FDA.reportPublic FDA data

OVA1

Primary DI
00860942000113
Brand
OVA1
Company
Aspira Women's Health Inc.
Model
3.0.3.006
Device description
Ova1® is a qualitative serum test that combines the results of five immunoassays into a single numerical 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. Ova1® is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay.
Published
2018-01-15
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
DEN090004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN090004000OVA1 TESTVermillion2009-09-11ONX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860942000113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860942000113008609420001138609420001130860942000113

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(844) 277.4721kits@vermillion.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
00860942000106Overa4.0.02022-11-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860942000106OveraAspira Women's Health Inc.ONX2022-11-23
00380740146269AlinityAbbott GmbHONX2020-08-10
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