(88 days)
For the quantitative determination of free protein S antigen in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the Sysmex® CS-5100 analyzer.
As an aid in the diagnosis of protein S deficiency in patients who are suspected of free protein S deficiency. The performance of this device has not been established in neonate and pediatric patient populations.
The INNOVANCE® Free PS Ag assay is an immunoturbidimetric assay. The reagent kit consists of two components. One component (Reagent) contains polystyrene particles coated with two different monoclonal antibodies both specific for free protein S. This latex reagent aggregates when mixed with samples containing free protein S. The degree of aggregation is directly proportional to the concentration of free protein S in the test sample and is detected turbidimetrically via the increase in turbidity.
The provided document describes the Siemens Healthcare Diagnostics Products GmbH's INNOVANCE Free PS Ag device (K181525) and its performance data in support of its substantial equivalence to a predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a single table of "acceptance criteria" against which all performance metrics are directly compared. Instead, it discusses various studies with implicit acceptance criteria (e.g., successful verification of LoQ, fulfillment of predetermined criteria for Passing-Bablok regression). I'll compile a table based on what can be inferred for key performance characteristics.
| Performance Metric | Acceptance Criteria (Inferred from study description) | Reported Device Performance |
|---|---|---|
| Measuring Interval (Limit of Quantitation - LoQ) | Lower limit of 10% of norm must be accurately measurable with Total Error ≤ 4.0% of norm. | Successfully verified. Study confirms lower limit of 10% of norm can be accurately measured. |
| Measuring Interval (Linearity) | Maximal deviation from theoretical ideal linearity: ± 3.2% of norm for |
§ 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).