← Product Code [JNF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNF) · K961984

# PORPHOBILINOGEN (PBG) (K961984)

_Trace America, Inc. · JNF · Dec 10, 1996 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNF/K961984

## Device Facts

- **Applicant:** Trace America, Inc.
- **Product Code:** [JNF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNF.md)
- **Decision Date:** Dec 10, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1590
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNF/K961984](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNF/K961984)

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