Atlas FDA

MDx-Chex for BCY

FDA 510(k) clearance K254167 · decided 2026-03-17

Clearance details

K-number
K254167
Device name
MDx-Chex for BCY
Applicant
Streck, LLC
Decision
Substantially Equivalent
Date received
2025-12-23
Decision date
2026-03-17
Days to decision
84 days
Clearance type
Traditional
Product code
PMN
Device class
2
Regulation number
866.3920
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
La Vista, NE, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit (K261475)Biofire Defense, LLC2026-07-17
FilmArray TF Control Panel M527 (K260577)Maine Molecular Quality Controls, Inc.2026-05-19
MDx-Chex for BCP (K260041)Streck, LLC2026-03-27
MDx-Chex for BCN (K254166)Streck2026-03-23
FilmArray GI Control Panel M238 (K251526)Maine Molecular Quality Controls, Inc.2025-08-14
SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control (K241289)Maine Molecular Quality Controls, Inc.2024-05-30
SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) (K233611)Maine Molecular Quality Controls, Inc.2024-03-26
MDx-Chex for BC-GP (K231221)Streck2023-07-27
MDx-Chex for BC-GN (K231223)Streck2023-07-27
SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control (K230868)Maine Molecular Quality Controls, Inc.2023-04-13
SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control (K221253)Maine Molecular Quality Controls, Inc.2023-02-03
BioFire JI Control Panel M420 (K203680)Maine Molecular Quality Controls, Inc.2022-07-22

Recalls involving this device

No recalls on record reference this clearance.