(183 days)
The “Wiener lab. Glicemia enzimática AA” test system is intended to be used in the quantitative determination of glucose in human serum and plasma on both manual and automated systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
End point method. The Wiener lab. Glicemia enzimatica AA is based on the following reaction system: Glucose + O2 + H2O -> GOD Gluconic Acid + H2O2; 2 H2O2 + 4-AP + 4-Hydroxybenzoate -> POD red. The amount of glucose is determined by measuring the absorbance of this pigment. GOD (glucose oxidase) POD (peroxidase) 4-AP (4-aminophenazone).
The provided text describes the "Wiener lab. Glicemia enzimática AA" test system, which is intended for the quantitative determination of glucose in human serum and plasma. The document highlights its substantial equivalence to a predicate device, the DMA GLUCOSE (Oxidase) test system.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document draws a comparison between the predicate device (DMA Test System) and the subject device (WIENER LAB. Test System). While it doesn't explicitly state "acceptance criteria" for the Wiener lab. device, it implicitly compares its performance parameters to those of the predicate device, suggesting that meeting or being comparable to the predicate's performance constitutes acceptance.
| Parameter | DMA Test System Performance | WIENER LAB. Test System Performance |
|---|---|---|
| Intentional Use | Quantitative determination of glucose in human serum and plasma. | Quantitative determination of glucose in human serum and plasma. |
| Test Principle | End point method. Reaction system: Glucose + O2 + H2O →GOD Gluconic Acid + H2O2; 2 H2O2 + 4-AP + 4-Hydroxybenzoate →POD red quinonimine | End point method. Reaction system: Glucose + O2 + H2O →GOD Gluconic Acid + H2O2; 2 H2O2 + 4-AP + 4-Hydroxybenzoate →POD red quinonimine |
| Essential Components | GOD - POD - Mutarotase - 4-AP - Hydroxybenzoate | GOD - POD - 4-AP - Hydroxybenzoate |
| Calibrator and Serum Controls | Available - provided separately | Available - provided separately |
| Instability/Deterioration | Blank Absorbance > 0.300. Abnormal values of controls. | Blank Absorbance > 0.160. Abnormally low Standard Absorbance. |
| Sample | Human serum, heparinized plasmas, potassium oxalate/fluoride and EDTA/fluoride plasmas | Human serum, heparinized plasmas, potassium oxalate/fluoride and EDTA/fluoride plasmas |
| Working Temperature Range | 37°C | Manual: 15 - 37°C; Automated: 37°C |
| Stability of final color | Not specified | 30 minutes |
| Wavelength of reading | 505 nm | 505 nm |
| Calibration | Single point | Single point |
| Linearity | 1000 mg/dl | 500 mg/dl |
| Minimum detection limit | 1.4 mg/dl | 0.544 mg/dl |
| Expected values | 75 - 113 mg/dl (70 - 105 mg/dl) | 70 - 110 mg/dl (70 - 105 mg/dl) |
| Intra-assay precision | Normal Serum Control: CV = 0.66%; Abnormal Serum Control: CV = 0.58% | Normal Serum Control: CV = 1.39%; Abnormal Serum Control: CV = 1.11% |
| Inter-assay precision | Normal Serum Control: CV = 1.22%; Abnormal Serum Control: CV = 0.91% | Normal Serum Control: CV = 1.92%; Abnormal Serum Control: CV = 1.62% |
| Sterility conditions | Not required | Not required |
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 in terms of patient samples. It provides performance characteristics (e.g., precision, linearity, detection limit) that would have been derived from testing, but the specifics of how many samples were used for these evaluations are not detailed.
The data provenance is not explicitly mentioned as country of origin, however, the submitter, Wiener Laboratorios S.A.I.C., is located in Rosario, Argentina. It’s not specified if the data is 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 given text. The document is for an in vitro diagnostic device, and ground truth in this context generally refers to the true concentration of glucose in the samples, established through reference methods or highly accurate laboratory techniques, not typically by expert interpretation as in imaging studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and therefore not provided, as the device is an in vitro diagnostic for quantitative measurement of glucose, not an AI imaging interpretation system that would require expert adjudication of results.
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 and therefore not provided. An MRMC study is relevant for imaging devices or AI-assisted diagnostic tools where human interpretation plays a role. This document concerns a chemical assay for glucose measurement, which does not involve human readers in the output interpretation in the same way.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device described, "Glicemia enzimatica AA," is a chemical assay test system. Its outputs are quantitative measurements of glucose. As such, it operates in a "standalone" fashion, providing a direct numerical result without human intervention for interpretation of the result itself (though a human performs the test and uses the result). The performance characteristics listed (precision, linearity, detection limit) directly reflect the algorithm/assay's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For an in vitro diagnostic device measuring glucose, the "ground truth" would typically be established based on:
- Reference methods: Highly accurate and precise analytical methods for glucose determination (e.g., isotope dilution-mass spectrometry, hexokinase reference method).
- Certified reference materials: Samples with known, validated glucose concentrations.
The document does not explicitly state the specific reference method used to establish the ground truth for the samples tested, but it would involve laboratory-based analytical techniques to determine the true glucose concentrations.
8. The sample size for the training set:
This information is not provided in the document. For an in vitro diagnostic like this, the "training set" concept is typically not directly applicable in the same way it is for machine learning models. Performance is usually established through analytical validation studies (e.g., linearity, precision, interference studies) which involve testing a range of samples and concentrations, but these are not explicitly termed "training sets."
9. How the ground truth for the training set was established:
As mentioned in point 8, the concept of a "training set" with ground truth in the machine learning sense is not directly relevant here. Instead, the performance of such a device is established through validation against recognized analytical standards and reference methods as described in point 7. The document does not detail the specific methods used to establish the "ground truth" for the samples in the performance evaluation studies.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.