Identifiers
- 510(k) Number
- K981427 FDA 510(k)
- FDA Product Code
- GKF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5600 FDA 510(k)
- Regulation Number
- 864.5600 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Stat Profile M Analyzer is an automated hematology instrument designed for rapid, whole-blood analysis in critical care settings. Classified as a Hematocrit device under the FDA’s Hematology advisory committee, it performs automated measurements to support clinical decision-making in acute patient care. Its primary function aligns with OpenFDA’s device classification as an automated hematology analyzer, enabling efficient hematological assessments without manual intervention.
This device is intended for use in hospital or clinical laboratory environments, where single-use reagents and disposable test cartridges are employed for each analysis. Supplied sterile and intended for single-use, it operates within FDA-cleared parameters under 510(k) clearance (K981427) and adheres to Class II regulatory standards (864.5600). Storage requires adherence to manufacturer guidelines, and its maintenance-free design reduces operational complexity. No MRI safety labeling is indicated in the regulatory data.
Frequently asked questions
What clinical applications does the STAT PROFILE M Analyzer support?
The STAT PROFILE M Analyzer is designed for automated hematocrit measurements in critical care settings, enabling rapid whole-blood analysis to support clinical decision-making. Its primary use aligns with acute patient care, where quick and precise hematological assessments are critical, such as in emergency rooms, intensive care units, or clinical laboratories.
How is the STAT PROFILE M Analyzer supplied, and is it reusable?
The STAT PROFILE M Analyzer is supplied with sterile single-use reagents and disposable test cartridges for each analysis. This design ensures patient safety and reduces contamination risks, as each cartridge is intended for one-time use only. The maintenance-free nature of the device further simplifies its operational workflow.
What regulatory clearance does the STAT PROFILE M Analyzer hold?
The STAT PROFILE M Analyzer holds FDA 510(k) clearance under the classification of a Hematocrit device, with the clearance number K981427. It adheres to Class II regulatory standards (864.5600) and is substantially equivalent to predicate devices, as determined by the FDA’s Hematology advisory committee.
Are there specific storage requirements for the STAT PROFILE M Analyzer?
Storage of the STAT PROFILE M Analyzer must follow the manufacturer’s guidelines to ensure optimal performance and longevity. While the device itself is maintenance-free, proper handling of single-use cartridges and reagents—including protection from extreme temperatures or contamination—is essential. The manufacturer’s instructions should be consulted for precise storage conditions.
Does the STAT PROFILE M Analyzer have any safety considerations for use in MRI environments?
The regulatory data for the STAT PROFILE M Analyzer does not indicate MRI safety labeling, meaning it should not be used in MRI environments unless explicitly approved for such settings. Clinicians should verify compatibility with their facility’s MRI protocols or consult the manufacturer for guidance.
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: Stat - Wiley Online Library, Stat Profile® | Nova Biomedical, Stat Profile Prime Plus® Comprehensive Critical Care Analyzer, PDF Instructions for Use Manual - novabiomedicaldocs.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K981427 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nova Biomedical Corp.
Sources (1)
- FDA 510(k) K981427 24 fields · synced Oct 1, 2026