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510(k) Data Aggregation
(190 days)
The LIAISON® XL 1,25 Dihydroxyvitamin D is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of 1,25 dihydroxyvitamin (1,25(OH)2D) in serum, EDTA and Lithium Heparin plasma. Results of the 1,25 Dihydroxyvitamin D are used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in adult populations. The test is to be performed on the LIAISON® XL Analyzer.
The LIAISON® XL 1,25 Dihydroxyviamin D Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® XL 1,25 Dihydroxyvitamin D assay.
The LIAISON® XL 1.25 Dihydroxyvitamin D Calibration Verifiers are assayed quality control materials intended for the quantitative verification of calibration and reportable range of the LIAISON® XL1,25 Dihydroxyvitamin D assay.
The LIAISON® XL 1,25 Dihydroxyvitamin D assay is a modified three-step sandwich assay that uses a recombinant fusion protein for capture of the 1,25 (OH)> D molecule and a murine monoclonal antibody which specifically recognizes the complex formed by the recombinant fusion protein with the 1,25(OH)2 D molecule. Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of 1,25(OH)> D present in the calibrators, controls or patient samples.
LIAISON® XL 1,25 Dihydroxyvitamin D Control set contains;
- 2 levels controls containing human serum spiked with 1,25 (OH)2 D, and . preservatives; 2 vials each level; lyophilized
The target concentration for control level 1 is 35 pg/mL. The target concentration for control Level 2 is 120 pg/mL.
The range of concentrations of each control is reported on the certificate of analysis provided with each LIAISON® XL 1.25 Dihydroxyvitamin D Control set.
LIAISON® XL 1,25 Dihydroxyvitamin D Calibration Verifier set contains:
- 4 levels containing human serum spiked with 1,25 (OH), D, and preservatives, . 1 vial each level, lyophilized
The target concentration for cal verifier A is 15 pg/mL. The target concentration for cal verifier B is 40 pg/mL. The target concentration for cal verifier C is 80 pg/mL. The target concentration for cal verifier D is 150 pg/mL.
The range of concentrations of each calibration verifier is reported on the certificate of analysis provided with each LIAISON® XL 1,25 Dihydroxyvitamin D Calibration Verifier set.
The provided document is a 510(k) Summary for the LIAISON® XL 1,25 Dihydroxyvitamin D assay and its associated control and calibration verifier sets. This summary describes the device's intended use and provides performance characteristics to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for each performance characteristic. Instead, it presents study results and implies that meeting these results demonstrates substantial equivalence. For instance, in the method comparison, a Deming Regression with a slope close to 1 and an intercept close to 0, and a high correlation coefficient (R) suggests good agreement. Similarly, for other studies like precision, linearity, and interference, the reported results are expected to fall within acceptable ranges for diagnostic assays, which are generally implied by the use of CLSI guidelines.
Therefore, the table below will summarize the reported performance as presented in the document, rather than explicit pre-defined acceptance criteria.
| Performance Characteristic | Reported Device Performance (LIAISON® XL 1,25 Dihydroxyvitamin D) | Predicate Device Performance (where applicable) |
|---|---|---|
| Method Comparison (vs. DiaSorin 1,25 Dihydroxyvitamin D 125I RIA) | Deming Regression: N=141, Slope = 0.973 (95% CI: 0.855 to 1.092), Intercept = -1.614 (95% CI: -7.475 to 4.248), R = 0.918 | - |
| Sample Matrix Comparison (vs. Serum) | SST Serum: Slope = 1.011 (0.99 to 1.03), Intercept = -0.285 (-1.08 to 0.83), R² = 0.9908 EDTA Plasma: Slope = 1.010 (0.98 to 1.04), Intercept = 0.321 (-1.15 to 1.64), R² = 0.9975 Lithium Heparin: Slope = 1.0000 (0.97 to 1.04), Intercept = 0.1000 (-1.24 to 1.31), R² = 0.9957 | - |
| Reference Range (U.S. Subjects, N=123) | Median = 47.8 pg/mL, Observed Range (2.5th to 97.5th Percentile) = 19.9 - 79.3 pg/mL | 25.1 - 66.1 pg/mL (for predicate) |
| Precision (Total %CV across lots) | Kit Control 1: 3.8% Kit Control 2: 3.6% Prec Serum 1: 6.6% Prec Serum 2: 5.7% Prec Serum 3: 5.0% Prec Serum 4: 4.1% Prec Serum 5: 4.8% Prec Serum 6: 5.9% Cal Ver A: 5.7% Cal Ver B: 3.5% Cal Ver C: 3.6% Cal Ver D: 3.7% | - |
| Linearity (Dilution Linearity) | Observed 1,25 (OH)2 D = 0.981(Expected) + 0.005; R = 0.9994 | - |
| High Dose Hook Effect | No hook effect observed up to 5000 pg/mL of 1,25 (OH)2 D | - |
| Recovery Study (Mean Recovery) | 94% | - |
| Analytical Specificity (Cross-Reactivity) | 1,25 (OH)2 D3: 103.4% 1,25 (OH)2 D2: 104.8% Zemplar: 113% 25(OH)D3: <0.1% (and other listed non-cross-reacting substances) | - |
| Interference Studies (Endogenous) | No significant interference (≤ ±10%) for: Hemoglobin (300 mg/dL), Bilirubin (40 mg/dL), Triglycerides (3,000 mg/dL), Cholesterol (400 mg/dL), Albumin (12 g/dL), Uric Acid (20 mg/dL), HAMA (3774 ng/mL), Rheumatoid Factor (7310 IU/mL) | - |
| Interference Studies (Exogenous) | No significant interference (≤ ±10%) for: Acetaminophen (20 mg/dL), Acetylsalicylic Acid (65 mg/dL), Salicylic Acid (60 mg/dL), Ibuprofen (50 mg/dL), Biotin (0.1mg/dL), Ascorbic Acid (6 mg/dL), Metaprolol (1.2 mg/dL), Propanolol (0.23 mg/dL), Hydrochlorothiazide (0.6 mg/dL), Furosemide (6 mg/dL), Valproic Acid (57.6 mg/dL), Spironolactone (0.6 µg/mL), Nifedipine (43 µg/dL), Verapamil (216 µg/dL), Losartan Potassium (2.25 µg/mL), Valsartan (11 µg/mL), Tetracycline (15.1 µg/mL), Enalapril (42.4 µg/dL), Doxycycline (34.6 µg/mL), Lisinopril (32.7 µg/dL) | - |
| Limit of Blank (LoB) | ≤ 0.35 pg/mL | - |
| Limit of Detection (LoD) | 0.70 pg/mL | - |
| Limit of Quantitation (LoQ) | 5.0 pg/mL | - |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Method Comparison: 141 samples. The provenance of these samples (e.g., country of origin, retrospective/prospective) is not specified in the provided text.
- Sample Matrix Comparison: 52 matched patient sets of serum, SST serum, EDTA plasma, and Lithium Heparin samples. Provenance not specified.
- Reference Range: 123 apparently healthy adults aged 21-75 years from mixed ethnic backgrounds (48% dark skinned and 52% light skinned). Samples collected in winter (48.8%) and summer (51.2%) from subjects from the northern, central, and southern regions of the U.S. This is prospectively collected data from the U.S.
- Precision: A coded panel of 6 frozen serum samples (2 spiked, 4 native), 2 lots of controls, and 2 lots of calibration verifiers. The origin of the serum samples is not specified.
- Linearity (Dilution Linearity): One serum sample pool. Provenance not specified.
- High Dose Hook Effect: A zero sample spiked with 1,25 (OH)2 D. This is a laboratory-prepared sample.
- Recovery Study: Five (5) high concentration serum samples and 5 low concentration serum samples. Provenance not specified.
- Analytical Specificity (Cross-Reactivity) & Interference Studies: Laboratory-prepared spiked samples and human serum samples. Provenance not specified for the base serum.
- Limit of Blank, Limit of Detection, and Limit of Quantitation: Not specified, likely laboratory-generated data following CLSI guidelines.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This document describes an in vitro diagnostic (IVD) immunoassay, not an imaging device or a device requiring human interpretation for ground truth establishment. Therefore, there are no experts used in the way described for establishing ground truth from image interpretation. The "ground truth" for this type of device is typically established through reference methods, gold standard assays (the predicate device in this case), and precise laboratory preparation of spiked or characterized samples.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is an IVD immunoassay, and ground truth is based on quantitative measurements from established methods, not expert consensus or adjudication of interpretations.
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
Not applicable. This is an IVD immunoassay, not an imaging device or one involving human readers for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the entire performance characterization presented in the document represents the standalone performance of the LIAISON® XL 1,25 Dihydroxyvitamin D assay. It's an automated chemiluminescent immunoassay, and its measurements are generated directly by the instrument, without a human-in-the-loop interpreting the results in a subjective manner as would be the case for an imaging algorithm. The output is a quantitative value of 1,25 dihydroxyvitamin D concentration.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this assay is established in several ways:
- Reference Method/Predicate Device: For method comparison, the DiaSorin 1,25 Dihydroxyvitamin D 125I RIA (K014030) served as the comparative method, acting as the gold standard for comparison.
- Defined Concentrations/Spiking: For linearity, hook effect, recovery, cross-reactivity, and interference studies, samples were prepared with known, defined concentrations of the analyte or interfering/cross-reacting substances.
- Healthy Population for Reference Range: For the reference range study, samples were collected from a defined "apparently healthy" adult population, with normal physiological values for related markers (Total Calcium, TSH, and PTH) to establish a normal range.
- Internally Certified Standards: The calibrators, controls, and calibration verifiers are traceable to in-house standards prepared from certified reference material (1α, 25 dihydroxyvitamin D).
8. The sample size for the training set
This document describes the validation of an IVD assay, not a machine learning or AI algorithm in the typical sense that would have a "training set" for model development. The performance studies detailed are verification and validation studies for a laboratory assay. Therefore, the concept of a "training set" as understood in AI/ML is not directly applicable here. The assay's "learning" or optimization would have occurred during its development phase, preceding these regulatory submission studies, and would not have been for an "algorithm" as typically defined in AI.
9. How the ground truth for the training set was established
As explained above, the concept of a "training set" as it pertains to AI/ML algorithms is not directly applicable to this IVD assay. The development process, which might be analogous to "training," would have involved optimizing assay reagents, conditions, and calibration procedures using various characterized samples and reference methods. The ground truth for such internal development would similarly rely on traceable standards, reference methods, and carefully prepared samples with known concentrations.
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