ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191184 FDA 510(k)
- FDA Product Code
- MJH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3300 FDA 510(k)
- Regulation Number
- 866.3300 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ImmuView S pneumoniae and L pneumophila Urinary Antigen Test is an in vitro diagnostic device classified as a urinary antigen test for the qualitative detection of Streptococcus pneumoniae and Legionella pneumophila serogroup 1 antigens in human urine. It is designed to aid in the rapid diagnosis of infections caused by these pathogens, supporting microbiological laboratory workflows.
This test is supplied as a single-use, lateral flow immunoassay kit for professional use in clinical microbiology laboratories. It requires no special storage conditions but must be protected from extreme temperatures and moisture. The device carries FDA 510(k) clearance and In Vitro Diagnostic Device Directive (IVDD) authorization, ensuring compliance with regulatory standards for diagnostic accuracy and safety. No MRI safety considerations apply, as the test is non-electronic and non-magnetic.
Frequently asked questions
What types of infections can this test help diagnose, and how does it work?
This test detects antigens for *Streptococcus pneumoniae* and *Legionella pneumophila* serogroup 1 in human urine, aiding in the rapid diagnosis of infections caused by these bacteria. It uses a lateral flow immunoassay format, meaning it’s a point-of-care or lab-based test that visually indicates the presence of these pathogens in urine samples, streamlining microbiology workflows.
Is this test single-use, and if so, how should it be stored?
Yes, the ImmuView test is designed for single-use only. It should be stored at room temperature but protected from extreme temperatures (e.g., freezing or excessive heat) and moisture to maintain integrity. No refrigeration or special conditions are required, but avoid exposure to conditions that could degrade the assay components.
What regulatory pathways has this device undergone, and what does that mean for clinical reliability?
The test holds FDA 510(k) clearance and In Vitro Diagnostic Device Directive (IVDD) authorization, confirming it meets U.S. and EU standards for diagnostic accuracy and safety. The clearance was granted under the *Microbiology* advisory committee, with a determination of *Substantially Equivalent* to predicate devices, ensuring its reliability for detecting *S. pneumoniae* and *L. pneumophila* antigens in clinical settings.
Are there any special handling requirements for this test, such as sterility or compatibility with other lab systems?
The test is sterile for single-use and does not require additional sterilization. Since it’s a lateral flow immunoassay, it’s designed for professional use in microbiology labs and doesn’t interact with electronic or MRI systems. No special lab infrastructure (e.g., centrifuges or incubators) is needed beyond standard urine sample handling.
How does the product code (MJH) relate to its intended use or regulatory classification?
The MJH product code categorizes this device under the FDA’s *Microbiology* classification (specifically for urinary antigen tests). This code reflects its role in diagnosing bacterial infections via urine analysis, aligning with the *Microbiology* advisory committee’s oversight during the 510(k) review process. It does not describe clinical indications but rather how the submission was filed.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K191184 | Class II | Active |
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Manufacturer
- Manufacturer
- SSI Diagnostica A/S
Sources (2)
- FDA 510(k) K191184 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026