(88 days)
The VALIDATE Chem 10 Calibration Verification Test Set is intended for in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity for automated and manual chemistry systems for the following analytes: alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, creatine kinase, gamma-glutamyl transferase, lactate dehydrogenase, lipase, and total bilirubin. The materials may also be utilized on Ortho-Clinical Diagnostic's Vitros analyzers for determining linearity of the Bu/Bc methods.
The VALIDATE Chem 10 Calibration Verification Test Set is used by trained laboratory professionals for the determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual clinical chemistry systems for the following analytes: alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, creatine kinase, lactate dehydrogenase, alkaline phophatase, arnylase, lipase, and total bilirubin. The materials may also be utilized on Ortho-Clinical Diagnostic's Vitros analyzers for determining linearity of the Bu/Bc methods.
VALIDATE Chem 10 Calibration Verification Test Set contains purified enzymes in a solution of bovine albumin. Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes. Each set contains five (5) levels. Each bottle contains 5.0 milliliters.
Here's a breakdown of the acceptance criteria and the study details for the VALIDATE Chem 10 Calibration Verification Test Set, based specifically on the provided text:
Executive Summary:
The VALIDATE Chem 10 Calibration Verification Test Set is a multi-analyte calibrator intended for in vitro diagnostic use to verify calibration, validate reportable ranges, and determine linearity for various chemistry systems. The device's performance was compared to two predicate devices (DOCUMENT Reflectance II Test Set and Ortho-Clinical Diagnostics VITROS Calibrator Kit 4) through linear regression analysis. The study demonstrated functional equivalence for calibration verification and linearity assessment.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical thresholds (e.g., "r > 0.99"). Instead, the study aims to show "functional equivalence" to the predicate devices through strong linear correlation. The reported device performance is presented as the correlation coefficients (r) and regression equations. A correlation coefficient close to 1 would indicate substantial equivalence.
| Analyte | Acceptance Criteria (Implied) | VALIDATE Chem 10 Performance (Correlation Coefficient, r) |
|---|---|---|
| ALP | Strong linear correlation with predicate devices | 0.9973 (vs. Predicate 1) |
| ALT | Strong linear correlation with predicate devices | 0.9995 (vs. Predicate 1) |
| AMY | Strong linear correlation with predicate devices | 0.9983 (vs. Predicate 1) |
| AST | Strong linear correlation with predicate devices | 0.9990 (vs. Predicate 1) |
| CK | Strong linear correlation with predicate devices | 0.9932 (vs. Predicate 1) |
| GGT | Strong linear correlation with predicate devices | 0.9975 (vs. Predicate 1) |
| LD | Strong linear correlation with predicate devices | 0.9997 (vs. Predicate 1) |
| LIP | Strong linear correlation with predicate devices | 0.9999 (vs. Predicate 1) |
| TBIL | Strong linear correlation with predicate devices | 0.9999 (vs. Predicate 2) |
| Bu (Bilirubin) | Strong linear correlation with predicate devices | 0.999 (vs. Predicate 2) |
| Bc (Bilirubin) | Strong linear correlation with predicate devices | 0.9995 (vs. Predicate 2) |
Note: The regression equations are also part of the reported performance, showing the relationship between the VALIDATE Chem 10 and the predicate devices. The phrase "functional equivalence" is the overarching acceptance criterion.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that the VALIDATE Chem 10 Calibration Verification Test Set contains five (5) levels for each analyte. For the predicate device Ortho-Clinical Diagnostics VITROS Calibrator Kit 4, it mentions 3 levels for TBIL and 4 levels for Bu/Bc. It also states "2 x 2.0 mL each level" for the DOCUMENT Reflectance II Test Set, but does not explicitly state the number of levels for this predicate. The study compared "pre-production lots" of the VALIDATE Chem 10. The exact number of individual measurements or "samples" taken for each level across all analytes is not explicitly stated in the provided text.
- Data Provenance: The document does not specify the country of origin for the data. It is a retrospective comparison study against predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of device (calibration verification materials) does not use "experts" to establish a ground truth in the way a diagnostic imaging device would. The "ground truth" for these materials is their precisely manufactured, known concentrations, which are then run on a clinical chemistry system and compared to the results obtained from predicate devices. The study compares the performance of the new device against established, legally marketed predicate devices.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring human adjudication of results. The comparison is analytical, based on statistical correlation of measured values.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images). This device is a quality control material, and its performance is evaluated through analytical comparison.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance evaluation was done in the sense that the new device's analytical performance was assessed independently by running it on the Ortho-Clinical Diagnostics VITROS instrument system and then comparing its results to those obtained from the predicate devices through linear regression analysis. There is no "human-in-the-loop" component to the device's function or the primary performance study described.
7. Type of Ground Truth Used
The ground truth for this device is the known, precisely manufactured concentrations of the analytes within the calibration verification test set, as well as the established performance of the legally marketed predicate devices. The study then assesses how well the new device's measured values correlate with those of the predicate devices on a target instrument system.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. It is a manufactured reagent product.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.