Identifiers
- 510(k) Number
- K160090 FDA 510(k)
- FDA Product Code
- ONX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.6050 FDA 510(k)
- Regulation Number
- 866.6050 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Lumipulse G ROMA is an Ovarian Adnexal Mass Assessment Score Test System, a qualitative in vitro diagnostic device used to evaluate the risk of malignancy in ovarian or adnexal masses. It integrates measurements of HE4 (Human Epididymis Protein 4) and CA125 (Carcinoembryonic Antigen 125) biomarkers, alongside menopausal status, to generate a numerical score ranging from 0.00 to 10.00. This score aids clinicians in assessing the likelihood of malignancy, supporting decision-making for further diagnostic or surgical intervention.
The Lumipulse G ROMA is supplied as a serum and plasma test for in vitro use, requiring a blood sample for analysis. It is intended for single-use and is classified under FDA 510(k) clearance (K160090) as a Class II device (ONX product code). The test is not intended for MRI environments, and no sterility or reprocessing instructions are specified. Storage conditions and regulatory compliance are governed by the manufacturer’s guidelines, adhering to FDA-submitted documentation for obstetrics/gynecology applications.
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: Lumipulse - Fujirebio, Lumipulse G ROMA (K160090) — FDA 510 (k) | Innolitics, Lumipulse - Fujirebio, PDF Fujirebio Diagnostics, Inc., Lumipulse G ROMA 510 (k) K160090 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160090 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fujirebio Diagnostics, Inc.
- FDA Applicant
- Fujirebio Diagnostics,Inc.
Sources (1)
- FDA 510(k) K160090 24 fields · synced Sep 20, 2026