(56 days)
The "Wiener lab. Bilirrubina Total AA" test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of total bilirubin in human sera and heparinized plasmas on both manual and automated systems. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.
Total bilirubin (both conjugated and free) is measured using a stable dichlorophenyl diazonium salt (DPD) to form an azobilirubin compound with maximal O.D. at 546 nm. Surfactants are used as reaction accelerators. The amount of bilirubin is determined by measuring the absorbance of this pigment.
The provided document describes the predicate device and the new device being submitted for 510(k) clearance, the Wiener lab. BILIRRUBINA TOTAL AA test system. It focuses on establishing substantial equivalence to the predicate device through a comparison of their features and performance characteristics, particularly related to analytical performance (precision, linearity, expected values).
However, the document does not contain information about:
- Specific acceptance criteria used in a study to prove the device meets these criteria. Instead, it presents performance characteristics and compares them to the predicate.
- A dedicated study design with a test set, training set, ground truth establishment, or expert involvement as would be typical for AI/ML-based device evaluation.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
The information provided is typical for an IVD (In Vitro Diagnostic) device submission where the focus is on analytical performance characteristics rather than clinical diagnostic accuracy based on image analysis or human interpretation.
Therefore, many of the requested fields cannot be filled from the given text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" but presents performance data for the new device and compares it to the predicate. The "acceptance" is implied by the concluding statement of substantial equivalence.
| Performance Characteristic | Predicate Device (DMA Test System) | Wiener LAB. Test System (Reported Performance) |
|---|---|---|
| Intended Use | Quantitative determination of total bilirubin in human serum and EDTA or heparinized plasma. | Quantitative determination of total bilirubin in human serum and heparinized plasma. |
| Test Principle | Total bilirubin measured using a stabilized diazonium salt of 3,5-dichloroaniline. | Total bilirubin measured using a stable dichlorophenyl diazonium salt (DPD). |
| Reagents | 3,5-dichlorophenyldiazonium tetrafluoroborate and surfactants. | R1: hydrochloric acid and surfactant; R2: dichlorophenyl diazonium salt. Sample blank: hydrochloric acid and surfactant. |
| Preparation of Working Reagent | Ready to use. | Reconstitute each Reagent 2 vial with stated volume of Reagent 1. |
| Stability of Final Color | 60 minutes at room temperature (15-30ºC). | 30 minutes at room temperature. |
| Wavelength of Reading | 540 nm. | 546 nm. |
| Calibration | Single point. | (Not specified for Wiener Lab, implied similar if not stated otherwise in comparison table). |
| Linearity | 20 mg/dl. | (Not specified for Wiener Lab, implied similar if not stated otherwise in comparison table). |
| Expected values | 0.0 - 1.5 mg/dl. | Adults: up to 1.0 mg/dl; Newborns: ranging from 2.0 to 16 mg/dl depending on birth condition and days of life. |
| Within-run precision | Low Serum Control: CV = 5.00%; Moderate Serum Control: CV = 2.20%; High Serum Control: CV= 1.56%. | Normal Level Serum: CV = 1.50%; High Level Serum: CV = 0.98%. |
| Run-to-run precision | Low Serum Control: CV = 6.40%; Moderate Serum Control: CV = 0.83%; High Serum Control: CV= 2.10%. | Normal Level Serum: CV = 2.68%; High Level Serum: CV = 1.08%. |
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The precision data (within-run and run-to-run) would have been generated using a laboratory test, but the specific sample sizes for these tests are not mentioned. There is no information about the country of origin or if the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is an IVD device, and the "ground truth" for analytical performance (precision, linearity) would be based on reference methods or spiked samples, not expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. As above, this concept applies to human interpretation of diagnostic results, not the analytical performance of an IVD reagent.
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. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is an IVD reagent kit; its performance is standalone in the sense that it produces a quantitative value, but there's no "algorithm" in the context of AI/ML.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For precision, the ground truth would be the known concentration of bilirubin in control samples as measured by a reference method or validated assays. For expected values, it would be based on large-scale population studies.
8. The sample size for the training set:
Not applicable. There is no "training set" in the context of AI/ML for this type of IVD device. The methods are chemical reactions, not learned algorithms.
9. How the ground truth for the training set was established:
Not applicable. See above.
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.