11-Dehydro Thromboxane B2 Kit, Urinary
The Urinary 11-Dehydro Thromboxane B2 (11dHTXB2) Kit (product code OBW) is a hematology in vitro diagnostic device that uses an enzyme-linked immunoassay (ELISA) to determine levels of 11-dehydro thromboxane B2 in human urine, aiding in the qualitative detection of aspirin effect in apparently healthy individuals following aspirin ingestion. It is intended for professional laboratory use only and helps assess platelet inhibition by aspirin therapy. This device is FDA Class 2 under regulation 864.5700 in the Hematology specialty, requiring 510(k) clearance, and is eligible for third-party review. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OBW
- Device Class
- FDA class 2
- Regulation Number
- 864.5700
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
Definition
The 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 aspirin effect in apparently healthy individuals post ingestion. For professional use only.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K062025 | ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 | May 29, 2007 | Substantially Equivalent | Corgenix, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.