# QBB · Placental Alpha Microglobulin-1 Immunoassay

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/QBB

## Overview

- **Product Code:** QBB
- **Device Name:** Placental Alpha Microglobulin-1 Immunoassay
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

A Placental Alpha Microglobulin-1 Immunoassay is a qualitative test intended to detect the presence of placental alpha microglobulin 1 (PAMG-1) in cervicovaginal secretions. The test is indicated as an aid to assess the risk of spontaneous preterm delivery in less than or equal to 7 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P160052](/device/P160052.md) | PartoSure test | Qiagen, Inc. | Apr 11, 2018 | APPR |

## Top Applicants

- Qiagen, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/QBB](https://fda.innolitics.com/productcode/QBB)

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