← Product Code [JZT](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZT) · K864699

# FLUORESCENCE CONCENTRATION ANALYZER (FCA) (K864699)

_Pandex Laboratories, Inc. · JZT · Dec 22, 1986 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZT/K864699

## Device Facts

- **Applicant:** Pandex Laboratories, Inc.
- **Product Code:** [JZT](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZT.md)
- **Decision Date:** Dec 22, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.4520
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

Immunofluorometer equipment for clinical use with its electrical power supply is a device used to measure the fluorescence of fluorochrome-labeled antigen-antibody complexes. The concentration of these complexes may be measured by means of reflected light. A beam of light is passed through a solution in which a fluorochrome has been selectively attached to serum protein antibody molecules in suspension. The amount of light emitted by the fluorochrome label is detected by a photodetector, which converts light energy into electrical energy. The amount of electrical energy registers on a readout system such as a digital voltmeter or a recording chart. This electrical readout is called the fluorescence value and is used to measure the concentration of antigen-antibody complexes.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZT/K864699](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZT/K864699)

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