Spectrum Saliva Collection Device
FDA 510(k) K223497 · Spectrum Solutions, LLC
510(k) numberK223497
Submission
- Device name
- Spectrum Saliva Collection Device
- Applicant
- Spectrum Solutions, LLC
Draper, UT, US - Received
- November 21, 2022
- Decision date
- February 17, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QBD – Microbial Nucleic Acid Storage And Stabilization Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.2950
- Specialty
- Microbiology
Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material.
Other 510(k)s with product code QBD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242820 | Puritan PurSafe Plus Collection and Transport SystemQBD · Traditional | Puritan Medical Products, LLC | 05/27/2025SE |
| K240797 | PPH Saliva Collection KitQBD · Traditional | Permantis Public Health | 10/11/2024SE |
| K222771 | Sample Preservative FluidQBD · Traditional | Hangzhou Bioer Technology Co., Ltd. | 06/26/2024SE |
| K233324 | Molecular Transport Media - MTMQBD · Traditional | Alb Luz | 06/17/2024SE |
| K221547 | InActiv BlueQBD · Traditional | Fertipro NV | 06/11/2024SE |
| K212878 | Sample preservation solutionQBD · Traditional | Zhejiang Gene Science Co., Ltd. | 04/08/2024SE |
| K231013 | DNA/RNA Shield SafeCollect Saliva Collection kitQBD · Traditional | Zymo Research | 09/28/2023SE |
| K221664 | CLEARinse CTS Specimen Collection and Transport SystemQBD · Traditional | Aardvark Medical, Inc. | 07/03/2023SE |
| K221802 | iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)QBD · Traditional | Mawi Dna Technologies | 04/03/2023SE |
| K220059 | Biosci Inactivated Transport Medium, Biosci ITMQBD · Traditional | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 01/19/2023SE |
Questions and answers
When was Spectrum Saliva Collection Device cleared by the FDA?
Spectrum Saliva Collection Device (K223497) received a 510(k) decision of Substantially Equivalent on February 17, 2023, 88 days after the submission was received.
What is the product code of K223497?
The FDA product code is QBD – Microbial Nucleic Acid Storage And Stabilization Device, a Class II (moderate risk) device regulated under 21 CFR 866.2950.