(231 days)
The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings for quantitative determination of Glucose, Creatinine, and Blood Urea Nitrogen, in heparinized arterial and venous whole blood.
Glucose (Glu) Measurements are used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell tumor.
Creatinine (Creat) Measurements are used in the diagnosis and treatment of certain renal conditions and for monitoring adequacy of dialysis.
Blood Urea Nitrogen (BUN) Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
The Stat Profile Prime Plus Analyzer System is designed to be a low cost, low maintenance analyzer for the hospital laboratory setting. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).
The system architecture and user interface for this proposed device is based on the previously cleared Stat Profile Prime CCS Analyzer System (K131703). The primary predicate for this proposed device is the Stat Profile pHOx Ultra Analyzer System (K110648).
The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed. The reporting of CO-Oximeter parameters (or not reporting them) will also be determined by the selection of the Sensor Cards:
Primary Sensor Card Port:
There are two options for the primary sensor card:
. Primary Sensor Card 1 shall enable and report the following listed analytes:
o PO2, PCO2, pH, Hct, tHb, Na, Cl, K, iCa, iMg, Glu, SO2, O2Hb, COHb, MetHb, HHb
. Primary Sensor Card 2 shall enable and report the following listed analytes:
o PO2, PCO2, pH, Hct, tHb, Na, Cl, K, iCa, iMg, Glu, SO2
Auxiliary Sensor Card Port:
The reporting of Creatinine and BUN parameters (Or not reporting them) shall be determined by the selection of the Auxiliary Sensor Card
Auxiliary Sensor Card 1 enables Creatinine and BUN parameters
. Auxiliary Sensor Card 2 is a "dummy" sensor card, and will not report any parameters.
Similar to the primary predicate device, the Stat Profile Prime Plus Analyzer is a blood gas/cooximetry/electrolyte/chemistry and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control will be used, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly at all times.
The Stat Profile Prime Plus Analyzer accepts samples from syringes, open tubes, and small cups. The minimum sample size for analysis is 135 µL.
Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.
Stat Profile Prime Plus Analyzer System Components:
The Stat Profile Prime Plus Analyzer System is comprised of the following components.
. Stat Profile Prime Plus Analyzer System
Primary Sensor Cartridge
. Auxiliary Sensor Cartridge
Stat Profile Prime Plus Auto-Cartridge Quality Control Pack
. Stat Profile Prime Plus Calibrator Cartridge
Stat Profile Prime Plus External Ampuled Control
IFU/Labeling
The provided text describes the acceptance criteria and study proving the device meets those criteria. The device in question is the Stat Profile Prime Plus Analyzer System, and the studies focus on its performance for measuring Glucose, Creatinine, and Blood Urea Nitrogen (BUN) in whole blood.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria & Reported Device Performance
The document states that the "blood comparison data for Glucose, Creatinine, and BUN, for the Stat Profile Prime Plus analyzers meet the acceptance criteria." While explicit numerical acceptance criteria are not presented in a table form, the performance is described relative to a predicate device (Stat Profile pHOx Ultra Analyzer System) and internal specifications. The linearity and precision studies also explicitly state that the acceptance criteria were met.
For a clearer representation, we can infer the acceptance criteria and performance based on the descriptions:
| Performance Metric | Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Method Comparison | Demonstrated equivalence to the predicate device (Stat Profile pHOx Ultra Analyzer) for Glucose, Creatinine, and BUN measurements in heparinized whole blood. | "The blood comparison data for Glucose, Creatinine, and BUN, for the Stat Profile Prime Plus analyzers meet the acceptance criteria." (Implies equivalence was successfully demonstrated). |
| Precision (Within Run) | Meet specified imprecision limits for within-run performance. | "The precision data for all parameters meet the within run imprecision specifications for the Stat Profile Prime Plus analyzers." |
| Precision (Run to Run) | Meet specified imprecision limits for between-analyzer run-to-run performance. | "The precision data for all parameters meet the between analyzer run to run imprecision specifications for the Stat Profile Prime Plus analyzers." |
| Linearity | Good correlation and linearity to reference analyzers across the claimed measurement range, meeting acceptance criteria. | "The linearity comparison data for all parameters for the Stat Profile Prime Plus analyzers shows good correlation and linearity to the reference analyzers across the claimed measurement range for all parameters and met the acceptance criteria." |
| Specificity/Interference | Identify significant interferents and determine concentrations at which interference occurs, with implied acceptable levels of bias for non-interfering substances. | Specific interfering substances (Hydroxyurea, Oxalate, Thiocyanate) were identified for Glucose and Creatinine at certain concentrations, showing bias. Conversely, "No interference observed" below certain concentrations. (This implies that at clinically relevant concentrations, significant interference is either absent or managed). For example, Hydroxyurea for Glucose: no interference at 0.2 mg/dL, bias of 19.2% at 0.4 mg/dL. |
2. Sample Size Used for the Test Set and Data Provenance
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Sample Size for Test Set:
- Precision/Reproducibility - Within Run: 20 replicates for one run of each of the following: internal controls (Levels 1-5), ampuled controls (Levels 1-5), and two whole blood samples (from syringes).
- Precision/Reproducibility - Run to Run: Triplicate analyses performed on a single whole blood sample in ten separate runs.
- Linearity Testing: Not explicitly stated, but performed using "various medical decision limits" and comparing to reference analyzers.
- Specificity/Interference Testing: Conducted using whole blood collected in lithium heparin vacutainers. Possible interfering substances tested at two analyte concentrations for each. The number of unique samples or overall sample size for this study is not explicitly stated beyond "many substances were screened".
- Method Comparison Studies: Performed to compare the Stat Profile Prime Plus to the Nova Stat Profile pHOx Ultra analyzer in a clinical laboratory setting. The number of samples is not specified.
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Data Provenance: The studies were performed in a "clinical laboratory setting" and involved "whole blood" samples. The document does not specify the country of origin for the data or explicitly state whether it was retrospective or prospective. Given the nature of performance testing for a medical device, it is typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable (N/A) to this device and study type. This device is an in-vitro diagnostic (IVD) analyzer that quantitatively measures analytes (Glucose, Creatinine, BUN). The "ground truth" for its performance studies is established by:
- Reference Methods/Analyzers: For method comparison and linearity studies.
- Known Concentrations: For controls and linearity samples.
- Established Analytical Specifications: For precision and interference studies.
There are no human experts classifying images or clinical conditions, so there is no panel of experts to establish a "ground truth" in the way described for AI/CADe systems.
4. Adjudication Method for the Test Set
This information is N/A. As explained above, the ground truth is based on quantitative measurements against reference methods or known concentrations, not on expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is N/A. This device is an analytical instrument for quantitative measurements, not an AI/CADe system designed to assist human readers (e.g., radiologists) in interpreting medical images. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is N/A. This device is a standalone analyzer. Its "performance" is its standalone capability to accurately and precisely measure analytes. There is no human-in-the-loop component in its direct operation for measurement that would require a separate "human-in-the-loop performance" study. The studies described (method comparison, precision, linearity, interference) directly evaluate the standalone performance of the instrument.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for this device's performance studies is based on:
- Reference Measurement Methods/Instruments: For comparison studies (e.g., comparing the Prime Plus Analyzer's results to those from the predicate device or other established reference analyzers).
- Known and Certified Control Materials: For quality control and precision studies, where the true concentration of analytes in the control samples is known.
- Spiked Samples: For linearity and interference studies, where samples are spiked with known concentrations of analytes or interfering substances.
8. The Sample Size for the Training Set
This information is N/A. This document describes the validation of a hardware-based analytical instrument with established biochemical measurement principles, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The device's measurement algorithms are based on scientific principles (e.g., enzymatic reactions, electrochemistry, Nernst equation) and are not "trained" on data in the way an AI model would be.
9. How the Ground Truth for the Training Set Was Established
This information is N/A for the same reasons as 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.