(58 days)
The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of Sodium (Na+), Ionized Calcium (Ca++) and Chloride (C1-) from arterial and venous heparinized whole blood. These parameters. along with derived parameters, aid in the diagnosis of a patient's electrolyte balance.
Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:
- · Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
- · Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
- Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
- · Chloride (Cl-) measurements are used in the diagnosis and metabolic and metabolic disorders, such as, cystic fibrosis and diabetic acidosis.
The GEM Premier ChemSTAT is a portable system that analyzes arterial and venous lithium heparinized whole blood at the point of health care delivery in a clinical setting and in a central laboratory for Na*, K*, Ca** and Cl . All tests are included in a single self-contained, disposable GEM Premier ChemSTAT PAK (cartridge).
Key Components:
Analyzer: The GEM Premier ChemSTAT analyzer has the internal logic and processing power necessary to perform analysis. It employs a unique touch-sensitive color screen and a simple set of menus and buttons for user interaction. The analyzer guides operators through the sampling process with simple, clear messages and prompts.
PAK (Cartridge): The disposable, multi-use GEM Premier ChemSTAT PAK is a completely closed cartridge that houses all components necessary to operate the instrument once the GEM PAK is validated. These components include the sensors, Process Control (PC) Solutions, sampler, and waste bag. The values of all PC Solutions are read from the GEM PAK Electronically Erasable Programmable Read Only Memory (EEPROM) chip. The components and processes used to manufacture the PC Solutions in the GEM PAK are traceable to National Institute of Standards and Technology (NIST) standards, Clinical & Laboratory Standards Institute (CLSI) procedures or other internal standards, where available and appropriate. The GEM Premier ChemSTAT PAK has flexible menus to assist facilities in maximizing efficiency. As part of this program, GEM ChemSTAT CVP (Calibration Valuation Products) are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up.
Intelligent Quality Management (iQM): Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier ChemSTAT system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process before and after sample measurement with real-time, automatic error detection, automatic correction and automatic documentation of all corrective actions. iQM performs 4 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, and reagents throughout the cartridge use-life. These checks include System, Sensor, Pattern Recognition (PR) and Stability Checks.
The provided FDA 510(k) summary for the GEM Premier ChemSTAT describes the device's analytical performance, which is a type of acceptance criteria study. This document is not for an AI/ML device, but rather for an in-vitro diagnostic device that measures specific analytes. Therefore, many of the requested elements pertaining to AI/MRMC studies, expert ground truth, and training sets are not applicable or not provided in this type of submission. However, I can extract information related to the device's analytical performance and the studies conducted to demonstrate its performance against predefined criteria.
Here's a breakdown of the acceptance criteria and performance study details, focusing on what is available in the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the analytical performance specifications and the comparison to the predicate device. The performance studies aim to demonstrate that the device meets these standards.
Table 1: Acceptance Criteria (Implicit from Study Outcomes) and Reported Device Performance for GEM Premier ChemSTAT
| Performance Metric | Analyte | Acceptance Criteria (Stated Goal / Implied Target) | Reported Device Performance |
|---|---|---|---|
| Precision (Internal) | Na+ | All results within specification (implied acceptable SD/CV based on clinical utility and state of the art) | Ranges from 0.4% to 0.6% Total %CV (Na+); 0.2% to 2.3% Total %CV (K+); 0.8% to 2.8% Total %CV (Ca++); 0.9% to 1.5% Total %CV (Cl-) |
| K+ | See above | ||
| Ca++ | See above | ||
| Cl- | See above | ||
| Reproducibility (Aqueous Controls - POC) | Na+ | All results at all sites within specification (implied acceptable Reproducibility SD/CV) | Reproducibility %CV ranges from 0.5% to 0.8% (Na+); 0.0% to 1.2% (K+); 0.7% to 1.7% (Ca++); 0.8% to 3.3% (Cl-) |
| K+ | See above | ||
| Ca++ | See above | ||
| Cl- | See above | ||
| External Precision (Whole Blood - POC) | Na+ | All results at all sites within specification; Measured data partitioned into Fixed Acceptance Range (Constant SD) or Variable Acceptance Range (Constant %CV). | Pooled "Within Sample SD of %CV" of 1.1% (Na+); 0.08% (K+); 0.006 (Ca++); 0.6% (Cl-) |
| K+ | See above | ||
| Ca++ | See above | ||
| Cl- | See above | ||
| LoB, LoD, LoQ | All Analytes | Established values for each analyte | Na+: LoB 69, LoD 70, LoQ 88; K+: LoB 0.0, LoD 0.1, LoQ 0.3; Ca++: LoB 0.00, LoD 0.01, LoQ 0.05; Cl-: LoB 4, LoD 4, LoQ 36 |
| Linearity | All Analytes | R2 close to 1.0, slope close to 1.0, intercept close to 0; Claimed reportable range supported. | Na+: Slope 1.023, Intercept -1.189, R2 0.9997; K+: Slope 0.995, Intercept 0.057, R2 0.9998; Ca++: Slope 0.986, Intercept 0.019, R2 0.9984; Cl-: Slope 1.011, Intercept -1.909, R2 0.9998. Claimed ranges are 100-180 mmol/L (Na+), 0.3-19.0 mmol/L (K+), 0.10-4.25 mmol/L (Ca++), 40-158 mmol/L (Cl-). |
| Analytical Specificity (Interference) | All Analytes | No significant interference with listed substances at specific concentrations (implied bias |
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.