BreathID Hp Lab System, BreathID Smart System
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
Identifiers
- 510(k) Number
- K220494 FDA 510(k)
- FDA Product Code
- MSQ FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3110 FDA 510(k)
- Regulation Number
- 866.3110 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BreathID Hp Lab System and BreathID Smart System are urea breath test devices designed for the detection of Helicobacter pylori infection. These systems analyze exhaled breath samples to measure urea metabolism, enabling non-invasive assessment of active infection or treatment response in gastrointestinal diagnostics.
Used in clinical and laboratory settings, these systems are intended for single-use applications and require no special sterility conditions beyond standard laboratory practices. The BreathID Hp Lab System is designed for batch testing in high-throughput environments, while the BreathID Smart System offers real-time results for point-of-care or follow-up testing. Both devices are classified as Class I under FDA regulations (K220494, MSQ) and comply with IVDD and MDR standards.
Frequently asked questions
What types of clinical settings can use the BreathID Hp Lab System and BreathID Smart System, and how do they differ in their intended use?
The BreathID Hp Lab System is designed for high-throughput batch testing in clinical or laboratory settings, ideal for processing multiple samples efficiently. In contrast, the BreathID Smart System is optimized for real-time results, making it suitable for point-of-care or follow-up testing in smaller-scale or outpatient environments. Both systems analyze exhaled breath to detect *Helicobacter pylori* infection via urea metabolism, but the Smart System prioritizes quick turnaround for immediate diagnostic decisions.
Are the BreathID devices single-use or reusable, and what does that mean for their maintenance and workflow?
Both the BreathID Hp Lab System and BreathID Smart System are designed for single-use applications, meaning each device is intended for one test cycle before disposal. This eliminates the need for cleaning, sterilization, or maintenance between uses, simplifying workflows in clinical or laboratory settings. The design ensures consistency and reduces cross-contamination risks, though standard laboratory hygiene practices should still be followed during sample handling.
How do I determine which model—BreathID Hp Lab System or BreathID Smart System—is best for my facility’s needs?
Choose the BreathID Hp Lab System if your facility requires high-volume testing with batch processing capabilities, such as a central laboratory or large gastroenterology clinic. Opt for the BreathID Smart System if you need real-time results for point-of-care testing, follow-up evaluations, or smaller-scale diagnostics, such as in outpatient offices or private practices. The Smart System’s design emphasizes speed and accessibility, while the Lab System prioritizes throughput efficiency.
Do the BreathID devices require special storage conditions beyond standard laboratory practices?
No special storage conditions are specified beyond standard laboratory practices for either the BreathID Hp Lab System or BreathID Smart System. Since both are single-use devices, they should be stored in a clean, dry environment protected from extreme temperatures or direct sunlight until use. Always follow the manufacturer’s instructions included with the device for optimal performance and shelf life.
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: BreathID® Hp Lab Urea Breath Test - Meridian Bioscience, BreathID® Hp H. pylori Detection | Meridian Bioscience, BreathID Hp Lab System, BreathID Smart System (K220494) — FDA 510 (k ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Active |
| EUDAMED | European Union | IVDD | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K220494 | Class I | Active |
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Manufacturer
- Manufacturer
- Meridian Bioscience Israel Ltd.
- FDA Applicant
- Meridian Bioscience Israel , Ltd.
Sources (2)
- FDA 510(k) K220494 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026