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 866.4540](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/866.4540) → JZW — Nephelometer

# JZW · Nephelometer

_Immunology · 21 CFR 866.4540 · Class 1_

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

## Overview

- **Product Code:** JZW
- **Device Name:** Nephelometer
- **Regulation:** [21 CFR 866.4540](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/866.4540)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## 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](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZW/K001647.md) | BN PROSPEC SYSTEM | Dade Behring, Inc. | Sep 26, 2000 | SESE |
| [K761234](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZW/K761234.md) | BEHRING LASER NEPHELOMETER | Behring Diagnostics, Inc. | Jun 7, 1990 | SESE |
| [K892223](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZW/K892223.md) | BEHRING NEPHELOMETER 100 | Behring Diagnostics, Inc. | May 4, 1989 | SESE |
| [K873407](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZW/K873407.md) | RRT SYSTEM LASER REFLECTOMETER ANALYZER | Incstar Corp. | Sep 23, 1987 | SESE |
| [K873401](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZW/K873401.md) | TURBOX | Unipath , Ltd. | Sep 23, 1987 | SESE |
| [K801949](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZW/K801949.md) | BCM-302 COLLIMATING CONE & COMPENSATIN | B C Medical , Ltd. | Oct 3, 1980 | SESE |
| [K801391](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZW/K801391.md) | DISC 120 TRANSPORTER | Travenol Laboratories, S.A. | Jul 14, 1980 | SESE |
| [K792014](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZW/K792014.md) | LANCER L-INA BUFFER, POLYMER, WASH SOLU | Sherwood Medical Industries | Nov 13, 1979 | SESE |
| [K781006](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZW/K781006.md) | IMMUNOCHEMISTRY SYS. MANUAL MODE | Beckman Instruments, Inc. | Aug 31, 1978 | SESE |
| [K761236](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZW/K761236.md) | ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR. | Behring Diagnostics, Inc. | Dec 30, 1976 | SESE |
| [K761235](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/JZW/K761235.md) | 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

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

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