(82 days)
IMMULITE® IGF Control Module is an assayed, bi-level control intended for use with IMMULITE 1000 and IMMULITE 2000 IGF-I, and IMMULITE 1000 and IMMULITE 2000 IGFBP-3 assays. It is intended as an aid in monitoring day-to-day assay performance.
IMMULITE Gastrin Control Module is an assayed, bi-level control intended for use with the IMMULITE/IMMULITE 1000 and IMMULITE 2000 Gastrin assay. It is intended as an aid in monitoring day-to-day assay performance.
IMMULITE® IGF Control Module contains one set of 2 vials, each 4.0mL after reconstitution, containing lyophilized IGF-I and IGFBP-3 in a protein buffer matrix.
IMMULITE Gastrin Control Module contains one set of 2 vials, each 2.0mL after reconstitution, containing lyophilized synthetic-human G-17 gastrin in a buffer matrix.
The provided document describes two devices: the IMMULITE® IGF Control Module and the IMMULITE® Gastrin Control Module. Both are quality control materials, and the studies performed focus on their stability and value assignment rather than typical diagnostic performance metrics (like sensitivity, specificity, or reader studies).
Here's an analysis based on the provided text:
IMMULITE® IGF Control Module
1. Table of Acceptance Criteria and Reported Device Performance (Stability)
| Level | Range (Acceptance Criteria) | +/-% Acceptance Criteria | Reported Performance (Implied from "meets the performance specifications") |
|---|---|---|---|
| IMMULITE 2000 IGF-I (ng/mL) | |||
| LGCOC10023 | 65 – 97 | 20 | Met |
| LGCOC20023 | 194 - 290 | 20 | Met |
| IMMULITE 2000 IGFBP-3 (µg/mL) (kit lots 210 and below) | |||
| LGCOC10023 | 0.84 - 1.20 | 17.6 | Met |
| LGCOC20023 | 3.5 - 4.9 | 16.7 | Met |
| IMMULITE 2000 IGFBP-3 (µg/mL) (kit lots 211 and above) | |||
| LGCOC10023 | 0.80 - 1.16 | 18.4 | Met |
| LGCOC20023 | 3.24 - 4.60 | 17.3 | Met |
| Open Vial Stability | N/A (difference between fresh and stored vial) | ±10% | Met |
Study Details:
-
2. Sample size used for the test set and the data provenance:
- Test Set Description: The "test set" for stability refers to samples of the IMMULITE® IGF Control Module (specifically lot 23 for shelf-life, and lot 024 for open-vial).
- Quantity: "Stability controls are run in duplicate (as a minimum)" at specified time points (1 day, 6, 12, 18, 24, 30, and 36 months). For open vial, a freshly opened vial was compared to one opened 35 days prior.
- Data Provenance: The study was conducted by Siemens Healthcare Diagnostics Inc. and is non-clinical, likely internal testing. No specific country of origin or retrospective/prospective nature (beyond the real-time stability) is mentioned.
-
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a quality control material; its "truth" is its inherent stability and value according to its manufacturing specifications, not a diagnostic finding requiring expert interpretation.
-
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Data points for stability are quantitative measurements, not subjective evaluations 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 device is a quality control material and not an AI-powered diagnostic tool.
-
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical control material, not an algorithm.
-
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For stability, the ground truth is the expected performance of the control material over time when stored under specified conditions, defined by the manufacturer's internal specifications and verified through testing against these predefined ranges.
- For Value Assignment, the controls are value assigned using assigned reference controls. These reference controls are prepared using IGF-I and IGFBP-3 antigen stock, and the controls are manufactured using qualified materials and measurement procedures.
-
8. The sample size for the training set:
- Value Assignment "Training": For value assignment, "IGF controls are required to have a minimum of 100 control points from at least 3 kit lots and 3 instruments on both IMMULITE 1000 and IMMULITE 2000 platforms and for both IGF-I and IGFBP-3." This serves as the data for establishing the expected values.
- Stability: This concept doesn't directly apply as stability is validated over time against defined criteria, not "trained."
-
9. How the ground truth for the training set was established:
- Value Assignment: The ground truth (assigned values for the controls) is established by running the controls (minimum 10 replicates) and reference controls (2 replicates) together in each assay, using an adjusted curve. The control values are calculated based on recovered values from each instrument independently and then averaged across all systems. Validation is performed by checking the recovery of patient samples and reference controls against their target ranges.
IMMULITE® Gastrin Control Module
1. Table of Acceptance Criteria and Reported Device Performance (Stability)
| Control Level | Range (Acceptance Criteria) | +/-% Acceptance Criteria | Reported Performance (Implied from "meets the performance specifications") |
|---|---|---|---|
| LGAC10030 | 85 - 113 | 14.0% | Met |
| LGAC20030 | 341 - 453 | 14.2% | Met |
| Open Vial Stability | N/A (difference between stored and fresh vial) | ±10% | Met |
Study Details:
-
2. Sample size used for the test set and the data provenance:
- Test Set Description: The "test set" for stability refers to samples of the IMMULITE® Gastrin Control Module (specifically lot 30 for shelf-life, and lot 030 for open-vial).
- Quantity: "Stability controls are run in duplicate (as a minimum)" at specified time points (1 day, 6, 12, 18, 24, 30, and 36 months). For open vial, a freshly opened vial was compared to one opened 35 days prior.
- Data Provenance: The study was conducted by Siemens Healthcare Diagnostics Inc. and is non-clinical, likely internal testing. No specific country of origin or retrospective/prospective nature (beyond the real-time stability) is mentioned.
-
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a quality control material; its "truth" is its inherent stability and value according to its manufacturing specifications, not a diagnostic finding requiring expert interpretation.
-
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Data points for stability are quantitative measurements, not subjective evaluations 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 device is a quality control material and not an AI-powered diagnostic tool.
-
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical control material, not an algorithm.
-
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For stability, the ground truth is the expected performance of the control material over time when stored under specified conditions, defined by the manufacturer's internal specifications and verified through testing against these predefined ranges.
- For Value Assignment, the controls are value assigned using assigned reference controls. These reference controls are prepared using qualified Gastrin antigen stock, and the controls are manufactured using qualified materials and measurement procedures.
-
8. The sample size for the training set:
- Value Assignment "Training": For value assignment, "Gastrin controls are required to have a minimum of 100 control points from at least 3 kit lots and 3 instruments on both IMMULITE/IMMULITE 1000 and IMMULITE 2000 platforms." This serves as the data for establishing the expected values.
- Stability: This concept doesn't directly apply as stability is validated over time against defined criteria, not "trained."
-
9. How the ground truth for the training set was established:
- Value Assignment: The ground truth (assigned values for the controls) is established by running the controls (minimum 10 replicates) and reference controls (2 replicates) together on an adjusted curve. The control values are assigned based on the recovered values for each run on each instrument independently and then averaged across all systems. Data is reviewed for outliers, bi-modality or skewness. Validation is performed by checking the recovery of patient samples and reference controls against their target ranges.
§ 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.