(28 days)
IMMULITE® 2000 Beta-2 Microglobulin Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Beta-2 Microglobulin assay on the IMMULITE 2000 systems
IMMULITE® 2000 High Sensitivity CRP Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE High Sensitivity CRP assay on the IMMULITE 2000 systems
The IMMULITE® 2000 Beta-2 Microglobulin Calibration Verification Material (CVM) contains one set of four vials each 3mL. CVM1 contains bovine protein buffer matrix with preservatives and CVM2, CVM3, and CVM4 contain various levels of human Beta-2 Microglobulin in a lyophilized bovine protein buffer matrix with preservatives.
The IMMULITE® 2000 High Sensitivity CRP Calibration Verification Material (CVM) contains one set of four vials, 2mL each. CVM1 contains a bovine protein/buffer with 0.098% sodium azide and preservative. CVM2, CVM3, and CVM4 contain various levels of human CRP in a bovine protein/buffer with 0.098% sodium azide and preservative.
This document describes two calibration verification materials (CVMs): IMMULITE® 2000 Beta-2 Microglobulin CVM and IMMULITE® 2000 High Sensitivity CRP CVM. Since they are distinct devices with separate studies and acceptance criteria, I will describe them separately.
IMMULITE® 2000 Beta-2 Microglobulin Calibration Verification Material
This device is a quality control material intended for in vitro diagnostic use in the verification of calibration of the IMMULITE Beta-2 Microglobulin assay on the IMMULITE 2000 systems.
1. Acceptance Criteria and Reported Device Performance
The device's performance is demonstrated through stability studies. The acceptance criteria for stability are divided into two parts:
- Part 1: Guideline Acceptance Criteria:
- CVM Level 2: Dose value to fall within ±15% of the assigned dose.
- CVM Level 3 and 4: Dose value to fall within ±20% of the assigned dose.
- Part 2: Review Limits Criteria: If Part 1 criteria are not met, the dose value of the controls must be within 2 Standard Deviations (SD) of the control target value when generated from the stability calibrator curve.
The document states that the stability study was conducted to validate real-time shelf life and open component (in-use or open vial) claims. It also reports:
- Real-time shelf life: Stable up to 9 years when stored at -20°C prior to opening. The study for lots 011 and 012 is ongoing until the 119-month time point.
- Open component (in-use) stability: 8 hours of stability at ambient or room temperature (15-25°C) after opening.
The document does not provide a direct table comparing the acceptance criteria to actual numerical results for each CVM level. Instead, it states that the testing demonstrated the device meets the performance specifications.
2. Sample Size and Data Provenance for Test Set
- Sample Size:
- For stability testing, CVMs were run in duplicate (as a minimum) at specified time points. Three lots were used: Lot 010, Lot 011, and Lot 012. Each lot had 4 CVM levels.
- For open component testing, CVM lot 012 was tested using IMMULITE 2000 Beta-2 Microglobulin (L2KBM) kit lot 247 at 2-hourly intervals for up to 9 hours.
- For Expected Values/Target Values/Reference Range establishment: Each CVM level was tested for a total of 15 replicates (5 runs and 3 replicates per run) using 3 different reagent kit lots and 5 IMMULITE 2000 systems.
- Data Provenance: The information does not specify the country of origin of the data. The studies are described as "non-clinical performance testing," implying they are internal validation studies conducted by the manufacturer. The data is prospective as it involves stability testing over time.
3. Number of Experts and Qualifications for Ground Truth
- This device is a calibration verification material. The "ground truth" for CVMs is typically established through precise analytical methods and traceability to reference materials. The document doesn't mention the involvement of "experts" in establishing ground truth in the same way clinical diagnostic devices might have radiologists or pathologists.
- The CVMs are described as traceable to an internal material which has been gravimetrically prepared. Value assignment involves generating dose values using a curve generated by assigned reference calibrators, with values averaged across systems. Quality control is performed by calculating recovery of patient samples (40 samples: 20 spiked and diluted urine, 10 neat urine, 10 diluted serum) and controls.
4. Adjudication Method for Test Set
Not applicable for a calibration verification material's performance studies. The evaluation is based on quantitative measurements against established internal and traceable standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a calibration verification material, not a diagnostic imaging device typically evaluated with MRMC studies comparing human readers with and without AI assistance.
6. Standalone Performance Study
Yes, the studies described are standalone performance studies for the calibration verification material itself. Its performance is evaluated independently against its established criteria and traceability.
7. Type of Ground Truth Used
The ground truth or reference values for the CVMs are established through:
- Traceability: To an internal material gravimetrically prepared.
- Value Assignment: Using assigned reference calibrators and averaging recovered values across systems.
- Validation: Through recovery calculation of patient samples (spiked and diluted urine, neat urine, diluted serum) and controls.
8. Sample Size for the Training Set
Not applicable. This is a calibration verification material; it does not involve machine learning or a "training set" in the conventional sense. The "training" of the assay itself (which these materials verify) would involve its own calibration process, which is distinct from the CVM performance study.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
IMMULITE® 2000 High Sensitivity CRP Calibration Verification Material
This device is a quality control material intended for in vitro diagnostic use in the verification of calibration of the IMMULITE High Sensitivity CRP assay on the IMMULITE 2000 systems.
1. Acceptance Criteria and Reported Device Performance
The device's performance is demonstrated through stability studies. The acceptance criteria for stability are divided into two parts:
- Part 1: Guideline Acceptance Criteria:
- CVM Level 2: Dose value to fall within ±20% of the assigned dose.
- CVM Level 3: Dose value to fall within ±6% of the assigned dose.
- CVM Level 4: Dose value to fall within ±10% of the assigned dose.
- Part 2: Review Limits Criteria: If Part 1 criteria are not met, the dose value of the controls must be within 2 Standard Deviations (SD) of the control target value when generated from the stability calibrator curve.
The document states that the stability study was conducted to validate real-time shelf life and open component (in-use or open vial) claims. It also reports:
- Real-time shelf life: Stable up to 11 months when stored at 2-8°C prior to opening. The study for lots 025, 026, and 090 is ongoing (up to 23, 12, and 11 months respectively).
- Open component (in-use) stability: 8 hours of stability at ambient or room temperature (15-25°C) after opening.
The document does not provide a direct table comparing the acceptance criteria to actual numerical results for each CVM level. Instead, it states that the testing demonstrated the device meets the performance specifications.
2. Sample Size and Data Provenance for Test Set
- Sample Size:
- For stability testing, CVMs were run in duplicate (as a minimum) at specified time points. Three lots were used: Lot 025, Lot 026, and Lot 090. Each lot had 4 CVM levels.
- For Expected Values/Target Values/Reference Range establishment: CVMs were tested on 15 replicates in total (comprised of 5 runs and 3 replicates per run) on 4 IMMULITE 2000 systems and 3 different reagent kit lots.
- Data Provenance: The information does not specify the country of origin of the data. The studies are described as "non-clinical performance testing," implying they are internal validation studies conducted by the manufacturer. The data is prospective as it involves stability testing over time.
3. Number of Experts and Qualifications for Ground Truth
- Similar to the Beta-2 Microglobulin CVM, this device is a calibration verification material. The "ground truth" for CVMs is typically established through precise analytical methods and traceability to reference materials. The document doesn't mention the involvement of "experts" in establishing ground truth in the same way clinical diagnostic devices might have radiologists or pathologists.
- The CVMs are described as traceable to WHO 1st IS 85/506 and CRM 470. Value assignment involves generating dose values using a curve generated by assigned reference calibrators, with values averaged across systems. Quality control is performed by calculating recovery of patient samples (28 samples: 21 normal, 7 spiked) and controls.
4. Adjudication Method for Test Set
Not applicable for a calibration verification material's performance studies. The evaluation is based on quantitative measurements against established internal and traceable standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a calibration verification material, not a diagnostic imaging device typically evaluated with MRMC studies comparing human readers with and without AI assistance.
6. Standalone Performance Study
Yes, the studies described are standalone performance studies for the calibration verification material itself. Its performance is evaluated independently against its established criteria and traceability.
7. Type of Ground Truth Used
The ground truth or reference values for the CVMs are established through:
- Traceability: To WHO 1st IS 85/506 and CRM 470.
- Value Assignment: Using assigned reference calibrators and averaging recovered values across systems.
- Validation: Through recovery calculation of patient samples (normal and spiked) and controls.
8. Sample Size for the Training Set
Not applicable. This is a calibration verification material; it does not involve machine learning or a "training set" in the conventional sense. The "training" of the assay itself (which these materials verify) would involve its own calibration process, which is distinct from the CVM performance study.
9. How 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.