(105 days)
The Audit™ MicroCV" General Chemistry Linearity Set consists of five levels of human based serum. Each level contains the following analytes: Acid Phosphatase, Albumin, Alkaline Phosphatase, ALT, Amylase, AST, Bilirubin (Total and Direct), BUN, Calcium, Chloride, Cholesterol, CO2 Creatine Kinase, Creatinine, Gamma-GT, Glucose, HDL Cholesterol, fron, LDH, LDL Cholesterol, Lactate, Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total Protein, Triglycerides and Uric Acid. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents and instruments.
This product may be used for proficiency testing in interlaboratory surveys and to perform CLIA directed calibration verification for these same analytes with similar instrumentation in accordance with current CLIA-88 guidelines and regulations.
In addition, levels B - E of this product may be used as unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. It is not intended to be used as an assayed quality control material for any other analyzer systems.
The Device is a QC material that will be used to determine the linearity of clinical chemistry assays as defined by CLIA-88 in Federal Register 42 CFR Part 493, Department of Health and Human Services, January 24, 2003.
Audit™ MicroCV™ General Chemistry Linearity Set is assayed quality control material consisting of human based serum. It is intended to simulate human patient serum samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for Acid Phosphatase, Albumin, Alkaline Phosphatase, ALT, Amylase, AST, Bilirubin (Total and Direct), BUN, Calcium, Chloride, Cholesterol, CO2 Creatine Kinase, Creatinine, Gamma-GT, Glucose, HDL Cholesterol, Iron, LDH, LDL Cholesterol, Magnesium, Comments, Potassium, Sodium, Total Protein, Lipase, La Crete, Triglycerides and Uric Acid. These five levels demonstrate a linear relationship to each other for their respective analytes, reagents and instruments.
This product may also be used as unassayed quality control material for these same analytes and may be used for proficiency testing in interlaboratory surveys. In addition, this product may also be used to perform CLIA directed calibration for these same analytes with similar reagents on similar instrumentation in accordance with current CLIA-88 guidelines and regulations.
The five levels QC material is to be assayed as an unknown for the determination of linearity.
Here's a breakdown of the acceptance criteria and the study details for the Audit™ MicroCV™ General Chemistry Linearity Set, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Internal Standard) | Reported Device Performance (Target Values) |
|---|---|
| Linearity: Coefficient of correlation (R²) ≥ 0.975 (for five linearity levels) | Achieved for all analytes. (Implied by the conclusion of "linearity confirmed.") |
| Storage Stability (Unopened Vial): 90-110% recovery of concentration/activity compared to reference vial (0 day) at 2-8°C. | Predicted 12 years at 2-8°C. |
| Open Vial Stability: 90-110% recovery of concentration/activity compared to reference vial (0 day). | Predicted 24 hours at 2-8°C. |
Note: The document specifies manufacturing targets for each analyte at five different levels (A-E) as an internal standard for production and value assignment. However, the overarching performance acceptance criteria for the device itself (as a linearity set) are linearity and stability. The individual analyte target values and ranges (e.g., Bicarbonate Level A: 10 ± 1 mmol/L) represent the intended composition of the product, which then must demonstrate linearity across these levels.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For stability studies:
- Stress Stability: Selected vials (Level A and Level E) from a lot were removed at different time intervals. The exact number of vials or lots is not specified beyond "selected vials."
- Open Bottle Study: "TEST" vials (not a specific number, implying multiple vials from a lot) were reconstituted and repeatedly accessed.
- Data Provenance: Retrospective, as the stress stability study was a "backward performed study." The "real time stability data is be collected," indicating the initial clearance relied on accelerated studies. The origin of the base matrix is a mixture of bovine serum and normal processed human serum.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. This device is an in vitro diagnostic quality control material, not an AI or imaging device requiring expert interpretation of results. The "ground truth" for its performance is established by analytical methods and statistical calculations. The "value assignment protocol" describes how target values are derived, which involves instrumental measurements rather than expert consensus on a diagnostic outcome.
4. Adjudication Method for the Test Set
- Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not an AI or imaging device; it is a laboratory quality control material. MRMC studies are used to evaluate the diagnostic performance of devices, often in comparison to human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No. This is not an algorithmic device. Its performance is intrinsic to its chemical composition and how it performs across analytical instruments.
7. The Type of Ground Truth Used
- Analytical Measurements and Statistical Calculation:
- Linearity Ground Truth: Established by plotting target values against designated levels and calculating the coefficient of correlation (R²). An R² ≥ 0.975 indicates linearity.
- Stability Ground Truth: Established by comparing the concentration/activity of analytes in stressed/opened vials against reference vials (zero day) using linear regression and modified Arrhenius equations to predict stability. The acceptable range is 90-110% recovery.
- Value Assignment Ground Truth: For each analyte, 30 values were collected (10 individual assays from a single vial, assayed in the morning and afternoon over five days from three instruments/labs if available). The average of these 30 data points served as the target value.
8. The Sample Size for the Training Set
- Not applicable. This product is a physical quality control material, not a machine learning model. It does not have a "training set" in the computational sense. The manufacturing targets and value assignments are based on internal analytical data from the production of the material itself.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
§ 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.