21 CFR 862.1540 — Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1540
Identification
An osmolality test system is a device intended to measure ionic and nonionic solute concentration in body fluids, such as serum and urine. Osmolality measurement is used as an adjunct to other tests in the evaluation of a variety of diseases, including kidney diseases (e.g., chronic progressive renal failure), diabetes insipidus, other endocrine and metabolic disorders, and fluid imbalances.
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 |
|---|---|---|---|---|
| JMZ | Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality | 1 | 2 | |
| JNA | Vapor Pressure, Osmolality Of Serum & Urine | 1 | 0 | |
| OND | Osmolality Of Tears | 1 | 1 | |
| PFQ | Mmp-9 Test System | 1 | 1 | 3rd Party |
