OSOM Mono Test - OSOM Mono Test
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K181436 FDA 510(k)
- FDA Product Code
- KTN FDA 510(k)
- Models / Variants
- OSOM Mono Test FDA 510(k)Sure Vue Signature Mono FDA 510(k)ImmunoCard STAT Mono FDA 510(k)Cardinal Health Mono II Rapid Test FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5640 FDA 510(k)
- Regulation Number
- 866.5640 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a rapid diagnostic test system for the qualitative detection of heterophilic antibodies associated with infectious mononucleosis. It is classified under the nomenclature ‘System, Test, Infectious Mononucleosis’ and functions as an immunology diagnostic tool to identify markers in serum, plasma, or whole blood samples.
The test is supplied as a single-use, non-sterile rapid diagnostic device intended for use in clinical settings, including laboratories and point-of-care environments. It is regulated under FDA 510(k) clearance (K181436) and falls under the classification of Class II medical devices (Regulation 866.5640). Storage and handling instructions are specified in the accompanying documentation, though no additional regulatory status beyond the stated clearance is implied.
Frequently asked questions
What types of samples can the OSOM Mono Test system detect heterophilic antibodies in, and how is it intended to be used in clinical settings?
The OSOM Mono Test system is designed to detect heterophilic antibodies associated with infectious mononucleosis in serum, plasma, or whole blood samples. It is intended for use in clinical settings, including laboratories and point-of-care environments, as a rapid diagnostic tool for immunology testing. The test is supplied as a single-use device, making it suitable for quick, on-site evaluation without the need for complex sample preparation.
Is the OSOM Mono Test system sterile, and how should it be stored according to the manufacturer’s instructions?
The OSOM Mono Test system is non-sterile and supplied as a single-use device. Storage and handling instructions are detailed in the accompanying documentation provided by Sekisui Diagnostics, LLC. Since it is not sterile, proper storage conditions (e.g., room temperature, protection from moisture) are critical to maintain test integrity until use.
Are there multiple models or variants of this test system, and if so, how do they differ?
Yes, this system includes several branded variants: OSOM Mono Test, Sure Vue Signature Mono, ImmunoCard STAT Mono, and Cardinal Health Mono II Rapid Test. While these are distinct commercial names for the same core technology, they are all rapid diagnostic tests for detecting heterophilic antibodies linked to infectious mononucleosis. The differences lie in branding and packaging, not in the underlying test mechanism or intended use.
How is this device regulated, and what does the FDA clearance (K181436) imply about its safety and effectiveness?
This device is regulated under FDA 510(k) clearance (K181436), classified as a Class II medical device under regulation 866.5640. The clearance indicates that Sekisui Diagnostics, LLC has demonstrated that the device is substantially equivalent to a legally marketed predicate device, meaning it meets established safety and performance standards for detecting heterophilic antibodies in infectious mononucleosis testing. The clearance does not imply approval for specific clinical indications but confirms compliance with regulatory requirements.
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: OSOM® Mono Test - Sekisui Diagnostics, OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard… - FDA.report, OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181436 | Class II | Active |
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Manufacturer
- Manufacturer
- Sekisui Diagnostics, LLC
Sources (1)
- FDA 510(k) K181436 24 fields · synced Oct 6, 2026