MDx-Chex for BCY
FDA 510(k) K254167 · Streck, LLC
510(k) numberK254167
Submission
- Device name
- MDx-Chex for BCY
- Applicant
- Streck, LLC
La Vista, NE, US - Received
- December 23, 2025
- Decision date
- March 17, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PMN – Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3920
- Specialty
- Microbiology
Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.
Other 510(k)s with product code PMN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitPMN · Traditional | Biofire Defense, LLC | 07/17/2026SE |
| K260577 | FilmArray TF Control Panel M527PMN · Traditional | Maine Molecular Quality Controls, Inc. | 05/19/2026SE |
| K260041 | MDx-Chex for BCPPMN · Traditional | Streck, LLC | 03/27/2026SE |
| K254166 | MDx-Chex for BCNPMN · Traditional | Streck | 03/23/2026SE |
| K251526 | FilmArray GI Control Panel M238PMN · Traditional | Maine Molecular Quality Controls, Inc. | 08/14/2025SE |
| K241289 | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlPMN · Special | Maine Molecular Quality Controls, Inc. | 05/30/2024SE |
| K233611 | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE…PMN · Traditional | Maine Molecular Quality Controls, Inc. | 03/26/2024SE |
| K231223 | MDx-Chex for BC-GNPMN · Traditional | Streck | 07/27/2023SE |
| K231221 | MDx-Chex for BC-GPPMN · Traditional | Streck | 07/27/2023SE |
| K230868 | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative…PMN · Special | Maine Molecular Quality Controls, Inc. | 04/13/2023SE |
More from Maine Molecular Quality Controls, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260041 | MDx-Chex for BCPPMN · Traditional | 03/27/2026SE |
| K254166 | MDx-Chex for BCNPMN · Traditional | 03/23/2026SE |
| K231776 | Cell-Free DNA BCTQMA · Traditional | 07/26/2024SE |
| 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 MDx-Chex for BCY cleared by the FDA?
MDx-Chex for BCY (K254167) received a 510(k) decision of Substantially Equivalent on March 17, 2026, 84 days after the submission was received.
What is the product code of K254167?
The FDA product code is PMN – Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays, a Class II (moderate risk) device regulated under 21 CFR 866.3920.