Written and maintained by CASRAI Editorial Board
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General product information only, from the FDA and manufacturer documents cited below. It is not medical advice and not a substitute for the instructions that come with a specific kit or for a laboratory’s own procedure.
A saliva collection kit for DNA testing is a spit tube with a funnel lid and a stabilizing liquid, a small cap for sealing the tube, instructions and return packaging. The FDA files this device type as DNA Specimen Collection, Saliva (product code OYJ, Class II). Whether a given kit is cleared for diagnostic use or labeled for research only is the first thing to check, and it is printed on the kit documents.
What a saliva collection kit is for
The FDA product classification database defines the device as “a collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing.” The same tube format is sold under several names, including dna collection kit and saliva collection tube; they describe one family of products, not separate device types. A kit is a unit for one donor and one collection (a typical arrangement, not a rule).
This page covers DNA and genomic saliva kits. Oral-fluid drug-test collection is a different device with different rules; see saliva drug testing. Buccal swab and blood kits are compared in the genetic testing lab supply checklist.
Checklist table
Typical contents of a stabilizer-based saliva DNA kit, as described in the manufacturer documents cited below. Individual products differ, so the kit’s own contents list governs.
| Item | Typical quantity | Why it is there | Notes from the source documents |
|---|---|---|---|
| Collection tube with funnel lid | 1 per donor | Receives the saliva | Tube is 16 mm in diameter and 93 mm high without cap on the OG-500 (DNA Genotek brochure) |
| Stabilizing liquid | Pre-filled in the tube | Lyses cellular and nuclear membranes to release and stabilize nucleic acids | Function per the FDA decision summary K192920; the OGR-500 instructions carry an “Do not ingest” warning |
| Small cap | 1 | Closes the tube for transport and storage after the funnel is removed | Labeled as a choking hazard in the OGR-500 instructions |
| Sponge (assisted-collection models only) | 1 on models 575 and 675 | Alternative to spitting directly into the container | Oragene-Dx models OGD-575 and OGD-675 include a sponge (K192920) |
| Instructions for use | 1 | Donor and collector steps, warnings, storage range | Includes the Use-by date legend (“Collect saliva by”) |
| Identification label and requisition | Per laboratory | Links the tube to the donor and the test order | Not specified in the manufacturer documents; set by the receiving laboratory |
| Return packaging | 1 | Transport to the laboratory | OG-500 package is 14.0 x 8.0 x 2.8 cm and 39 g (manufacturer figure) |
What varies by kit model
Spit tube versus sponge-assisted
The FDA decision summary for Oragene-Dx (K192920) lists six models (OGD-500, 510, 575, 600, 610 and 675). Saliva is collected by spitting directly into the container or, with the sponge models 575 and 675, transferred with a sponge. The summary states the device may be collected by a healthcare professional or by a lay user.
Research use only versus diagnostic
The same spit-tube format appears with different labeling. The OGR-500 instructions are marked “For Research Use Only / Not for use in diagnostic procedures”. The OG-500 brochure and Oragene-Dx are labeled for in vitro diagnostic use; K192920 gives the indication as non-invasive collection of saliva for in vitro diagnostic testing of human DNA. It is listed as an over-the-counter device and can be used with both prescription and over-the-counter molecular diagnostic test systems. A kit labeled research-only is not labeled for diagnostic procedures regardless of how similar it looks. For the wider category, see what an in vitro diagnostic is.
Storage, expiry and restocking
- The OGR-500 instructions give a storage range of 15 to 30 C before use and print a Use-by (“Collect saliva by”) date on the label.
- The OG-500 brochure states a pre-use shelf life of 30 months and post-collection sample stability of “years”; these are manufacturer claims for that product.
- K192920 states samples can be transported or stored long term at ambient conditions. Specific shelf-life and stability numbers were established in the predicate submission (K110701) and are not given in the summary.
- Each kit carries its own Use-by date on the label. For a sibling checklist, see the urine collection kit guide.
FDA classification and rules that apply
The FDA product classification database (date checked: 2026-10-31) lists code OYJ, device name “DNA Specimen Collection, Saliva”, Class 2, regulation number 21 CFR 862.1675. That regulation is titled “Blood specimen collection device” and identifies a device to collect and handle blood specimens; saliva DNA kits are filed under the same regulation number through code OYJ. The Oragene-Dx 510(k) K192920 lists panel Clinical Chemistry, product code OYJ, 21 CFR 862.1675, Class II, with predicate K110701.
For the sample itself, see biospecimen. For another body-fluid container, see the sputum cup guide.
FAQ
Is a DNA collection kit the same as a saliva collection tube?
Both names describe the spit tube, funnel lid and stabilizer format that the FDA classifies as DNA Specimen Collection, Saliva (code OYJ). The product’s own contents list shows what a given kit includes.
Can a lay user collect the sample?
For Oragene-Dx, K192920 states the sample may be collected by a healthcare professional or by a non-healthcare professional such as a lay user.
Can the sample be shipped without refrigeration?
K192920 states the samples can be transported or stored long term at ambient conditions for that device. Other products may differ; use the instructions for your kit.
Is a saliva DNA kit the same as a saliva drug-test kit?
No. Oral-fluid drug testing uses a different collection process and is covered on the saliva drug test page.
Sources
- FDA, Product Classification, code OYJ (DNA Specimen Collection, Saliva): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=OYJ (date checked: 2026-10-31)
- 21 CFR 862.1675, Blood specimen collection device, eCFR: https://www.ecfr.gov/current/title-21/part-862/section-862.1675 (date checked: 2026-10-31)
- FDA 510(k) decision summary K192920, Oragene-Dx, DNA Genotek: https://www.accessdata.fda.gov/cdrh_docs/reviews/K192920.pdf (date checked: 2026-10-31)
- DNA Genotek, OGR-500 user instructions PD-PR-00279, Issue 1/2012-10: https://www.dnagenotek.com/row/pdf/PD-PR-00279.pdf (date checked: 2026-10-31)
- DNA Genotek, OG-500 brochure PD-BR-017, Issue 6/2016-08: https://www.dnagenotek.com/row/pdf/PD-BR-017.pdf (date checked: 2026-10-31)
