Overa

Primary DI
00860942000106
Brand
Overa
Company
Aspira Women's Health Inc.
Model
4.0.0
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.
Published
2022-11-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ONXOvarian Adnexal Mass Assessment Score Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONXOvarian Adnexal Mass Assessment Score Test SystemObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150588000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150588000OVA1 Next GenerationVermillion, Inc.2016-03-18ONX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860942000106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860942000106008609420001068609420001060860942000106

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-277-4721kits@aspirawh.com
844.277.4721aspirasupport@aspirawh.com

Regulatory Flags#

DUNS number
861471498
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860942000113OVA13.0.3.0062018-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740146269AlinityAbbott GmbHONX2020-08-10
00860942000113OVA1Aspira Women's Health Inc.ONX2018-01-15
00365702702127ROMA Calculation Tool Using Elecsys AssayRoche Diagnostics GmbHONX2016-10-28
00869164000017Lumipulse G ROMAFujirebio Diagnostics, Inc.ONX2016-09-19
00869164000024ROMAFujirebio Diagnostics, Inc.ONX2016-09-19
00380740138738ARCHITECTABBOTT LABORATORIESONX2016-09-09