Identifiers
- 510(k) Number
- DEN130013 FDA 510(k)
- FDA Product Code
- PEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3361 FDA 510(k)
- Regulation Number
- 866.3361 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The Vitek MS is an automated MALDI-TOF mass spectrometry system for microorganism identification of cultured isolates. Classified as a mass spectrometry device under FDA regulation 866.3361, it employs matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) technology to analyze microbial samples, enabling rapid and precise identification of pathogens.
This system is intended for use in microbiology laboratories, supporting clinical diagnostics and research applications. Supplied as a reusable device, it operates within Class II medical device regulations and requires proper maintenance and calibration. The Vitek MS is authorized under FDA 510(k) clearance (K130013) and adheres to microbiology-specific standards for microbial identification, ensuring compliance with regulatory requirements for laboratory diagnostics.
Frequently asked questions
What is the Vitek MS used for?
The Vitek MS is designed for automated identification of microorganisms from cultured isolates in microbiology laboratories. It uses matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) technology to analyze microbial samples, enabling faster and more accurate pathogen identification compared to traditional methods. This supports clinical diagnostics and research applications by streamlining workflows and improving turnaround times for identifying infectious agents.
Is the Vitek MS a single-use or reusable device?
The Vitek MS is a reusable device. As an automated mass spectrometry system, it requires regular maintenance, calibration, and cleaning to ensure consistent performance and accuracy. Reusability aligns with its intended use in clinical microbiology labs, where reliability and durability are critical for continuous operation.
How is the Vitek MS supplied, and what does this mean for users?
The Vitek MS is supplied as a standalone, reusable system. This means users receive the core instrument, which must be integrated into their laboratory infrastructure, including power, network connectivity, and software support. The system is not disposable, so laboratories must allocate resources for maintenance, training, and compliance with manufacturer guidelines to ensure proper functionality and regulatory adherence.
What regulatory pathway does the Vitek MS follow?
The Vitek MS is authorized under FDA 510(k) clearance (K130013), specifically classified as a Class II medical device under regulation 866.3361. This pathway confirms that the device meets FDA standards for safety and effectiveness as a mass spectrometry system for microorganism identification. Laboratories using this device must ensure compliance with FDA guidelines and manufacturer instructions to maintain regulatory standing.
Does the Vitek MS require special storage or handling?
While the Vitek MS itself is a durable, reusable instrument, its proper operation depends on maintaining optimal conditions for its components and software. The system should be stored in a controlled environment—protected from extreme temperatures, humidity, and physical damage—to preserve calibration and performance. Additionally, consumables (e.g., MALDI plates, reagents) must be stored according to manufacturer specifications to avoid degradation, ensuring accurate microbial identification results.
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: Biomerieux Vitek MS Automated Mass Spectrometry | QuestPair
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN130013 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
- FDA Applicant
- bioMerieux, Inc.
Sources (1)
- FDA 510(k) DEN130013 24 fields · synced Oct 5, 2026