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510(k) Data Aggregation
(60 days)
The "Wiener lab. Albumina AA" albumin test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of albumin in human sera. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Albumin reacts specifically with bromcresol green to produce a colored complex. Increase of absorbance at 625 nm with respect to the reagent Blank is proportional to the albumin concentration in sample.
The provided text describes a 510(k) summary for the "WIENER LAB ALBUMINA AA" test system, which is intended for the quantitative determination of albumin in human sera. The document aims to demonstrate substantial equivalence to a predicate device, the ABBOTT ALBUMIN BCG test system.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" but provides comparative performance characteristics between the WIENER LAB ALBUMINA AA test system and its predicate, the ABBOTT ALBUMIN BCG test system. These can be inferred as the performance metrics the device aimed to meet or be comparable to.
| Performance Characteristic | Predicate Device (ABBOTT ALBUMIN BCG) | WIENER LAB ALBUMINA AA (Reported Performance) |
|---|---|---|
| Intended Use | Quantitative determination of albumin in human sera and plasma. | Quantitative determination of albumin in human sera. |
| Test Principle | Albumin reacts specifically with bromcresol green (BCG) to produce a colored complex. Increase of absorbance at 625 nm with respect to the reagent Blank is proportional to the albumin concentration in sample. | Albumin reacts specifically with bromcresol green to produce a colored complex. Increase of absorbance at 625 nm with respect to the reagent Blank is proportional to the albumin concentration in sample. |
| Essential Components | BCG | BCG |
| Reagents | Single reagent ready to use | Single reagent ready to use |
| Storage and Stability | Stable until expiration date printed on the labels when stored at room temperature. | Stable until expiration date printed on the labels when stored at room temperature. |
| Serum Controls | Available - provided separately | Available - provided separately |
| Sample | Human sera and plasmas | Human sera |
| Wavelength of reading | 600 nm | 600 to 650 nm |
| Linearity | up to 7 g/dl | up to 7 g/dl (Implied, as it's not explicitly different) |
| Minimum Detection Limit | 0.1 g/dl | 0.02 g/dl |
| Analytical Sensitivity | 0.2 g/dl | 0.7 g/dl |
| Expected values | Male: 4.2-5.5 g/dl, Female: 3.7-5.3 g/dl, Hospitalized Adult: 3.5-5.0 g/dl | 3.5 - 4.8 g/dl |
| Intra-assay Precision (Normal Serum Control) | CV = 1.8 - 1.2 - 1.5% (in different analyzers) | CV = 2.10 % |
| Intra-assay Precision (Abnormal Serum Control) | CV = 1.7-1.4-0.8% (in different analyzers) | CV = 2.48 % |
| Inter-assay Precision (Normal Serum Control) | CV = 2.1 - 1.9 - 2.0 % (in different analyzers) | CV = 3.57 % |
| Inter-assay Precision (Abnormal Serum Control) | CV = 2.3 - 2.2 - 1.6 % (in different analyzers) | CV = 3.99 % |
Note: For "Linearity," "Test Principle," "Essential Components," "Reagents," "Storage and Stability," and "Serum Controls," the document implies substantial equivalence without providing distinct values for the new device if they are the same as the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for any test set or the data provenance (country of origin, retrospective/prospective). It mentions precision studies (intra-assay and inter-assay) were conducted using "Normal Serum Control" and "Abnormal Serum Control," but the number of samples or runs is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided in the document. The device is an in-vitro diagnostic test for albumin measurement, not an imaging device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the document, as it pertains to expert reviews of diagnostic interpretations, which is not the nature of this device.
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
This information is not applicable. The device is a laboratory assay for quantitative albumin measurement and does not involve "human readers" or "AI assistance" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The "WIENER LAB ALBUMINA AA" test system is a standalone in-vitro diagnostic device. Its performance characteristics listed (precision, sensitivity, detection limit) are inherently standalone performance measures of the assay itself without human-in-the-loop performance modifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance metrics presented (precision, linearity, sensitivity, detection limit), the "ground truth" would be established by reference methods or validated calibrated controls used in the laboratory setting. The document does not specify the exact methods or materials used to establish these reference values for the studies, but it is characteristic of clinical chemistry assays to use certified reference materials and established analytical techniques.
8. The sample size for the training set
This information is not applicable and not provided. The development of a chemical assay like this typically involves formulation and optimization rather than "training" an algorithm with a dataset in the way machine learning models are trained.
9. How the ground truth for the training set was established
This information is not applicable. As explained above, the concept of a "training set" and "ground truth" for a training set does not directly apply to the development of this type of chemical assay. Assay development involves optimizing reagent concentrations, reaction conditions, and calibration procedures to achieve desired analytical performance characteristics.
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