(41 days)
HemosIL Factor X Deficient Plasma is human plasma immunodepleted of Factor X and intended for the in vitro diagnostic quantitative determination of Factor X activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.
HemosIL Factor X Deficient Plasma is human plasma immunodepleted of Factor X and intended for the in vitro diagnostic quantitative determination of Factor X activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.
Abnormalities of the extrinsic pathway factors are determined by performing a modified prothrombin time (PT) test. Patient plasma is diluted and added to a plasma deficient in Factor X. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the Factor X in the patient plasma, interpolated from a calibration curve.
Acceptance Criteria and Study for HemosIL Factor X Deficient Plasma
This document describes the acceptance criteria and the study that demonstrates the HemosIL Factor X Deficient Plasma device meets these criteria, as derived from the provided 510(k) summary (K031122).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the performance metrics presented for substantial equivalence to predicate devices. These criteria are based on method comparison (slope and correlation coefficient) and precision (within-run and between-run coefficient of variation).
| Metric / Test Type | Predicate Device 1 (Hemoliance Factor X Deficient Plasma on ELECTRA) | Predicate Device 2 (IL Test Factor X Deficient Plasma on ACL Family) | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (HemosIL Factor X Deficient Plasma) |
|---|---|---|---|---|
| Method Comparison | vs. Predicate Hemoliance Factor X Deficient Plasma on ELECTRA: | |||
| ELECTRA 1600C (n=63): Slope = 0.9461, r = 0.9948 |
vs. Predicate IL Test Factor X Deficient Plasma on ACL Family:
ACL 3000 (n=62): Slope = 1.0328, r = 0.9849
ACL Futura (n=62): Slope = 1.0680, r = 0.9840 |
| Slope | A slope close to 1.0 (indicating proportional agreement) | A slope close to 1.0 (indicating proportional agreement) | Demonstrated to be close to 1.0 across different systems and predicates (e.g., 0.9461 to 1.0680). |
| Correlation Coefficient (r) | A high correlation coefficient (typically ≥ 0.975 as a common standard for method comparison in IVDs) | A high correlation coefficient (typically ≥ 0.975) | Demonstrated to be high across different systems and predicates (e.g., 0.9840 to 0.9948). |
| Within Run Precision| (Not explicitly stated for predicate in this summary, but typically a low CV% is expected for IVDs) | (Not explicitly stated for predicate in this summary, but typically a low CV% is expected for IVDs) | CV% for Normal Control: Low (e.g.,
§ 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).