11dhTxB2 Test Kit (11-Dehydro Thromboxane B2)

Basic Information

• Brand Name: 11dhTxB2 Test Kit (11-Dehydro Thromboxane B2)
• Primary DI: 00855360006274
• Version / Model: 12136
• Catalog Number: 12136
• Company Name: CORGENIX MEDICAL CORPORATION
• Labeler DUNS: 619834542
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-08
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 01a01a7a-ac05-4ad6-9ceb-d1fa7aaf9897

Device Description

INTENDED USE The 11dhTxB2 Test Kit is an enzyme-linked immunoassay (ELISA) to determine levels of 11-Dehydro Thromboxane B2 (11dhTxB2) in human urine which aids in the qualitative detection of acetylsalicylic acid (ASA) effect in apparently healthy individuals post ingestion. For In Vitro Diagnostic Use. SUMMARY OF THE ASSAY Activated platelets produce Thromboxane A2 (TxA2), a potent vasoconstrictor and inducer of platelet aggregation. TxA2 is generated by Thromboxane synthase from molecules derived from arachidonic acid by cyclooxygenase-1 (COX-1). TxA2 has a short half-life in plasma and is rapidly hydrolyzed to Thromboxane B2 (TxB2). TxB2, in turn, is metabolized to 11-Dehydro Thromboxane B2 (11dhTxB2).The measurement of stable metabolites of TxA2, such as urinary11dhTxB2, is a means of quantitating TxA2 production in vivo and thus a direct way to analyze ASA’s effect post ingestion. PRINCIPLE OF THE TEST The 11dhTxB2 Test Kit measures urinary 11dhTxB2 and is performed as a competitive ELISA. Diluted samples (Reference Solution, controls, and patient urine), purified 11dhTxB2 conjugated to alkaline phosphatase (AP), and purified mouse monoclonal antibody directed to 11dhTxB2 are combined and incubated in microwells coated with a polyclonal anti-mouse antibody. The monoclonal antibody then binds to the polyclonal anti-mouse antibody coated on the microtiter plate. After the removal of unbound complexes by washing, the bound AP-11dhTxB2 conjugate is assayed by the addition of para-nitrophenylphosphate (pNPP) chromogenic substrate. Color develops in the wells at an intensity inversely proportional to the sample urine concentration of 11dhTxB2, and is read at 405nm. Results (pg/mL) are calculated against a reference curve prepared from the Reference Solution provided in the kit. Final results are reported as pg 11dhTxB2 per mg creatinine to normalize results for urine concentration. Refer to product package insert.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OBW	11-Dehydro Thromboxane B2 Kit, Urinary	Hematology	864.5700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62213	Thromboxane IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of thromboxane in a clinical specimen, using an enzyme immunoassay (EIA) method. Thromboxane is typically used as a marker of platelet activity, which may be affected by a variety of conditions and treatments (e.g., aspirin intake).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855360006274	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K062025	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius