Overa

Basic Information

• Brand Name: Overa
• Primary DI: 00860942000106
• Version / Model: 4.0.0
• Company Name: Aspira Women's Health Inc.
• Labeler DUNS: 861471498
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-23
• Public Version: 2
• Public Version Date: 2023-07-26
• Public Version Status: Update
• Public Device Record Key: a0635653-7c2e-4c5b-8621-73d46e89204c

Device Description

The Overa® test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The Overa® test is intended to aid in assessing whether a woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy as part of the preoperative evaluation. The Overa® test must be interpreted in conjunction with an independent clinical and imaging evaluation. The test is not intended as a screening or stand-alone diagnostic assay.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ONX	Ovarian Adnexal Mass Assessment Score Test System	Obstetrics/Gynecology	866.6050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57967	Medical equipment clinical data interfacing software	An application software designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is intended to transfer waveform, infusion data, laboratory data from medical devices/lab equipment into an electronic medical record (EMR) or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests; it is not primarily intended to manage diagnostic/patient images.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860942000106	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K150588	000