Product Code: JFL FDA class 2 21 CFR 862.1160

Ph Rate Measurement, Carbon-Dioxide

Clinical Chemistry

pH Rate Measurement for Carbon Dioxide is a clinical chemistry test system that determines carbon dioxide concentration in blood or other specimens through pH-based measurement methods, supporting assessment of acid-base balance and respiratory function. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and adherence to general and special controls. The product code is JFL, regulated under 21 CFR 862.1160, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: JFL
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

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 28 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K191298	i-STAT CHEM8+ cartridge with the i-STAT 1 System	Feb 07, 2020	Substantially Equivalent	Abbott Point of Care, Inc.
K040975	GENCHEM CO2 ACID REAGENT	Dec 27, 2004	Substantially Equivalent	Genchem, Inc.
K014034	MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)	Dec 18, 2001	Substantially Equivalent	Beckman Coulter, Inc.
K963541	SIGMA DIAGNOSTICS CO2 ACID REAGENT	Oct 24, 1996	Substantially Equivalent	Sigma Diagnostics, Inc.
K963538	SIGMA DIAGNOSTICS CO2ALKALINE BUFFER	Oct 11, 1996	Substantially Equivalent	Sigma Diagnostics, Inc.
K963540	SIGMA DIAGNOSTICS ELECTROLYTE BUFFER	Sep 27, 1996	Substantially Equivalent	Sigma Diagnostics, Inc.
K963005	NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)	Aug 23, 1996	Substantially Equivalent	Nova Biomedical Corp.
K933696	SIGMA ELECTROLYTE REFERENCE REAGENT	Jan 03, 1994	Substantially Equivalent	Sigma Chemical Co.
K933691	SIGMA CO2 ALKALINE BUFFER REAGENT	Dec 17, 1993	Substantially Equivalent	Sigma Chemical Co.
K933692	SIGMA CO2 ACID REAGENT	Dec 09, 1993	Substantially Equivalent	Sigma Chemical Co.
K933695	SIGMA ELECTROLYTE BUFFER	Oct 22, 1993	Substantially Equivalent	Sigma Chemical Co.
K925553	HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813	Feb 12, 1993	Substantially Equivalent	Hichem Diagnostics
K925552	HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812	Feb 12, 1993	Substantially Equivalent	Hichem Diagnostics
K900185	NIIC MODEL: DX901 ASPIRATION SYSTEM	May 24, 1990	Substantially Equivalent	Niic U.S.A., Inc.
K897183	SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS	Mar 30, 1990	Substantially Equivalent	Beckman Instruments, Inc.
K900420	BICARBONATE REAGENTS PRODUCT #7713 & #7714	Mar 01, 1990	Substantially Equivalent	American Research Products Co.
K873129	CARBON DIOXIDE REAGENT KIT	Oct 23, 1987	Substantially Equivalent	A-Kem, Inc.
K842656	REPLACEMENT PARTS NOVA ELECTROLYTE ANAL	Aug 12, 1984	Substantially Equivalent	Shaban Mfg. Co.
K822117	FERMCOTEST CO2 REAGNET	Sep 30, 1982	Substantially Equivalent	Fermco Biochemics, Inc.
K820388	LIQUIZYME CO2REAGENT SET	Mar 08, 1982	Substantially Equivalent	American Research Products Co.
K811381	ASTRA	Aug 13, 1981	Substantially Equivalent	Chem-Elec, Inc.
K802035	BAKER DIAG. ULTRARATE CO2 REAGENT KIT	Sep 26, 1980	Substantially Equivalent	J.T. Baker Chemical Co.
K800586	NSI CARBON DIOXIDE REAGENT KIT	Apr 04, 1980	Substantially Equivalent	Nobel Scientific Industries, Inc.
K800218	CARBON DIOXIDE CUP REAGENT & REF.RGT.	Feb 26, 1980	Substantially Equivalent	Fisher Scientific Co., LLC
K792254	NOVA 3+3 CHLORIDE/TOTAL CARBON DIOXIDE	Dec 06, 1979	Substantially Equivalent	Nova Biomedical Corp.
K791687	CO2 REFERENCE REAGENT	Sep 17, 1979	Substantially Equivalent	Hi Chem, Inc.
K791686	CO2 CUP REAGENT	Sep 17, 1979	Substantially Equivalent	Hi Chem, Inc.
K771592	STAT/LYTE ANALYZER	Oct 18, 1977	Substantially Equivalent	Technicon Instruments Corp.