Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart E — Immunology Laboratory Equipment and Reagents](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents) → [21 CFR 866.4520](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/866.4520) → JZT — Fluorometer

# JZT · Fluorometer

_Immunology · 21 CFR 866.4520 · Class 1_

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

## Overview

- **Product Code:** JZT
- **Device Name:** Fluorometer
- **Regulation:** [21 CFR 866.4520](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/866.4520)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## 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.

## 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 the limitations in § 866.9.

## Recent Cleared Devices (14 of 14)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K962499](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZT/K962499.md) | ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER | Bartels, Inc. | Sep 5, 1996 | SESE |
| [K883349](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZT/K883349.md) | QLIA IMMUNOCHEMISTRY SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | Sep 7, 1988 | SESE |
| [K882677](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZT/K882677.md) | STAT-20 FLUOROMETER | Weaver Medical | Jul 12, 1988 | SESE |
| [K864699](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZT/K864699.md) | FLUORESCENCE CONCENTRATION ANALYZER (FCA) | Pandex Laboratories, Inc. | Dec 22, 1986 | SESE |
| [K863434](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZT/K863434.md) | THE FIAX 5000 FLUOROMETER | Whittaker Bioproducts, Inc. | Oct 29, 1986 | SESE |
| [K862674](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZT/K862674.md) | PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM | Hybritech, Inc. | Aug 15, 1986 | SESE |
| [K852240](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZT/K852240.md) | SMS, SCREEN MACHINE SYSTEM | Pandex Laboratories, Inc. | Jun 11, 1985 | SESE |
| [K842049](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZT/K842049.md) | FLUOROSKAN | Flow Laboratories, Inc. | Dec 3, 1984 | SESE |
| [K843356](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZT/K843356.md) | FIAX 100 FLUOROMETER | Intl. Diagnostic Technology | Sep 17, 1984 | SESE |
| [K834070](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZT/K834070.md) | IMMPULSE SYSTEM | Paragon Diagnostics, Inc. | Mar 23, 1984 | SESE |
| [K831870](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZT/K831870.md) | ALLERGENETICS FLUORO-FAST READER | Axonics, Inc. | Aug 12, 1983 | SESE |
| [K800698](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZT/K800698.md) | AUTOFLUOR SYSTEM | California Immuno Diagnostic, Inc. | May 28, 1980 | SESE |
| [K782150](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZT/K782150.md) | FLUROMETER, DADE | Dade, Baxter Travenol Diagnostics, Inc. | Feb 15, 1979 | SESE |
| [K770662](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZT/K770662.md) | VIEWER, FLUOROMETIC, MODEL 721 | Corning Medical & Scientific | Apr 15, 1977 | SESE |

## Top Applicants

- Pandex Laboratories, Inc. — 2 clearances
- Axonics, Inc. — 1 clearance
- Bartels, Inc. — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- California Immuno Diagnostic, Inc. — 1 clearance

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

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