Cell-Free DNA BCT
FDA 510(k) K231776 · Streck, Inc.
510(k) numberK231776
Submission
- Device name
- Cell-Free DNA BCT
- Applicant
- Streck, Inc.
La Vista, NE, US - Received
- June 16, 2023
- Decision date
- July 26, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- QMA – Blood Collection Device For Cell-Free Nucleic Acid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1676
- Specialty
- Clinical Chemistry
A blood collection device for cell-free nucleic acids is a device intended for medical purposes to collect, store, transport, and handle blood specimens and to stabilize and isolate cell-free nucleic acid components prior to further testing.
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|---|---|---|
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| K254167 | MDx-Chex for BCYPMN · Traditional | 03/17/2026SE |
| K231223 | MDx-Chex for BC-GNPMN · Traditional | 07/27/2023SE |
| K231221 | MDx-Chex for BC-GPPMN · Traditional | 07/27/2023SE |
| K212576 | MDx-Chex for BCID2PMN · Traditional | 01/19/2022SE |
| K170091 | UA-Cellular CompleteJJW · Traditional | 02/09/2017SE |
| K160590 | XN CheckJPK · Traditional | 12/22/2016SE |
| K160588 | XN Check BFJPK · Traditional | 12/22/2016SE |
| K160586 | Xn-L CheckJPK · Traditional | 12/22/2016SE |
Questions and answers
When was Cell-Free DNA BCT cleared by the FDA?
Cell-Free DNA BCT (K231776) received a 510(k) decision of Substantially Equivalent on July 26, 2024, 406 days after the submission was received.
What is the product code of K231776?
The FDA product code is QMA – Blood Collection Device For Cell-Free Nucleic Acid, a Class II (moderate risk) device regulated under 21 CFR 862.1676.