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 864.5425](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5425) → LGP — Assay, Alpha-2-Antiplasmin

# LGP · Assay, Alpha-2-Antiplasmin

_Hematology · 21 CFR 864.5425 · Class 2_

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

## Overview

- **Product Code:** LGP
- **Device Name:** Assay, Alpha-2-Antiplasmin
- **Regulation:** [21 CFR 864.5425](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5425)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)
- **3rd-party reviewable:** yes

## Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

## Classification Rationale

Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K864213](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LGP/K864213.md) | IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY | Instrumentation Laboratory CO | Nov 25, 1986 | SESE |
| [K850411](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LGP/K850411.md) | GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY | Warner-Lambert Co. | May 8, 1985 | SESE |
| [K833890](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LGP/K833890.md) | COATEST ANTIPLASMIN | Kabivitrum, Inc. | Jan 30, 1984 | SESE |
| [K803110](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LGP/K803110.md) | PROTEOLYTIC ENZYME CONTROL | American Dade | Feb 17, 1981 | SESE |
| [K802840](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/LGP/K802840.md) | ALPHA-ANTIPLASM ASSAY | American Dade | Feb 17, 1981 | SESE |

## Top Applicants

- American Dade — 2 clearances
- Instrumentation Laboratory CO — 1 clearance
- Kabivitrum, Inc. — 1 clearance
- Warner-Lambert Co. — 1 clearance

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

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