(30 days)
Lumipulse & E2-III Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G E2-III on the LUMIPULSE® G System.
The Lumipulse G E2-III Calibrator kit contains 3 bottles (1.5mL each) of Lumipulse G E2-III Calibrators 1, 2 and 3. Calibrators 1 – 3 contain estradiol in 0.15M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.
Lumipulse G E2-III Calibrators CAL 233849. Liquid 1x3 concentrations Each calibrator kit contains one bottle each of Calibrators 1 – 3. The calibrator kit is packaged separately.
CAL 1 E2 calibrator 1 (1 × 1.5 mL)
E₂ calibrator 2 (1 x 1.5 mL) CAL 2
CAL 3 E2 calibrator 3 (1 × 1.5 mL)
*Contains 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.
The calibrator values vary for each lot. The actual values are printed on the calibration card included in the kit.
The provided document describes the Lumipulse® G E2-III Calibrators, which are intended for in vitro diagnostic use in the calibration of the Lumipulse G E2-III assay on the LUMIPULSE® G System. This device is a calibrator, not a diagnostic device that performs analysis or provides clinical outcomes, hence many typical performance metrics for diagnostic tools (like sensitivity, specificity, clinical cut-off, etc.) are marked as "Not applicable." The document focuses on the analytical performance related to being a calibrator.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device as a calibrator, the performance metrics are related to its stability and value assignment, not diagnostic accuracy in the traditional sense.
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf-life Stability | Confirmed for 18 months at 2-10°C | |
| Sensitivity (Cal. 1 / Cal. 3 luminescence ratio) | Ratio ≥ 10 | Met the criterion of ≥ 10 |
| Accuracy (3 serum samples, ± 20% variation) | Variation within ± 20% | Met the criterion within ± 20% for each replicate |
| Reproducibility (3 serum samples, CV ≤ 10%) | CV of 10% or less | Met the criterion of 10% CV or less for each sample |
| Transport Simulation (Temperature Stress - Japan Study) | ||
| Sensitivity (E2 Cal. 1 / E2 Cal. 6 luminescence ratio) | Ratio ≥ 10 | Luminescence ratio was 38-39, met criteria of ≥ 10 |
| Accuracy (Variation for each calibrator, n=1) | Ratios within 100 ± 20% | Accuracy ranged from 98-109%, met criteria of 100 ± 20% |
| Value Assignment (Calibrator 2) | ||
| Acceptable value of CAL2 | -20% - +20% range of 50 pg/mL (i.e., 40-60 pg/mL) | Values vary for each lot, actual values printed on calibration card, indicating it meets its specified lot-specific range. |
| Value Assignment (Calibrator 1 & 3 Rate Match Ratio) | ||
| Acceptable rate mean ratio of CAL3 or CAL1 | 0.95 - 1.05 | Not explicitly stated as "met criteria" but the process indicates adjustment to meet this. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Shelf-life stability: 3 Lots of Calibrators, tested in replicates of 2 for sensitivity, and 3 serum samples (215.9 - 1530.2 pg/mL) in replicates of 6 for accuracy and reproducibility.
- Transport Simulation (Japan Study): Not explicitly stated, but includes "calibrators" (plural) and "E2 calibrator 1 / E2 calibrator 6" for sensitivity, and "each calibrator" (n=1) for accuracy.
- Real Time & Open-vial Stability (Malvern, PA Study): 3 Lots of Calibrators, tested in duplicate; controls in replicates of 1; panels in replicates of 3.
- Data Provenance: Studies were conducted at Fujirebio, Inc. (Tokyo, Japan) and Fujirebio Diagnostics, Inc. (Malvern, PA, USA). This indicates combination of international and USA-based data. The studies are prospective in nature, as they involve testing over specified intervals (e.g., 0, 1, 2, 4, 6, 9, 10, 13, 16 and 19 months for shelf-life stability).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a calibrator, and its "ground truth" relates to its assayed values and stability, not interpretations by human experts in a clinical context.
4. Adjudication Method for the Test Set
Not applicable. The performance criteria involve analytical measurements (luminescence ratios, CVs, variation against assigned values), not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic interpretation devices where multiple readers review cases. This device is a calibrator.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a calibrator for an automated immunoassay system (LUMIPULSE® G System). Its performance is inherently "standalone" in the sense that it doesn't involve human interpretation to achieve its function. The studies evaluate the chemical and physical stability and accuracy of the calibrator itself for use in the automated system.
7. Type of Ground Truth Used
The ground truth for the calibrators is established through:
- Gravimetric preparation: Calibrators are prepared gravimetrically.
- Traceability to international standards: Traceable to BCR-577 by IRMM (Institute for Reference Materials and Measurements) and verified against ID-GC/MS.
- Rate-matching and measurement against secondary calibrators: Calibrator values are "rate-matched" and adjusted based on measurements in the Lumipulse G E2-III assay and comparison to secondary calibrators.
- Known concentrations: Target values are established for Calibrator 2 (50 pg/mL with a range of 40-60 pg/mL), Calibrator 1 (0 pg/mL), and Calibrator 3 (2000 pg/mL).
8. Sample Size for the Training Set
Not applicable. This device is a calibrator, not an AI/ML algorithm that requires a training set. Its function is to provide known reference points for an assay.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a calibrator 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.