(56 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, VITROS 3600 Immunodiagnostic System 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, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or Heparin).
VITROS 3600 Immunodiagnostic System
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
The VITROS Immunodiagnostic Product TSH Reagent and Calibrators is intended for use on the VITROS 3600 Immunodiagnostic System.
The VITROS 3600 Immunodiagnostic System utilizes the existing VITROS ECi/ECIQ Immunodiagnostic System technology (K962919) and adds increased operating efficiency and throughput by utilizing the same immunoassay hardware and software subsystem design as the VITROS 5600 Integrated System (K081543). All VITROS Immunodiagnostic Product technology, methodologies and analytical methods currently available on the existing two systems (VITROS ECi/ECIQ Immunodiagnostic System and VITROS 5600 Integrated System) are available on the new VITROS 3600 Immunodiagnostic System.
This document describes a Special 510(k) submission for the VITROS Immunodiagnostic Products TSH Reagent Pack, TSH Calibrators, and VITROS 3600 Immunodiagnostic System. The primary purpose of this submission is to notify FDA of the modification to allow the existing TSH Reagent Pack and Calibrators to be used with the new VITROS 3600 Immunodiagnostic System.
The information provided focuses on the substantial equivalence of the modified device to a previously cleared predicate device (K081543) and does not contain detailed primary study data or acceptance criteria typically found in initial device clearance submissions. Therefore, a comprehensive table of acceptance criteria and reported device performance directly from a new study is not available in the provided text. Instead, the document asserts substantial equivalence based on shared technology and performance characteristics with established systems.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific acceptance criteria or report new device performance metrics from a dedicated study for this particular Special 510(k) submission. This is because the submission's core argument is substantial equivalence to a previously cleared device (K081543, for the VITROS TSH assay on the VITROS 5600 Integrated System) and prior cleared technology (K962919, for the VITROS ECi/ECiQ Immunodiagnostic System).
The submission states: "The modified device has the same intended use, fundamental scientific technology and operating principle as the predicate device. The modified VITROS Immunodiagnostic Products TSH assay is substantially equivalent to the product previously cleared with Premarket Notification number K081543."
This implies that the performance of the VITROS TSH assay on the VITROS 3600 system is expected to meet the same performance criteria that were established and accepted for the K081543 submission. Without access to K081543, specific quantitative acceptance criteria cannot be listed here.
2. Sample size used for the test set and the data provenance
The provided text does not include information about a specific test set sample size or data provenance (country of origin, retrospective/prospective) for this Special 510(k) submission. Given that this is a Special 510(k) focused on system modification and substantial equivalence, new clinical performance studies with dedicated test sets are often not required if the changes do not significantly impact safety or effectiveness. The claim is that the VITROS 3600 uses the existing VITROS ECi/ECiQ technology and the same immunoassay hardware and software subsystem design as the VITROS 5600.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
This information is not provided in the document. As this is a laboratory diagnostic device, ground truth for TSH measurements would typically be based on established reference methods, external quality assurance programs, or certified reference materials, rather than expert consensus on individual cases.
4. Adjudication method for the test set
This information is not provided in the document. It is unlikely to be relevant for a submission of this nature, focused on an in vitro diagnostic device measuring a specific analyte.
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 device is an in vitro diagnostic immunodiagnostic system for measuring Thyroid Stimulating Hormone (TSH). It is not an AI-assisted diagnostic imaging device or a device involving human "readers" in the context of interpretation that would necessitate an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable in the context of "algorithm only." The device is an automated in vitro diagnostic instrument. Its performance is evaluated as a standalone system (instrument, reagent, calibrators) in measuring TSH concentration. The "algorithm" here would refer to the instrument's internal measurement and calculation processes, and its "standalone performance" is what the overall system performance studies (implicitly referenced by substantial equivalence to K081543) would evaluate. The results are quantitative measurements, not interpretations requiring human review in the same way an imaging algorithm might.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the ground truth type used for the original validation of the TSH assay (K081543). However, for quantitative in vitro diagnostic assays like TSH, ground truth is typically established through:
- Reference Intervals: Established by analyzing samples from a healthy population using a highly accurate and precise reference method.
- Assigned Values of Certified Reference Materials: Using internationally recognized standards and calibrators.
- Correlation with Established Methods: Comparing results to a legally marketed predicate device or gold standard method for TSH measurement.
8. The sample size for the training set
This information is not provided as the submission is not focused on developing a new algorithm but adapting an existing assay to a new instrument platform. The concept of a "training set" is generally more relevant for machine learning algorithms or new assay development, neither of which is the primary focus of this Special 510(k). All "technology, methodologies and analytical methods" are stated to be "currently available on the existing two systems."
9. How the ground truth for the training set was established
This information is not provided and is likely not applicable for the reasons stated in point 8.
§ 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.