(260 days)
HemosIL Chromogenic Factor IX is an automated assay for the photometric, quantitative determination of factor IX activity in 3.2% citrated plasma on the ACL TOP® Family and ACL TOP Family 50 Series in the laboratory setting by a healthcare professional. HemosIL Chromogenic Factor IX is indicated for use on patients when identifying factor IX deficiency or measuring factor IX activity from patients on replacement therapy. For adult population only. For prescription use only.
Factor IX activity in a patient's plasma is determined using a chromogenic method, in which human factor IX is activated by human factor XIa, and, when formed, factor IXa activates human factor X in the presence of human factor VIII, calcium and phospholipid. The amount of factor Xa generated is proportionate to the factor IX activity and is determined from the hydrolysis of a chromogenic factor Xa substrate. Results are determined by comparing a chromogenic signal to a calibration curve.
Here's a breakdown of the acceptance criteria and the studies that demonstrate the device's performance, based on the provided FDA 510(k) summary for the HemosIL Chromogenic Factor IX:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" in a separate table. However, it presents performance characteristics that implicitly serve as success metrics for the device's substantial equivalence. I've extrapolated these based on the study findings.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance | Study Performed |
|---|---|---|---|
| Precision (Within-run %CV) | Acceptable %CV for different Factor IX levels | ACL TOP Family: Normal Control (3.5%), Special Test Control (3.3%), Sample 1 (5.4%), Sample 2 (3.7%), Sample 3 (3.3%) | |
| ACL TOP Family 50 Series: Normal Control (2.7%), Special Test Control (2.5%), Sample 1 (3.3%), Sample 2 (3.1%), Sample 3 (3.4%) | Precision Study (EP05-A3) | ||
| Precision (Total %CV) | Acceptable %CV for different Factor IX levels | ACL TOP Family: Normal Control (5.6%), Special Test Control (5.1%), Sample 1 (7.3%), Sample 2 (5.1%), Sample 3 (5.2%) | |
| ACL TOP Family 50 Series: Normal Control (4.5%), Special Test Control (3.9%), Sample 1 (5.3%), Sample 2 (3.8%), Sample 3 (4.5%) | |||
| Aggregated ACL TOP Family: Normal Control (5.8%), Special Test Control (5.3%), Sample 1 (8.4%), Sample 2 (5.4%), Sample 3 (5.8%) | Precision Study (EP05-A3) | ||
| Reproducibility (Total %CV) | Acceptable %CV across sites, runs, and days | Normal Control (8.3%), Special Test Control (5.6%), Sample 1 (21.1%), Sample 2 (7.1%), Sample 3 (5.1%), Sample 4 (6.1%), Sample 5 (6.8%), Concentrate Sample 1 (7.3%), Concentrate Sample 2 (4.9%), Concentrate Sample 3 (5.8%) | Reproducibility Study (EP05-A3) |
| Limit of Blank (LoB) | Low enough to distinguish from true zero | 0.1% | LoB, LoD, LoQ Studies (CLSI EP17-A2) |
| Limit of Detection (LoD) | Low enough to detect presence of analyte | 0.3% | LoB, LoD, LoQ Studies (CLSI EP17-A2) |
| Limit of Quantitation (LoQ) | Low enough for reliable quantitative measurement | 0.6% | LoB, LoD, LoQ Studies (CLSI EP17-A2) |
| Linear Range | Span the expected clinical range | 1.0 to 150% | Linearity Study (CLSI EP06, 2nd Ed.) |
| Interference | No significant interference from common substances | Hemoglobin (1000 mg/dL), Bilirubin (unconjugated/conjugated) (40 mg/dL), Triglycerides (1500 mg/dL), Unfractionated heparin (2.0 IU/mL), Low molecular weight heparin (2.0 IU/mL), Dabigatran (5.0 mg/L), Rivaroxaban (0.05 mg/L), Fondaparinux (1.02 mg/L), Lupus anticoagulant (dRVVT Screen/Confirm Ratio 1.8) | Interference Study (CLSI EP07, 3rd Ed.) |
| Normal Reference Interval | Established a suitable range for healthy individuals | 71.1 to 134.1% (0.7-1.3 IU/mL) | Normal Reference Interval Study (CLSI EP28-A3c) |
| Recovery of Factor IX Replacement Therapies | Acceptable recovery rates for various therapies | AlphaNine SD (90%), BeneFIX (93%), Rebinyn (112%), Idelvion (159%) | Recovery Study |
| Method Comparison (Overall Correlation with Predicate) | High correlation (r) and acceptable slope/intercept | r = 0.972, Slope = 1.015, Intercept = -0.920 | Multicenter Method Comparison Study (CLSI EP09c) |
| Method Comparison (Predicted Bias) | Acceptable bias at various Factor IX levels | 1%: -0.90 (-2.03 to -0.19 CI) | |
| 5%: -0.84 (-1.89 to -0.17 CI) | |||
| 50%: -0.3% (-2.5% to 0.8% CI) | |||
| 100%: 0.6% (-1.4% to 2.2% CI) | Multicenter Method Comparison Study (CLSI EP09c) | ||
| System Comparison (ACL TOP Family 50 Series vs. ACL TOP Family systems) | High correlation (r) and acceptable slope/intercept | r = 0.998, Slope = 0.980, Intercept = 1.731 | Internal Method Comparison Study |
| In-Use Stability (Reagents) | Meets specified stability claims | Reagent A/B: 72 hrs at 2-8°C, 4 months 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).