(30 days)
In vitro test for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid (CSF) on COBAS INTEGRA systems.
Glucose measurements are used in diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and pancreatic islet cell tumors.
The cassette COBAS INTEGRA Glucose HK Gen. 3 contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA SYSTEMS for the quantitative determination of glucose in serum, plasma, urine, and cerebrospinal fluid (CSF). The test principle is an enzymatic reference method with hexokinase.
The provided text is a 510(k) Summary for the COBAS INTEGRA Glucose HK Gen. 3 device, which describes an in vitro diagnostic reagent system for the quantitative determination of glucose. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than fulfilling specific acceptance criteria in the way a new, novel device might. Therefore, the information provided focuses on comparative performance rather than predefined acceptance thresholds.
Based on the provided document, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission seeking substantial equivalence, the "acceptance criteria" are generally that the modified device performs as well as, or better than, the predicate device. The performance characteristics of the COBAS INTEGRA Glucose HK Gen. 3 (modified device) are compared with its predicate device (COBAS INTEGRA Glucose HK Liquid, K972250).
| Feature | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (COBAS INTEGRA Glucose HK Gen. 3) |
|---|---|---|
| Measuring Range | 0-40 mmol/L (0-720 mg/dL) | 0.12-40 mmol/L (0.12-720 mg/dL) |
| Extended Measuring Range | 0-400 mmol/L (0-7200 mg/dL) | 0.12-400 mmol/L (2.16-7200 mg/dL) |
| Precision (Within run CV%) | Serum & Plasma: 1.7% @ 5.3 mmol/L; 0.72% @ 33.2 mmol/L | Serum & Plasma: 0.41% @ 4.48 mmol/L; 0.47% @ 12.48 mmol/L |
| Urine: 1.7% @ 1.7 mmol/L; 1.8% @ 37.1 mmol/L | Urine: 1.35% @ 0.83 mmol/L; 0.64% @ 2.42 mmol/L | |
| CSF: 1.6% @ 1.7 mmol/L; 1.8% @ 3.3 mmol/L | CSF: 1.13% @ 3.20 mmol/L; 1.49% @ 9.31 mmol/L | |
| Precision (Between run/day CV%) | Serum & Plasma: 2.6% @ 5.3 mmol/L; 1.5% @ 33.2 mmol/L | Serum & Plasma: 1.09% @ 4.44 mmol/L; 0.90% @ 12.46 mmol/L |
| Urine: 4.3% @ 1.7 mmol/L; 2.9% @ 37.1 mmol/L | Urine: 0.75% @ 0.84 mmol/L; 0.83% @ 2.43 mmol/L | |
| CSF: 2.3% @ 1.7 mmol/L; 1.9% @ 3.3 mmol/L | (Not explicitly stated for between day in CSF, only within run) | |
| Linearity | 0-40 mmol/L (before dilution) | 0.12-40 mmol/L (before dilution) |
| Lower Detection Limit | Serum & Plasma: 0.033 mmol/L | Serum, Plasma, Urine & CSF: 0.12 mmol/L |
| Urine: 0.22 mmol/L | ||
| CSF: 0.023 mmol/L | ||
| Endogenous Interferences | Hemolysis, Icterus, Lipemia - no significant interferences for predicate | Hemolysis: up to 1200 H Index; Icterus: up to 60 I Index; Lipemia: up to 1900 L Index (quantitative limits provided) |
| Exogenous Interferences | Falsely low results by elevated pyruvates; Gammopathy may cause unreliable results | Tetracyclin can cause falsely low results in urine; Gammopathy may cause unreliable results |
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 primarily describes comparative performance data. Specific sample sizes for "test sets" or the provenance of the data (country of origin, retrospective/prospective) are not explicitly stated. The data presented such as precision data, linearity, and interference studies imply internal validation studies were performed, but details on the samples used (e.g., number of patient samples, type of samples beyond serum/plasma/urine/CSF) are absent in this summary.
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 is an analytical performance study for an in vitro diagnostic device, not an imaging device or a device requiring human interpretation for "ground truth". Therefore, there are no "experts" in the sense of clinical specialists establishing ground truth for the test set. Ground truth for glucose measurements is typically established through a reference method or validated calibrators and controls.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of analytical performance study. Adjudication methods are relevant for human interpretation tasks, such as reading medical images.
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
Not applicable. This is an in vitro diagnostic device measuring glucose, not an AI-assisted diagnostic tool that aids human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is an automated in vitro diagnostic test system. The reported performance characteristics (precision, linearity, lower detection limit, interferences) are inherent to the device and reagent system itself, operating without human intervention for the measurement process once the sample is loaded. Thus, the performance data provided can be considered standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for glucose measurements is established by:
- Reference method: The test principle is an "enzymatic reference method with hexokinase."
- Traceability: It is "Standardized against Isotope Dilution Mass Spectrometry," which is a highly accurate and precise reference method for measuring glucose.
8. The sample size for the training set
This document does not specify a "training set" in the context of machine learning or AI models. It refers to the development and validation of an analytical measurement system. Data used for method development (e.g., reagent formulation optimization) would be part of standard product development but is not explicitly defined as a "training set" in this summary.
9. How the ground truth for the training set was established
Not applicable as there is no mention of a "training set" for an AI/ML algorithm. For the analytical method development, ground truth would be established through highly accurate reference methods and calibrators, similar to how the device's performance is validated.
§ 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.