DiviTum®TKa

Primary DI
07350095910030
Brand
DiviTum®TKa
Company
Biovica International AB
Model
95010
Device description
DiviTumTKa is an in vitro diagnostic device intended for the semi-quantitative measurement of thymidine kinase activity (TKa) in human serum. The assay is to be used as an aid in monitoring disease progression in previously diagnosed hormone receptor positive, metastatic postmenopausal female breast cancer patients. A TKa value of < 250 DuA is associated with the decreased likelihood of disease progression within 30 days or 60 days post testing. DiviTumTKa results should be used in conjunction with other clinical methods for monitoring breast cancer.
Published
2023-01-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QTEThymidine Kinase Activity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QTEThymidine Kinase ActivityImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202852000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202852000DiviTum TKaBiovica International AB2022-07-29QTE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350095910030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350095910030073500959100307350095910030

GMDN Terms#

Term, Definition table
TermDefinition
Thymidine kinase IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of thymidine kinase in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used as a prognostic marker to monitor the progression of haematological malignancies [e.g., non-Hodgkin lymphoma, chronic lymphocytic leukaemia (CLL)] and assess the response to treatment.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (858) 230-6044us@biovica.com

Regulatory Flags#

DUNS number
776734126
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true