(144 days)
The ABX PENTRA 400 is a discrete photometric benchtop chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes. ABX PENTRA Glucose HK CP, Glucose PAP CP reagents with associated calibrators and controls are for quantitative in vitro determination of glucose in serum and plasma using glucose hexokinase and glucose oxidase methods by colorimetry. Glucose measurements are used in diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. The option of an I.S.E. (Ion Selective Electrode) module is intended for the quantitative determination of Sodium, Chloride, and Potassium by potentiometry using ion selective electrode with associated calibrators and controls. Measurement of these elements are used in diagnosis and treatment diseases involving electrolyte imbalance.
The ABX PENTRA 400 is a benchtop clinical chemistry analyzer using two measuring principals absorbance and ion selective electrodes. The instrument may be summarized as follows: Multi-parametric (up to 52 simultaneous tests + 3 ISE tests), Patient per patient, On routine or Stat, 150 to 300 tests / hour (in single or bi-reaction mode) (analytical cycle of 12seconds), random access working on primary tubes or sample cups, ABX PENTRA reagent cassettes are compact and ready-to-use, Automatic readers are used to identify newly loaded reagent cassettes and samples for patient identification. The ABX PENTRA 400 offers both Closed and Open channels for a multitude of applications (clinical chemistry, TDM, plasma protein, hemostasis, optional ISE module).
The provided text describes the ABX PENTRA 400 Clinical Chemistry Analyzer and various associated components. The study focuses on demonstrating substantial equivalence to predicate devices, rather than establishing primary performance criteria for an AI device. Therefore, several of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness, standalone performance, ground truth for training set) are not applicable or cannot be extracted from this type of regulatory submission for a clinical chemistry analyzer.
However, I can provide the acceptance criteria and reported device performance for the analytes tested, as well as some information about the study design that can be inferred.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides performance data for several analytes (Glucose HK CP, Glucose PAP CP, Chloride-E, Potassium-E, Sodium-E). The "acceptance criteria" are implicitly met by the reported performance figures demonstrating substantial equivalence to predicate devices. For a clinical chemistry analyzer, key performance indicators include accuracy, precision (measured as CV Total), linearity/measuring range, and correlation with existing methods.
| Analyte (reagent/electrode) | Performance Metric | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|---|---|
| ABX PENTRA Glucose HK CP | Detection limit | Not explicitly stated, but within acceptable clinical range | 1.98 mg/dl |
| Accuracy and Precision | CV Total within acceptable limits | CV Total |
§ 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.