Search Results

The Lumipulse® G LH Calibrator kit contains 2 bottles (1.5mL each) of Lumipulse® G LH Calibrators 1 and 2. Calibrators 1 and 2 contain luteinizing hormone (LH) in 0.15M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide.

Lumipulse® G LH Calibrators CAL 230916, Liquid 1x2 concentrations

Each calibrator kit contains one bottle each of Calibrators 1 – 2. The calibrator kit is packaged separately.

CAL 1 0 mlU/mL LH calibrator (1 x 1.5 mL) CAL 2 250 mIU/mL LH calibrator (1 x 1.5 mL) *Contains luteinizing hormone (LH) in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: sodium azide

The Lumipulse® G LH calibrator set is designed specifically for use on the LUMIPULSE® G System which has been previously cleared under K142895.

AI/ML Overview

The provided text describes the Lumipulse® G LH Calibrators device, focusing on its regulatory approval, intended use, and performance characteristics, particularly its stability. This device is a calibrator, not a diagnostic or AI-powered imaging device, therefore many of the requested elements for AI/imaging studies are not applicable.

Here's the information extracted and organized based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a calibrator, and its performance is primarily assessed through stability studies and traceability.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Shelf-Life Stability	Sensitivity: Ratio of 20 mIU/mL LH luminescence to 0 mIU/mL LH luminescence ≥ 20.
Accuracy: Ratios of measured values to pre-assigned values should be within 100 +/- 20% for each replicate.
Within-run Reproducibility: CV ≤ 10% for each sample.	Met criteria for up to 13 months at 10°C (demonstrating stability for the claimed 12 months shelf-life). Specific sensitivity ratio and accuracy ranges were met. The CV for precision was ≤ 10%.
Real-Time Intended Storage Stability (Malvern, PA study)	Mean concentration of each panel within ±10% mean concentration at Study Initiation.
% CV value of each panel ≤ 10%. (Goal: 12 months)	Lumipulse G LH Calibrators were determined to be stable at intended storage conditions for up to 6 months for all 3 lots (Time Point 2 testing). Study is ongoing to support the 12-month claim.
Transport Simulation Stability (Temperature Change - Tokyo, Japan study)	Visual Inspection: Cleared criteria.
Sensitivity: Ratio of 2 mlU/mL to 0 mIU/mL LH luminescence ≥ 21.
Accuracy: Each value after stress within 100 +/- 20% of reference value for control and serum samples.	Visual inspection cleared. Sensitivity test (ratio ≥ 21) met criteria. Accuracy test (values within 100 +/- 20% of reference) met criteria.
Transport Simulation Stability (Temperature - Malvern, PA study)	%CV ≤ 10% for all transport conditions tested at study initiation.	Met acceptance criteria of %CV ≤ 10% for all transport conditions tested at study initiation. Study is ongoing.
Value Assignment	Acceptable rate mean ratio for 3 runs (secondary calibrator to Lumipulse G LH calibrator) 0.95 – 1.05.	Achieved (implied by the process description and overall substantial equivalence finding). Specific values are not reported but the methodology is described.
Target Values/Ranges	Level 1: 0 mIU/mL LH
Level 2: 250 mIU/mL LH (Target Range: 238-262 mIU/mL)	These are the stated target values and ranges for the calibrators themselves, which the device is designed to embody. The performance studies confirm that assigned values and stability maintain these specifications.

2. Sample Size and Data Provenance

Test Set (Stability Studies):
- Shelf-Life Stability (Tokyo, Japan): Three lots of Lumipulse G LH Calibrators. Tested at Month 0, 3, 7, and 13.
  - Sensitivity: 0 and 20 mIU/mL LH solutions in replicates of 3.
  - Accuracy: 3 samples (5,850-162,217 mIU/mL) in replicates of 3.
  - Within-run Reproducibility: 4 samples (5.850-162.217 mIU/mL) in replicates of 6.
- Transport Simulation Stability (Tokyo, Japan): Not explicitly stated as "samples" but implied for a single set of Lumipulse G LH Calibrators and other components.
  - Sensitivity: 0 and 2 mlU/mL LH solutions (replicates not specified but implied).
  - Accuracy: 3 control samples (4.1-55.6 mlU/mL) in replicates of 1, and 4 serum samples (11.1-294.0 mlU/mL) in replicates of 2.
- Real-Time (Intended Storage and Open Use) Stability (Malvern, PA): Three lots of Lumipulse G LH Calibrators. Tested in duplicate at specified intervals up to 13 months. The number of "panels" is not specified but implied to contain various concentrations.
- Transport Simulation Stability (Malvern, PA): Not explicitly stated, implied to be samples from the calibrator lots. Calibrators tested in duplicate, controls in replicates of 1, and panels in replicates of 3.
Data Provenance:
- Tokyo, Japan: Studies conducted at Fujirebio, Inc. with a predecessor instrument (LUMIPULSE Forte (f)) confirmed to have agreement with LUMIPULSE G1200. This is retrospective data for the "predecessor instrument," but it's used to support the current device.
- Malvern, PA, USA: Studies conducted at Fujirebio Diagnostics, Inc. on the LUMIPULSE G1200 System. These are ongoing real-time studies, so they are prospective for the current device's claims.

The document does not specify a separate "test set" in the context of an algorithm's performance against ground truth, as it's a calibrator.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This is a medical device (calibrator) whose performance is evaluated through analytical studies, not expert review of images or clinical cases. The "ground truth" for calibrators is their assigned value and traceability to international standards.

4. Adjudication Method for the Test Set

Not applicable. This concept is typically used in clinical trials or diagnostic studies for resolving discrepancies in expert opinions. Performance here is based on quantitative analytical measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is relevant for diagnostic imaging interpretation, assessing the impact of a device on human expert performance. This device is a calibrator for an in-vitro diagnostic assay.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical calibrator used within an assay system, not a standalone algorithm. Its performance is intrinsically linked to its use in the LUMIPULSE G System.

7. Type of Ground Truth Used

The ground truth for the Lumipulse® G LH Calibrators is established through:

Traceability to International Standards: The calibrators are traceable to the 2nd International Standard, 1988 (code: 80/552) provided by the National Institute for Biological Standards and Control (NIBSC).
Gravimetric Preparation and Value Assignment: Calibrators are prepared gravimetrically, and their values are assigned based on measurement against secondary calibrators, ensuring accuracy against the fundamental international standard.

8. Sample Size for the Training Set

Not applicable. This device is a calibrator, not an AI algorithm that undergoes "training." Its manufacturing and validation process (including stability and value assignment) are based on established analytical chemistry principles.

9. How the Ground Truth for the Training Set Was Established

Not applicable (as above). The concept of a "training set" and "ground truth establishment" pertains to machine learning algorithms. For a calibrator, its "truth" is its certified concentration and its traceability to a universally accepted standard through rigorous analytical testing.

Ask a Question

Ask a specific question about this device

Page 1 of 1