21 CFR 862.1020 — Acid Phosphatase, Nitrophenylphosphate
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1020
Identification
An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.
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 |
|---|---|---|---|---|
| CJN | Acid Phosphatase, Nitrophenylphosphate | 2 | 1 | |
| CJR | Acid Phosphatase, Thymol Blue Monophosphate | 2 | 2 | |
| CJX | Acid Phosphatase, Disodium Phenylphosphate | 2 | 0 | |
| CKB | Acid Phosphatase, Naphthyl Phosphate | 2 | 24 | |
| CKE | Acid Phosphatase, Thymolphthale Inmonophosphate | 2 | 9 | |
| CKH | Acid Phosphatase, Beta Glycerophosphate | 2 | 0 | |
| JFH | Acid Phosphatase (Prostatic), Tartrate Inhibited | 2 | 45 |
Special Controls
CKE — Acid Phosphatase, Thymolphthale Inmonophosphate
*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
CKH — Acid Phosphatase, Beta Glycerophosphate
*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
JFH — Acid Phosphatase (Prostatic), Tartrate Inhibited
*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
