(50 days)
The Sigma Diagnostics INFINITY™ Glucose Reagent is intended for the in vitro quantitative, diagnostic determination of glucose in human serum or urine on both automated and manual systems.
The Sigma Diagnostics INFINITY™ Glucose Reagent is a device intended to measure glucose quantitatively in serum or urine. Measurements obtained by the device 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 Sigma Diagnostics INFINITY™ Glucose Reagent is based on the hexokinase/glucose-6-phosphate dehydrogenase method. The series of reactions involved in the assay system is as follows:
- Hexokinase (HK) catalyses the phosphorylation of glucose by adenosine-5'-triphosphate (ATP) producing adenosine-5'-diphosphate (ADP) and glucose-6-phosphate (G-6-P).
Glucose + ATP ________________________________________________________________________________________________________________________________________________________________ - G-6-P is oxidized to 6-phosphogluconate (6-PG) with the reduction of nicotinamide adenine dinucleotide (NAD*) to reduced NAD (NADH) by glucose-6-phosphate dehydrogenase (G-6-PDH). The amount of NADH formed is proportional to the concentration of glucose in the sample and can be measured by the increase in absorbance at 340 nm.
G-6-P + NAD*
The provided text is a 510(k) summary for the INFINITY™ Glucose Reagent. It describes the intended use and the method of glucose determination, and states that it is substantially equivalent to a previously cleared device. However, this document does not contain the specific acceptance criteria for performance, nor does it detail a study proving the device meets said criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (TRACE Scientific Glucose Reagents cleared as K980026) rather than presenting a detailed performance study with acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated from the document:
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A table of acceptance criteria and the reported device performance:
- Cannot be provided as this information is not in the document. The document states that the device is "substantially equivalent to" the predicate device, implying its performance is comparable, but does not list specific criteria or performance metrics.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided as no specific performance studies are detailed in this 510(k) summary.
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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):
- Cannot be provided as no specific performance studies are detailed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided as no specific performance studies are detailed.
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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 reagent, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an algorithm. This is a chemical reagent for quantitative measurement of glucose. The "standalone performance" would relate to its analytical performance (accuracy, precision, linearity, etc.), which is implied to be equivalent to the predicate but not explicitly detailed or quantified with acceptance criteria in this document.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For a glucose reagent, the "ground truth" would typically be established by a reference method. The document states: "The hexokinase/glucose-6-phosphate dehydrogenase method developed by the American Association of Clinical Chemistry and Centers for Disease Control has been accepted as the reference method for glucose determination." It also states, "The Sigma Diagnostics INFINITY Glucose Reagent is based on the reference method." Therefore, the ground truth for validation would likely be measurements obtained using the hexokinase/glucose-6-phosphate dehydrogenase reference method.
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The sample size for the training set:
- Not applicable. This device is a chemical reagent, not a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable. (See point 8).
Summary of available information:
The 510(k) summary for the INFINITY™ Glucose Reagent does not include detailed acceptance criteria or the specifics of a study proving the device meets such criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device (TRACE Scientific Glucose Reagents cleared as K980026). The "ground truth" for glucose determination is based on the established hexokinase/glucose-6-phosphate dehydrogenase reference method.
To obtain the detailed performance data, acceptance criteria, and study methods, one would typically need to review the full 510(k) submission or the predicate device's documentation if the substantial equivalence argument relies on prior clearance. This summary document is a high-level overview.
§ 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.