Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7720](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7720) → GGQ — Test, Prothrombin Consumption

# GGQ · Test, Prothrombin Consumption

_Hematology · 21 CFR 864.7720 · Class 2_

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

## Overview

- **Product Code:** GGQ
- **Device Name:** Test, Prothrombin Consumption
- **Regulation:** [21 CFR 864.7720](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7720)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A prothrombin consumption tests is a device that measures the patient's capacity to generate thromboplastin in the coagulation process. The test also is an indirect indicator of qualitative or quantitative platelet abnormalities. It is a screening test for thrombocytopenia (decreased number of blood platelets) and hemophilia A and B.

## Classification Rationale

Class II (special controls). The device 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). The device 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K803081](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGQ/K803081.md) | QUANTICHECK CONTROL PLASMA | Abbott Laboratories | Mar 17, 1981 | SESE |
| [K800656](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGQ/K800656.md) | A-GENT QUANTICHROM THROMBIGEN-E | Abbott Laboratories | May 30, 1980 | SESE |

## Top Applicants

- Abbott Laboratories — 2 clearances

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

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