(27 days)
Lumipulse G Prolactin Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G Prolactin on the LUMIPULSE G System.
Lumipulse G Prolactin Calibrator kit contains 2 bottles (1,5 mL each) of Lumipulse G Prolactin Calibrators 1 and 2. Calibrator 2 contains prolactin in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.
Lumipulse® G Prolactin Calibrators CAL 230954, Liquid 1x2 concentrations Each calibrator kit contains one bottle each of Calibrators 1 – 2. The calibrator kit is packaged separately.
CAL 1 0 ng/mL Prolactin calibrator (1 x 1.5 mL)
CAL 2 400 ng/mL Prolactin calibrator (1 x 1.5 mL)
Contains prolactin in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.
The provided text describes the performance characteristics and studies for the Lumipulse® G Prolactin Calibrators, a medical device used for in vitro diagnostic calibration.
Here's an analysis of the acceptance criteria and the studies performed, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This device is a calibrator, not a diagnostic test with typical sensitivity/specificity metrics. The performance criteria focus on its ability to provide stable and accurate reference points for the Lumipulse G Prolactin assay.
| Acceptance Criteria Category | Specific Criteria / Test | Reported Device Performance |
|---|---|---|
| Traceability | Traceable to 3rd International Standard, 1988 (code: 84/500) provided by NIBSC. | Calibrators prepared gravimetrically, traceable to NIBSC 3rd International Standard (84/500). |
| Value Assignment (Calibrator 2) | Acceptable rate mean ratio between secondary calibrator and Lumipulse G Prolactin Calibrator 2: 0.95 - 1.05. | Achieved acceptable rate mean ratio (0.95 - 1.05). |
| Value Assignment (Target Range) | Calibrator 1: 0 ng/mL | |
| Calibrator 2: 380 – 420 ng/mL | Calibrator 1: 0 ng/mL | |
| Calibrator 2: 400 ng/mL (within target range). | ||
| Shelf-Life Stability (Long-term) | 12 months at 2-10°C, with maintained sensitivity, specificity (implied by assay performance), and reproducibility. | Product passed 13-month test; 12 months shelf-life confirmed (stored at 2-10°C). |
| Transport Simulation (Temperature Stress - Tokyo) | Visual assessment: 0/28 under stress conditions meeting specification. | |
| Sensitivity (S/N): ≥51 under stress conditions. | ||
| Accuracy (vs. test values): within 100 ± 20% under stress conditions. | Visual assessment: 0/28 under stress conditions, met specification. | |
| Sensitivity (S/N): 171 under stress conditions, met S/N≥51 specification. | ||
| Accuracy: 99-109% under stress conditions, met 100 ± 20% specification. | ||
| Real-Time (Intended Storage) Stability (Malvern) | Calibrators determined stable at intended storage conditions for up to 6 months (interim results). Will continue to support 12 months. | Stable for up to 6 months at 2-10°C for all 3 lots (ongoing study). |
| Transport Simulation Stability (Malvern) | %CV ≤ 10% for all transport conditions. | Met %CV≤ 10% at study initiation (ongoing study). |
| Open-vial (In-Use) Stability | Mean concentration of each panel from each time point within ±10% mean concentration at Study Initiation. | |
| %CV value of each time point ≤ 10%. | Testing continues until data supports 12 months (ongoing study). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly delineate a "test set" in the context of typical algorithm evaluation (e.g., retrospective vs. prospective patient data). Instead, the studies involve multiple lots of the calibrators themselves.
- Sample Size for Calibrators:
- Long-term stability (Tokyo): 3 lots of reagents (calibrators and samples).
- Value Assignment: 10 replicates of Lumipulse G Prolactin Calibrators and 10 replicates of secondary calibrators for calculation and adjustment.
- Real-Time (Intended Storage) Stability (Malvern): 3 lots of calibrators.
- Transport Simulation (Malvern): Not specified number of "calibrators" but describes the conditions and testing.
- Open-vial (In-Use) Stability: Not specified number of calibrator vials directly, but "panels" are used for evaluation.
- Data Provenance:
- Tokyo, Japan: Long-term stability and one transport simulation study were conducted here using the LUMIPULSE Forte (f) instrument (which uses the same cartridges and calibrators as the LUMIPULSE G1200 System).
- Malvern, PA, USA: Real-time (intended storage) stability and a separate transport simulation study are ongoing at this location using the LUMIPULSE G1200 System.
Since this is a calibrator, the "data" primarily refers to the performance of the calibrator itself and its ability to maintain its specified values over time and under various conditions, rather than a patient dataset in the traditional sense. These are prospective studies of the calibrator product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is a calibrator, not a diagnostic device that interprets clinical output requiring expert review of medical images or patient data to establish ground truth. The "ground truth" for the calibrator levels and traceability is established through reference to an international standard (NIBSC 3rd International Standard, 1988 (code: 84/500)) and gravimetric preparation.
4. Adjudication Method for the Test Set
N/A. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers or experts provide independent assessments that then need to be reconciled for a definitive ground truth. This is not applicable for a device like a calibrator, where performance is measured against established analytical standards and physical properties.
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
N/A. This is a calibrator for an in vitro diagnostic assay, not an AI-powered diagnostic device or an imaging system. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is an in vitro diagnostic calibrator, meaning it's a physical and chemical component used to calibrate an automated assay system. It doesn't involve "algorithms" or "human-in-the-loop performance" in the way an AI diagnostic device would.
7. The Type of Ground Truth Used
The ground truth for the calibrators is established through:
- International Standard Traceability: The calibrators are traceable to the 3rd International Standard, 1988 (code: 84/500) provided by the National Institute for Biological Standards and Control (NIBSC).
- Gravimetric Preparation: The calibrators are prepared gravimetrically, meaning their concentrations are determined by precise weighing of components to achieve the desired analyte levels.
- Secondary Calibrator Rate-Matching: Calibrator 2 is rate-matched to a respective secondary calibrator.
This ground truth is based on established international standards and precise laboratory manufacturing and measurement techniques, rather than clinical outcomes or pathology.
8. The Sample Size for the Training Set
N/A. There is no "training set" in the context of artificial intelligence or machine learning for this device. The device is a calibrator, not an algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
N/A. As stated above, this device does not involve a training set for an algorithm.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.