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) → OYJ — Dna Specimen Collection, Saliva

# OYJ · Dna Specimen Collection, Saliva

_Clinical Chemistry · 21 CFR 862.1675 · Class 2_

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

## Overview

- **Product Code:** OYJ
- **Device Name:** Dna Specimen Collection, Saliva
- **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 (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K212745](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/OYJ/K212745.md) | ORAcollect®•Dx | DNA Genotek, Inc. | Oct 27, 2022 | SESE |
| [K192947](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/OYJ/K192947.md) | AncestryDNA Saliva Collection Kit | Ancestry Genomics, Inc. | Aug 13, 2020 | SESE |
| [K192920](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/OYJ/K192920.md) | Oragene®•Dx | DNA Genotek, Inc. | Jan 14, 2020 | SESE |
| [K152556](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/OYJ/K152556.md) | Oragene Dx | DNA Genotek, Inc. | May 26, 2016 | SESE |
| [K152464](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/OYJ/K152464.md) | ORAcollect.Dx | DNA Genotek, Inc. | May 26, 2016 | SESE |
| [K141410](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/OYJ/K141410.md) | ORAGENE DX OGD-500.001 | DNA Genotek, Inc. | Feb 19, 2015 | SESE |
| [K110701](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/OYJ/K110701.md) | ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 | DNA Genotek, Inc. | Dec 2, 2011 | SESE |

## Top Applicants

- DNA Genotek, Inc. — 6 clearances
- Ancestry Genomics, Inc. — 1 clearance

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

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