21 CFR 862.1445 — Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1445
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CEX | Chromatographic Separation, Lactate Dehydrogenase Isoenzymes | 2 | 8 | |
| CFE | Electrophoretic, Lactate Dehydrogenase Isoenzymes | 2 | 28 | |
| JGF | Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes | 2 | 6 |
Special Controls
CEX — Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
*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.
eCFR
CFE — Electrophoretic, Lactate Dehydrogenase Isoenzymes
*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.
eCFR
JGF — Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
*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.
eCFR
