21 CFR 862.1465 — Olive Oil Emulsion (Turbidimetric), Lipase
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1465
Identification
A lipase test system is a device intended to measure the activity of the enzymes lipase in serum. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CET | Olive Oil Emulsion (Turbidimetric), Lipase | 1 | 15 | |
| CFG | Oil Emulsion/Thymolphthalein (Titrimetric), Lipase | 1 | 2 | |
| CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | 1 | 20 |
