21 CFR 862.1450 — Acid, Lactic, Enzymatic Method
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1450
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KHP | Acid, Lactic, Enzymatic Method | 1 | 27 | |
| NGD | Test, Lactic Acid, Over The Counter | 1 | 0 | 3rd Party |
