FDA product code OYJ: Dna Specimen Collection, Saliva
OYJ is the FDA product code for dna specimen collection, saliva. It is a Class II device, regulated under 21 CFR 862.1675 and reviewed by the Clinical Chemistry panel. FDA has cleared 7 510(k) submissions under OYJ, 1 in the last five years, from 2 different applicants. The average 510(k) review took 267 days (median 266). FDA has posted 1 recall for OYJ devices, 1 initiated in the last five years.
Definition
A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing.
Classification
| Field | Value |
|---|---|
| Device name | Dna Specimen Collection, Saliva |
| Device class | Class II |
| Regulation | 21 CFR 862.1675 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for OYJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 2 | 195 |
| 2022 | 1 | 423 |
Compare with all 510(k) review times · Search every OYJ clearance
Top OYJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| DNA Genotek, Inc. | 6 | 2022-10-27 |
| Ancestry Genomics, Inc. | 1 | 2020-08-13 |
Most recent OYJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K212745 | DNA Genotek, Inc. | ORAcollect®Dx | 2022-10-27 | 423 |
| K192947 | Ancestry Genomics, Inc. | AncestryDNA Saliva Collection Kit | 2020-08-13 | 300 |
| K192920 | DNA Genotek, Inc. | Oragene®Dx | 2020-01-14 | 90 |
| K152556 | DNA Genotek, Inc. | Oragene Dx | 2016-05-26 | 261 |
| K152464 | DNA Genotek, Inc. | ORAcollect.Dx | 2016-05-26 | 269 |
Recalls for OYJ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-02-18.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code OYJ?
OYJ is the FDA product code for dna specimen collection, saliva. It is a Class II device, regulated under 21 CFR 862.1675 and reviewed by the Clinical Chemistry panel.
What device class is OYJ?
Class II, regulation 21 CFR 862.1675. Typical premarket route: 510(k).
How long does a 510(k) take for product code OYJ?
Across 7 cleared submissions the average was 267 days from receipt to decision (median 266).
Which companies have the most OYJ clearances?
DNA Genotek, Inc. (6); Ancestry Genomics, Inc. (1).
Have OYJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-02-18.
Next steps
- Run an FDA pathway report with predicate devices for product code OYJ
- Run a recall and safety report across every OYJ manufacturer
- Watch product code OYJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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