHS Enzymatic, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
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 - KHS Enzymatic, Carbon-dioxide

All 67
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K140248.
Liquid CO2-2 (LCO2-2)
K152085 · Randox Laboratories, Ltd. · Feb 2016
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
K120765 · Ortho-Clinical Diagnostics, Inc. · Oct 2012
ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781
K100289 · Siemens Healthcare Diagnostics · May 2010
VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES
K093611 · Ortho-Clinical Diagnostics, Inc. · Apr 2010
SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291
K091153 · Beckman Coulter, Inc. · Jul 2009
CARBON DIOXIDE LIQUID STABLE REAGENT
K070251 · Pointe Scientific, Inc., · Apr 2007