(290 days)
The MAGLUMI 2000 TSH assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH) in human serum. The measurement of TSH is used in the diagnosis of thyroid disorders.
The MAGLUMI 2000 Immunoassay system is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical serum specimens. The MAGLUMI 2000 Immunoassay system's assay application utilizes chemiluminescents technology for clinical use.
The MAGLUMI 2000 system is a floor model, fully automated instrument system that utilizes chemiluminescent technology and uses pre-packaged reagent packs to measure a variety of analytes in human body fluids. It is controlled through a combination of custom and off-the-shelf software.
MAGLUMI 2000 TSH kit consists of the following reagents: Magnetic Microbeads- coated with anti-TSH monoclonal antibody, phosphate buffer, NaN3(
The provided text describes the performance characteristics of the MAGLUMI 2000 TSH assay and MAGLUMI 2000 Immunoassay Analyzer. Below is an attempt to extract and organize the information as requested, though some categories may not be fully addressed due to the nature of the document (a 510(k) summary for a diagnostic test, not an AI-powered device).
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a table format alongside device performance for all aspects. However, performance characteristics are presented, from which implied acceptance ranges can be inferred (e.g., for precision, interference, and linearity). The comparison study shows the performance relative to a predicate device.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | CV% within acceptable limits for diagnostic assays. | Within-Run CV: 1.38% - 4.73% |
| Between-Run CV: 0% - 4.38% | ||
| Between-Day CV: 0% - 2.90% | ||
| Total CV: 2.447% - 5.95% (Across various control, calibrator, and serum pools) | ||
| Linearity | Good correlation (R²) and close agreement between observed/expected values across the measuring range. | Measuring Range: 0.02 - 91.78 µIU/mL |
| Relationship: Observed = 1.0001 (Expected) + 0.0474, R² = 0.9990 | ||
| Detection Limit | Quantifiable detection limits. | LOB: 0.001 µIU/mL |
| LOD: 0.006 µIU/mL | ||
| LOQ: 0.01 µIU/mL | ||
| Hook Effect | No hook effect observed within the specified range. | No hook effect observed up to 3000 µIU/mL. |
| Interference | No significant deviation from expected results with common interfering substances. | No interference observed for: |
- Conjugate Bilirubin (60 mg/dL)
- Hemoglobin (2000 mg/dL)
- Triglycerides (1000 mg/dL)
- Acetaminophen (20 mg/dL)
- Ibuprofen (50 mg/dL)
- Aspirin (50 mg/dL)
- Biotin (10 ng/mL)
- Unconjugate bilirubin (40 mg/dL)
- Rheumatoid factor (124 IU/mL)
- Human anti-mouse antibodies (HAMA) (300 ng/mL)
- Total protein (12.5 mg/mL) |
| Specificity (Cross-reactivity) | Low cross-reactivity with structurally related hormones. | Less than 2% cross-reactivity with hCG (200 IU/mL), FSH (1500 mIU/mL), and LH (600 mIU/mL). |
| Method Comparison | Good correlation with predicate device. | Correlation with ADVIA CENTAUR TSH assay: Y = 1.0178X - 0.0773, R² = 0.9974 (for TSH values 0.02 - 91.78 uIU/mL) |
| Expected Values/Reference Range | Establishment of a normal range for the intended population. | Normal Range: 0.658 – 4.864 µIU/mL (based on 126 healthy adult samples, central 95% frequency distribution). |
| Stability (Reagents) | Stable for specified duration under given conditions. | Accelerated Stability (Controls, Calibrators): 12 months at 2-8°C.
Shelf Life Stability (Reagent Kit): 12 months at 2-8°C.
Open Kit Stability: 4 weeks at 2-8°C. |
| Traceability | Traceable to an international standard. | Traceable to the WHO international standard for human TSH (IRP 81/565) for controls and calibrators. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Precision Study:
- Sample Size: 4 controls, 2 calibrators, 6 spiked patient serum pools, and 4 native patient sample pools. Each level analyzed 80 times (20 days x 2 runs/day x duplicate) per instrument. (Total N = 240 samples per level across 3 instruments for calculated statistics in the table).
- Data Provenance: Not specified (e.g., country of origin). The study design (e.g., "collected over 20 days") suggests prospective testing during the assay development/validation phase.
- Linearity Study:
- Sample Size: 2 primary samples to create a series of intermediate serum dilutions (number of intermediate dilutions not explicitly stated, but 11 data points shown in the table).
- Data Provenance: Not specified.
- Detection Limit Study:
- Sample Size: Not explicitly stated, derived from CLSI EP17-A guidelines.
- Data Provenance: Not specified.
- Interference Study:
- Sample Size: Human serum samples with low and high TSH concentrations were used for each interfering substance (e.g., "0.97 and 5.4" or "0.7 and 6.1" µIU/mL). The number of individual samples is not described, but it involved at least two TSH concentrations for each interferent.
- Data Provenance: Not specified.
- Specificity Study:
- Sample Size: Human serum samples with various TSH concentrations (number not specified) spiked with potential cross-reactants.
- Data Provenance: Not specified.
- Comparison Studies:
- Sample Size: 337 patient serum samples.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
- Expected Values/Reference Range:
- Sample Size: 126 serum samples.
- Data Provenance: From "normal, apparently healthy adult (22 years and older) individuals." Not specified (e.g., country of origin, retrospective or prospective).
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 is a diagnostic assay for a biomarker (TSH), not an image-based AI device requiring expert interpretation for ground truth. Therefore, this information is not applicable and not provided in the document. The "ground truth" for the test sets (e.g., precision, linearity, interference) is based on the known concentrations of controls, calibrators, spiked samples, or comparison to a predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As a diagnostic assay, "adjudication" in the sense of reconciling divergent expert opinions on an output is not relevant. The performance studies evaluate the assay's analytical characteristics against established scientific protocols and reference methods.
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 document describes a diagnostic immunoassay system, not an AI-assisted diagnostic tool requiring human readability.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is an automated immunoassay system (MAGLUMI 2000 Immunoassay Analyzer) performing the quantitative determination of TSH using a specific assay (MAGLUMI 2000 TSH assay). Its performance is inherently "standalone" in that it produces a quantitative result from a sample without human interpretive intervention post-assay. The results are then interpreted by clinicians.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the analytical performance studies (precision, linearity, detection limits, interference, specificity) is primarily based on:
- Known concentrations: For controls, calibrators, and spiked samples.
- Comparison to a legally marketed predicate device: For method comparison (ADVIA CENTAUR TSH assay).
- International standards: Traceability to WHO international standard for human TSH (IRP 81/565).
- Established scientific protocols: CLSI guidelines.
8. The sample size for the training set
This document describes the validation of a diagnostic immunoassay system, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI. The performance studies detailed are for validation.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for an AI algorithm.
§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.