(46 days)
The VALIDATE Chem 9 Calibration Verification Test Set is intended for in vitro diagnostic use for quantitatively verifying calibration, validating reportable ranges, and determining linearity for automated and manual chemistry systems for the following eighteen analytes: albumin (ALB), calcium (CA), cholesterol (CHOL), chloride (CL), carbon dioxide (CO2), creatinine (CRE), glucose (GLU), iron (FE), lactate (LAC), lithium (LI), magnesium (MG), phosphorus (PQ4), potassium (K), sodium (NA), total protein (TP), triglyceride (TRIG), urea nitrogen (BUN), and uric acid (UA).
The VALIDATE Chem 9 Calibration Verification Test Set is used by trained laboratory professionals for the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated, and manual clinical chemistry systems for the following eighteen analytes. albumin, calcium, cholesterol, chloride, carbon dioxide, creatinine, glucose, iron, lactate, lithium, magnesium, phosphorus, potassium, sodium, total protein, triglyceride, urea nitrogen, and uric acid.
VALIDATE Chem 9 Calibration Verification Test Set contains purified chemicals in a protein matrix. Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes. Each set contains one bottle each of five (5) levels. Each bottle contains 5 milliliters.
Here's a breakdown of the acceptance criteria and study information for the VALIDATE Chem 9 Calibration Verification Test Set, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the VALIDATE Chem 9 device are not explicitly stated as numerical thresholds (e.g., "correlation coefficient must be > 0.99"). Instead, the primary acceptance criterion is "functional equivalence for calibration verification and linearity assessment" to the predicate devices. This functional equivalence is demonstrated through linear regression analysis and correlation coefficients.
The reported device performance, represented by the correlation coefficients (r) and regression equations, establishes this equivalence.
| Analyte | Acceptance Criteria (Implied) | VALIDATE Chem 9 Performance (Correlation Coefficient (r)) | VALIDATE Chem 9 Regression Equation (Y = slope(X) + intercept) | Predicate 1 (DOCUMENT Serum) Performance (Correlation Coefficient (r)) | Predicate 1 (DOCUMENT Serum) Regression Equation (Y = slope(X) + intercept) | Predicate 2 (Ortho-Clinical VITROS) Performance (Correlation Coefficient (r)) | Predicate 2 (Ortho-Clinical VITROS) Regression Equation (Y = slope(X) + intercept) |
|---|---|---|---|---|---|---|---|
| ALB | Functional equivalence to predicate devices (demonstrated by high correlation and similar regression). | 0.9942 | x - 0.1 | 0.998 | 0.997x + 0.022 | (Not applicable for this analyte) | (Not applicable for this analyte) |
| BUN | Functional equivalence to predicate devices (demonstrated by high correlation and similar regression). | 0.9999 | 1.0138x - 0.4276 | 0.999 | 1.005x + 0.618 | (Not applicable for this analyte) | (Not applicable for this analyte) |
| CA | Functional equivalence to predicate devices (demonstrated by high correlation and similar regression). | 0.9974 | 1.01x + 0.288 | 0.999 | 0.995x + 0.035 | (Not applicable for this analyte) | (Not applicable for this analyte) |
| CHOL | Functional equivalence to predicate devices (demonstrated by high correlation and similar regression). | 0.9999 | 0.9935x + 1.8102 | 0.995 | 1.058x - 6.192 | (Not applicable for this analyte) | (Not applicable for this analyte) |
| CL | Functional equivalence to predicate devices (demonstrated by high correlation and similar regression). | 0.9996 | 0.9581x + 3.6226 | 0.998 | 1.010x - 1.389 | (Not applicable for this analyte) | (Not applicable for this analyte) |
| CO2 | Functional equivalence to predicate devices (demonstrated by high correlation and similar regression). | 0.9971 | 0.875x + 1.675 | 0.998 | 1.009x - 0.176 | (Not applicable for this analyte) | (Not applicable for this analyte) |
| CRE | Functional equivalence to predicate devices (demonstrated by high correlation and similar regression). | 0.9986 | 0.9364 + 0.1791 | 0.999 | 0.974x + 0.073 | (Not applicable for this analyte) | (Not applicable for this analyte) |
| FE | Functional equivalence to predicate devices (demonstrated by high correlation and similar regression). | 0.9988 | 0.9205x + 14.617 | 0.998 | 1.119x - 14.492 | (Not applicable for this analyte) | (Not applicable for this analyte) |
| GLU | Functional equivalence to predicate devices (demonstrated by high correlation and similar regression). | 0.9999 | 1.0132x - 0.7707 | 0.999 | 1.050x - 9.370 | (Not applicable for this analyte) | (Not applicable for this analyte) |
| K | Functional equivalence to predicate devices (demonstrated by high correlation and similar regression). | 0.9987 | 0.9984x - 0.2576 | 0.999 | 0.983 + 0.170 | (Not applicable for this analyte) | (Not applicable for this analyte) |
| LITH | Functional equivalence to predicate devices (demonstrated by high correlation and similar regression). | 0.9997 | 0.9733x + 0.0187 | 0.994 | 0.924x + 0.015 | (Not applicable for this analyte) | (Not applicable for this analyte) |
| MG | Functional equivalence to predicate devices (demonstrated by high correlation and similar regression). | 0.9993 | 0.9832 + 0.1053 | 0.998 | 1.051x - 0.082 | (Not applicable for this analyte) | (Not applicable for this analyte) |
| NA | Functional equivalence to predicate devices (demonstrated by high correlation and similar regression). | 0.9991 | 1.0042x + 1.8979 | 0.998 | 1.076x - 7.561 | (Not applicable for this analyte) | (Not applicable for this analyte) |
| PO4 | Functional equivalence to predicate devices (demonstrated by high correlation and similar regression). | 0.9998 | 0.975x + 0.035 | 0.999 | 0.992x + 0.093 | (Not applicable for this analyte) | (Not applicable for this analyte) |
| TP | Functional equivalence to predicate devices (demonstrated by high correlation and similar regression). | 0.9986 | 1.097x - 0.5097 | 0.998 | 1.086x - 0.261 | (Not applicable for this analyte) | (Not applicable for this analyte) |
| TRIG | Functional equivalence to predicate devices (demonstrated by high correlation and similar regression). | 0.9999 | 1.0226x - 3.6259 | 0.999 | 1.018x + 2.292 | (Not applicable for this analyte) | (Not applicable for this analyte) |
| URIC ACID | Functional equivalence to predicate devices (demonstrated by high correlation and similar regression). | 0.9997 | 0.97x + 0.161 | 0.999 | 0.992x + 0.040 | (Not applicable for this analyte) | (Not applicable for this analyte) |
| LAC | Functional equivalence to predicate devices (demonstrated by high correlation and similar regression). | 1.0000 | 1.012x - 0.0272 | (Not applicable for this analyte) | (Not applicable for this analyte) | 0.9995 | 0.9398x + 0.0692 |
Note: For the LAC analyte, the comparison is specifically against Ortho-Clinical Diagnostics VITROS Calibrator Kit 1, which primarily targets lactate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that performance was evaluated on "pre-production lots of VALIDATE Chem 9 Calibration Verification Test Set." It also mentions, "Each analyte was tested in triplicate." However, the specific number of distinct samples or cases in the test set is not explicitly stated. The core of the test involves comparing values obtained from the VALIDATE Chem 9 kit to those from predicate devices across multiple concentration levels (5 levels for VALIDATE Chem 9 and DOCUMENT Serum, 3 levels for Ortho-Clinical VITROS).
- Data Provenance: The document does not specify the country of origin of the data. The study appears to be prospective in nature, as it uses "pre-production lots" of the VALIDATE Chem 9 device for comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not involve "experts" in the human diagnostic sense (e.g., radiologists). Instead, the "ground truth" or reference values are established by the well-characterized and legally marketed predicate devices (DOCUMENT Serum Multi-Analyte CAL·VER and Ortho-Clinical Diagnostics VITROS Calibrator Kit 1). The performance of these predicate devices on the VITROS instrument system serves as the benchmark against which the new device is compared.
4. Adjudication Method for the Test Set
Not applicable. This study involves a direct measurement comparison between calibration verification materials on an instrument system, not human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a study comparing in vitro diagnostic calibration materials, not a human-in-the-loop diagnostic imaging study involving human readers or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This study is inherently a "standalone" performance evaluation of the calibration verification test set, as it assesses its behavior on an instrument system (specifically the VITROS instrument system). There is no human intervention in the performance of the calibration verification process itself, beyond the initial setup by laboratory professionals. The comparison is between the new device and existing devices, all performing their function as "algorithms" (or chemical/physical standards) on the instrument.
7. The Type of Ground Truth Used
The "ground truth" is established by the performance of the legally marketed predicate devices (DOCUMENT Serum Multi-Analyte CAL·VER and Ortho-Clinical Diagnostics VITROS Calibrator Kit 1) on the VITROS instrument system. This can be considered a form of reference standard comparison against established and accepted laboratory calibration materials.
8. The Sample Size for the Training Set
Not applicable. This device is a chemical calibration verification test set, not an AI/ML algorithm that requires a training set. Its "performance" is inherent to its chemical composition and how it interacts with analytical instruments.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML device requiring a training set.
§ 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.