(79 days)
This kit is intended for the quantitative determination of thyrotropin in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism, using the 1235 AutoDELFIA™ automatic immunoassay system.
The AutoDELFIA™ Neonatal hTSH L assay is a solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies are directed against separate antigenic determinants on the hTSH molecule. Standards, controls and test specimen containing hTSH are reacted simultaneously with immobilised monoclonal antibodies in assay buffer. The assay buffer elutes hTSH from the dried blood spots on the filter paper discs. The complete assay requires only one incubation step. Enhancement solution dissociates europium ions from the labelled antibody into solution where they form highly fluorescent chelates with components of the enhancement solution. The fluorescence in each well is then measured. The fluorescence of each sample is proportional to the concentration of hTSH in the sample.
The provided text describes the 510(k) summary for the AutoDELFIA™ Neonatal hTSH L Kit, which is intended for screening newborns for congenital hypothyroidism. The study that proves the device meets acceptance criteria is primarily a comparison to a predicate device.
Here's an analysis based on the information provided:
Acceptance Criteria and Device Performance
The document describes a comparison study against a predicate device, the AutoDELFIA™ Neonatal hTSH kit, to demonstrate substantial equivalence. The key performance metrics are the reference ranges and mean values of hTSH concentrations.
| Acceptance Criteria | Reported Device Performance (AutoDELFIA™ Neonatal hTSH L kit) | Predicate Device (AutoDELFIA™ Neonatal hTSH kit) |
|---|---|---|
| Reference Range | 0.69 - 12.7 µU/mL blood | 0.55 - 14.9 µU/mL blood |
| Mean Value | 4.13 µU/mL blood | 3.96 µU/mL blood |
The qualitative acceptance criteria is "substantially equivalent" to the predicate device. The performance data presented (reference ranges and mean values) are used to support this claim of substantial equivalence. The frequency distributions are also presented to visually demonstrate the similarity.
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: 860 newborns.
- Data Provenance: Not explicitly stated, but given the context of U.S. regulatory submission by a U.S.-based company, it's highly likely the data is from the U.S. The study is retrospective, as the hTSH concentrations were "measured in 860 newborns" using both kits.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This study does not involve expert interpretation to establish ground truth in the typical sense of diagnostic imaging or clinical assessment. It's a quantitative assay where the "ground truth" for the comparison is the measurement obtained by the predicate device and the new device. Therefore, no experts were explicitly used to establish a ground truth for the test set as would be the case in subjective diagnostic tasks. The ground truth for hTSH levels is assumed to be the quantitative measurement itself.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- There was no adjudication method described. This is a quantitative assay comparison, not a subjective diagnostic task requiring expert consensus.
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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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is an in vitro diagnostic device (IVD) for laboratory analysis, not a device that involves human readers interpreting outputs or AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this study represents a standalone performance evaluation of the AutoDELFIA™ Neonatal hTSH L kit in comparison to a predicate device. Both devices are automated immunoassays, meaning they function independently to produce a quantitative result without direct human interpretation in each measurement step.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" used for this comparative study is the quantitative hTSH concentration measured by the predicate device (AutoDELFIA™ Neonatal hTSH kit). The new device's performance is gauged against this established method to demonstrate substantial equivalence.
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The sample size for the training set:
- The document does not provide information about a "training set." This type of in vitro diagnostic device study typically focuses on validation and comparison to a predicate, rather than an AI/ML development pipeline with distinct training and test sets.
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How the ground truth for the training set was established:
- As there's no mention of a training set, the establishment of ground truth for it is not applicable based on the provided text.
§ 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.