JZT · Fluorometer
Immunology · 21 CFR 866.4520 · Class 1
Overview
| Product Code | JZT |
|---|---|
| Device Name | Fluorometer |
| Regulation | 21 CFR 866.4520 |
| Device Class | Class 1 |
| Review Panel | Immunology |
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 | ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER | Bartels, Inc. | Sep 5, 1996 | SESE |
| K883349 | QLIA IMMUNOCHEMISTRY SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | Sep 7, 1988 | SESE |
| K882677 | STAT-20 FLUOROMETER | Weaver Medical | Jul 12, 1988 | SESE |
| K864699 | FLUORESCENCE CONCENTRATION ANALYZER (FCA) | Pandex Laboratories, Inc. | Dec 22, 1986 | SESE |
| K863434 | THE FIAX 5000 FLUOROMETER | Whittaker Bioproducts, Inc. | Oct 29, 1986 | SESE |
| K862674 | PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM | Hybritech, Inc. | Aug 15, 1986 | SESE |
| K852240 | SMS, SCREEN MACHINE SYSTEM | Pandex Laboratories, Inc. | Jun 11, 1985 | SESE |
| K842049 | FLUOROSKAN | Flow Laboratories, Inc. | Dec 3, 1984 | SESE |
| K843356 | FIAX 100 FLUOROMETER | Intl. Diagnostic Technology | Sep 17, 1984 | SESE |
| K834070 | IMMPULSE SYSTEM | Paragon Diagnostics, Inc. | Mar 23, 1984 | SESE |
| K831870 | ALLERGENETICS FLUORO-FAST READER | Axonics, Inc. | Aug 12, 1983 | SESE |
| K800698 | AUTOFLUOR SYSTEM | California Immuno Diagnostic, Inc. | May 28, 1980 | SESE |
| K782150 | FLUROMETER, DADE | Dade, Baxter Travenol Diagnostics, Inc. | Feb 15, 1979 | SESE |
| K770662 | 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
