(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 Glucose (Glu), Lactate (Lac), Hematocrit (Hct), pH and partial pressure of carbon dioxide (pCO2) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status and metabolite balance.
- · Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
- · Lactate (Lac) measurement is used to evaluate the acid-base status of patients suspected of having lacidosis, to monitor tissue hypoxia and strenuous physical exertion, and in the diagnosis of hyperlactatemia.
- Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of ed cells).
- · DH and pCO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.
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 Glu, Lac, Hct, pH, and pCO2. 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 text describes a 510(k) premarket notification for the GEM Premier ChemSTAT device, a portable system for analyzing whole blood samples. The document focuses on demonstrating substantial equivalence to a predicate device (GEM Premier 4000) through various performance studies.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct numerical targets in a single table, but rather implied through the successful completion of various performance studies and the conclusion that "All results were within specification." The reported device performance is presented in several tables detailing precision, linearity, and method comparison.
Here's a compilation of the reported device performance, which implies the acceptance criteria were met if these results were deemed "within specification":
Table of Reported Device Performance (Implied Acceptance Criteria)
| Analyte | Test Type | Performance Metric | Reported Value (Range) | Implied Acceptance Criteria (e.g., "within specification" or "meets acceptable performance") |
|---|---|---|---|---|
| Glucose | Internal Precision (Whole Blood) | Total %CV | 0.5% - 2.3% | Meets acceptable precision |
| (mg/dL) | Reproducibility (Aqueous Controls, POC) | Reproducibility %CV | 0.2% - 10.5% (across various control levels) | Meets acceptable reproducibility |
| External Precision (Whole Blood, POC) | Within Sample SD or %CV | SD: 0.6 - 1.7; %CV: 0.8% - 1.0% | Meets acceptable precision in external settings | |
| Linearity | Slope | 1.023 | Slope close to 1 | |
| Intercept | -0.502 | Small intercept | ||
| R² | 1.0000 | High linearity | ||
| Clinical Testing (Method Comparison) | Slope | 1.019 | Slope close to 1 | |
| Intercept | -0.558 | Small intercept | ||
| R | 0.999 | High correlation with predicate | ||
| LoB, LoD, LoQ | LoB / LoD / LoQ | 0 / 1 / 1 | Within expected low detection/quantification limits | |
| Lactate | Internal Precision (Whole Blood) | Total %CV | 1.6% - 8.9% | Meets acceptable precision |
| (mmol/L) | Reproducibility (Aqueous Controls, POC) | Reproducibility %CV | 0.8% - 8.6% (across various control levels) | Meets acceptable reproducibility |
| External Precision (Whole Blood, POC) | Within Sample SD or %CV | SD: 0.07 - 0.08; %CV: 1.7% - 2.5% | Meets acceptable precision in external settings | |
| Linearity | Slope | 1.004 | Slope close to 1 | |
| Intercept | 0.000 | Small intercept | ||
| R² | 0.9998 | High linearity | ||
| Clinical Testing (Method Comparison) | Slope | 1.000 | Slope close to 1 | |
| Intercept | -0.100 | Small intercept | ||
| R | 0.997 | High correlation with predicate | ||
| LoB, LoD, LoQ | LoB / LoD / LoQ | 0.0 / 0.0 / 0.1 | Within expected low detection/quantification limits | |
| Hematocrit | Internal Precision (Whole Blood) | Total %CV | 0.5% - 1.6% | Meets acceptable precision |
| (%) | Reproducibility (Aqueous Controls, POC) | Reproducibility %CV | 0.0% - 0.2% (across various control levels) | Meets acceptable reproducibility |
| External Precision (Whole Blood, POC) | Within Sample SD | 0.4 - 0.6 | Meets acceptable precision in external settings | |
| Linearity | Slope | 0.984 | Slope close to 1 | |
| Intercept | 1.909 | Small intercept | ||
| R² | 0.9975 | High linearity | ||
| Clinical Testing (Method Comparison) | Slope | 1.032 | Slope close to 1 | |
| Intercept | -0.626 | Small intercept | ||
| R | 0.997 | High correlation with predicate | ||
| LoB, LoD, LoQ | LoB / LoD / LoQ | 2 / 3 / 10 | Within expected low detection/quantification limits | |
| pH | Internal Precision (Whole Blood) | Total %CV | 0.1% - 0.2% | Meets acceptable precision |
| Reproducibility (Aqueous Controls, POC) | Reproducibility SD | 0.003 - 0.008 | Meets acceptable reproducibility | |
| External Precision (Whole Blood, POC) | Within Sample SD | 0.007 - 0.009 | Meets acceptable precision in external settings | |
| Linearity | Slope | 1.006 | Slope close to 1 | |
| Intercept | -0.042 | Small intercept | ||
| R² | 0.9996 | High linearity | ||
| Clinical Testing (Method Comparison) | Slope | 1.006 | Slope close to 1 | |
| Intercept | -0.038 | Small intercept | ||
| R | 0.995 | High correlation with predicate | ||
| LoB, LoD, LoQ | LoB / LoD / LoQ | 8.69 / 8.62 / 8.06 | Within expected low detection/quantification limits (Note: pH limits appear inverted here compared to typical reportable ranges, indicating potential for very high or very low pH detection) | |
| pCO2 | Internal Precision (Whole Blood) | Total %CV | 1.2% - 4.8% | Meets acceptable precision |
| (mmHg) | Reproducibility (Aqueous Controls, POC) | Reproducibility SD or %CV | SD: 0.4 - 2.5; %CV: 2.1% - 2.8% (for CVP/PVP levels) | Meets acceptable reproducibility |
| External Precision (Whole Blood, POC) | Within Sample SD or %CV | SD: 0.7 - 1.2; %CV: 1.4% - 1.6% | Meets acceptable precision in external settings | |
| Linearity | Slope | 1.030 | Slope close to 1 | |
| Intercept | -0.843 | Small intercept | ||
| R² | 0.9994 | High linearity | ||
| Clinical Testing (Method Comparison) | Slope | 1.000 | Slope close to 1 | |
| Intercept | 0.000 | Small intercept | ||
| R | 0.996 | High correlation with predicate | ||
| LoB, LoD, LoQ | LoB / LoD / LoQ | 1 / 3 / 3 | Within expected low detection/quantification limits |
Study Details:
-
Sample Size Used for the Test Set and Data Provenance:
- Internal Precision Study – Whole Blood: 5 concentrations of whole blood per analyte, run on 3 analyzers for 5 days, 8 replicates per run per level (N=120 per level/analyte).
- Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting: 7 levels (Glucose, Lactate) or 6 levels (Hct, pH, pCO2) of quality control material, run in triplicate, twice a day for 5 days (30 replicates per level). Pooled N=90 across 3 sites for each control level for each analyte.
- External Precision – Whole Blood: Various N values per analyte and POC site, ranging from 3 to 198 (pooled). The text states "Less than 10% of samples included in the study were contrived." This indicates the majority are real patient samples.
- LoB, LoD, and LoQ: Not specified how many physical samples, but performed using three (3) lots of GEM Premier ChemSTAT PAKs (cartridges).
- Linearity: Minimum of 9 levels per analyte (whole blood spiked or diluted). Each blood level analyzed in triplicate on six (6) GEM Premier ChemSTAT test analyzers (except pH and pCO2, which were tested on 3 analyzers). N per level: 18 for Glucose, Lactate, Hematocrit; 9 for pH, pCO2.
- Analytical Specificity: Not explicitly stated N, but various test substances were screened at specified concentrations.
- Clinical Testing (Method Comparison):
- Glucose: N=432
- Lactate: N=432
- Hematocrit: N=431
- pH: N=552
- pCO2: N=559
- Provenance: Lithium heparinized whole blood patient samples from the intended use population. Samples from three (3) external point-of-care (POC) sites and an internal Customer Simulation Laboratory (CSL). Less than 10% of samples were contrived. This implies the data is a mix of prospective (patient samples from POC sites) and potentially some retrospective (if sourced from a biobank, though "patient samples" often implies prospective collection for the study) and/or controlled spiked samples. The specific country of origin is not stated but "external point-of-care (POC) sites" and "internal Customer Simulation Laboratory (CSL) at IL" (Instrumentation Laboratory Co., Bedford, MA) suggest US-based data.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This document describes in vitro diagnostic (IVD) device performance against established analytical methods and a predicate device, not an AI/ML device relying on human expert interpretation of images. Therefore, the concept of "experts establishing ground truth" in the sense of radiologists or pathologists for an AI model's output does not directly apply here.
- The "ground truth" for the test set values (sample concentrations) for analytes like Glucose, Lactate, Hct, pH, and pCO2 would typically be established by a reference method or the established predicate device (GEM Premier 4000) itself, which is considered the "truth" for comparison in the method comparison study. The laboratory professionals operating these devices and following standard protocols implicitly ensure the accuracy of these reference values.
- For the reproducibility study, "nine (9) different operators" were involved at "three (3) external clinical point-of-care (POC) sites". These would be healthcare professionals (e.g., nurses, lab technicians) trained to use the device. Their qualifications are not specified beyond being "health care professionals."
-
Adjudication Method for the Test Set:
- Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective human interpretation of data, often for diagnostic image analysis where disagreement among readers needs resolution.
- For an IVD device measuring quantitative analytes, the "ground truth" is typically the result from a reference standard instrument or method. Discrepancies are usually investigated through analytical means (re-testing, troubleshooting) rather than human adjudication of interpretive differences. The document does not mention any such adjudication process.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size:
- No, an MRMC study was not done. MRMC studies are specifically designed for evaluating diagnostic tools where human readers interpret cases, often with and without AI assistance (e.g., radiology AI).
- This submission is for an IVD device for quantitative measurements of analytes, not an AI/ML-driven diagnostic imaging device. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.
-
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- This device is an IVD instrument, not an algorithm/software in the typical AI sense. Its performance (accuracy, precision, linearity) is inherently "standalone" in how it processes a blood sample to produce a result, without needing human "in-the-loop" interpretation of the measurement itself.
- Clinical testing (method comparison) directly assesses the device's standalone performance against a predicate device.
-
The Type of Ground Truth Used:
- The ground truth for the analytical studies (precision, linearity, LoB/D/Q, specificity) is based on analytical standards, control materials with known concentrations, and comparison to a legally marketed predicate device (GEM Premier 4000).
- For the clinical testing/method comparison, the predicate device (GEM Premier 4000) provides the comparative "ground truth" for patient samples, ensuring the new device yields comparable results within acceptable ranges. This is a common approach for IVD substantial equivalence.
-
The Sample Size for the Training Set:
- This document describes a conventional IVD device, not an AI/ML device that requires a "training set" in the machine learning sense. The device is based on established electrochemical and conductivity principles (Amperometry, Potentiometry, Conductivity), not on learning from a large dataset.
- Therefore, there is no explicit "training set" size or process described. The "training" of such a device involves its initial design, calibration protocols, and quality control procedures during manufacturing, which are validated through the performance studies presented.
-
How the Ground Truth for the Training Set Was Established:
- As there is no "training set" in the AI/ML context, this question is not applicable to the GEM Premier ChemSTAT device as described. The "ground truth" for calibrating and setting up an IVD device's internal algorithms (e.g., sensor response curves, temperature compensation) would be established using traceable reference materials and industry-standard analytical methods during the device's development and manufacturing.
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February 16, 2019
Instrumentation Laboratory Co. Gabriella Erdosv Regulatory Affairs Manager 180 Hartwell Road Bedford, MA 01730
Re: K183546
Trade/Device Name: GEM Premier ChemSTAT Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, KHP, GKF, CHL Dated: December 19, 2018 Received: December 20, 2018
Dear Gabriella Erdosy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183546
Device Name GEM Premier ChemSTAT
Indications for Use (Describe)
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 Glucose (Glu), Lactate (Lac), Hematocrit (Hct), pH and partial pressure of carbon dioxide (pCO2) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status and metabolite balance.
- · Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
- · Lactate (Lac) measurement is used to evaluate the acid-base status of patients suspected of having lacidosis, to monitor tissue hypoxia and strenuous physical exertion, and in the diagnosis of hyperlactatemia.
- Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of ed cells).
- · DH and pCO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K183546: GEM Premier ChemSTAT
510(k) Summary
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
| Submitter's Information | Instrumentation Laboratory (IL) Co.180 Hartwell RoadBedford, MA 01730, USA |
|---|---|
| ------------------------- | ------------------------------------------------------------------------------------ |
| Contact Person | Gabriella Erdosy |
|---|---|
| Phone: 781-861-4571 | |
| Fax: 781-861-4207 | |
| Email: gerdosy@ilww.com |
| Preparation Date | February 11, 2019 |
|---|---|
| ------------------ | ------------------- |
| Device Trade Name | GEM Premier ChemSTAT |
|---|---|
| ------------------- | ---------------------- |
| Predicate Device | GEM Premier 4000 | K133407 |
|---|---|---|
| ------------------ | ------------------ | --------- |
| Regulatory Information | |||||
|---|---|---|---|---|---|
| Analyte | RegulationSection | Regulatory Description | Classification | ProductCode | Panel |
| Glucose | 862.1345 | Glucose test system | Class II | CGA | Chemistry(75) |
| Lactate | 862.1450 | Lactic acid test system | Class I | KHP | Chemistry(75) |
| Hematocrit | 864.5600 | Automated hematocritinstrument | Class II | GKF | Hematology(81) |
| pH and pCO2 | 862.1120 | Blood Gases (pCO2) andBlood pH system | Class II | CHL | Chemistry(75) |
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Device Description
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 Glu, Lac, Hct, pH, and pCO2. All tests are included in a single self-contained, disposable GEM Premier ChemSTAT PAK (cartridge).
| Key Components | Description |
|---|---|
| Analyzer | The GEM Premier ChemSTAT analyzer has the internal logic andprocessing power necessary to perform analysis. It employs aunique touch-sensitive color screen and a simple set of menus andbuttons for user interaction. The analyzer guides operators throughthe sampling process with simple, clear messages and prompts. |
| PAK (Cartridge) | The disposable, multi-use GEM Premier ChemSTAT PAK is acompletely closed cartridge that houses all components necessaryto operate the instrument once the GEM PAK is validated. Thesecomponents include the sensors, Process Control (PC) Solutions,sampler, and waste bag.The values of all PC Solutions are read from the GEM PAKElectronically Erasable Programmable Read Only Memory(EEPROM) chip. The components and processes used tomanufacture the PC Solutions in the GEM PAK are traceable toNational Institute of Standards and Technology (NIST) standards,Clinical & Laboratory Standards Institute (CLSI) procedures or otherinternal standards, where available and appropriate.The GEM Premier ChemSTAT PAK has flexible menus to assistfacilities in maximizing efficiency.As part of this program, GEM ChemSTAT CVP (Calibration ValuationProducts) are external solutions intended to complete thecalibration process and final accuracy assessment of the iQMcartridge calibration following warm-up. |
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| Device Description (Cont.) | |
|---|---|
| Intelligent Quality Management(iQM) | Intelligent Quality Management (iQM) is used as the qualitycontrol and assessment system for the GEM Premier ChemSTATsystem. iQM is an active quality process control program designedto provide continuous monitoring of the analytical process beforeand after sample measurement with real-time, automatic errordetection, automatic correction and automatic documentation ofall corrective actions.iQM performs 4 types of continuous, quality checks to monitorthe performance of the GEM PAK, sensors, and reagentsthroughout the cartridge use-life. These checks include System,Sensor, Pattern Recognition (PR) and Stability Checks. |
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Indications for Use / Intended Use
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 Glucose (Glu), Lactate (Lac), Hematocrit (Hct), pH, and partial pressure of carbon dioxide (pCQ₂) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status and metabolite balance.
- . Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
- Lactate (Lac) measurement is used to evaluate the acid-base status of patients suspected of ● having lactic acidosis, to monitor tissue hypoxia and strenuous physical exertion, and in the diagnosis of hyperlactatemia.
- Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
- pH and pCO2 measurements in whole blood are used in the diagnosis and treatment of life-● threatening acid-base disturbances.
Special Conditions for Use Statement
- . For prescription use only.
- For clinical laboratory and point-of-care use
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| Substantial Equivalency | |||
|---|---|---|---|
| Item | Candidate Device:GEM Premier ChemSTAT | Predicate Device:GEM Premier 4000 | |
| 510(k) No. | K183546 | K133407 | |
| Manufacturer | Instrumentation Laboratory Co. | Same | |
| Intended Use | 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 Glucose (Glu), Lactate (Lac), Hematocrit (Hct), pH and partial pressure of carbon dioxide (pCO2) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status and metabolite balance. | Same | |
| Intended User | Central Laboratory and Point-of-Care | Same | |
| Measurement Principle | GluLacHctpHpCO2 | AmperometryAmperometryConductivityPotentiometryPotentiometry | SameSameSameSameSame |
| Sample Volume | 150 μL | 65 to 150 μL(dependent on sample mode) | |
| Sample Type | Lithium heparinized whole blood(arterial and venous) | Same(arterial, venous and capillary) | |
| Substantial Equivalency (Cont.) | |||
| Item | Candidate Device:GEM Premier ChemSTAT | Predicate Device:GEM Premier 4000 | |
| Reportable Range | Glu | 4 to 685 mg/dL | Same |
| Lac | 0.3 to 17.0 mmol/L | Same | |
| Hct | 15 to 72% | Same | |
| pH | 7.00 to 8.00 | Same | |
| pCO2 | 6 to 125 mmHg | Same | |
| PAK Storage Temperature | 15-25°C | Same | |
| Calibration | 2-point calibration | Same |
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Performance Summary
Internal Precision Study – Whole Blood
In accordance with CLSI EP05-A3, an internal precision study was performed using five (5) different concentrations of whole blood per analyte, each run on three (3) GEM Premier ChemSTAT analyzers for five (5) days, with one (1) run per day and eight (8) replicates measured per run per level (N=120).
All results were within specification.
| Analyte | WholeBloodLevel | N | Mean | Within RunSD | Within Run%CV | TotalSD | Total%CV |
|---|---|---|---|---|---|---|---|
| Glucose(mg/dL) | Level 1 | 120 | 24 | 0.5 | 2.3% | 0.5 | 2.3% |
| Level 2 | 120 | 48 | 0.9 | 1.9% | 0.9 | 1.9% | |
| Level 3 | 120 | 122 | 1.3 | 1.1% | 1.7 | 1.4% | |
| Level 4 | 120 | 356 | 2.7 | 0.8% | 3.2 | 0.9% | |
| Level 5 | 120 | 620 | 3.2 | 0.5% | 5.4 | 0.9% | |
| Lactate(mmol/L) | Level 1 | 120 | 0.7 | 0.06 | 8.9% | 0.06 | 8.9% |
| Level 2 | 120 | 2.0 | 0.06 | 2.8% | 0.07 | 3.3% | |
| Level 3 | 120 | 4.9 | 0.05 | 1.1% | 0.11 | 2.3% | |
| Level 4 | 120 | 7.8 | 0.13 | 1.7% | 0.18 | 2.3% | |
| Level 5 | 120 | 14.2 | 0.23 | 1.6% | 0.34 | 2.4% | |
| Hct(%) | Level 1 | 120 | 18 | 0.3 | 1.6% | 0.3 | 1.6% |
| Level 2 | 120 | 33 | 0.3 | 0.9% | 0.4 | 1.1% | |
| Level 3 | 120 | 44 | 0.3 | 0.7% | 0.4 | 0.9% | |
| Level 4 | 120 | 57 | 0.3 | 0.5% | 0.4 | 0.7% | |
| Level 5 | 120 | 65 | 0.4 | 0.7% | 0.5 | 0.8% |
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| Analyte | WholeBloodLevel | N | Mean | Within RunSD | Within Run%CV | TotalSD | Total%CV |
|---|---|---|---|---|---|---|---|
| pH | Level 1 | 120 | 7.07 | 0.008 | 0.1% | 0.008 | 0.1% |
| Level 2 | 120 | 7.25 | 0.007 | 0.1% | 0.007 | 0.1% | |
| Level 3 | 120 | 7.34 | 0.008 | 0.1% | 0.008 | 0.1% | |
| Level 4 | 120 | 7.49 | 0.009 | 0.1% | 0.010 | 0.1% | |
| Level 5 | 120 | 7.69 | 0.010 | 0.1% | 0.013 | 0.2% | |
| pCO2(mmHg) | Level 1 | 120 | 110 | 1.4 | 1.3% | 1.4 | 1.3% |
| Level 2 | 120 | 71 | 0.9 | 1.2% | 0.9 | 1.2% | |
| Level 3 | 120 | 51 | 0.7 | 1.4% | 0.7 | 1.4% | |
| Level 4 | 120 | 29 | 0.4 | 1.5% | 0.5 | 1.6% | |
| Level 5 | 120 | 12 | 0.6 | 4.8% | 0.6 | 4.8% |
Internal Precision Study – Whole Blood (Cont.)
{11}------------------------------------------------
Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting
In accordance with CLSI EPOS-A3, a reproducibith controls at three (3) external clinical point-of-care (POC) sites. The studies were run by a total of nine (9) different operators on six (6) different GEM Premier ChemSTAT instruments, usingle lot of GEM Premier ChemSTAT PAKs (cartridges). Each site used seven (7) levels of quality control material for Glu and S (2 levels of GEM ChemSTAT PVP) , six (6) levels for Hct (2 levels of GEM ChemSTAT CVP and 4 levels of GEM Cherels of (6) levels for pH and pCO2 (2 levels of GEM ChemSTAT CVP and 4 levels of GEM ChemSTAT PVP), running each control level in triplicate, twice a day for 5 days, for a total of 30 replicates per level (N=90 pooled across 3 sites).
All results at all sites were within specification.
| Pooled Multi-Site POC Data | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Analyte | ControlLevel | N | Mean | Repeatability | Between-Run | Between-Day | Between-Site | Reproducibility | |||||
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | ||||
| Glucose(mg/dL) | CVP Level 1 | 90 | 392 | 1.0 | 0.2% | 3.9 | 1.0% | 0.7 | 0.2% | 4.3 | 1.1% | 5.9 | 1.5% |
| CVP Level 2 | 90 | 78 | 1.5 | 1.9% | 0.0 | 0.0% | 0.6 | 0.8% | 0.0 | 0.0% | 1.6 | 2.1% | |
| PVP Level 1 | 90 | 642 | 1.3 | 0.2% | 1.4 | 0.2% | 1.1 | 0.2% | 6.5 | 1.0% | 6.8 | 1.1% | |
| PVP Level 2 | 90 | 393 | 1.6 | 0.4% | 1.3 | 0.3% | 1.3 | 0.3% | 3.3 | 0.8% | 4.2 | 1.1% | |
| PVP Level 3 | 90 | 115 | 1.4 | 1.2% | 0.6 | 0.5% | 0.0 | 0.0% | 0.0 | 0.0% | 1.5 | 1.3% | |
| PVP Level 4 | 90 | 80 | 0.6 | 0.7% | 0.3 | 0.4% | 0.5 | 0.6% | 0.3 | 0.3% | 0.9 | 1.1% | |
| PVP Level 5 | 90 | 14 | 0.5 | 3.6% | 0.0 | 0.0% | 0.2 | 1.6% | 1.4 | 9.7% | 1.5 | 10.5% | |
| Pooled Multi-Site POC Data | |||||||||||||
| Analyte | Control Level | Repeatability | Between-Run | Between-Day | Between-Site | Reproducibility | |||||||
| N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | ||
| Lactate(mmol/L) | CVP Level 1 | 90 | 8.2 | 0.04 | 0.5% | 0.04 | 0.5% | 0.02 | 0.3% | 0.03 | 0.3% | 0.07 | 0.8% |
| CVP Level 2 | 90 | 1.7 | 0.03 | 1.8% | 0.00 | 0.0% | 0.01 | 0.7% | 0.04 | 2.4% | 0.05 | 3.1% | |
| PVP Level 1 | 90 | 15.7 | 0.07 | 0.4% | 0.07 | 0.4% | 0.07 | 0.5% | 0.09 | 0.6% | 0.15 | 0.9% | |
| PVP Level 2 | 90 | 8.1 | 0.06 | 0.7% | 0.04 | 0.5% | 0.04 | 0.4% | 0.07 | 0.9% | 0.11 | 1.3% | |
| PVP Level 3 | 90 | 5.0 | 0.03 | 0.6% | 0.00 | 0.0% | 0.04 | 0.8% | 0.03 | 0.6% | 0.06 | 1.2% | |
| PVP Level 4 | 90 | 1.7 | 0.03 | 1.5% | 0.01 | 0.4% | 0.01 | 0.6% | 0.01 | 0.9% | 0.03 | 1.9% | |
| PVP Level 5 | 90 | 0.5 | 0.02 | 4.1% | 0.00 | 0.0% | 0.03 | 5.1% | 0.03 | 5.6% | 0.04 | 8.6% | |
| Hematocrit(%) | CVP Level 1 | 90 | 42 | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% |
| CVP Level 2 | 90 | 22 | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | |
| critPVP Level 1 | 90 | 18 | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | |
| critPVP Level 2 | 90 | 23 | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | |
| critPVP Level 3 | 90 | 43 | 0.1 | 0.2% | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | 0.1 | 0.2% | |
| critPVP Level 4 | 90 | 68 | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | |
| Pooled Multi-Site POC Data | |||||||||||||
| Analyte | ControlLevel | N | Mean | Repeatability | Between-Run | Between-Day | Between-Site | Reproducibility | |||||
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | ||||
| pH | CVP Level 1 | 90 | 7.11 | 0.005 | 0.1% | 0.002 | 0.0% | 0.002 | 0.0% | 0.000 | 0.0% | 0.006 | 0.1% |
| CVP Level 2 | 90 | 7.54 | 0.003 | 0.0% | 0.001 | 0.0% | 0.001 | 0.0% | 0.001 | 0.0% | 0.003 | 0.0% | |
| PVP Level 1 | 90 | 7.59 | 0.004 | 0.1% | 0.001 | 0.0% | 0.002 | 0.0% | 0.002 | 0.0% | 0.005 | 0.1% | |
| PVP Level 2 | 90 | 7.11 | 0.007 | 0.1% | 0.000 | 0.0% | 0.003 | 0.0% | 0.000 | 0.0% | 0.008 | 0.1% | |
| PVP Level 3 | 90 | 7.36 | 0.003 | 0.0% | 0.004 | 0.1% | 0.000 | 0.0% | 0.001 | 0.0% | 0.005 | 0.1% | |
| PVP Level 4 | 90 | 7.55 | 0.004 | 0.1% | 0.001 | 0.0% | 0.002 | 0.0% | 0.002 | 0.0% | 0.005 | 0.1% | |
| pCO2(mmHg) | CVP Level 1 | 90 | 92 | 1.2 | 1.4% | 1.6 | 1.7% | 0.0 | 0.0% | 0.2 | 0.2% | 2.0 | 2.2% |
| CVP Level 2 | 90 | 16 | 0.3 | 2.0% | 0.0 | 0.0% | 0.1 | 0.6% | 0.3 | 1.9% | 0.4 | 2.8% | |
| PVP Level 1 | 90 | 60 | 1.1 | 1.9% | 0.0 | 0.0% | 0.2 | 0.3% | 0.5 | 0.9% | 1.3 | 2.1% | |
| PVP Level 2 | 90 | 92 | 2.1 | 2.3% | 0.6 | 0.6% | 0.8 | 0.9% | 0.8 | 0.8% | 2.5 | 2.7% | |
| PVP Level 3 | 90 | 38 | 0.6 | 1.6% | 0.2 | 0.5% | 0.0 | 0.0% | 0.3 | 0.9% | 0.7 | 1.9% | |
| PVP Level 4 | 90 | 16 | 0.4 | 2.4% | 0.1 | 0.8% | 0.1 | 0.5% | 0.2 | 1.2% | 0.4 | 2.8% |
{12}------------------------------------------------
Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting (Cont.)
{13}------------------------------------------------
Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting (Cont.)
{14}------------------------------------------------
External Precision – Whole Blood
A precision study was performed with whole blood patient samples at three (3) external clinical point-ofcare (POC) sites. The studies were run by six (6) different operators on three (3) different GEM Premier ChemSTAT instruments, using a single lot of GEM Premier ChemSTAT PAKs (cartridges). Less than 10% of samples included in the study were contrived.
For data analysis and acceptance criteria application, measured data for each analyte were partitioned into zones and identified as Fixed Acceptance Range (Constant SD) or Variable Acceptance Range (Constant %CV).
| Analyte | Fixed or VariableAcceptance Range | Site | N | Mean | Within SampleSD of %CV |
|---|---|---|---|---|---|
| Glucose(mg/dL) | Fixed(SD) | POC 1 | 12 | 38 | 1.7 |
| POC 2 | 3 | 23 | 0.6 | ||
| Variable(%CV) | POC 3 | 15 | 49 | 1.7 | |
| Pooled | 30 | 42 | 1.6 | ||
| Variable(%CV) | POC 1 | 54 | 122 | 1.0% | |
| POC 2 | 63 | 112 | 0.8% | ||
| POC 3 | 51 | 115 | 1.0% | ||
| Pooled | 168 | 116 | 0.9% | ||
| Lactate(mmol/L) | Fixed(SD) | POC 1 | 9 | 1.9 | 0.07 |
| POC 2 | 27 | 1.8 | 0.08 | ||
| Variable(%CV) | POC 3 | 9 | 2.2 | 0.07 | |
| Pooled | 45 | 1.9 | 0.08 | ||
| Variable(%CV) | POC 1 | 57 | 5.7 | 1.7% | |
| POC 2 | 39 | 3.7 | 2.5% | ||
| POC 3 | 54 | 3.8 | 1.8% | ||
| Pooled | 150 | 4.5 | 1.9% |
All results at all sites were within specification.
{15}------------------------------------------------
| Analyte | Fixed or VariableAcceptance Range | Site | N | Mean | Within SampleSD of %CV |
|---|---|---|---|---|---|
| Hematocrit(%) | Fixed(SD) | POC 1 | 69 | 32 | 0.5 |
| POC 2 | 66 | 40 | 0.4 | ||
| POC 3 | 63 | 31 | 0.6 | ||
| Pooled | 198 | 35 | 0.5 | ||
| pH | Fixed(SD) | POC 1 | 63 | 7.26 | 0.008 |
| POC 2 | 66 | 7.36 | 0.009 | ||
| POC 3 | 66 | 7.31 | 0.007 | ||
| Pooled | 195 | 7.31 | 0.008 | ||
| pCO2(mmHg) | Fixed(SD) | POC 1 | 54 | 49 | 1.2 |
| POC 2 | 60 | 40 | 0.7 | ||
| POC 3 | 60 | 50 | 0.9 | ||
| Pooled | 174 | 46 | 0.9 | ||
| pCO2(mmHg) | Variable(%CV) | POC 1 | 18 | 74 | 1.4% |
| POC 2 | 6 | 66 | 1.6% | ||
| POC 3 | 3 | 78 | 1.5% | ||
| Pooled | 27 | 73 | 1.5% |
External Precision – Whole Blood (Cont.)
{16}------------------------------------------------
LoB, LoD and LoQ
In accordance with CLSI EP17-A2, Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) were established for Glu, Lac, Hct, pH, and pCO2, using three (3) lots of GEM Premier ChemSTAT PAKs (cartridges).
| Analyte | LoB | LoD | LoQ |
|---|---|---|---|
| Glucose (mg/dL) | 0 | 1 | 1 |
| Lactate (mmol/L) | 0.0 | 0.0 | 0.1 |
| Hematocrit (%) | 2 | 3 | 10 |
| pH | 8.69 | 8.62 | 8.06 |
| pCO2 (mmHg) | 1 | 3 | 3 |
Following are the combined data results for LoB, LoD and LoQ:
Linearity
In accordance with CLSI EP06-A, a minimum of nine (9) levels per analyte were prepared by spiking or diluting whole blood to challenge the claimed reportable range for Glu, Lac, Hct, pH, and pCO₂. Each blood level was analyzed in triplicate on six (6) GEM Premier ChemSTAT test analyzers (except pH and pCO2, which were tested on 3 analyzers) and results compared to the reference analyzer.
Combined data from limit of quantitation (LoQ) and linearity were used to support the lower limits of the claimed reportable ranges.
| Analyte | # ofLevels | N perLevel | Slope | Intercept | R² | TestedRange | ReportableRange |
|---|---|---|---|---|---|---|---|
| Glucose(mg/dL) | 9 | 18 | 1.023 | -0.502 | 1.0000 | 3 to 749 | 4 to 685 |
| Lactate(mmol/L) | 9 | 18 | 1.004 | 0.000 | 0.9998 | 0.2 to 17.8 | 0.3 to 17.0 |
| Hematocrit(%) | 9 | 18 | 0.984 | 1.909 | 0.9975 | 13 to 74 | 15 to 72 |
| pH | 10 | 9 | 1.006 | -0.042 | 0.9996 | 6.76 to 8.10 | 7.00 to 8.00 |
| p CO2(mmHg) | 9 | 9 | 1.030 | -0.843 | 0.9994 | 2 to 137 | 6 to 125 |
{17}------------------------------------------------
Analytical Specificity
In accordance with EP07 3d Edition, an interference study was conducted on the GEM Premier ChemSTAT for Glu, Lac, Hct, pH, and pCO2.
The table below and on the next two pages lists the substances that were screened with no observed interference on Glu, Lac, Hct, pH, and/or pCO₂:
| Test Substance | Test Concentration | Tested analytes where interference was not observed |
|---|---|---|
| Acetaminophen | 1030 µmol/L | Glucose, Lactate |
| Acetoacetate | 2 mmol/L | Glucose, Lactate |
| Albumin (Human) | 60 g/L | Hct |
| Ascorbic acid | 298 µmol/L | Glucose, Lactate |
| Atracurium | 50 mg/L | Glucose, Lactate, Hct, pH, pCO2 |
| Bilirubin | 40 mg/dL | Glucose, Lactate, Hct, pH, pCO2 |
| Ceftriaxone | 1510 µmol/L | Glucose, Lactate, Hct, pH, pCO2 |
| Chlorpromazine | 10.3 µmol/L | Glucose, Lactate |
| Dobutamine | 0.121 mg/dL | Glucose, Lactate |
| Dopamine | 4.06 µmol/L | Glucose, Lactate |
| Epinephrine | 0.5 µmol/L | Glucose, Lactate, Hct, pH, pCO2 |
| Ethanol | 130 mmol/L | Glucose, Lactate |
| Ethylene glycol | 8.8 mmol/L | Glucose, Lactate |
| Etomidate | 50 mg/L | Glucose, Lactate, Hct, pH, pCO2 |
| Fentanyl | 0.03 µg/mL | Glucose, Lactate, Hct, pH, pCO2 |
| Fructose | 1 mmol/L | Glucose |
| Furosemide | 48.1 µmol/L | Glucose, Lactate, Hct, pH, pCO2 |
| Gadodiamide | 1.4 mmol/L | Glucose, Lactate, Hct, pH, pCO2 |
| Glycolic acid | 1.0 mmol/L | Glucose |
| Test Substance | Test Concentration | Tested analytes where interference was not observed |
| Hematocrit | 25% | pH, pCO₂, Glucose, Lactate |
| Hematocrit | 60% | pH, pCO₂, Glucose, Lactate |
| Hemoglobin (Hemolysis) | 1000 mg/dL | Glucose, Lactate, Hct, pH, pCO₂ |
| Heparin | 100,000 U/L | Glucose, Lactate |
| β-hydroxybutyrate | 2 mmol/L | Glucose, Lactate, pH |
| Ibuprofen | 1060 µmol/L | Glucose, Lactate, Hct, pH, pCO₂ |
| Icodextrin | 20 mg/dL | Glucose, Lactate |
| Isoniazid | 438 µmol/L | Glucose, Lactate |
| Leukocytes / Platelets | 24.81 / 452 (x10³/µl)27.60 / 564 (x10³/µl) | Hct 30%Hct 60% |
| Maltose | 360 mg/dL | Glucose, Lactate |
| Methadone | 10.3 µmol/L | Glucose, Lactate, Hct, pH, pCO₂ |
| Midazolam | 0.376 mg/dL | Glucose, Lactate, Hct, pH, pCO₂ |
| Morphine | 27.3 µmol/L | Glucose, Lactate, Hct, pH, pCO₂ |
| N-Acetyl-L-cysteine | 920 µmol/L | Glucose, Lactate, Hct, pH, pCO₂ |
| Phenobarbital | 2970 µmol/L | Glucose, Lactate, Hct, pH, pCO₂ |
| Piperacillin | 110 mg/dL | Glucose, Lactate, Hct, pH, pCO₂ |
| pO2 | 30 mmHg | Glucose, Lactate |
| Pralidoxime iodide | 4 mg/dL | Glucose, Lactate |
| Propofol | 4.8 mg/dL | Glucose, Lactate, Hct, pH, pCO₂ |
| Suxamethonium | 68 µmol/L | Glucose, Lactate, Hct, pH, pCO₂ |
| Tazobactam | 3.05 mg/dL | Glucose, Lactate, Hct, pH, pCO₂ |
| Thiocyanate | 898 µmol/L | Glucose, Lactate |
| Test Substance | Test Concentration | Tested analytes where interference was not observed |
| Thiopental | 1660 µmol/L | pCO2 |
| Triglycerides(Intralipid) | 2000 mg/dL(1% Intralipid) | Glucose, Lactate, Hct, pH, pCO2 |
| Uric acid | 1.4 mmol/L | Glucose, Lactate |
| Vancomycin | 82.8 µmol/L | Glucose, Lactate, Hct, pH, pCO2 |
| Xylose | 20 mg/dL | Glucose |
{18}------------------------------------------------
Analytical Specificity (Cont.)
{19}------------------------------------------------
Analytical Specificity (Cont.)
The table below lists substances that demonstrated interference with Glu, Lac, Hct, pH and/or pCO2 and the concentration of the interfering substance, as well as the bias observed and its direction (positive / negative):
| InterferingSubstance | AffectedAnalytes | AnalyteConcentration | InterferingConcentrationTested | BiasObserved(Mean) | LowestInterferingConcentrationwith AnalyteImpact | Bias Observedat the LowestConcentration |
|---|---|---|---|---|---|---|
| Galactose | Glucose | 40 mg/dL | 3.33 mmol/L | +13 % | 2.77 mmol/L | +10 % |
| 220 mg/dL | No Interference Observed | |||||
| Glycolic acid | Lactate | 1.0 mmol/L | 1.0 mmol/L | +1.5mmol/L | 0.3 mmol/L | +0.4 mmol/L |
| 1.7 mmol/L | +1.6mmol/L | 0.3 mmol/L | +0.4 mmol/L | |||
| Hydroxyurea | Glucose | 40 mg/dL | 3.08 mg/dL | +207 % | 0.15 mg/dL | +10 % |
| 220 mg/dL | +34 % | 0.90 mg/dL | +10 % | |||
| Hydroxyurea | Lactate | 1.0 mmol/L | 3.08 mg/dL | +3.8mmol/L | 0.30 mg/dL | +0.4 mmol/L |
| 1.7 mmol/L | +3.5mmol/L | 0.33 mg/dL | +0.4 mmol/L | |||
| Mannose | Glucose | 40 mg/dL | 20 mg/dL | +12 % | 19 mg/dL | +10 % |
| 220 mg/dL | No Interference Observed | |||||
| Thiopental | pH | 7.40 | 1660 μmol/L | +0.04 | 789 µmol/L | +0.02 |
| 7.25 | +0.03 | 1175 µmol/L | +0.02 |
{20}------------------------------------------------
| Analyte | Reference Range | Unit |
|---|---|---|
| Glu* | 65 to 95 | mg/dL |
| 3.6 to 5.3 | mmol/L | |
| Lac* | 0.36 to 0.75 (arterial at rest) | mmol/L |
| 2.24 to 6.76 (arterial at rest) | mg/dL | |
| 0.56 to 1.39 (venous at rest) | mmol/L | |
| 5.0 to 12.5 (venous at rest) | mg/dL | |
| Hct* | 39-51 (male) and 35-47 (female) | % |
| pH* | 7.35 to 7.45 | pH |
| cH* | 44.7 to 35.5 | nmol/L |
| cH* | 44.7 to 35.5 | nEq/L |
| pH* | 7.32 to 7.43 (venous) | pH |
| cH* | 47.9 to 37.2 (venous) | nmol/L |
| cH* | 47.9 to 37.2 (venous) | nEq/L |
| pCO2** | 35 to 48 (male) and 32 to 45 (female) | mmHg |
| 4.6 to 6.4 (male) and 4.3 to 6.0 (female) | kPa | |
| 6 to 7 mmHg (0.80 to 0.93 kPa) higher than arterial pCO2(venous blood, right atrium) |
Reference Ranges
- Burtis, Carl and David Bruns, Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, Elsevier Saunders, 7th Edition, 2015, pages 952-982.
** Wu, A., Tietz Clinical Guide to Laboratory Tests, W.B. Saunders Co., St. Louis MO, 4th Edition, 2006, pages 216.
{21}------------------------------------------------
Clinical Testing
In accordance with EP09c, a method comparison study was conducted on the GEM Premier ChemSTAT compared to the predicate device, the GEM Premier 4000 (K133407), using lithium heparinized whole blood patient samples from the intended use population. Less than 10% of samples included in the study were contrived.
- Study Design: ●
- Three (3) external point-of-care (POC) sites
- For pH and pCO2 only, internal Customer Simulation Laboratory (CSL) at IL, where multiple intended ● POC users were brought on site to run spiked samples to cover the reportable ranges.
The pooled results from the POC sites and the IL internal Customer Simulation Laboratory (CSL) are presented below.
| Pooled Point-of-Care Sites and CSL Data | |||||
|---|---|---|---|---|---|
| Analyte | N | Slope | Intercept | R | Sample Range |
| Glucose (mg/dL) | 432 | 1.019 | -0.558 | 0.999 | 35 to 684 |
| Lactate (mmol/L) | 432 | 1.000 | -0.100 | 0.997 | 0.6 to 16.0 |
| Hematocrit (%) | 431 | 1.032 | -0.626 | 0.997 | 16 to 71 |
| pH | 552 | 1.006 | -0.038 | 0.995 | 7.03 to 7.87 |
| pCO2 (mmHg) | 559 | 1.000 | 0.000 | 0.996 | 7 to 120 |
| Conclusion | The technological and functional characteristics of the new GEMPremier ChemSTAT as described above are substantially equivalent tothat of the predicate device (GEM Premier 4000) for Glucose, Lactate,Hematocrit, pH and pCO2. |
|---|---|
| The analytical and clinical study results demonstrate that the GEMPremier ChemSTAT is safe and effective for its intended purpose andequivalent in performance to the predicate device (K133407). |
§ 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.