JKL · Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry
Clinical Chemistry · 21 CFR 862.1060 · Class 1
Overview
| Product Code | JKL |
|---|---|
| Device Name | Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry |
| Regulation | 21 CFR 862.1060 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A delta-aminolevulinic acid test system is a device intended to measure the level of delta-aminolevulinic acid (a precursor of porphyrin) in urine. Delta-aminolevulinic acid measurements are used in the diagnosis and treatment of lead poisoning and certain porphyrias (diseases affecting the liver, gastrointestinal, and nervous systems that are accompanied by increased urinary excretion of various heme compounds including delta-aminolevulinic acid).
Classification Rationale
Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K921534 | DSL DHEA (DSL 8900) | Diagnostic Systems Laboratories, Inc. | May 26, 1992 | SESE |
| K842310 | HEMATOLOGY ANALYZER | Hml Inc/Biotechnology Transfer | Sep 6, 1984 | SESE |
Top Applicants
- Diagnostic Systems Laboratories, Inc. — 1 clearance
- Hml Inc/Biotechnology Transfer — 1 clearance
