Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7695](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7695) → LCO — Platelet Factor 4 Radioimmunoassay

# LCO · Platelet Factor 4 Radioimmunoassay

_Hematology · 21 CFR 864.7695 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO

## Overview

- **Product Code:** LCO
- **Device Name:** Platelet Factor 4 Radioimmunoassay
- **Regulation:** [21 CFR 864.7695](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7695)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)
- **3rd-party reviewable:** yes

## Identification

A platelet factor 4 radioimmunoassay is a device used to measure the level of platelet factor 4, a protein released during platelet activation by radioimmunoassay. This device measures platelet activiation, which may indicate a coagulation disorder, such as myocardial infarction or coronary artery disease.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K243374](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO/K243374.md) | HemosIL CL HIT-IgG(PF4-H) | Instrumentation Laboratory (IL) Co. | Jan 28, 2025 | SESE |
| [K201570](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO/K201570.md) | PF4 Enhanced assay | Immucor Gti Diagnostics, Inc. | Sep 11, 2020 | SESE |
| [K201311](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO/K201311.md) | PF4 IgG assay | Immucor Gti Diagnostics, Inc. | Jun 18, 2020 | SESE |
| [K170854](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO/K170854.md) | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls | Instrumentation Laboratory CO | Sep 8, 2017 | SESE |
| [K153137](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO/K153137.md) | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls | Instrumentation Laboratory CO | Jul 8, 2016 | SESE |
| [K071781](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO/K071781.md) | PF4 IGG | Genetic Testing Institute | Dec 19, 2007 | SESE |
| [K071255](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO/K071255.md) | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A | Hyphen Biomed | Sep 7, 2007 | SESE |
| [K053559](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO/K053559.md) | PF4 ENHANCED SOLID PHASE ELISA | Genetic Testing Institute | Jan 20, 2006 | SESE |
| [K040293](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO/K040293.md) | HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY | Akers Laboratories, Inc. | May 28, 2004 | SESE |
| [K003767](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO/K003767.md) | ASSERACHROM HPIA TEST KIT | Diagnostica Stago, Inc. | Feb 12, 2001 | SESE |
| [K983379](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO/K983379.md) | GTI-PF4 ELISA | Genetic Testing Institute | Mar 9, 1999 | SESE |
| [K890633](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO/K890633.md) | ENZYGNOST PLATELET FACTOR 4 (PF4) KIT | Behring Diagnostics, Inc. | Apr 21, 1989 | SESE |
| [K862774](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO/K862774.md) | ASSERACHROM PF4 KIT | American Bioproducts Co. | Sep 4, 1986 | SESE |

## Top Applicants

- Genetic Testing Institute — 3 clearances
- Immucor Gti Diagnostics, Inc. — 2 clearances
- Instrumentation Laboratory CO — 2 clearances
- Akers Laboratories, Inc. — 1 clearance
- American Bioproducts Co. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO)

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