Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1450](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1450) → KHP — Acid, Lactic, Enzymatic Method # KHP · Acid, Lactic, Enzymatic Method _Clinical Chemistry · 21 CFR 862.1450 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP ## Overview - **Product Code:** KHP - **Device Name:** Acid, Lactic, Enzymatic Method - **Regulation:** [21 CFR 862.1450](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1450) - **Device Class:** 1 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## Identification A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood). ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. ## Recent Cleared Devices (20 of 27) Showing 20 most recent of 27 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K130113](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K130113.md) | PICCOLO LACTATE TEST SYSTEM | Abaxis, Inc. | Mar 11, 2013 | SESE | | [K113216](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K113216.md) | RAPIDPOINT 500 BLOOD GAS ANALYER | Siemens Healthcare Diagnostics | May 3, 2012 | SESE | | [K112955](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K112955.md) | NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM | Nova Biomedical Corporation | Jan 5, 2012 | SESE | | [K112430](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K112430.md) | I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE | Abbott Pont of Care, Inc. | Dec 20, 2011 | SESE | | [K100602](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K100602.md) | NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS | Nova Biomedical Corp. | Aug 17, 2011 | SESE | | [K093297](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K093297.md) | EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE | Epocal, Inc. | Jun 9, 2010 | SESE | | [K013938](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K013938.md) | IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE | Diametrics Medical, Inc. | Jan 28, 2002 | SESE | | [K011478](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K011478.md) | I-STAT SYSTEM | I-Stat Corp. | Jul 2, 2001 | SESE | | [K980908](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K980908.md) | LACTATE PRO SYSTEM | Kdk Corp. | Sep 11, 1998 | SESE | | [K982071](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K982071.md) | I-STAT LACTATE TEST | I-Stat Corp. | Jun 29, 1998 | SESE | | [K971944](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K971944.md) | LACTEST I | Jwt, Inc. | Dec 17, 1997 | SESE | | [K951331](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K951331.md) | ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR | Boehringer Mannheim Corp. | Aug 11, 1995 | SESE | | [K936066](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K936066.md) | STAT PROFILE PLUS 9 ANALYZER | Nova Biomedical Corp. | Mar 9, 1995 | SESE | | [K934271](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K934271.md) | BECKMAN SYNCHRON LACTATE REAGENT | Beckman-Diagnostic Systems Group | Nov 9, 1993 | SESE | | [K914508](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K914508.md) | DIMENSION(R) LACTIC ACID METHOD | E.I. Dupont DE Nemours & Co., Inc. | Nov 27, 1991 | SESE | | [K913330](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K913330.md) | URINE COLLECTION KIT/DEVICE | Medical Implements, Inc. | Aug 26, 1991 | SESE | | [K913197](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K913197.md) | KODAK EKTACHEM DT SLIDES (LAC) | Eastman Kodak Company | Aug 26, 1991 | SESE | | [K910534](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K910534.md) | SYNCHRON LACTATE REAGENT | Beckman Instruments, Inc. | Apr 8, 1991 | SESE | | [K901131](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K901131.md) | YSI MODEL 1500 SPORT L-LACTATE ANALYZER | Yellow Springs Instrument Co., Inc. | Aug 27, 1990 | SN | | [K897147](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K897147.md) | SIGMA PROCEDURE NO. 735 | Sigma Diagnostics, Inc. | Apr 3, 1990 | SESE | ## Top Applicants - E.I. Dupont DE Nemours & Co., Inc. — 2 clearances - Eastman Kodak Company — 2 clearances - I-Stat Corp. — 2 clearances - Nova Biomedical Corp. — 2 clearances - Yellow Springs Instrument Co., Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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