MBT Compass HT CA Software; MBT FAST Shuttle US IVD
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- MBT FAST Shuttle IVD EUDAMED
- Device Name
- MBT FAST Shuttle IVD EUDAMED
- Model / Reference
- MBT FAST Shuttle IVD EUDAMED1878263 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251204326465 EUDAMED
- Basic UDI-DI
- 425120430100001012EN EUDAMED
- 510(k) Number
- K251495 FDA 510(k)
- FDA Product Code
- QBN FDA 510(k)
- EMDN Code
- W02039099 VARIOUS MICROBIOLOGY INSTRUMENTS - OTHER EUDAMED
- Models / Variants
Classification
- Device Class
- Class A EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3378 FDA 510(k)
- Regulation Number
- 866.3378 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
Yes
New Device
No
The MBT Compass HT CA Software; MBT FAST Shuttle US IVD is a Mass Spectrometry, MALDI-TOF, Microorganism Identification System for cultured isolates, designed under the FDA regulation 866.3378 and classified as a Class II device. It functions as an in vitro diagnostic tool for identifying bacteria and microorganisms from human specimens, leveraging matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry technology. The system is intended for microbiology laboratories to streamline pathogen identification, improving diagnostic accuracy and efficiency in clinical settings.
This device is supplied as a software and IVD combination, intended exclusively for prescription use in the USA and Puerto Rico. It is not single-use or reusable but operates within a regulated workflow requiring compliance with FDA 510(k) clearance (K251495) and IVDR conformity. The system is non-sterile and must be stored and handled according to manufacturer guidelines to ensure proper functionality. No MRI safety information is specified, and the product code QBN identifies its submission category under microbiology advisory review.
Frequently asked questions
What types of clinical samples can the MBT Compass HT CA Software identify, and how does it improve diagnostic workflows in microbiology labs?
The MBT Compass HT CA Software is designed to identify bacteria and microorganisms from cultured isolates obtained from human specimens. It uses MALDI-TOF mass spectrometry to analyze microbial protein profiles, enabling faster and more accurate pathogen identification compared to traditional methods. This streamlines workflows in microbiology labs by reducing manual testing time, improving diagnostic efficiency, and enhancing accuracy in identifying clinically relevant microorganisms.
Is the MBT Compass HT CA Software single-use, reusable, or part of a reusable system, and what are the storage requirements?
The MBT Compass HT CA Software is not single-use or reusable—it is a software and IVD combination that operates within a regulated workflow. The system itself is non-sterile, so it does not require sterile handling like disposable consumables. However, it must be stored and handled according to the manufacturer’s guidelines to ensure proper functionality and compliance with FDA and IVDR requirements.
What regulatory pathways does the MBT Compass HT CA Software follow, and where is it authorized for use?
The MBT Compass HT CA Software is authorized for use in the United States and Puerto Rico under FDA 510(k) clearance (K251495) and IVDR conformity. It is classified as a Class II device under FDA regulation 866.3378 and falls under the Microbiology (QBN) product code, reviewed by the Microbiology (MI) Advisory Committee. This means it has undergone FDA evaluation for safety and effectiveness before market authorization.
Are there specific models or variations of the MBT Compass HT CA Software, and how does the FAST Shuttle component integrate with it?
The MBT Compass HT CA Software is supplied as a software and IVD combination, with the MBT FAST Shuttle US IVD serving as a complementary component for automated sample processing. While the exact models aren’t detailed in the specifications, the system is designed for microbiology labs to integrate sample preparation with MALDI-TOF identification, improving efficiency. The FAST Shuttle likely automates sample handling, reducing manual intervention in the workflow.
How should the MBT Compass HT CA Software be maintained to ensure optimal performance and compliance?
Since the MBT Compass HT CA Software is non-sterile and operates within a regulated workflow, maintenance involves following the manufacturer’s guidelines for software updates, calibration, and system validation to ensure accuracy and compliance with FDA and IVDR requirements. Regular training for lab staff on proper handling, data interpretation, and adherence to the prescribed workflow (including sample preparation and identification protocols) is also critical to maintaining performance and regulatory compliance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MBT Compass HT Software - Bruker, MBT Compass HT CA Software; MBT FAST Shuttle US IVD (K251495) — FDA 510 ..., MBT Compass Software (K251495) | Medical Device Navigator, MBT Compass HT CA Software; MBT FAST Shuttle US IVD… - FDA.report
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K251495 | Class II | Active |
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Manufacturer
- Manufacturer
- Bruker Daltonics GmbH & Co. KG
Sources (2)
- FDA 510(k) K251495 24 fields · synced Sep 20, 2026
- EUDAMED 4f6d0d25-faf4-4898-8857-70ee5496e830 61 fields · synced Jul 24, 2026