Product code OYJ— Clinical Chemistry

AncestryDNA Saliva Collection Kit

Classification name: Dna Specimen Collection, Saliva
Device class: Class 2
Regulation: 21 CFR 862.1675
Advisory panel: Clinical Chemistry
Total cleared: 7
First cleared: 2011-12-02
Most recent: 2022-10-27

FDA classification definition

“A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing.”
— U.S. Food and Drug Administration, device classification record for product code OYJ under 21 CFR 862.1675, via openFDA

Market context for product code OYJ

FDA has cleared 7 devices under product code OYJ between 2011 and 2022, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20221 clearance
20202 clearances
20162 clearances
20151 clearance
20111 clearance

Top applicants under product code OYJ

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

Recent clearances under product code OYJ

K212745 — ORAcollect®DxDNA Genotek, Inc.·2022-10-27
K192947 — AncestryDNA Saliva Collection KitAncestry Genomics, Inc.·2020-08-13
K192920 — Oragene®DxDNA Genotek, Inc.·2020-01-14
K152464 — ORAcollect.DxDNA Genotek, Inc.·2016-05-26
K152556 — Oragene DxDNA Genotek, Inc.·2016-05-26
K141410 — ORAGENE DX OGD-500.001DNA Genotek, Inc.·2015-02-19
K110701 — ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500DNA Genotek, Inc.·2011-12-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.