510(k) K240854
K240854 is an FDA 510(k) premarket notification submitted by Accelerate Diagnostics, Inc. for the device "Accelerate Arc System". The FDA issued a decision of Substantially Equivalent on September 26, 2024. The device falls under product code QNJ (Mass Spectrometry, Microorganism Identification, Blood Culture), a Class II device regulated under 21 CFR 866.3378. Accelerate Diagnostics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2024
- Date Received
- March 28, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mass Spectrometry, Microorganism Identification, Blood Culture
- Device Class
- Class II
- Regulation Number
- 866.3378
- Review Panel
- MI
- Submission Type
Blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system with organisms subsequently identified by spectrometry.