(143 days)
VITROS Immunodiagnostic Products TSH Reagent Pack: For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or Heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems and VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
VITROS Immunodiagnostic Products TSH Calibrators: For in vitro use in the calibration of the VITROS ECI/ECIQ Immunodiagnostic Systems and VITROS 5600 Integrated System for the quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or Heparin).
VITROS Chemistry Products PHYT Slides: For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System.
VITROS Chemistry Products Calibrator Kit 9: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950 and 5.1 FS Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ACET, CRBM, DGXN, PHBR, and PHYT.
VITROS 5600 Integrated System: For use in the in vitro quantitative, semi-quantitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
The VITROS Immunodiagnostic Products TSH assay and VITROS Chemistry Products PHYT assay are intended for use on the VITROS 5600 Integrated System. The VITROS 5600 Integrated System combines the existing VITROS 5,1 FS Chemistry System (K031924) and the VITROS ECi/ECiQ Immunodiagnostic System (K962919) into a single system. All technology, methodologies and analytical methods currently available on the existing two systems are available on the new integrated system.
This is a 510(k) premarket notification for modifications to existing assays (VITROS Immunodiagnostic Products TSH and VITROS Chemistry Products PHYT) to be used with a new integrated system (VITROS 5600 Integrated System). The submission focuses on demonstrating substantial equivalence to previously cleared devices.
Therefore, the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of a new diagnostic algorithm's performance are not explicitly detailed in the provided text. This is because the submission is for a system modification rather than a new algorithmic diagnostic device with performance metrics like sensitivity, specificity, etc.
However, based on the context of a 510(k) for a laboratory diagnostic system, we can infer the types of performance criteria that would be relevant for demonstrating substantial equivalence for the modified use of the assays on the new system. These would typically include:
- Method Comparison: Showing that results obtained on the new integrated system are comparable to those obtained on the predicate systems.
- Precision: Demonstrating acceptable within-run and between-run variability on the new system.
- Linearity/Analytical Measurement Range: Confirming the ability to accurately measure analytes across a defined range on the new system.
- Interference: Ensuring common interfering substances do not significantly impact results on the new system.
- Stability: Verifying the stability of reagents and calibrators when used with the new system.
- Reference Range: Confirming the appropriate reference intervals for the assays on the new system.
Since the provided text does not contain detailed study results for these specific performance characteristics (as it's a summary document), I cannot fill out all sections. I will address what can be inferred or is explicitly stated:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria for performance metrics (e.g., "TSH bias must be within X%") or report detailed performance data. Instead, the submission relies on the concept of "substantial equivalence" of the modified device to the predicate devices. This implies that the performance on the new combined system is expected to be equivalent to the already cleared separate systems.
| Acceptance Criteria (Inferred from Substantial Equivalence for IVD assays) | Reported Device Performance (Inferred/Not explicitly detailed in summary) |
|---|---|
| Method Comparison: Results from VITROS 5600 Integrated System are comparable to predicate systems (VITROS ECi/ECiQ and VITROS 5,1 FS Chemistry System). | The submission asserts "All technology, methodologies and analytical methods currently available on the existing two systems are available on the new integrated system" and that the "modified devices have the same intended use, fundamental scientific technology and operating principle as the predicate devices." This implies performance equivalence. |
| Precision: Acceptable within-run and between-run precision for TSH and PHYT assays on VITROS 5600. | Not explicitly detailed in the summary. Implied to be equivalent to predicate. |
| Accuracy/Bias: Acceptable accuracy for TSH and PHYT assays on VITROS 5600. | Not explicitly detailed in the summary. Implied to be equivalent to predicate. |
| Analytical Measurement Range: Proper quantification across the defined analytical range for TSH and PHYT on VITROS 5600. | Not explicitly detailed in the summary. Implied to be equivalent to predicate. |
| Interference: No significant interference from common substances when using TSH and PHYT assays on VITROS 5600. | Not explicitly detailed in the summary. Implied to be equivalent to predicate. |
| Reagent/Calibrator Stability: Demonstrated stability when used with VITROS 5600. | The new system uses "reagents, calibrators and controls identical to the VITROS ECi/ECiQ Immunodiagnostic System and VITROS 5,1 FS Chemistry System," implying their established stability carries over. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the summary document. For method comparison studies in IVDs, hundreds of clinical samples are typically used across the analytical range.
- Data Provenance: Not explicitly stated. Assumed to be clinical samples relevant to the intended use.
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 not applicable in the context of this 510(k) for an in vitro diagnostic (IVD) system. For IVDs, "ground truth" is typically established by reference methods, comparison to predicate devices, or spiking studies, not by expert interpretation of images or clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Diagnostic assays like TSH and PHYT use quantitative measurements, and "adjudication" in the sense of resolving discrepancies between human readers is not relevant. The comparison would be between the numerical results of the new system and the predicate system.
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 system for quantitative measurement, not an AI-assisted diagnostic imaging device that involves human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device (VITROS 5600 Integrated System running the TSH and PHYT assays) is a standalone automated system for quantitative measurement. Its performance is evaluated intrinsically through analytical studies (precision, accuracy, method comparison, etc.) as described under point 1.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this type of IVD device, ground truth would typically be established by:
- Reference Methods: Comparison against established, highly accurate analytical methods.
- Predicate Device Comparison: Demonstrating statistical equivalence of results when compared to the existing cleared devices (VITROS ECi/ECiQ and VITROS 5,1 FS Chemistry System) on the same samples.
- Spiked Samples: Using samples with known concentrations of the analyte.
The submission heavily relies on the "substantial equivalence" to predicate devices, indicating that the predicate device's performance effectively serves as the "ground truth" for comparison.
8. The sample size for the training set:
Not applicable in the AI/machine learning sense. For IVD systems, "training" refers to calibration and quality control. The training of the system for measuring TSH and PHYT would involve:
- Calibration: Using the specific calibrators (VITROS Immunodiagnostic Products TSH Calibrators and VITROS Chemistry Products Calibrator Kit 9). The sample sizes for calibration materials are determined by statistical design to ensure accurate curve fitting.
- Quality Control: Regular testing of quality control materials to ensure the system is performing within specifications.
9. How the ground truth for the training set was established:
- Calibrators: The ground truth (assigned value) for the calibrators is established through a rigorous process by the manufacturer, typically involving reference methods, traceability to international standards (if available for TSH), and extensive internal validation studies.
- Quality Control Materials: Similar to calibrators, assigned values for quality control materials are established by the manufacturer through reference methods and internal validation.
§ 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.