Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2800](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2800) → JRE — Refractometer For Clinical Use

# JRE · Refractometer For Clinical Use

_Clinical Chemistry · 21 CFR 862.2800 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE

## Overview

- **Product Code:** JRE
- **Device Name:** Refractometer For Clinical Use
- **Regulation:** [21 CFR 862.2800](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2800)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A refractometer for clinical use is a device intended to determine the amount of solute in a solution by measuring the index of refraction (the ratio of the velocity of light in a vacuum to the velocity of light in the solution). The index of refraction is used to measure the concentration of certain analytes (solutes), such a plasma total proteins and urinary total solids. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions.

## 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 § 862.9.

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K954977](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE/K954977.md) | URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) | Teco Diagnostics | Mar 11, 1996 | SESE |
| [K941906](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE/K941906.md) | MODEL 2730 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | Jan 17, 1995 | SESE |
| [K941903](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE/K941903.md) | MODEL 2740 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | Jan 17, 1995 | SESE |
| [K941901](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE/K941901.md) | MODEL 2721 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | Jan 17, 1995 | SESE |
| [K941905](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE/K941905.md) | MODEL 3461 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | Dec 13, 1994 | SESE |
| [K941904](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE/K941904.md) | MODEL A300CL CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | Dec 13, 1994 | SESE |
| [K941902](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE/K941902.md) | MODEL 3471 CLINICAL REFRACTOMETER | Vee Gee Scientific, Inc. | Dec 13, 1994 | SESE |
| [K891681](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE/K891681.md) | DILECTRON URINARY CONDUCTIVITY PROBE | Gyrus Medical , Ltd. | May 1, 1990 | SESE |
| [K842168](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE/K842168.md) | ATAGO URINE SPECIFIC GRAVITY & SERUM | Kyoto Diagnostics, Inc. | Jul 16, 1984 | SESE |
| [K831213](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE/K831213.md) | SPECIFIC GRAVITY INSTRUMENT | Iris | Jun 30, 1983 | SESE |
| [K811342](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE/K811342.md) | REAGENT STRIPS FOR URINALYSIS | Miles Laboratories, Inc. | Sep 1, 1981 | SESE |
| [K802959](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE/K802959.md) | NIKON URINE REFRACTOMER SG-1 | Nippon Kogaku, Inc. | Dec 19, 1980 | SESE |
| [K790862](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE/K790862.md) | BIOVATION DIGITAL URINOMETER | Biovation, Inc. | Jun 28, 1979 | SESE |

## Top Applicants

- Vee Gee Scientific, Inc. — 6 clearances
- Biovation, Inc. — 1 clearance
- Gyrus Medical , Ltd. — 1 clearance
- Iris — 1 clearance
- Kyoto Diagnostics, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE)

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