GTI-FVIII Inhibitor Assay
510(k) K993553
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993553 | Date1 Feb 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GGP
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7290
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The GTI-FVIII Inhibitor Assay is a qualitative and quantitative test for Factor VIII deficiency, designed to detect and measure inhibitors in patients with hemophilia A. This in vitro diagnostic device quantifies the presence of Factor VIII inhibitors, aiding in the assessment of treatment response and management of bleeding disorders. It is classified under hematology diagnostics and is intended for laboratory use to support clinical decision-making in coagulation disorders.
This assay is supplied as a reagent kit for use in clinical laboratories and has been cleared by the FDA under 510(k) K993553 as substantially equivalent to a predicate device. It is intended for single-use and requires adherence to standard laboratory protocols for handling, storage, and testing. The device is regulated under FDA regulation number 864.7290 and falls under device class II, with a product code of GGP. Stability studies confirm reliability over a period of up to 27 months under specified conditions.
Other devices from Genetic Testing Institute
Questions
AI-generated answers, 1 Oct 2026
What is the GTI-FVIII Inhibitor Assay used for?
The GTI-FVIII Inhibitor Assay is designed to detect and measure Factor VIII inhibitors in patients with hemophilia A. Inhibitors are antibodies that interfere with Factor VIII treatment, complicating bleeding disorder management. By quantifying these inhibitors, clinicians can assess treatment response and adjust care accordingly, ensuring better outcomes for patients.
How is the GTI-FVIII Inhibitor Assay supplied and intended for use?
This assay is supplied as a reagent kit specifically for laboratory use. It is intended for single-use only and requires adherence to standard clinical laboratory protocols for handling, storage, and testing. The kit is engineered to support in vitro diagnostic testing, providing accurate results for clinical decision-making in coagulation disorders.
What are the storage and stability conditions for the GTI-FVIII Inhibitor Assay?
The GTI-FVIII Inhibitor Assay has undergone stability studies confirming reliability for up to 27 months when stored under specified conditions. While exact storage details are not provided in the data, typical reagent kits require refrigeration (2–8°C) and protection from light. Always follow the manufacturer’s instructions for optimal performance and longevity.
Is the GTI-FVIII Inhibitor Assay reusable or single-use?
The GTI-FVIII Inhibitor Assay is explicitly designed for single-use only. This ensures accuracy, reduces contamination risks, and maintains regulatory compliance. Reusing diagnostic reagents can compromise test integrity and patient safety, so strict adherence to single-use protocols is essential.
What regulatory approval does the GTI-FVIII Inhibitor Assay hold?
The assay has been cleared by the FDA under 510(k) number K993553, demonstrating substantial equivalence to a predicate device. It falls under FDA regulation number 864.7290 and is classified as a Class II medical device with product code GGP. This classification reflects its role in supporting clinical decision-making in hematology diagnostics.