JNF · Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen
Clinical Chemistry · 21 CFR 862.1590 · Class 1
Overview
| Product Code | JNF |
|---|---|
| Device Name | Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen |
| Regulation | 21 CFR 862.1590 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A porphobilinogen test system is a device intended to measure porphobilinogen (one of the derivatives of hemoglobin which can make the urine a red color) in urine. Measurements obtained by this device are used in the diagnosis and treatment of porphyrias (primarily inherited diseases associated with disturbed porphyrine metabolism), lead poisoning, and other diseases characterized by alterations in the heme pathway.
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K961984 | PORPHOBILINOGEN (PBG) | Trace America, Inc. | Dec 10, 1996 | SESE |
Top Applicants
- Trace America, Inc. — 1 clearance
