Cleared Traditional

K140248 - S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)

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) Official FDA 510(k) Summary (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
Combination Product No
PCCP Authorized No
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 85
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K140248.
Carbon Dioxide Reagent Set
K170200 · Teco Diagnostics, Inc. · Jun 2017
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K152085 · Randox Laboratories, Ltd. · Feb 2016
AU BICARBONATE REAGENT
K131546 · Beckman Coulter Ireland, Inc. · Oct 2013
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
K123953 · Alfa Wassermann Diagnostic Technologies, Inc. · May 2013
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
K120765 · Ortho-Clinical Diagnostics, Inc. · Oct 2012
ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
K113435 · Alfa Wassermann · Jul 2012