Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2720](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2720) → JJK — Oncometer, Plasma, For Clinical Use

# JJK · Oncometer, Plasma, For Clinical Use

_Clinical Chemistry · 21 CFR 862.2720 · Class 1_

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

## Overview

- **Product Code:** JJK
- **Device Name:** Oncometer, Plasma, For Clinical Use
- **Regulation:** [21 CFR 862.2720](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2720)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A plasma oncometer for clinical use is a device intended to measure plasma oncotic pressure, which is that portion of the total plasma osmotic pressure contributed by protein and other molecules too large to pass through a specified semipermeable membrane. Because variations in plasma oncotic pressure are indications of certain disorders, measurements of the variations are useful in the diagnosis and treatment of these disorders.

## 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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K863099](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJK/K863099.md) | ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT | Abbott Laboratories | Sep 16, 1986 | SESE |
| [K823196](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJK/K823196.md) | SPECIAL CONTROL SERUM FOR HDL-CHOLES | Boehringer Mannheim Corp. | Nov 29, 1982 | SESE |
| [K802120](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJK/K802120.md) | HEPA-SHURE -L | Nuclear Medical Laboratories, Inc. | Oct 20, 1980 | SESE |
| [K760975](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJK/K760975.md) | WEIL ONCOMETER (IL 186) | Instrumentation Laboratory CO | Jan 12, 1977 | SESE |

## Top Applicants

- Abbott Laboratories — 1 clearance
- Boehringer Mannheim Corp. — 1 clearance
- Instrumentation Laboratory CO — 1 clearance
- Nuclear Medical Laboratories, Inc. — 1 clearance

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

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