(285 days)
For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides are used on VITROS Systems to quantitatively measure glucose (GLU) concentration in serum, plasma, urine and cerebrospinal fluid.
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.
The VITROS GLU Slide is a multilayered, analytical element coated on a polyester support. A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. The oxidation of sample glucose is catalyzed by glucose oxidase to form hydrogen peroxide and gluconate. This reaction is followed by an oxidative coupling catalyzed by peroxidase in the presence of dye precursors to produce a dye. The intensity of the dye is measured by reflected light.
The document describes the non-clinical testing and performance of the VITROS Chemistry Products GLU Slides (modified) to demonstrate its substantial equivalence to the legally marketed predicate device, the VITROS Chemistry Products GLU Slides (current).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a table format with specific thresholds. Instead, it presents results from various analytical performance studies, implying that the obtained performance (e.g., correlation coefficients, precision values, LOB/LOD/LOQ) met the internal criteria for demonstrating equivalence to the predicate device. For the purpose of this response, I will list the reported performance values from the "Non-Clinical Testing Analytical Performance" section, as these are the data used to prove the device meets the underlying requirements for equivalence.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Modified VITROS GLU Slides) |
|---|---|---|
| Method Comparison (vs. Predicate) | Strong correlation to predicate (slope near 1, intercept near 0, high R) | |
| Serum (N=113) slope | N/A (implied close to 1) | 1.01 |
| Serum (N=113) y-intercept | N/A (implied close to 0) | -0.80 mg/dL |
| Serum (N=113) Correlation | N/A (implied close to 1) | 1.000 |
| Urine (N=105) slope | N/A (implied close to 1) | 1.03 |
| Urine (N=105) y-intercept | N/A (implied close to 0) | -0.81 mg/dL |
| Urine (N=105) Correlation | N/A (implied close to 1) | 0.999 |
| CSF (N=165) slope | N/A (implied close to 1) | 1.04 |
| CSF (N=165) y-intercept | N/A (implied close to 0) | -2.74 mg/dL |
| CSF (N=165) Correlation | N/A (implied close to 1) | 1.000 |
| Precision (Within Lab CV%) | N/A (implied low CV% for different concentrations) | |
| Serum (29.4 mg/dL) | N/A | 1.3 % |
| Serum (90.3 mg/dL) | N/A | 1.6 % |
| Serum (287.2 mg/dL) | N/A | 1.2 % |
| Serum (571.2 mg/dL) | N/A | 0.9 % |
| Urine (31.6 mg/dL) | N/A | 1.5 % |
| Urine (301.4 mg/dL) | N/A | 1.5 % |
| Urine (574.5 mg/dL) | N/A | 1.0 % |
| CSF (37.2 mg/dL) | N/A | 1.5 % |
| CSF (49.2 mg/dL) | N/A | 1.3 % |
| CSF (88.9 mg/dL) | N/A | 1.2 % |
| CSF (283.0 mg/dL) | N/A | 1.3 % |
| CSF (609.3 mg/dL) | N/A | 0.7 % |
| Limit of Quantitation (LoQ) | 20 mg/dL for all fluid types (specified for a properly operating system) | |
| Serum LoQ | 20 mg/dL | 9 mg/dL |
| Urine LoQ | 20 mg/dL | 18 mg/dL |
| CSF LoQ | 20 mg/dL | 20 mg/dL |
| Linearity | Linear across the measuring range for each fluid type | Linear across the measuring range of each fluid type |
| Matrix Comparison (Plasma vs. Serum) | Serum, EDTA, sodium and lithium heparin, and sodium fluoride/potassium oxalate plasma deemed suitable. | Suitable for use |
| Interfering Substances | Substances exhibiting bias less than stated acceptance criteria are cited as non-interfering. | Various substances identified with or without interference. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Sizes for Test Set (Method Comparison):
- Serum: 113 observations
- Urine: 105 observations
- CSF: 165 observations
- Sample Sizes for Test Set (Precision):
- Minimum of 80 observations (2 replicates per run, 2 runs per day over 20 days) for serum, urine, and CSF specimens. The tables show 88 observations over 22 days for each pool/control.
- Sample Sizes for Test Set (LoB/LoD/LoQ) and Linearity: Not explicitly stated as distinct sample sizes, but implied to be sufficient for CLSI protocols. For linearity, 14 concentration levels with six replicate determinations for each body fluid type.
- Data Provenance: The document does not specify the country of origin of the data. It indicates these were human samples for method comparison ("human serum, urine and CSF samples") and various pools/controls for precision testing. It implies these were collected prospectively for the purpose of the study to compare the modified device against the current predicate by following CLSI protocols.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not applicable to this document. The device is an in vitro diagnostic (IVD) chemistry product that quantitatively measures glucose concentration. The "ground truth" for its performance studies is established by quantitative comparisons to a predicate device (e.g., method comparison), statistical analysis of precision, and adherence to established analytical performance guidelines (CLSI protocols), not by expert consensus or interpretation of images.
4. Adjudication Method for the Test Set
This is not applicable for this type of IVD device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., radiology studies) where disagreement among reviewers needs resolution to establish a consensus ground truth. This document describes analytical performance studies of a quantitative measurement 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 is not applicable. This document describes an IVD device for quantitative glucose measurement, not an AI-assisted diagnostic tool that involves human readers or interpretation of cases.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
This is not applicable in the context of "algorithm only." The device itself is an automated chemical analyzer component (slides) for measuring glucose. The performance studies describe the standalone analytical performance of the device (modified VITROS GLU Slides) when used on VITROS Systems, primarily compared to the predicate device and assessed for its inherent analytical characteristics (precision, linearity, limits). There is no "human-in-the-loop" component in the direct measurement process itself beyond loading samples and running the system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in these studies is primarily established by:
- Comparison to a Legally Marketed Predicate Device: For method comparison, the results generated by the predicate VITROS Chemistry Products GLU Slides (current) are used as the reference "truth" to assess the modified device's equivalence.
- CLSI Protocol Standards: For precision, linearity, and detection limits, the "ground truth" is defined by adherence to CLSI (Clinical and Laboratory Standards Institute) protocols and the statistical methodologies they outline for establishing these performance characteristics. This involves statistical calculations and comparisons to pre-defined statistical acceptance criteria (even if not explicitly listed in the table, they are inherent in CLSI guidelines).
8. The Sample Size for the Training Set
This is not applicable. The document describes the analytical performance studies of a modified IVD assay. There is no mention of machine learning or AI components that would require a "training set" in the conventional sense. The "training" of the device is through its manufacturing and calibration, not through a data-driven model.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" in the context of this device's development as described.
§ 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.