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510(k) Data Aggregation
(144 days)
The DiaSorin LIAISON® XL HCG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the quantitative determination of total human chorionic gonadotropin (hCG and ßhCG) in human serum for early detection of pregnancy. Total hCG is the measurement of intact and beta-hCG.
The method for the quantitative determination of hCG is a sandwich chemiluminescence immunoassay. A specific mouse monoclonal antibody is coated on the magnetic particles (solid phase); another monoclonal antibody is linked to an isoluminol derivative (isoluminol-antibody conjugate). All assay steps and incubations are performed by the LIAISON® XL Analyzer.
During the first incubation, hCG present in calibrators, samples or controls binds to the solid phase monoclonal antibody, and subsequently after a washing step in a second incubation the antibody conjugate reacts with hCG already bound to the solid phase.
Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU, relative light units) and is directly related to hCG concentration present in calibrators, samples or controls.
Here's an analysis of the DiaSorin LIAISON® XL HCG Premarket Notification (K131037) based on the provided text, focusing on acceptance criteria and study details:
Acceptance Criteria and Device Performance for DiaSorin LIAISON® XL HCG
The DiaSorin LIAISON® XL HCG assay is a chemiluminescent immunoassay (CLIA) for the quantitative determination of total human chorionic gonadotropin (hCG and βhCG) in human serum for early detection of pregnancy. The submission aims to demonstrate substantial equivalence to the Roche ELECSYS® HCG +Beta Test (K003178).
The document details several performance studies to support the device's claims.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" as pass/fail thresholds for each performance characteristic. Instead, it reports the results of the performance studies which implicitly serve as the basis for demonstrating substantial equivalence. For the purpose of this analysis, I will infer the intended acceptance of "good performance" based on the reported values and comparison to the predicate where applicable.
| Performance Characteristic | Implicit Acceptance Criteria (or Reference) | Reported Device Performance (DiaSorin LIAISON® XL HCG) |
|---|---|---|
| Method Comparison | Good correlation with predicate device | y = 0.973x - 0.2233; R² = 0.9933 (vs. predicate) |
| Reference Range | Clearly defined ranges for non-pregnant populations | - Premenopausal (<50): 97.5% < 1.54 mIU/mL hCG - Postmenopausal (≥50): 97.5% < 6.67 mIU/mL hCG |
| Reproducibility/Precision | Low %CV for within-run and total precision across different hCG levels | - QC1 (6.4 mIU/mL): Total %CV 10.7% - QC2 (23.3 mIU/mL): Total %CV 6.0% - QC3 (175.1 mIU/mL): Total %CV 3.5% - HCG-11 (60.2 mIU/mL): Total %CV 4.9% - HCG-12 (25.5 mIU/mL): Total %CV 6.3% - HCG-13 (431.4 mIU/mL): Total %CV 3.0% - HCG-14 (893.2 mIU/mL): Total %CV 3.2% - HCG-15 (4169.0 mIU/mL): Total %CV 3.7% - HCG-16 (9607.6 mIU/mL): Total %CV 3.2% |
| Dilution Linearity | Good linear regression between obtained and expected concentrations | Y (obtained mIU/mL) = 1.0158X (expected mIU/mL) - 0.1450 |
| LoB (Limit of Blank) | Low value | 0.17 mIU/L |
| LoD (Limit of Detection) | Low value | 0.36 mIU/L |
| LoQ (Limit of Quantitation) | Low value | 1.5 mIU/L |
| Recovery | % recovery near 100% across spiked levels | - 5 mIU/mL: 91.8% - 25 mIU/mL: 105.9% - 500 mIU/mL: 94.9% - 5000 mIU/mL: 92.9% - 9000 mIU/mL: 96.9% |
| Interfering Substances | No significant interference at specified concentrations | No interference reported at tested concentrations for various substances (Triglycerides, Hemoglobin, Bilirubin, Albumin, RF, LH, FSH, hGH, TSH, common medications) |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison: One hundred sixty-three (163) serum samples. The data provenance is not explicitly stated (e.g., country of origin) but is implied to be clinical samples spanning the assay's reportable range. The study was performed according to CLSI EP9-A2 guideline. It is a retrospective analysis using collected samples.
- Reference Range/Expected Values:
- 74 healthy, non-pregnant premenopausal women (<50 years old).
- 70 healthy, postmenopausal women (≥ 50 years old).
- The study was performed according to CLSI Approved Guideline C28-A3. Data provenance is not explicitly stated.
- Reproducibility/Precision: A coded panel comprised of 6 frozen serum samples (low, medium, high levels) and 3 commercial controls. Each sample/control was tested 160 times (N=160 in the table). This study was performed at DiaSorin Inc., implying internal, controlled data. The CLSI document EP05-A2 was consulted.
- Dilution Linearity: Two serum pools containing high hCG concentrations. Details on individual sample numbers beyond "two serum pools" are not provided. The study followed CLSI EP6-A.
- LoB/LoD/LoQ: The methodology followed CLSI EP17-A2, which typically involves multiple replicates of blank and low-concentration samples. Specific sample sizes are not explicitly stated for individual calculations but are implied by the CLSI standard.
- Recovery: Five levels of spiked samples (prepared from five human sera), tested in duplicates.
- Interfering Substances: Controlled studies at two hCG levels for each interfering substance, implying multiple tests per substance. The testing was based on CLSI-EP7-A2.
The data appears to be primarily from internal studies (e.g., DiaSorin Inc. for reproducibility) or clinical samples whose specific origin (e.g., country) is not disclosed but collected according to CLSI guidelines, indicating a general clinical relevance. All studies appear to be retrospective analyses of collected samples or controlled laboratory experiments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
For this type of in-vitro diagnostic device (an immunoassay for HCG), the "ground truth" for the test set is established by the actual concentration of hCG in the samples, measured through established reference methods or spiking procedures. This is typically determined by laboratory equipment calibration against recognized standards (e.g., WHO reference standard IS 75/537, as noted for traceability). It does not involve human experts (like radiologists) interpreting images or clinical cases to establish ground truth.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation of data (e.g., image-based diagnosis). Since this is an immunoassay for quantitative measurement of a biomarker, "adjudication" in that sense is not applicable. The accuracy of measurements is assessed against established reference materials or methods, and potential discrepancies would be investigated through re-testing, calibration checks, or review of laboratory protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic imaging devices where different human readers interpret cases with and without AI assistance. This submission pertains to an automated in-vitro diagnostic assay for a biochemical marker, which does not involve human readers interpreting "cases" in the same way.
6. Standalone (Algorithm Only) Performance
Yes, the performance data presented (Method Comparison, Reference Range, Reproducibility, Dilution Linearity, LoB/LoD/LoQ, Recovery, Interfering Substances) is the standalone performance of the DiaSorin LIAISON® XL HCG assay. As an automated immunoassay, it operates without direct human intervention in the measurement process once the sample is loaded and the assay initiated. The results are generated directly by the LIAISON® XL Analyzer.
7. The Type of Ground Truth Used
The ground truth used for the performance studies is primarily:
- Reference Intervals: Established by testing samples from well-defined healthy populations (premenopausal, postmenopausal women) whose non-pregnant status is the established biological ground truth.
- Known Concentrations: For method comparison, linearity, LoB/LoD/LoQ, and recovery, the ground truth is often established through:
- Predicate Device Measurements: In method comparison, the predicate device results (Roche Elecsys® HCG +Beta Test) serve as a comparative ground truth.
- Spiked Samples: For recovery and linearity studies, samples are "spiked" with known concentrations of hCG (traceable to WHO reference standard IS 75/537), providing a known expected value.
- Reference Materials: Calibration and accuracy are traceable to the 3rd WHO reference standard IS 75/537, which is the ultimate gold standard for hCG concentration.
- CLSI Guidelines: Adherence to CLSI guidelines ensures standardized and accepted methods for determining these performance characteristics.
8. The Sample Size for the Training Set
The document does not specify a "training set" size. This is because the DiaSorin LIAISON® XL HCG assay is a traditional immunoassay, not an AI/machine learning model that requires a distinct training phase on a dataset of images or complex inputs to learn patterns. The "training" in this context refers to the development and optimization of the assay reagents, protocols, and instrument parameters by DiaSorin scientists, not the algorithmic training of an AI system.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no "training set" in the context of an AI/machine learning system. For the development and optimization of the immunoassay, the "ground truth" would have been established through a rigorous process of:
- Analytical Chemistry and Biology: Ensuring antibody specificity, optimal reaction conditions, signal detection, and calibration against internationally recognized standards (like the WHO hCG reference standard).
- Internal Development and Verification: DiaSorin's R&D team would have used a wide range of precisely characterized HCG samples (known concentrations, spiked samples, clinical samples) to develop and refine the assay. The ultimate "ground truth" during this phase would be the known concentration of HCG in these samples, traceable to the WHO standard.
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