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) → PRJ — Capillary Blood Collection Device For Alternative Site Collection

# PRJ · Capillary Blood Collection Device For Alternative Site Collection

_Clinical Chemistry · 21 CFR 862.1675 · Class 2_

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

## Overview

- **Product Code:** PRJ
- **Device Name:** Capillary Blood Collection Device For Alternative Site Collection
- **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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K190225](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/PRJ/K190225.md) | TAP Blood Collection Device | Seventh Sense Biosystems, Inc. | Nov 5, 2019 | SESE |
| [K161521](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/PRJ/K161521.md) | TAP Blood Collection Device | Seventh Sense Biosystems, Inc. | Feb 16, 2017 | SESE |

## Top Applicants

- Seventh Sense Biosystems, Inc. — 2 clearances

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

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