(30 days)
Pacific Hemostasis Immunodepleted Factor V Deficient Plasma is intended for use in a clinical laboratory for the quantitative measurement of Factor V activity. Factor V activity in patient or control plasma is assayed by the amount of Prothrombin Time (PT) correction produced by the test plasma when mixed with Factor V deficient plasma. Results are compared to the degree of PT correction of a reference plasma with known Factor V activity. A pool of normal plasma is considered to vield 100% correction in the PT time, and has 100% of the normal Factor V concentration.
Pacific Hemostasis Immunodepleted Factor V Deficient Plasma is intended for use in the quantitative determination of Factor V activity in patient plasma… Factor..V. activity in plasma is assayed by the amount of Prothrombin Time correction produced " The correction of the unknown by the test plasma when mixed with factor deficient plasma. is compared to that produced by a reference plasma of known normal activity.
Pacific Hemostasis (PH) Immunodepleted Factor V Deficient Plasma is a lyophilized preparation of fresh human plasma with added buffers. PH Immunodepleted Factor V Deficient plasma is intended for use in a clinical laboratory for the quantitative measurement of Factor V activity. The product is prepared from pooled normal plasma depleted of factor V by immobilized, highly specific antibodies. The Factor V activity contained in the product is less than 1% of normal levels. All other coaqulation factors are within the normal range. The reconstitution volume is 1.0 mL (with deionized or distilled The product is available in packages containing 10 vials. The water). reconstituted plasma is stable for 8 hours when stored stoppered at 2-8°C. Each unit of source material used in the preparation of this product has been tested by an FDA approved method and found non-reactive for HB Ag (Hepatitis B Surface antigen) and negative for antibodies to HIV and HCV. However, since no known test method can offer complete assurance that product derived from human blood will not transmit Hepatitis. AIDS, or other infectious diseases, this product should be handled as potentially infectious biological material.
Here's an analysis of the provided text, focusing on the acceptance criteria and study data for the "Immunodepleted Factor V Deficient Plasma" device.
A significant limitation of this document is that it is a 510(k) summary from 1997, which means it pre-dates the modern standards for reporting clinical study details for medical devices, especially AI/ML-enabled devices. The focus here is on demonstrating substantial equivalence to a predicate device rather than strictly defining and proving acceptance criteria in the current sense. Therefore, certain requested information (like specific AI/ML study details, expert qualifications for ground truth, or MRMC studies) is not applicable or not provided in this type of document.
Device Name: Immunodepleted Factor V Deficient Plasma (Human, Dried)
Predicate Device: Dade® Immunoadsorbed Factor V Deficient Plasma (Human), K912679
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) (substantial equivalence), the "acceptance criteria" are implicitly met by demonstrating comparable performance to the predicate device within acceptable laboratory variability. The specific numerical targets for "acceptance" are derived from the performance of the predicate device and general good laboratory practice for coagulation assays.
| Performance Metric | Acceptance Criteria (Implicitly: Comparable to Predicate) | Reported Device Performance (Pacific Hemostasis) | Predicate Device Performance (Dade) |
|---|---|---|---|
| Standard Curve Precision (Day-to-Day) | |||
| Mean Slope CV (%) | Comparable (e.g., within a reasonable percentage of predicate) | 0.83% | 2.42% |
| R² Range | ≥0.99 (high linearity) | 0.996-0.999 | 0.996-0.999 |
| Recovery of Factor V Activity (Day-to-Day Precision) | |||
| Normal Reference Plasma (%CV) | Comparable (e.g., ≤10% for typical lab values) | 4.5% (UCRP) | 5.6% (UCRP) |
| Abnormal Reference Plasma (%CV) | Comparable (e.g., ≤10% or clinically acceptable) | 3.5% (ACRP) | 4.8% (ACRP) |
| Low Abnormal Reference Plasma (%CV) | Comparable (with understanding of higher variability at low levels) | 6.7% (Level 1), 7.4% (Level 2), 12.5% (Level 3) | 5.6% (Level 1), 3.9% (Level 2), 4.0% (Level 3) |
| Correlation with Assigned FV Values | |||
| Slope | Close to 1.0 | 0.915 | 0.977 |
| R² (Correlation Coefficient) | Close to 1.0 (very high correlation) | 0.989 | 0.991 |
| Reconstituted Stability (8 hours @ 4°C) | |||
| Standard Curve Slope Change | Minimal change (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).