JGF · Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
Clinical Chemistry · 21 CFR 862.1445 · Class 2
Overview
| Product Code | JGF |
|---|---|
| Device Name | Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes |
| Regulation | 21 CFR 862.1445 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A lactate dehydrogenase isoenzymes test system is a device intended to measure the activity of lactate dehydrogenase isoenzymes (a group of enzymes with similar biological activity) in serum. Measurements of lactate dehydrogenase isoenzymes are used in the diagnosis and treatment of liver diseases, such as viral hepatitis, and myocardial infarction.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K981338 | LD-1 | Abbott Laboratories | May 18, 1998 | SESE |
| K925188 | ABBOTT QUICKSTART LD-1, MODIFICATION | Em Diagnostic Systems, Inc. | Feb 5, 1993 | SESE |
| K914261 | ABBOTT QUICKSTART LD-1,#5A30 | Em Diagnostic Systems, Inc. | Oct 21, 1991 | SESE |
| K890996 | LD1 ISOENZYME REAGENT KIT | Trace Scientific , Ltd. | May 5, 1989 | SESE |
| K871240 | ABBOTT A-GENT LD-1 ISOZYME REAGENT | Abbott Laboratories | May 13, 1987 | SESE |
| K860367 | MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) | Alpkem Corp. | Apr 11, 1986 | SESE |
Top Applicants
- Abbott Laboratories — 2 clearances
- Em Diagnostic Systems, Inc. — 2 clearances
- Alpkem Corp. — 1 clearance
- Trace Scientific , Ltd. — 1 clearance
