Product Code: KHS FDA class 2 21 CFR 862.1160

Enzymatic, Carbon-Dioxide

Clinical Chemistry

Enzymatic Carbon Dioxide is a clinical chemistry reagent system that uses enzymatic methods to measure total carbon dioxide or bicarbonate concentration in blood or serum, providing an assessment of the patient's acid-base status and electrolyte balance as part of a metabolic panel. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KHS, regulated under 21 CFR 862.1160, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: KHS
Device Class: FDA class 2
Regulation Number: 862.1160
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 86 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K170200	Carbon Dioxide Reagent Set	Jun 01, 2017	Substantially Equivalent	Teco Diagnostics, Inc.
K152085	Liquid CO2-2 (LCO2-2)	Feb 24, 2016	Substantially Equivalent	Randox Laboratories, Ltd.
K140248	S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)	Mar 11, 2014	Substantially Equivalent	Hitachi Chemical Diagnostics, Inc.
K131546	AU BICARBONATE REAGENT	Oct 09, 2013	Substantially Equivalent	Beckman Coulter Ireland, Inc.
K123953	ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT	May 02, 2013	Substantially Equivalent	Alfa Wassermann Diagnostic Technologies, Inc.
K120765	VITROS CHEMISTRY PRODUCTS ECO2 SLIDES	Oct 24, 2012	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K113435	ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT	Jul 02, 2012	Substantially Equivalent	Alfa Wassermann
K111960	ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS	Nov 18, 2011	Substantially Equivalent	Elitechgroup
K100060	EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475	Dec 15, 2010	Substantially Equivalent	Vital Diagnostics (Manufacturing) Ptyltd
K100289	ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781	May 10, 2010	Substantially Equivalent	Siemens Healthcare Diagnostics
K093611	VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;	Apr 15, 2010	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K091153	SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291	Jul 13, 2009	Substantially Equivalent	Beckman Coulter, Inc.
K073223	S-TEST C02	Jun 26, 2008	Substantially Equivalent	Alfa Wassermann Diagnostic Technologies, Inc.
K071340	CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL	Oct 05, 2007	Substantially Equivalent	Thermofisher Scientific OY
K070251	CARBON DIOXIDE LIQUID STABLE REAGENT	Apr 30, 2007	Substantially Equivalent	Pointe Scientific, Inc.,
K060619	DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A	Jul 21, 2006	Substantially Equivalent	Diazyme Laboratories
K061238	DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE	May 25, 2006	Substantially Equivalent	Dade Behring, Inc.
K060295	CARBON DIOXIDE	May 04, 2006	Substantially Equivalent	Abbott Laboratories
K042362	MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12	Dec 27, 2004	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K032377	ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID	Aug 21, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K031879	COBAS INTEGRA CARBON DIOXIDE ASSAY	Jul 17, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K012332	JAS CARBON DIOXIDE LIQUID REAGENT	Sep 06, 2001	Substantially Equivalent	Jas Diagnostics, Inc.
K010864	ANALYST PANELS + ANALYTICAL TEST ROTOR	May 21, 2001	Substantially Equivalent	Hemagen Diagnostics, Inc.
K010206	DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137	Mar 16, 2001	Substantially Equivalent	Dade Behring, Inc.
K002354	CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80	Sep 26, 2000	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K001133	VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2	Apr 24, 2000	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K992475	CARESIDE CO2, TOTAL	Sep 15, 1999	Substantially Equivalent	Careside, Inc.
K991108	CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01	May 25, 1999	Substantially Equivalent	A.P. Total Care, Inc.
K990754	CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50	Apr 20, 1999	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K983019	CARBON DIOXIDE-SL ASSAY, CAT # 253-01	Sep 14, 1998	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K982056	RAICHEM CO2 REAGENT	Jun 24, 1998	Substantially Equivalent	Reagents Applications, Inc.
K981840	CO2	Jun 08, 1998	Substantially Equivalent	Abbott Laboratories
K980996	COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)	Jun 05, 1998	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K981231	CO2	May 12, 1998	Substantially Equivalent	Abbott Mfg., Inc.
K960035	CARBON DIOXIDE - DST	Apr 08, 1996	Substantially Equivalent	Trace America, Inc.
K960793	SYNERMED ENZYMATIC CO2 REAGENT KIT	Mar 11, 1996	Substantially Equivalent	Synermed, Inc.
K955302	SERUM BICARBONATE/CARBON DIOXIDE	Feb 29, 1996	Substantially Equivalent	Data Medical Associates, Inc.
K951221	TOTAL CO2	Feb 15, 1996	Substantially Equivalent	Randox Laboratories, Ltd.
K952410	CARBON DIOXIDE - DST	Oct 05, 1995	Substantially Equivalent	Trace America, Inc.
K942735	CARBON DIOXIDE (C02)	Mar 20, 1995	Substantially Equivalent	Teco Diagnostics
K933461	BOEHRINGER MANNHEIM BICARBONATE ASSAY	Dec 05, 1994	Substantially Equivalent	Boehringer Mannheim Corp.
K941156	TECHNISON AXON SYSTEM	Apr 26, 1994	Substantially Equivalent	Miles, Inc.
K932267	ENZYMATIC CO2 REAGENT, MODIFICATION	Sep 24, 1993	Substantially Equivalent	Intersect Systems, Inc.
K931887	BICARBONATE	Aug 03, 1993	Substantially Equivalent	Em Diagnostic Systems, Inc.
K924711	BICARBONATE	Dec 03, 1992	Substantially Equivalent	Em Diagnostic Systems, Inc.
K924428	SYNERMED ENZYMATIC CO2 REAGENT KIT	Dec 03, 1992	Substantially Equivalent	Synermed, Inc.
K914486	COULTER CARBON DIOXIDE REAGENT	Nov 27, 1991	Substantially Equivalent	Coulter Corp.
K912806	ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22	Sep 11, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K903409	SYSTEMATE BICARBONATE OLYMPUS BICARBONATE	Oct 04, 1990	Substantially Equivalent	Em Diagnostic Systems, Inc.
K903305	TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD	Sep 27, 1990	Substantially Equivalent	Technicon Instruments Corp.
K903144	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (ECO2)	Sep 25, 1990	Substantially Equivalent	Eastman Kodak Company
K904007	BICARBONATE REAGENTS AMRESCO PRODUCT #4326020	Sep 13, 1990	Substantially Equivalent	Amresco, Inc.
K902229	COULTER CARBON DIOXIDE REAGENT	Jun 12, 1990	Substantially Equivalent	Coulter Corp.
K896812	CARBON DIOXIDE REAGENT	Feb 23, 1990	Substantially Equivalent	Pointe Scientific, Inc.,
K896258	CO2 REAGENT (340 NM)	Feb 13, 1990	Substantially Equivalent	Sigma Chemical Co.
K896590	CARBON DIOXIDE REAGENT	Feb 01, 1990	Substantially Equivalent	Pointe Scientific, Inc.,
K895748	BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS	Dec 21, 1989	Substantially Equivalent	Catachem, Inc.
K894509	BICARBONATE TEST ITEM NUMBER: 65412	Sep 15, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K891991	BICARBONATE; SYSTEM PACK REAGENTS	Jun 09, 1989	Substantially Equivalent	Boehringer Mannheim Corp.
K890305	BICARBONATE TEST ITEM NUMBER: SR1006	Feb 17, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K884821	ABBOTT SPECTRUM(R) BICARBONATE REAGENT	Dec 27, 1988	Substantially Equivalent	Abbott Laboratories
K880868	CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18	Nov 01, 1988	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K883055	DART CARBON DIOXIDE	Aug 30, 1988	Substantially Equivalent	Coulter Electronics, Inc.
K882497	ENZYMATIC CO2 REAGENT SET	Aug 02, 1988	Substantially Equivalent	American Monitor Corp.
K881938	BICARBONATE (CO2) REAGENT-2 VIAL	Jun 15, 1988	Substantially Equivalent	Trace Scientific , Ltd.
K881169	CARBON DIOXIDE REAGENT	Apr 28, 1988	Substantially Equivalent	Intersect Systems, Inc.
K880866	CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10	Apr 28, 1988	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K880794	RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL	Apr 18, 1988	Substantially Equivalent	Trace America, Inc.
K880609	ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM)	Mar 16, 1988	Substantially Equivalent	Technicon Instruments Corp.
K880268	CO2 REAGENT	Mar 15, 1988	Substantially Equivalent	Sigma Diagnostics, Inc.
K874941	BIOTROL BICARBONATE (CO2) UV HP)	Jan 05, 1988	Substantially Equivalent	Biotrol, USA, Inc.
K874435	BICARBONATE	Nov 23, 1987	Substantially Equivalent	Boehringer Mannheim Corp.
K872108	ABBOTT SPECTRUM BICARBONATE REAGENT KIT	Jun 17, 1987	Substantially Equivalent	Abbott Laboratories
K870062	BICARBONATE PROCEDURE	Feb 13, 1987	Substantially Equivalent	Data Medical Associates, Inc.
K863544	EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95	Sep 29, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K861673	BICARBONATE PROCEDURE	Jul 01, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K854544	RAICHEM CO2 REAGENT	Dec 13, 1985	Substantially Equivalent	Reagents Applications, Inc.
K850903	DATA ZYME CO2 PROCEDURE	Apr 08, 1985	Substantially Equivalent	Data Medical Associates, Inc.
K844987	ROCHE REAGENTS REAGENT FOR CO2	Jan 18, 1985	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K841664	ENZYMATIC CO2 DIAGNOSTIC CHEMICAL	Jun 08, 1984	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K841726	DEMAND C02	Jun 07, 1984	Substantially Equivalent	Cooper Biomedical, Inc.
K840773	CARBON DIOXIDE REAGENT	Apr 04, 1984	Substantially Equivalent	American Dade
K822079	ENZYMATIC CO2	Jul 27, 1982	Substantially Equivalent	American Monitor Corp.
K810356	BICARBONATE TEST	Feb 23, 1981	Substantially Equivalent	Boehringer Mannheim Corp.
K771507	MULTISTAT III BICARBONATE TEST	Oct 25, 1977	Substantially Equivalent	Instrumentation Laboratory CO
K760546	REAGENT KIT, ENZYMATIC CO2	Nov 01, 1976	Substantially Equivalent	Beckman Instruments, Inc.