(381 days)
The AutoDELFIA® Neonatal IRT L 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. Standards, 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 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 the measured. The fluorescence of each sample is proportional to the concentration of IRT in the sample.
This document describes the AutoDELFIA Neonatal IRT L kit, an in vitro diagnostic device used for screening newborns for cystic fibrosis by quantitatively determining immunoreactive trypsin(ogen) (IRT) in dried blood specimens. The submission seeks to demonstrate substantial equivalence to a previously cleared device, the AutoDELFIA Neonatal IRT kit (K003668).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison of the new device (AutoDELFIA Neonatal IRT L kit, B022-112) with the predicate device (AutoDELFIA Neonatal IRT kit, B005-112). The goal is to show equivalent analytical performance characteristics.
| Acceptance Criterion (Implicitly based on Predicate Device Performance) | AutoDELFIA Neonatal IRT L kit Performance (B022-112) |
|---|---|
| Precision (Total variation) | CV% 9.5 - 11.0 |
| Limit of blank | 0.18 ng/mL (95th %tile) |
| Linearity | Linear range 13 - 370 ng/mL |
| Hook effect | No effect found up to IRT conc. 40,000 ng/mL |
| IRT distribution in newborns (Mean) | 22 ng/mL blood |
| IRT distribution in newborns (Median) | 18 ng/mL blood |
| IRT distribution in newborns (90th %tile) | 38 ng/mL blood |
| IRT distribution in newborns (95th %tile) | 47 ng/mL blood |
| IRT distribution in newborns (99th %tile) | 68 ng/mL blood |
Note: The text explicitly states "The analytical performance characteristics of the two kits are equivalent" implying that the performance of the new device matching or being comparably close to the predicate device serves as the acceptance criteria. For the IRT distribution, the differences are noted, suggesting that while not identical, they are considered within acceptable equivalence for substantial equivalence.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size used for the test set for the studies on precision, limit of blank, linearity, hook effect, or IRT distribution.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The studies described are analytical performance studies of an IVD kit, not studies requiring expert interpretation of results for ground truth. The "ground truth" for these tests would typically be defined by reference methods or established statistical analysis of the assay's performance characteristics.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple readers or experts assess cases. This document describes analytical performance studies of a diagnostic assay kit. Therefore, an adjudication method is not applicable and not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes the analytical validation of an in vitro diagnostic kit, not a study involving human readers interpreting results with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an automated immunoassay system (AutoDELFIA® automatic immunoassay system) that performs quantitative measurements. The performance data presented (precision, limit of blank, linearity, hook effect, IRT distribution) are standalone performance metrics of the assay kit itself, without human interpretation as part of the primary measurement. Human intervention would be for laboratory procedures and interpretation of the quantitative result against clinical cut-offs, but the device performance itself is standalone in terms of generating the IRT concentration.
7. The Type of Ground Truth Used
For the analytical performance characteristics:
- Precision: Established by repeated measurements.
- Limit of blank: Determined statistically from blank sample readings.
- Linearity: Assessed by analyzing samples of known, serially diluted concentrations.
- Hook effect: Investigated using samples with very high IRT concentrations.
- IRT distribution in newborns: This likely represents observed data from a population of newborns, which serves as the "ground truth" for reflecting the typical range of IRT in the target population. However, the exact method for establishing this, beyond sample analysis, is not detailed.
In essence, the "ground truth" for these studies is derived from analytical measurements and statistical analysis against reference materials or established methods, rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
The document describes the validation of an IVD kit, not an AI/ML algorithm that typically has a "training set." Therefore, the concept of a "training set sample size" as commonly understood in AI/ML is not applicable to this submission. The kit is based on established fluoroimmunometric assay principles and monoclonal antibodies.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" in the AI/ML context is not applicable. The assay's performance is established through calibration and validation studies using known standards and samples, similar to how analytical methods are developed and validated in general.
§ 862.1170 Chloride test system.
(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.