(90 days)
The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a Factor VIII activity assay to enable the performance of a modified Nijmegen-Bethesda assay using 3.2% citrated human plasma. It enables the determination of a functional FVIII inhibitor titer to aid in the clinical management of congenital hemophilia A in individuals aged 2 years or older. For in vitro diagnostic use.
The FVIII Inhibitor Kit is used in the CDC modification of the Nijmegen-Bethesda assay and contains the following components:
Imidazole Buffered Pooled Normal Plasma (IB-PNP): Pooled normal plasma from a minimum of twenty donors with a factor VIII activity value of 95-113% and buffered with imidazole to a pH of 7.3 – 7.5.
Imidazole Buffered Bovine Serum Albumin (IB-BSA): A 4% BSA solution buffered with imidazole to a pH of 7.3-7.5.
Negative Factor VIII Inhibitor Control: Pooled normal plasma from a minimum of five donors buffered with HERES to a pH of 6.2-8.2
Positive Factor VIII Inhibitor Control: HEPES buffered (pH 6.2-8.2) immunodepleted FVIII deficient plasma to which anti-human FVIII antibodies have been added.
The document provided describes the performance characteristics and studies for the CRYOcheck FVIII Inhibitor Kit, rather than an AI/ML-driven medical device. Therefore, a direct mapping to all the requested criteria for AI/ML device acceptance (such as MRMC studies, number of experts for ground truth, adjudication methods, and training set details) is not possible.
However, I can extract and present the information relevant to the device's performance and the studies conducted to demonstrate its effectiveness, aligning with the spirit of the acceptance criteria for a diagnostic kit.
Device: CRYOcheck™ FVIII Inhibitor Kit
Intended Use: For clinical laboratory use in conjunction with a Factor VIII activity assay to enable the performance of a modified Nijmegen-Bethesda assay using 3.2% citrated human plasma. It enables the determination of a functional FVIII inhibitor titer to aid in the clinical management of congenital hemophilia A in individuals aged 2 years or older. For in vitro diagnostic use.
Acceptance Criteria and Reported Device Performance
Since this is an in-vitro diagnostic kit and not an AI/ML device, the "acceptance criteria" are related to standard analytical performance characteristics. The table below summarizes the key performance metrics and the reported results.
| Acceptance Criterion (Performance Metric) | Reported Device Performance |
|---|---|
| Precision (Multi-Reagent Lot) | - Kit Negative Control: SD 0.1 BU/mL (304.1% CV) - Kit Positive Control: 9.4% CV - Negative Plasma Sample: SD 0.1 BU/mL (24.4% CV) - Low Plasma Sample: 8.2% CV - Mid Plasma Sample: 9.9% CV - High Plasma Sample: 6.7% CV |
| (Aggregated Data for all 3 lots) |
- Negative Plasma Sample: SD 0.1 BU/mL (29.0% CV)
- Low Plasma Sample: 8.2% CV
- Mid Plasma Sample: 8.3% CV
- High Plasma Sample: 8.4% CV |
| Reproducibility (Multi-Reagent Lot Site to Site) | - Kit Negative Control: SD 0.1 BU/mL (422.7% CV) - Kit Positive Control: 16.0% CV - Negative Plasma Sample: SD 0.1 BU/mL (28.4% CV) - Low Plasma Sample: 10.6% CV - Mid Plasma Sample: 8.3% CV - High Plasma Sample: 13.2% CV
(Pooled 3-Site Data) The results demonstrated a pooled reproducibility of ≤16% CV for the positive samples and 0.1 BU/mL SD for the negative plasma sample. |
| Linearity/Assay Reportable Range | Linearity Range: 0.2 to 1402.9 BU/mL. |
| Shelf-Life Stability | Supported a 12-month shelf-life stability claim when stored at
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).