(130 days)
The AutoDELFIA Neonatal IRT kit is intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the 1235 AutoDELFIA® automatic immunoassay system.
The AutoDELFIA 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 and 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 the dried blood on filter paper disks. The complete assay requires only one incubation step. Enhancement Solution dissociates europium ions from the labeled 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 IRT in the sample.
The provided text describes a 510(k) premarket notification for the AutoDELFIA Neonatal IRT kit. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance data in the format typically used for AI/ML device evaluations. As such, many of the requested fields for AI/ML device studies are not directly applicable or explicitly stated in this document.
However, I can extract information related to the device's analytical performance characteristics, which serve as a form of acceptance criteria for this type of in-vitro diagnostic device.
Here's an attempt to populate the table and answer the questions based on the provided text, indicating where information is not available.
1. Table of Acceptance Criteria and the Reported Device Performance
For this in-vitro diagnostic device, "acceptance criteria" are generally established by demonstrating performance characteristics that are comparable to or better than a legally marketed predicate device, and that meet the required analytical performance for its intended use.
| Characteristic (Feature) | Acceptance Criteria (from Predicate Device) | Reported Device Performance (New Device: B005-212/B005-204) |
|---|---|---|
| Measuring Range | 4 (as defined by LoB) to 500 (as defined by upper calibrator) ng/mL blood | 16 to 480 ng/mL blood |
| Linearity Range | No claims for linearity in labeling. | 16 to 480 ng/mL blood |
| Analytical Sensitivity / Limit of Blank (LoB) |
§ 862.1725 Trypsin test system.
(a)
Identification. A trypsin test system is a device intended to measure the activity of trypsin (a pancreatic enzyme important in digestion for the breakdown of proteins) in blood and other body fluids and in feces. Measurements obtained by this device are used in the diagnosis and treatment of pancreatic disease.(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.