(22 days)
This kit is intended for the quantitative determination of 17 a- OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the 1235 AutoDELFIA automatic immunoassay system.
The AutoDELFIA Neonatal 17α-ΟΗ-progesterone (17-ΟΗΡ) assay is a solid phase, time-resolved fluoroimmunoassay based on the competition between europium-labeled 17-OHP and sample 17-OHP for a limited number of binding sites on 17-OHP specific polyclonal antibodies (derived from rabbit). Danazol facilitates the release of 17-OHP from the binding proteins. A second antibody, directed against rabbit IgG, is coated to the solid phase, giving convenient separation of the antibodybound and free antigen. Enhancement Solution dissociates europium ions from the labeled antiserum 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 inversely proportional to the quantity of 17-OHP in the sample.
The provided text does not contain detailed acceptance criteria or a specific study that outlines how the device demonstrably meets those criteria. The document is a 510(k) summary for the "AutoDELFIA® Neonatal 17 α-OH-progesterone kit," which focuses on establishing substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.
However, based on the information provided, we can infer some aspects related to device performance and study design:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria. Instead, it relies on the concept of "substantial equivalence" to a predicate device. The performance of the modified kit was found to be "equivalent" and "suitable for its intended use."
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Equivalence to predicate device (K912026 / K935047) in intended use and assay principle. | Performance of the modified kit was found to be equivalent to the predicate AutoDELFIA Neonatal 17a-OH-progesterone kit. |
| Suitability for intended use (screening newborns for CAH). | Performance was found to be suitable for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size used for the performance evaluation. It mentions "in-house studies and by studies in neonatal screening laboratories."
- Data Provenance: The studies were conducted "in-house" and "in neonatal screening laboratories." The country of origin for the submitting company (Wallac Oy) is Finland, suggesting that some or all of the studies might have taken place in Finland or other European neonatal screening centers. The document does not specify if the data was retrospective or prospective.
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. The device is for quantitative determination and screening, which typically relies on established medical thresholds and clinical diagnoses rather than expert consensus on individual test results for ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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
- No MRMC study mentioned: The device is an immunoassay kit for quantitative determination, not an AI-powered diagnostic imaging or interpretation tool that would involve human readers. Therefore, an MRMC study and analysis of human reader improvement with AI would not be applicable or relevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implicitly a standalone device: The AutoDELFIA system is an automated immunoassay system. The "kit" refers to the reagents and consumables used with this system to perform the quantitative determination of 17α-OH-progesterone. As such, the performance of the kit, when used with the AutoDELFIA system, is inherently "standalone" in generating a quantitative result. There isn't a human-in-the-loop interpreting a visual output from the algorithm in the way one might with an imaging AI.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state how ground truth was established for the performance studies. For a screening test like this, ground truth for CAH would typically be established through:
- Clinical diagnosis: Confirmation of CAH through subsequent diagnostic tests, genetic testing, and clinical assessment.
- Pathology/Biochemical confirmation: Measurement of other steroid hormones, genetic analysis, or enzyme activity tests that definitively diagnose CAH.
Given the nature of the device as a quantitative assay for a biomarker, the comparison would likely be against established clinical diagnostic criteria for CAH.
8. The Sample Size for the Training Set
This information is not provided. As an immunoassay kit, it's unlikely to have a "training set" in the machine learning sense. The "training" in developing such a kit would involve optimizing reagent concentrations, reaction conditions, and calibration procedures, which is a different paradigm than data-driven AI model training.
9. How the Ground Truth for the Training Set was Established
Not applicable as it's not an AI model requiring a training set with explicitly established ground truth in the AI sense. Development of the assay would involve various analytical validation studies.
§ 862.1395 17-Hydroxyprogesterone test system.
(a)
Identification. A 17-hydroxyprogesterone test system is a device intended to measure 17-hydroxyprogesterone (a steroid) in plasma and serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis and treatment of various disorders of the adrenal glands or the ovaries.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.