DEVICE: 11dhTxB2 Test Kit (11-Dehydro Thromboxane B2) (00855360006274)
Device Identifier (DI) Information
11dhTxB2 Test Kit (11-Dehydro Thromboxane B2)
12136
In Commercial Distribution
12136
CORGENIX MEDICAL CORPORATION
12136
In Commercial Distribution
12136
CORGENIX MEDICAL CORPORATION
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
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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).
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FDA Product Code
[?]Product Code | Product Code Name |
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OBW | 11-Dehydro Thromboxane B2 Kit, Urinary |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K062025 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
01a01a7a-ac05-4ad6-9ceb-d1fa7aaf9897
July 06, 2018
3
August 08, 2016
July 06, 2018
3
August 08, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-729-5661
technicalsupport@corgenix.com
technicalsupport@corgenix.com