Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart F — Automated and Semi-Automated Hematology Devices](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices) → [21 CFR 864.5600](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5600) → GKF — Instrument, Hematocrit, Automated

# GKF · Instrument, Hematocrit, Automated

_Hematology · 21 CFR 864.5600 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF

## Overview

- **Product Code:** GKF
- **Device Name:** Instrument, Hematocrit, Automated
- **Regulation:** [21 CFR 864.5600](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5600)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

An automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (15 of 15)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K160415](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF/K160415.md) | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) | Instrumentation Laboratory CO | Dec 14, 2016 | SESE |
| [K983551](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF/K983551.md) | CRIT-SCAN II MONITOR | In-Line Diagnostics Corp. | May 27, 1999 | SESE |
| [K981427](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF/K981427.md) | STAT PROFILE M ANALYZER | Nova Biomedical Corp. | May 12, 1998 | SESE |
| [K981426](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF/K981426.md) | STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS | Nova Biomedical Corp. | May 12, 1998 | SESE |
| [K981425](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF/K981425.md) | STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS | Nova Biomedical Corp. | May 12, 1998 | SESE |
| [K953519](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF/K953519.md) | MICROSPIN 24 | Vulcon Technologies | Nov 3, 1995 | SESE |
| [K915825](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF/K915825.md) | MARATHON 6K GENERAL-PURPOSE CENTRIFUGE | Fisher Scientific Co., LLC | Mar 11, 1992 | SESE |
| [K915441](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF/K915441.md) | MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE | Fisher Scientific Co., LLC | Jan 8, 1992 | SESE |
| [K904336](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF/K904336.md) | NEW COBE SATURATION/HEMATOCRIT MONITOR | Cobe Laboratories, Inc. | Dec 27, 1990 | SESE |
| [K880373](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF/K880373.md) | IONOMETER E-HK AND ACCESSORIES | Smash Ent., Inc. | Mar 17, 1988 | SESE |
| [K870860](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF/K870860.md) | CHEMPRO 1000(TM) | Arden Medical Systems, Inc. | Apr 14, 1987 | SESE |
| [K864646](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF/K864646.md) | SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE | E.I. Dupont DE Nemours & Co., Inc. | Jan 5, 1987 | SESE |
| [K864039](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF/K864039.md) | MICROHEMATOCRIT CENTRIFUGE | Plaza Medical, Inc. | Oct 29, 1986 | SESE |
| [K802199](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF/K802199.md) | STAT-CRIT HEMATOCRIT MEASURING INSTRU | United States Surgical, A Division of Tyco Healthc | Feb 4, 1981 | SESE |
| [K781059](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF/K781059.md) | CUTTER/COMPUR MINI CENTRIFUGE | Cutter Laboratories, Inc. | Aug 14, 1978 | SESE |

## Top Applicants

- Nova Biomedical Corp. — 3 clearances
- Fisher Scientific Co., LLC — 2 clearances
- Arden Medical Systems, Inc. — 1 clearance
- Cobe Laboratories, Inc. — 1 clearance
- Cutter Laboratories, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKF)

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