(30 days)
The IMMULITE® Free T4 Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Free T4 assay on the IMMULITE 2000 systems.
The IMMULITE® IGF-1 Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE IGF-1 assay on the IMMULITE 2000 systems.
The IMMULITE® Prolactin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Prolactin assay on the IMMULITE 2000 systems.
The IMMULITE® 2000 Free T4 Calibration Verification Material (CVM) contains one set of four vials each ImL. CVMIcontains a lyophilized processed human serum matrix with 1.58% sodium azide and preservative and CVM2, CVM3, and CVM4 contain various levels of lyophilized Free T4 in a processed human serum matrix with 1.58% sodium azide and preservative. CVMs are supplied frozen in a lyophilized form.
The IMMULITE® 2000 IGF-I Calibration Verification Material (CVM) contains one set of four vials, 2mL (CVM1) each. CVM1 contains a processed bovine protein/buffer matrix with preservatives. CVM2, CVM3, and CVM4 contain various levels of IGF-I in a processed bovine protein/buffer matrix with preservatives. The CVMs are supplied frozen in a liquid form.
IMMULITE® 2000 Prolactin Calibration Verification Material (CVM) contains one set of four vials, 3 mL each. CVM1 contains a lyophilized equine serum/buffer matrix with preservative. CVM2, CVM3, and CVM4 contain various levels of lyophilized prolactin in an equine serum/buffer matrix with preservative CVMs are supplied frozen in a lyophilized form.
Here's a breakdown of the acceptance criteria and study information for each of the three IMMULITE® 2000 Calibration Verification Materials (CVMs) mentioned in the provided text.
IMMULITE® 2000 Free T4 Calibration Verification Material
1. Table of Acceptance Criteria and Reported Device Performance
| Level | Acceptance Criteria (Dose Value) | Reported Performance (Guideline ±2SD Range) | Target Mean (ng/dL) | Standard Deviation (SD) |
|---|---|---|---|---|
| LFT4CVM1 | - | ≤0.3 ng/dL | 0.00* | - |
| LFT4CVM2 | Within ±10% of assigned dose | 1.69 ng/dL | 1.51 | 0.09 |
| LFT4CVM3 | Within ±10% of assigned dose | 3.19 ng/dL | 2.90 | 0.145 |
| LFT4CVM4 | Within ±15% of assigned dose | 7.88 ng/dL | 6.85* | 0.515 |
| Part 2 | Dose value of controls within 2SD of the control target value when generated from stability calibrator curve. | - | - | - |
Note: The reported performance "Guideline ±2SD Range" is derived from the established Target Mean and Standard Deviation, and suggests the expected range within which the CVMs should perform. The exact demonstration of conformity to the ±10% or ±15% acceptance criteria based on this study is not explicitly stated as a pass/fail within this summary, but the derived ranges imply performance within expected limits.
2. Sample Size and Data Provenance for Test Set
- Sample Size:
- 27 replicates for each CVM level (9 runs and 3 replicates per run).
- 5 different reagent kit lots.
- 9 IMMULITE 2000 systems.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). Implied to be internal, prospective testing by the manufacturer.
3. Number of Experts and Qualifications for Ground Truth of Test Set
Not applicable for this type of device (calibration verification material). The "ground truth" refers to the assigned dose values and established statistically derived ranges.
4. Adjudication Method for Test Set
Not applicable for this type of device. The evaluation is based on quantitative measurements against predefined statistical criteria.
5. MRMC Comparative Effectiveness Study
No. This is not a comparative effectiveness study involving human readers.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This is a physical calibration verification material, not an algorithm. Performance is demonstrated through stability and value assignment studies in conjunction with the IMMULITE 2000 systems.
7. Type of Ground Truth Used
- Assigned Reference Calibrators: The CVMs are value assigned using assigned reference calibrators.
- Internal Material Gravimetrically Prepared: The CVMs are traceable to an internal material which has been gravimetrically prepared.
- Statistical Derivation: Target Mean and ± 2 Standard Deviation (SD) are used to establish Guideline Ranges.
8. Sample Size for Training Set
No explicit "training set" in the context of machine learning. The "Value Assignment" process is analogous to establishing the ground truth/reference for the CVMs. This involved:
- 6 levels of Total Free T4 calibrators (used internally, not commercialized).
- 6 levels of commercially available controls.
- 30 normal patient samples.
9. How Ground Truth for Training Set was Established
The ground truth (value assignment) for the CVMs was established using:
- Assigned reference calibrators.
- CVM dose values generated using curves from these assigned reference calibrators.
- CVM values calculated from recovered values for each run on each instrument independently and then averaged across all systems.
- Quality control performed by calculating recovery of patient samples, spiked patient samples, and controls using the assigned CVM values.
IMMULITE® 2000 IGF-I Calibration Verification Material
1. Table of Acceptance Criteria and Reported Device Performance
| Level | Acceptance Criteria (Dose Value) | Reported Performance (Guideline ±2SD Range) | Target Mean (ng/mL) | Standard Deviation (SD) |
|---|---|---|---|---|
| LGFCVM1 | Within ±10% of assigned dose (implied for all levels as per general criteria) | ≤25.00 ng/mL | 0.00 | - |
| LGFCVM2 | Within ±10% of assigned dose | 29.1 ng/mL | 34.7 | 2.8 |
| LGFCVM3 | Within ±10% of assigned dose | 206 ng/mL | 237 | 15.5 |
| LGFCVM4 | Within ±10% of assigned dose | 1554 ng/mL | 1727* | 86.5 |
| Part 2 | Dose value of controls within 2SD of the control target value when generated from stability calibrator curve. | - | - | - |
Note: The reported performance "Guideline ±2SD Range" is derived from the established Target Mean and Standard Deviation, and suggests the expected range within which the CVMs should perform. The exact demonstration of conformity to the ±10% acceptance criteria based on this study is not explicitly stated as a pass/fail within this summary, but the derived ranges imply performance within expected limits.
2. Sample Size and Data Provenance for Test Set
- Sample Size:
- 27 replicates for each CVM level (9 runs and 3 replicates per run).
- 7 IMMULITE 2000 systems.
- 3 different reagent kit lots.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). Implied to be internal, prospective testing by the manufacturer.
3. Number of Experts and Qualifications for Ground Truth of Test Set
Not applicable for this type of device (calibration verification material). The "ground truth" refers to the assigned dose values and established statistically derived ranges.
4. Adjudication Method for Test Set
Not applicable for this type of device. The evaluation is based on quantitative measurements against predefined statistical criteria.
5. MRMC Comparative Effectiveness Study
No. This is not a comparative effectiveness study involving human readers.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This is a physical calibration verification material, not an algorithm. Performance is demonstrated through stability and value assignment studies in conjunction with the IMMULITE 2000 systems.
7. Type of Ground Truth Used
- Assigned Reference Calibrators: The CVMs are value assigned using assigned reference calibrators.
- Internal Material Gravimetrically Prepared: The CVMs are traceable to an internal material which has been gravimetrically prepared.
- Statistical Derivation: Target Mean and ± 2 Standard Deviation (SD) are used to establish Guideline Ranges.
8. Sample Size for Training Set
No explicit "training set" in the context of machine learning. The "Value Assignment" process is analogous to establishing the ground truth/reference for the CVMs. This involved:
- 6 levels of IGF-I calibrators (used internally, not commercialized).
- 2 levels of commercially available controls.
- 60 samples (10 spiked samples and 50 normal patient samples).
9. How Ground Truth for Training Set was Established
The ground truth (value assignment) for the CVMs was established using:
- Assigned reference calibrators.
- CVM dose values generated using curves from these assigned reference calibrators.
- CVM values calculated from recovered values for each run on each instrument independently and then averaged across all systems.
- Quality control performed by calculating recovery of patient samples and controls using the assigned CVM values, ensuring controls fall within their target ranges.
IMMULITE® 2000 Prolactin Calibration Verification Material
1. Table of Acceptance Criteria and Reported Device Performance
| Level | Acceptance Criteria (Dose Value) | Reported Performance (Guideline ±2SD Range) | Target Mean (ng/mL) | Standard Deviation (SD) |
|---|---|---|---|---|
| LPRCVM1 | Within ±10% of assigned dose (implied for all levels as per general criteria) | 0.00 ≤0.5 ng/mL | 0.00* | - |
| LPRCVM2 | Within ±10% of assigned dose | 7.10 - 10.0 ng/mL | 8.55 | 0.725 |
| LPRCVM3 | Within ±10% of assigned dose | 36.7 - 48.7 ng/mL | 42.7 | 3.0 |
| LPRCVM4** | Within ±10% of assigned dose (after dilution for target value within reportable range) | - | 195 | - |
| 80% LPRCVM4 + 20% LPRCVM1 | Within ±10% of assigned dose | 131 - 181 ng/mL | 156* | 12.5 |
| Part 2 | Dose value of controls within 2SD of the control target value when generated from stability calibrator curve. | - | - | - |
Note: The reported performance "Guideline ±2SD Range" is derived from the established Target Mean and Standard Deviation, and suggests the expected range within which the CVMs should perform. The exact demonstration of conformity to the ±10% acceptance criteria based on this study is not explicitly stated as a pass/fail within this summary, but the derived ranges imply performance within expected limits. LPRCVM4 requires dilution for its target value to be within the reportable range of the assay.
2. Sample Size and Data Provenance for Test Set
- Sample Size:
- 27 replicates for each CVM level (9 runs and 3 replicates per run).
- 8 IMMULITE 2000 systems.
- 4 different reagent kit lots.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). Implied to be internal, prospective testing by the manufacturer.
3. Number of Experts and Qualifications for Ground Truth of Test Set
Not applicable for this type of device (calibration verification material). The "ground truth" refers to the assigned dose values and established statistically derived ranges.
4. Adjudication Method for Test Set
Not applicable for this type of device. The evaluation is based on quantitative measurements against predefined statistical criteria.
5. MRMC Comparative Effectiveness Study
No. This is not a comparative effectiveness study involving human readers.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This is a physical calibration verification material, not an algorithm. Performance is demonstrated through stability and value assignment studies in conjunction with the IMMULITE 2000 systems.
7. Type of Ground Truth Used
- Assigned Reference Calibrators: The CVMs are value assigned using assigned reference calibrators.
- 3rd IS 84/500: The CVMs are traceable to this international standard.
- Statistical Derivation: Target Mean and ± 2 Standard Deviation (SD) are used to establish Guideline Ranges.
8. Sample Size for Training Set
No explicit "training set" in the context of machine learning. The "Value Assignment" process is analogous to establishing the ground truth/reference for the CVMs. This involved:
- 8 levels of Prolactin calibrators (used internally, not commercialized).
- 6 levels of commercially available controls.
- 30 samples (10 normal patients and 20 spiked normal patient samples).
9. How Ground Truth for Training Set was Established
The ground truth (value assignment) for the CVMs was established using:
- Assigned reference calibrators.
- CVM dose values generated using curves from these assigned reference calibrators.
- CVM values calculated from recovered values for each run on each instrument independently and then averaged across all systems.
- Quality control performed by calculating recovery of patient samples and controls using the assigned CVM values.
§ 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.