(93 days)
The Phospholin ES Activated Partial Thromboplastin Time reagent is a liquid activated reagent with phospholipids derived from soybean lecithin for use in the determination of Activated Partial Thromboplastin Time (APTT) and related coagulation procedures. Phospholin ES is to be used as an APTT reagent (qualitative assay) on patient plasma for the routine screening in the general patient population for deficiencies involving the intrinsic pathway of coagulation. Phospholin ES is sensitive to lupus-like inhibitors.
R2 Diagnostics Phospholin ES is a liquid reagent containing ellagic acid as the activator and phospholipids derived from soybean lecithin. The reagent also contains buffer and preservatives. Phospholin ES is an in vitro diagnostic reagent intended for use for the performance of the activated partial thromboplastin time two-stage test (APTT) and related coagulation factor assays. Phospholin ES is sensitive to lupus anticoagulants. Phospholin ES as with any APTT test requires the addition on 0.02-0.025M Calcium Chloride to perform the assay.
Here's a breakdown of the acceptance criteria and study information for the R2 Diagnostics Phospholin ES device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document frames its "acceptance criteria" and "device performance" in terms of substantial equivalence to a predicate device. The performance criteria are primarily correlation coefficients and precision for various sample types.
| Acceptance Criterion (Type) | Predicate Device Performance | Proposed Device Performance (Reported) |
|---|---|---|
| Correlation: Normal & Abnormal Patients (Photo-optical) | N/A (implied by predicate's established performance) | R = 0.92, Slope = 0.864 |
| Correlation: Normal & Abnormal Patients (Mechanical) | N/A | R = 0.93, Slope = 1.09 |
| Correlation: Lupus Anticoagulant Samples (Photo-optical) | N/A | R = 0.94, Slope = 0.866 |
| Correlation: Lupus Anticoagulant Samples (Mechanical) | N/A | R = 0.99, Slope = 0.627 |
| Precision: Within-run CV |
§ 864.7925 Partial thromboplastin time tests.
(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).