Search Results

The GSP Neonatal IRT kit is intended for the quantitative determination of IRT in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the GSP® instrument.

The GSP Neonatal IRT assay is a solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies (derived from mice) are directed against two separate antigenic determinants on the IRT molecule. Calibrators, controls or test specimens containing IRT are reacted simultaneously with immobilized monoclonal antibodies directed against a specific antigenic site on the IRT molecule and europium-labeled monoclonal antibodies (directed against a different antigenic site) in assay buffer. The assay buffer elutes IRT from dried blood on filter paper disks. The complete assay requires only one incubation step. DELFIA Inducer dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of the DELFIA Inducer. The fluorescence in each well is then measured. The fluorescence of each sample is proportional to the concentration of IRT in the sample.

The provided text describes the GSP Neonatal IRT kit, a device for screening newborns for cystic fibrosis. It compares the new device to a predicate device (AutoDELFIA Neonatal IRT kit) and presents information on its performance characteristics.

Here’s a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document describes a substantial equivalence claim, not a separate clinical study with independent acceptance criteria beyond demonstrating equivalence to the predicate device. The "study" here is the comparison and characterization of the new device's performance against the established predicate device (AutoDELFIA Neonatal IRT kit, K0003668). The acceptance criteria are largely implicitly defined by the performance characteristics of the predicate device, where the new device is shown to have similar or improved performance in analytical parameters.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not explicitly state a sample size for a test set in the context of a clinical study. The performance characteristics reported (e.g., precision, analytical sensitivity, measuring range) are typically derived from analytical verification and validation studies in a laboratory setting.

• Sample Size: Not explicitly stated for a "test set" in a clinical context. The precision data lists various IRT concentrations tested, and each CV% (Coefficient of Variation) would have been derived from replicate measurements.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies generating these performance characteristics were retrospective or prospective. It describes the device's analytical performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

N/A. This is an in-vitro diagnostic device for measuring a biomarker (IRT). The "ground truth" for its performance is based on analytical measurements and comparison to a known standard, not on expert clinical evaluation or interpretation of images.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data (e.g., images) by multiple human readers, not in the analytical validation of an in-vitro diagnostic assay measuring a biomarker.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

N/A. An MRMC study is not applicable to the analytical performance evaluation of this type of in-vitro diagnostic device. This device measures a quantitative biomarker and does not involve human interpretation of cases or "readers" in the traditional sense, nor does it aim to improve human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

The device itself is a "standalone" assay in the sense that it quantifies IRT levels directly from a blood spot sample using an instrument. There is no human interpretation of an algorithm output, but rather a direct measurement that aids in screening. The GSP® instrument performs the assay automatically.

7. The Type of Ground Truth Used

The ground truth for the device's performance (especially for parameters like measuring range, sensitivity, and precision) would be established by:

• Reference materials/calibrators: Samples with known concentrations of IRT (calibrated using gravimetric methods, as mentioned).
• Established analytical methods: Comparison to recognized analytical techniques for IRT measurement.
  This is not "expert consensus, pathology, or outcomes data" in the clinical sense, but rather a robust analytical validation against known standards.

8. The Sample Size for the Training Set

N/A. This document pertains to an in-vitro diagnostic kit for measuring a biomarker, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The device's performance is based on its chemical and immunological assay design.

9. How the Ground Truth for the Training Set was Established

N/A. As stated above, this is not an AI/ML device that uses a "training set."

Ask a specific question about this device