KHP · Acid, Lactic, Enzymatic Method
Clinical Chemistry · 21 CFR 862.1450 · Class 1
Overview
| Product Code | KHP |
|---|---|
| Device Name | Acid, Lactic, Enzymatic Method |
| Regulation | 21 CFR 862.1450 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Cleared Devices (27)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K130113 | PICCOLO LACTATE TEST SYSTEM | Abaxis, Inc. | Mar 11, 2013 | SESE |
| K113216 | RAPIDPOINT 500 BLOOD GAS ANALYER | Siemens Healthcare Diagnostics | May 3, 2012 | SESE |
| K112955 | NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM | Nova Biomedical Corporation | Jan 5, 2012 | SESE |
| K112430 | I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE | Abbott Pont of Care, Inc. | Dec 20, 2011 | SESE |
| K100602 | NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS | Nova Biomedical Corp. | Aug 17, 2011 | SESE |
| K093297 | EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE | Epocal, Inc. | Jun 9, 2010 | SESE |
| K013938 | IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE | Diametrics Medical, Inc. | Jan 28, 2002 | SESE |
| K011478 | I-STAT SYSTEM | I-Stat Corp. | Jul 2, 2001 | SESE |
| K980908 | LACTATE PRO SYSTEM | Kdk Corp. | Sep 11, 1998 | SESE |
| K982071 | I-STAT LACTATE TEST | I-Stat Corp. | Jun 29, 1998 | SESE |
| K971944 | LACTEST I | Jwt, Inc. | Dec 17, 1997 | SESE |
| K951331 | ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR | Boehringer Mannheim Corp. | Aug 11, 1995 | SESE |
| K936066 | STAT PROFILE PLUS 9 ANALYZER | Nova Biomedical Corp. | Mar 9, 1995 | SESE |
| K934271 | BECKMAN SYNCHRON LACTATE REAGENT | Beckman-Diagnostic Systems Group | Nov 9, 1993 | SESE |
| K914508 | DIMENSION(R) LACTIC ACID METHOD | E.I. Dupont DE Nemours & Co., Inc. | Nov 27, 1991 | SESE |
| K913330 | URINE COLLECTION KIT/DEVICE | Medical Implements, Inc. | Aug 26, 1991 | SESE |
| K913197 | KODAK EKTACHEM DT SLIDES (LAC) | Eastman Kodak Company | Aug 26, 1991 | SESE |
| K910534 | SYNCHRON LACTATE REAGENT | Beckman Instruments, Inc. | Apr 8, 1991 | SESE |
| K901131 | YSI MODEL 1500 SPORT L-LACTATE ANALYZER | Yellow Springs Instrument Co., Inc. | Aug 27, 1990 | SN |
| K897147 | SIGMA PROCEDURE NO. 735 | Sigma Diagnostics, Inc. | Apr 3, 1990 | SESE |
| K884189 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC) | Eastman Kodak Company | Jan 11, 1989 | SESE |
| K880787 | EASY-TEST LACTIC ACID (LA) | Diagnostic Systems | Mar 15, 1988 | SESE |
| K861741 | TDX REA LACTIC ACID | Abbott Laboratories | Jul 7, 1986 | SESE |
| K852261 | YSI MODEL 2372 TOTAL BLOOD LACTATE KIT | Yellow Springs Instrument Co., Inc. | Aug 15, 1985 | SESE |
| K840778 | LACTATE REAGENT | American Dade | Apr 13, 1984 | SESE |
| K802064 | DUPONT ACALACTIC ACID (LA) TEST | E.I. Dupont DE Nemours & Co., Inc. | Sep 26, 1980 | SESE |
| K790421 | ROCHE LACTATE ANALYZER 640 | Roche Medical Electronics, Inc. | May 15, 1979 | SESE |
Top Applicants
- Yellow Springs Instrument Co., Inc. — 2 clearances
- Nova Biomedical Corp. — 2 clearances
- I-Stat Corp. — 2 clearances
- Eastman Kodak Company — 2 clearances
- E.I. Dupont DE Nemours & Co., Inc. — 2 clearances
