(28 days)
Lumipulse G FSH-N Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G FSH-N on the LUMIPULSE G System.
Master calibration data are recorded in a two-dimensional bar code on the Lumipulse G FSH-N Immunoreaction Cartridge case. The calibration curve is created based on recorded master calibration data and the calibration data. The follicle-stimulating hormone (FSH) concentration of a specimen is automatically calculated from the calibration curve. The result of the calculation is reported in mIU/mL.
Lumipulse® G FSH-N Calibrators:
Lumipulse® G FSH-N Calibrators REF 230930 Each calibrator kit contains one bottle each of calibrators 1 - 2 and consists of the following:
CAL 1 0 mlU/mL FSH calibrator (1 x 1.5 mL) CAL 2 250 mlU/mL FSH calibrator (1 x 1.5 mL) *Contains follicle-stimulating hormone (FSH) in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.
Here's a breakdown of the acceptance criteria and study information for the Lumipulse® G FSH-N Calibrators, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Long-Term Stability (Sensitivity) | Luminescence ratio (2 mIU/mL / 0 mIU/mL FSH) ≥ 20 | Results met the criterion of the ratio of ≥ 20. |
| Long-Term Stability (Accuracy) | Variation of ratios against assigned values within ± 20% for each replicate (for 3 serum samples ranged 10.5 - 185.0 mIU/mL) | Results met the criterion within ± 20% for each replicate. |
| Long-Term Stability (Reproducibility) | CV ≤ 10% for each sample (for 3 serum samples ranged 10.5 - 185.0 mIU/mL) | Results met the criterion of 10% CV or less for each sample. |
| Real-Time (Intended Storage) Stability | Mean concentration of each panel from each time point within ± 10% mean concentration at Study Initiation. | For all 3 lots, Time Point 2 (month 6) met the acceptance criteria. (Study ongoing) |
| Open-Vial (in-use) Stability | Mean concentration of each panel from each time point within ± 10% mean concentration at Study Initiation. | For all 3 lots, Time Point 2 (month 6) met the acceptance criteria. (Study ongoing) |
| Transport Simulation (Temperature) - Tokyo, Japan (Sensitivity) | Luminescence ratio (FSH-N calibrator 2 / FSH-N calibrator 1) ≥ 10 | The luminescence ratio was 90 under control conditions and 87 under stress conditions, meeting the criteria of ≥ 10. |
| Transport Simulation (Temperature) - Tokyo, Japan (Accuracy) | Ratios of measured values (n=1) against assigned values within 100 ± 20% | The accuracy ranged from 99-108% under control and 96-104% under stress, meeting the criteria of 100 ± 20%. |
| Transport Simulation (Temperature) - Malvern, PA | %CV ≤ 10% for all transport conditions tested (at study initiation) | At study initiation, the assay met the acceptance criteria of %CV ≤ 10% for all transport conditions tested. (Study ongoing) |
| Value Assignment (Mean Ratio) | Mean ratio of secondary calibrator (10 replicates) to tertiary calibrator (10 replicates) between 0.97 - 1.03 | Not explicitly stated if this was the reported device performance, but the process describes how the tertiary calibrator is "rate-matched" and "adjusted if necessary" to achieve this. |
2. Sample Size Used for the Test Set and Data Provenance
-
Long-Term Stability (Tokyo, Japan):
- 3 Lots of Lumipulse G FSH Calibrators.
- 3 Lots of Lumipulse G FSH Immunoreaction Cartridges.
- FSH solutions of 0 and 2 mIU/mL were measured in replicates of 3 at each test point.
- 3 serum samples (ranged 10.5 - 185.0 mIU/mL) were tested in replicates of 3 for accuracy and replicates of 6 for reproducibility.
- Provenance: Fujirebio, Inc. (Tokyo, Japan); data stored at 10°C, measured at 0, 3, 7, and 13 months.
-
Real-Time (Intended Storage) Stability (Malvern, PA):
- 3 Lots of Lumipulse G FSH-N calibrators.
- Tested in duplicate at Month 0, 6, 12, and 13.
- Provenance: Fujirebio Diagnostics, Inc. (Malvern, PA); study ongoing.
-
Open-Vial (in-use) Stability (Malvern, PA):
- 3 Lots of Lumipulse G FSH-N calibrators.
- Tested in duplicate at Month 0, 6, 12, and 13.
- Provenance: Fujirebio Diagnostics, Inc. (Malvern, PA); study ongoing.
-
Transport Simulation (Tokyo, Japan):
- Not explicitly stated, but the study implies testing of the Lumipulse G FSH-N Calibrators.
- Replicates: Luminescence ratio (FSH-N calibrator 2 / FSH-N calibrator 1) for sensitivity, and single measurements (n=1) for accuracy.
- Provenance: Fujirebio, Inc. (Tokyo, Japan).
-
Transport Simulation (Malvern, PA):
- Lumipulse G FSH-N Calibrators and Lumipulse G FSH-N ICs.
- Calibrators were tested in duplicate, controls in replicates of 1, and panels in replicates of 3.
- Provenance: Fujirebio Diagnostics, Inc. (Malvern, PA); study ongoing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This device is a calibrator, not a diagnostic device requiring human interpretation of results. Therefore, the concept of "experts establishing ground truth" in the clinical sense (e.g., radiologists interpreting images) is not applicable here. The "ground truth" or reference values are established through metrological traceability and value assignment protocols.
4. Adjudication Method for the Test Set
Not applicable, as this is related to human interpretation and not directly relevant for a calibrator's performance evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This document describes performance of a calibrator.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance characteristics described (stability, traceability, value assignment, transport simulation) are all standalone performance evaluations of the calibrator product itself. The calibrator's ability to provide accurate and stable calibration values is assessed independently.
7. The Type of Ground Truth Used
The ground truth for the calibrators is established through a combination of:
- Metrological Traceability: Calibrators are traceable to the 1st International Standard, 1997 (code 92/510) provided by the National Institute for Biological Standards and Control (NIBSC).
- Gravimetric Preparation: Calibrators are prepared gravimetrically.
- Value Assignment Protocol: Involves provisional value assignment based on measurements using secondary calibrators, then rate-matching and adjusting tertiary calibrators to secondary calibrators.
8. The Sample Size for the Training Set
The concept of a "training set" in the context of an AI/machine learning algorithm is not applicable here. This device is a chemical calibrator for an immunoassay system, not an AI or algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
§ 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.