(226 days)
Diatron Glucose Hexokinase Method is for the in vitro quantitative determination of Glucose in serum for use with Diatron Pictus 700 Chemistry Analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes.
Diatron ISE is for the in vitro quantitative determination of Sodium (Na+), Potassium (K+), and Chloride (Cl-) concentrations in serum on the Diatron Pictus 700 Chemistry Analyzer. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements are used in monitoring electrolyte balance and in the diagnosis and treatment of diseases/conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.
The Diatron Pictus 700 Clinical Chemistry Analyzer is a wet-chemistry analyzer for the direct determination of sodium, potassium, chloride and glucose concentrations in serum, and to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. It is for in vitro diagnostic use.
The Pictus 700 Clinical Chemistry Analyzer is an automatic, floor-standing, wet chemistry system, designed for the qualitative and quantitative analyses of various diagnostic test systems. This premarket notification is for the direct quantitative measurements of Na (sodium), K (potassium), CI (chloride) and glucose in serum samples. Additionally, other types of chemistry assays may be performed on the analyzer, provided that suitable colorgenerating reactions or reactions with variation of color are used. The system is intended for use in clinical laboratories.
The instrument consists of an analyzer unit and an operations computer with a screen that allows the user to input commands for system operation and data display. The analyzer unit includes two temperature-controlled incubation rotors and a multi-wavelength photometer, a cooled carousel for loading barcoded sample tubes or micro cups and reagent cartridges, and two probes that deliver reagents and samples to the incubation rotors and the ISE measurement flow cell. The analyzer unit also houses containers for wash solution and waste. An ISE module, installed on the analyzer unit, is used to measure sodium, potassium and chloride ionic activity in serum.
The provided text describes the acceptance criteria and the study performance for the Diatron ISE, Diatron Glucose Hexokinase Method, and Diatron Pictus 700 Clinical Chemistry Analyzer. This is a submission for a 510(k) premarket notification for an in vitro diagnostic device, specifically a clinical chemistry analyzer and associated assay methods. The studies presented are nonclinical performance studies to demonstrate substantial equivalence to a predicate device, not clinical effectiveness studies involving human subjects in an MRMC setting.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the claim of substantial equivalence to the predicate device and the successful demonstration of various analytical performance characteristics. The document explicitly states acceptance criteria for linearity.
| Study/Parameter | Analyte(s) | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Functional Sensitivity/LoD/LoQ | Sodium | Highest dilution concentration (lowest concentration) with 24 hrs exposed to red cells in the sample draw." |
- Linearity: Eleven levels of each analyte were tested, in duplicate.
- Precision: Control samples (low, middle, and high levels) were tested in duplicate, twice a day, for 20 days, for a total of 80 results per level.
- Interferences: A two-level control set (low and high analyte levels) was spiked to seven or eight levels of interferent. Spiked samples plus neat samples were tested in duplicates.
- Method Comparison:
- Sodium: N=69 clinical specimens
- Potassium: N=69 clinical specimens (listed under Sodium, but context implies N=69 for K as well given the table structure)
- Chloride: N=69 clinical specimens
- Glucose: N=136 clinical specimens
- Data Provenance: Clinical specimens were "previously-collected serum samples that had been stored frozen and then thawed prior to analysis." The country of origin is not specified but typically for a US FDA submission, these would be collected in the US or under similar regulatory standards. The data is retrospective in that it uses "previously-collected" and "stored frozen" samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is an analytical performance study for an in vitro diagnostic device, not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for the test samples in this context relates to their known concentrations as determined by a reference method or the predicate device.
4. Adjudication Method for the Test Set
Not applicable. This is an analytical performance study for an in vitro diagnostic device, where quantitative results are compared to reference methods/predicate, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size on Human Readers
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically done for AI-driven diagnostic imaging devices where human readers' performance (with or without AI assistance) is evaluated. This submission is for an automated clinical chemistry analyzer.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are essentially "standalone" performance evaluations of the Diatron Pictus 700 Clinical Chemistry Analyzer and its associated methods (Diatron Glucose Hexokinase Method and Diatron ISE). The performance measured is that of the automated instrument itself, without direct human intervention in the analytical process being tested for. The output is a quantitative measurement of analytes.
7. The Type of Ground Truth Used
The ground truth for the analytical studies are based on:
- Reference methods/assigned values: For linearity, samples were assigned their reference values arithmetically from labeled values. For method comparison, the predicate system served as the comparative method against which the new device's performance was evaluated.
- Known concentrations: For precision, control samples with known low, medium, and high concentrations were used.
- Spiked samples: For interference studies, samples were spiked with known concentrations of interferents to assess their impact.
8. The Sample Size for the Training Set
Not applicable. This is not a study involving machine learning with distinct training and test sets in the typical sense of AI algorithm development. This is a traditional analytical validation for an in vitro diagnostic device.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reason stated in point 8.
§ 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.