(93 days)
VALIDATE® Heparin Calibration Verification / Linearity Test Kit solutions are assayed quality control materials intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for Heparin Anti-Xa activity on automated instruments in a clinical laboratory setting by laboratory personnel. The product is intended for use on the IL ACL TOP® analyzer.
Each VALIDATE® Heparin Calibration Verification / Linearity Test Kit contains one analyte set of Heparin in a human plasma base matrix. The kit includes a set containing five liquid levels, 3.0 mL each. The set is provided to establish the relationship between theoretical and actual performance of Heparin Anti-X activity. Material of human origin used in the manufacture of this test kit was tested at the donor level using FDA approved methods and was found to be non-reactive for HBsAG and to antibodies to HCV and HIV-1/2.
The provided text describes the performance data for the VALIDATE® Heparin Calibration Verification / Linearity Test Kit. Here's a breakdown of the acceptance criteria and study details based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state the numerical acceptance criteria for linearity, precision, or reproducibility in a table format. However, it indicates qualitative acceptance.
| Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Linearity | Known relationship between levels (equal deltas) demonstrated. | "Product linearity performance was demonstrated for this automated system." |
| Precision | Met CV% acceptance criteria. | "All levels of the VALIDATE® Heparin kit met the CV% acceptance criteria on the IL ACL TOP 500® instrument system." |
| Reproducibility | Met CV% acceptance criteria. | "All levels of the VALIDATE® Heparin kit met the CV% acceptance criteria on the IL ACL TOP 500® instrument system." |
| Stability | 90 to 110% of DOM value. | "All product levels tested within the acceptance criteria limits after 2 freeze-thaw vial events." |
| Shelf Life | Support for extended stability claim. | "Stability of the VALIDATE® Heparin Calibration / Linearity Test Kit was set at 5 months based on available real-time stability studies. Real time stability studies are ongoing to support an extended stability claim." |
2. Sample Size Used for the Test Set and Data Provenance
- Precision Test: 80 replicates per kit level (5 levels, so 5 * 80 = 400 total replicates for precision across three lots of the VALIDATE® Heparin product).
- Reproducibility Test: 75 replicates per kit level (5 levels, so 5 * 75 = 375 total replicates for reproducibility for one lot of the VALIDATE® Heparin product).
- Stability Test: Four product lots were tested. The number of replicates per time point is not specified, but time points included "date of manufacture (DOM), followed by testing at specific intervals post manufacture."
- Freeze-thaw/open vial stress stability assessment: Not specified, but involved testing "All product levels."
- Data Provenance: The document states "All supporting data is retained on file at Maine Standards Company LLC." This suggests the data was generated internally by Maine Standards Company LLC. It is a prospective study as the testing was conducted to evaluate the performance of the new device. The country of origin is implicitly the USA (Maine Standards Company LLC is located in Maine, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an in vitro diagnostic (IVD) calibration verification/linearity test kit, not a device that relies on expert interpretation of results. Its performance is measured against established analytical targets and statistical criteria like CV% (Coefficient of Variation).
4. Adjudication Method for the Test Set
Not applicable. The performance is assessed based on quantitative measurements and meeting predefined statistical criteria (e.g., CV% limits, recovery percentages). There is no "ground truth" established through expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where multiple human readers interpret cases, and their performance with and without AI assistance is compared. This device is an IVD calibration product.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The device itself is a test kit used on an automated instrument (IL ACL TOP 500® analyzer). Its "performance" is inherently standalone in that it is a measurement tool. The studies described (precision, reproducibility, linearity, stability) evaluate the performance of the physical test kit itself when run on the specified automated instrument without direct human interpretation of the analytical results beyond operating the instrument and collecting data.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Known concentrations: Levels 1 and 5 are prepared independently, and intermediate levels are prepared by equal part dilutions following CLSI EP6-A guidelines, establishing a known linear relationship and target concentrations.
- Reference Standards: The VALIDATE® Heparin kit is traceable through the IL HemosIL® calibrator to the 5th International WHO Standard 97/578 for UF heparin and the 2nd International WHO Standard 01/608 for LMW heparin. This establishes a "gold standard" for the analyte measurement.
- Statistical Performance Metrics: Meeting specified CV% acceptance criteria quantifies the precision and reproducibility against statistical norms.
- Recovery Targets: For stability, acceptance criteria are defined as 90 to 110% of the Date of Manufacture (DOM) value.
8. The Sample Size for the Training Set
Not applicable. This device is an IVD calibration verification/linearity test kit, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
§ 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.