Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1675](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1675) → PJE — Blood/Plasma Collection Device For Dna Testing

# PJE · Blood/Plasma Collection Device For Dna Testing

_Clinical Chemistry · 21 CFR 862.1675 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/PJE

## Overview

- **Product Code:** PJE
- **Device Name:** Blood/Plasma Collection Device For Dna Testing
- **Regulation:** [21 CFR 862.1675](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1675)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

## Classification Rationale

Class II.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K231469](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/PJE/K231469.md) | PAXgene® Blood DNA Tube | Preanalytix GmbH | Jun 21, 2023 | SESE |
| [K142821](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/PJE/K142821.md) | PAXgene Blood DNA Tube | Preanalytix GmbH | Sep 9, 2015 | SESE |
| [K042927](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/PJE/K042927.md) | VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES | Greiner Bio-One Vacuette North America | Apr 15, 2005 | SESE |
| [K031359](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/PJE/K031359.md) | S-MONOVETTE EDTA K2-GEL | Sarstedt, Inc. | Sep 12, 2003 | SESE |
| [K014104](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/PJE/K014104.md) | VACUETTE EDTA K2 TUBES | Greiner Vacuette North America, Inc. | Feb 1, 2002 | SESE |
| [K012043](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/PJE/K012043.md) | VACUETTE EDTA K2 GEL TUBES | Greiner Vacuette North America, Inc. | Sep 24, 2001 | SESE |
| [K010328](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/PJE/K010328.md) | MULTIPLE (IZON DNA BLOOD COLLECTION KIT) | Izon Business Products, Inc. | Apr 9, 2001 | SESE |
| [K972075](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/PJE/K972075.md) | VACUTAINER BRAND PPT PLASMA PREPARATION TUBE | Becton Dickinson Vacutainer Systems | Feb 24, 1998 | SESE |

## Top Applicants

- Greiner Vacuette North America, Inc. — 2 clearances
- Preanalytix GmbH — 2 clearances
- Becton Dickinson Vacutainer Systems — 1 clearance
- Greiner Bio-One Vacuette North America — 1 clearance
- Izon Business Products, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/PJE](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/PJE)

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