JKJ · Fluorometric Measurement, Porphyrins
Clinical Chemistry · 21 CFR 862.1595 · Class 1
Overview
| Product Code | JKJ |
|---|---|
| Device Name | Fluorometric Measurement, Porphyrins |
| Regulation | 21 CFR 862.1595 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A porphyrins test system is a device intended to measure porphyrins (compounds formed during the biosynthesis of heme, a constituent of hemoglobin, and related compounds) in urine and feces. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning, porphyrias (primarily inherited diseases associated with disturbed porphyrin metabolism), 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.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K893038 | PROTOFLUOR Z | Helena Laboratories | Nov 17, 1989 | SESE |
| K871499 | PROTOFLUOR Z | Helena Laboratories | Aug 25, 1987 | SESE |
| K780455 | QUANTITATIVE DETERMINATION OF PORPHYRINS | Whale Scientific, Inc. | Jul 27, 1978 | SESE |
Top Applicants
- Helena Laboratories — 2 clearances
- Whale Scientific, Inc. — 1 clearance
