Product Code: KHP FDA class 1 21 CFR 862.1450

Acid, Lactic, Enzymatic Method

Clinical Chemistry

Enzymatic Method Lactic Acid is a clinical chemistry reagent system that uses enzymatic reactions to quantify lactic acid concentration in blood or other biological specimens, supporting the assessment of tissue oxygenation, lactate metabolism, and conditions such as lactic acidosis or sepsis. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KHP, regulated under 21 CFR 862.1450, within the Clinical Chemistry medical specialty.

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Basic Information

Product Code: KHP
Device Class: FDA class 1
Regulation Number: 862.1450
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K130113	PICCOLO LACTATE TEST SYSTEM	Mar 11, 2013	Substantially Equivalent	Abaxis, Inc.
K113216	RAPIDPOINT 500 BLOOD GAS ANALYER	May 03, 2012	Substantially Equivalent	Siemens Healthcare Diagnostics
K112955	NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM	Jan 05, 2012	Substantially Equivalent	Nova Biomedical Corporation
K112430	I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE	Dec 20, 2011	Substantially Equivalent	Abbott Pont of Care, Inc.
K100602	NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS	Aug 17, 2011	Substantially Equivalent	Nova Biomedical Corp.
K093297	EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE	Jun 09, 2010	Substantially Equivalent	Epocal, Inc.
K013938	IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE	Jan 28, 2002	Substantially Equivalent	Diametrics Medical, Inc.
K011478	I-STAT SYSTEM	Jul 02, 2001	Substantially Equivalent	I-Stat Corp.
K980908	LACTATE PRO SYSTEM	Sep 11, 1998	Substantially Equivalent	Kdk Corp.
K982071	I-STAT LACTATE TEST	Jun 29, 1998	Substantially Equivalent	I-Stat Corp.
K971944	LACTEST I	Dec 17, 1997	Substantially Equivalent	Jwt, Inc.
K951331	ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR	Aug 11, 1995	Substantially Equivalent	Boehringer Mannheim Corp.
K936066	STAT PROFILE PLUS 9 ANALYZER	Mar 09, 1995	Substantially Equivalent	Nova Biomedical Corp.
K934271	BECKMAN SYNCHRON LACTATE REAGENT	Nov 09, 1993	Substantially Equivalent	Beckman-Diagnostic Systems Group
K914508	DIMENSION(R) LACTIC ACID METHOD	Nov 27, 1991	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K913330	URINE COLLECTION KIT/DEVICE	Aug 26, 1991	Substantially Equivalent	Medical Implements, Inc.
K913197	KODAK EKTACHEM DT SLIDES (LAC)	Aug 26, 1991	Substantially Equivalent	Eastman Kodak Company
K910534	SYNCHRON LACTATE REAGENT	Apr 08, 1991	Substantially Equivalent	Beckman Instruments, Inc.
K901131	YSI MODEL 1500 SPORT L-LACTATE ANALYZER	Aug 27, 1990	Substantially Equivalent for Some Indications	Yellow Springs Instrument Co., Inc.
K897147	SIGMA PROCEDURE NO. 735	Apr 03, 1990	Substantially Equivalent	Sigma Diagnostics, Inc.
K884189	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC)	Jan 11, 1989	Substantially Equivalent	Eastman Kodak Company
K880787	EASY-TEST LACTIC ACID (LA)	Mar 15, 1988	Substantially Equivalent	Diagnostic Systems
K861741	TDX REA LACTIC ACID	Jul 07, 1986	Substantially Equivalent	Abbott Laboratories
K852261	YSI MODEL 2372 TOTAL BLOOD LACTATE KIT	Aug 15, 1985	Substantially Equivalent	Yellow Springs Instrument Co., Inc.
K840778	LACTATE REAGENT	Apr 13, 1984	Substantially Equivalent	American Dade
K802064	DUPONT ACALACTIC ACID (LA) TEST	Sep 26, 1980	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K790421	ROCHE LACTATE ANALYZER 640	May 15, 1979	Substantially Equivalent	Roche Medical Electronics, Inc.