(28 days)
The IMMULITE® C-Peptide Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE C-Peptide assay on the IMMULITE 2000 systems.
The IMMULITE® SHBG Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE SHBG assay on the IMMULITE 2000 systems.
The IMMULITE® Total Testosterone Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Total Testosterone assay on the IMMULITE 2000 systems.
IMMULITE® 2000 C-Peptide Calibration Verification Material (CVM) contains one set of four vials each 2mL. CVM1 contains a lyophilized buffered human albumin with bovine protein. 0.197% sodium azide and preservative CVM2, CVM3 and CVM4 contain various levels of lyophilized C-Peptide in buffered human albumin with bovine protein, 0.197% sodium azide and preservative. CVMs are supplied frozen in a lyophilized form.
IMMULITE® 2000 SHBG Calibration Verification Material (CVM) contains one set of four vials, 2mL (CVM1) and 2 mL (CVM2, CVM3 and CVM4) each. CVM1 contains a lyophilized buffered bovine protein/buffer matrix with 3.64% sodium azide and preservative. CVM2, CVM3, and CVM4 contain various levels of lyophilized SHBG in bovine protein/buffer matrix with 3.64% sodium azide and preservative CVMs are supplied frozen in lyophilized form.
IMMULITE® 2000 Total Testosterone Calibration Verification Material (CVM) contains one set of four vials, 2 mL each. CVM1 contains processed human serum with 0.98% sodium azide and other preservative. CVM2, CVM3, and CVM4 contain various levels of testosterone in processed human serum with 0.98% sodium azide and other preservative. The CVMs are supplied frozen in a liquid form.
The provided text describes three distinct devices: IMMULITE® 2000 C-Peptide, SHBG, and Total Testosterone Calibration Verification Materials (CVMs). Each device has its own acceptance criteria and associated performance testing. I will address each of them separately.
1. IMMULITE® 2000 C-Peptide Calibration Verification Material
Table of Acceptance Criteria and Reported Device Performance (Stability Studies):
| CVM Level | Acceptance Criteria (Shelf Life) | Acceptance Criteria (Open Vial) | Reported Performance (Shelf Life) | Reported Performance (Open Vial) |
|---|---|---|---|---|
| LPEPCVM1 | Not explicitly stated (likely qualitative, e.g., no significant change) | Same as Shelf Life Acceptance Criteria | Stable up to 6 years at 2-8°C | Stable for 8 hours at 15-25°C |
| LPEPCVM2 | Dose value to fall between ±15% of assigned dose; OR within 2SD of control target value (Part 2) | Same as Shelf Life Acceptance Criteria | Stable up to 6 years at 2-8°C | Stable for 8 hours at 15-25°C |
| LPEPCVM3 | Dose value to fall between ±10% of assigned dose; OR within 2SD of control target value (Part 2) | Same as Shelf Life Acceptance Criteria | Stable up to 6 years at 2-8°C | Stable for 8 hours at 15-25°C |
| LPEPCVM4 | Dose value to fall between ±15% of assigned dose; OR within 2SD of control target value (Part 2) | Same as Shelf Life Acceptance Criteria | Stable up to 6 years at 2-8°C | Stable for 8 hours at 15-25°C |
Study Details for C-Peptide CVM:
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1. Sample sized used for the test set and the data provenance:
- Shelf Life Stability: Data points at 1 day, 1642 days (~4.5 years), 1825 days (5 years), and 2190 days (6 years). Testing was run in duplicate (at minimum) for each CVM level.
- Open Vial Stability: Data points at 0, 2, 4, and 8 hours for each CVM level.
- Value Assignment: 27 replicates (9 runs, 3 replicates per run) using 5 different reagent kit lots and 9 IMMULITE 2000 systems. 6 levels of commercially available controls and 59 normal patient samples were used to validate CVM value assignments.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Implied to be prospective, internal performance testing.
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2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is for a calibration verification material, where internal reference methods and defined target values form the "ground truth."
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3. Adjudication method for the test set: Not applicable. Performance is based on pre-defined analytical acceptance criteria.
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4. 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 quality control material, not an AI-assisted diagnostic device.
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5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an in vitro diagnostic material. The device's performance is its ability to maintain its assigned values over time and conditions.
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6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for CVMs is based on assigned reference calibrators which are traceable to WHO 1st IRP 84/510. Quality control is performed by calculating the recovery of patient samples and controls using the assigned CVM values against their target ranges.
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7. The sample size for the training set: Not applicable. This is not a machine learning/AI device with a training set. The term "training set" is generally used in the context of supervised learning for AI.
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8. How the ground truth for the training set was established: Not applicable.
2. IMMULITE® 2000 SHBG Calibration Verification Material
Table of Acceptance Criteria and Reported Device Performance (Stability Studies):
| CVM Level | Acceptance Criteria (Shelf Life) | Acceptance Criteria (Open Vial) | Reported Performance (Shelf Life) | Reported Performance (Open Vial) |
|---|---|---|---|---|
| LSHCVM1 | Not explicitly stated (likely qualitative, e.g., no significant change) | Same as Shelf Life Acceptance Criteria | Stable up to 9 years at 2-8°C | Stable for 8 hours at 15-25°C |
| LSHCVM2 | Dose value to fall between ±10% of assigned dose; OR within 2SD of control target value (Part 2) | Same as Shelf Life Acceptance Criteria | Stable up to 9 years at 2-8°C | Stable for 8 hours at 15-25°C |
| LSHCVM3 | Dose value to fall between ±10% of assigned dose; OR within 2SD of control target value (Part 2) | Same as Shelf Life Acceptance Criteria | Stable up to 9 years at 2-8°C | Stable for 8 hours at 15-25°C |
| LSHCVM4 | Dose value to fall between ±20% of assigned dose; OR within 2SD of control target value (Part 2) | Same as Shelf Life Acceptance Criteria | Stable up to 9 years at 2-8°C | Stable for 8 hours at 15-25°C |
Study Details for SHBG CVM:
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1. Sample sized used for the test set and the data provenance:
- Shelf Life Stability: Data points at 1 day, 2190 days (6 years), 2555 days (7 years), and 3285 days (9 years). Testing was run in duplicate (at minimum) for each CVM level.
- Open Vial Stability: Data points at 0, 2, 4, and 8 hours for each CVM level.
- Value Assignment: 27 replicates (9 runs, 3 replicates per run) on 8 IMMULITE 2000 systems using 1 reagent kit lot. 4 levels of commercially available controls and 28 normal patient samples were used to validate CVM value assignments.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Implied to be prospective, internal performance testing.
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2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Analytical performance based on pre-defined criteria.
-
3. Adjudication method for the test set: Not applicable.
-
4. 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.
-
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
-
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for CVMs is based on assigned reference calibrators traceable to an internal gravimetrically prepared material. Quality control is performed by calculating the recovery of patient samples and controls using the assigned CVM values against their target ranges.
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7. The sample size for the training set: Not applicable.
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8. How the ground truth for the training set was established: Not applicable.
3. IMMULITE® 2000 Total Testosterone Calibration Verification Material
Table of Acceptance Criteria and Reported Device Performance (Stability Studies):
| CVM Level | Acceptance Criteria (Shelf Life) | Acceptance Criteria (Open Vial) | Reported Performance (Shelf Life) | Reported Performance (Open Vial) |
|---|---|---|---|---|
| LTWCVMI | Not explicitly stated (likely qualitative, e.g., no significant change) | Same as Shelf Life Acceptance Criteria | Stable up to 26 months at -20°C | Stable for 6 hours at 15-25°C |
| LTWCVM2 | Dose value to fall between ±15% of assigned dose; OR within 2SD of control target value (Part 2) | Same as Shelf Life Acceptance Criteria | Stable up to 26 months at -20°C | Stable for 6 hours at 15-25°C |
| LTWCVM3 | Dose value to fall between ±10% of assigned dose; OR within 2SD of control target value (Part 2) | Same as Shelf Life Acceptance Criteria | Stable up to 26 months at -20°C | Stable for 6 hours at 15-25°C |
| LTWCVM4 | Dose value to fall between ±9% of assigned dose; OR within 2SD of control target value (Part 2) | Same as Shelf Life Acceptance Criteria | Stable up to 26 months at -20°C | Stable for 6 hours at 15-25°C |
Study Details for Total Testosterone CVM:
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1. Sample sized used for the test set and the data provenance:
- Shelf Life Stability: Data points at 1 day, 182 days (~6 months), 365 days (1 year), and 790 days (~26 months). Testing was run in duplicate (at minimum) for each CVM level.
- Open Vial Stability: Data points at 0, 2, 4, and 8 hours for each CVM level.
- Value Assignment: 27 replicates (9 runs, 3 replicates per run) on 9 IMMULITE 2000 systems using 5 different reagent kit lots. 6 levels of commercially available controls and 32 samples (23 spiked samples, 4 normal female, and 5 normal male samples) were used to validate CVM value assignments.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Implied to be prospective, internal performance testing.
-
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Analytical performance based on pre-defined criteria.
-
3. Adjudication method for the test set: Not applicable.
-
4. 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.
-
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
-
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for CVMs is based on assigned reference calibrators traceable to an internal gravimetrically prepared material. Quality control is performed by calculating the recovery of patient samples and controls using the assigned CVM values against their target ranges.
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7. The sample size for the training set: Not applicable.
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8. How the ground truth for the training set was established: Not applicable.
§ 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.