JZW · Nephelometer
Immunology · 21 CFR 866.4540 · Class 1
Overview
| Product Code | JZW |
|---|---|
| Device Name | Nephelometer |
| Regulation | 21 CFR 866.4540 |
| Device Class | Class 1 |
| Review Panel | Immunology |
Identification
Immunonephelometer equipment for clinical use with its electrical power supply is a device that measures light scattering from antigen-antibody complexes. The concentration of these complexes may be measured by means of reflected light. A beam of light passed through a solution is scattered by the particles in suspension. The amount of light 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 light-scattering value and is used to measure the concentration of antigen-antibody complexes. This generic type of device includes devices with various kinds of light sources, such as laser equipment.
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 (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K001647 | BN PROSPEC SYSTEM | Dade Behring, Inc. | Sep 26, 2000 | SESE |
| K761234 | BEHRING LASER NEPHELOMETER | Behring Diagnostics, Inc. | Jun 7, 1990 | SESE |
| K892223 | BEHRING NEPHELOMETER 100 | Behring Diagnostics, Inc. | May 4, 1989 | SESE |
| K873407 | RRT SYSTEM LASER REFLECTOMETER ANALYZER | Incstar Corp. | Sep 23, 1987 | SESE |
| K873401 | TURBOX | Unipath , Ltd. | Sep 23, 1987 | SESE |
| K801949 | BCM-302 COLLIMATING CONE & COMPENSATIN | B C Medical , Ltd. | Oct 3, 1980 | SESE |
| K801391 | DISC 120 TRANSPORTER | Travenol Laboratories, S.A. | Jul 14, 1980 | SESE |
| K792014 | LANCER L-INA BUFFER, POLYMER, WASH SOLU | Sherwood Medical Industries | Nov 13, 1979 | SESE |
| K781006 | IMMUNOCHEMISTRY SYS. MANUAL MODE | Beckman Instruments, Inc. | Aug 31, 1978 | SESE |
| K761236 | ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR. | Behring Diagnostics, Inc. | Dec 30, 1976 | SESE |
| K761235 | LASER STANDARD SERUM | Behring Diagnostics, Inc. | Dec 30, 1976 | SESE |
Top Applicants
- Behring Diagnostics, Inc. — 4 clearances
- B C Medical , Ltd. — 1 clearance
- Beckman Instruments, Inc. — 1 clearance
- Dade Behring, Inc. — 1 clearance
- Incstar Corp. — 1 clearance
