(130 days)
The Pool Norm is a normal human plasma pool intended for use as a normal control for the activated partial thromboplastin time (APTT) and dilute Russell's viper venom time (dRVVT) assays carried out with the following tests:
- APTT: STA® - PTT A (REF 00595) on STA-R®, STA Compact® and STA Satellite® analyzers
- dRVVT: STA® - Staclot® dRVV Screen (REF 00339, 00333), STA® - Staclot® dRVV Confirm (REF 00334) on STA-R® and STA Compact® analyzers.
This reagent is to be used in clinical laboratories by certified medical laboratory personnel. For in vitro diagnostic use only. For prescription use.
Pool Norm is a lyophilized pool of at least 20 citrated normal human plasmas, containing buffer, stabilizers and preservatives.
The provided document describes the Pool Norm device, a normal human plasma pool intended for use as a normal control for activated partial thromboplastin time (APTT) and dilute Russell's viper venom time (dRVVT) assays. The study presented focuses on the device's precision performance.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the reported precision study. However, the study aims to demonstrate repeatability (within-run precision) and within-laboratory precision, which are standard measures for the performance of control materials. The reported performance is given as Standard Deviation (SD) in seconds and Coefficient of Variation (CV) in percentage for three different lots of Pool Norm on three different analyzer types.
Since explicit acceptance criteria are not provided, we will assume that the reported precision values are considered acceptable by the manufacturer for the intended use of the device. A common industry expectation for coagulation controls is a CV of less than 5% for within-laboratory precision, though this can vary. All reported CVs are well below this general benchmark.
| Assay | Analyzer Type | Sample Pool Norm Lot | Perfromance Metric | Reported Performance (SD (sec) / CV (%)) | (Assumed) Acceptance Criteria (Example) |
|---|---|---|---|---|---|
| STA® - PTT A | STA-R® | 110150 | Repeatability | 0.3 sec / 1.0 % | CV |
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.