(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 Creatinine (Crea), Blood Urea Nitrogen (BUN) and Total Carbon Dioxide (tCO2) 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.
- · Creatinine (Crea) measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
- · Blood Urea Nitrogen (BUN) or urea measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.
- · Total carbon dioxide/tCO2 (also referred to as bicarbonate/HCO3-) is used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
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 Creatinine, BUN and tCO₂. 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.
Here's a breakdown of the acceptance criteria and study information for the GEM Premier ChemSTAT device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a dedicated table format. However, it indicates that "All results were within specification" and successful performance in comparison to predicate devices. For this summary, I've inferred the performance metrics as the reported study outcomes.
| Analyte | Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Creatinine (Crea) | Internal Precision (Total %CV) | Within specification (not explicitly stated, but < 3.6% for all levels is good) | 2.1% - 3.6% (Levels 1-5, N=120) |
| Reproducibility (CVP) | Within specification (not explicitly stated, but < 6.8% for CVP Level 1 is good) | 3.2% - 10.1% (Levels 1-4, N=90) | |
| Reproducibility (PVP) | Within specification (not explicitly stated, but < 8.8% for PVP Level 1 is good) | 1.7% - 8.8% (Levels 1-5, N=90) | |
| External Precision (SD) | Within specification (not explicitly stated, but < 0.014 for fixed range) | 0.011 - 0.014 (POC 1-3, Pooled_N=147 for fixed range) | |
| External Precision (%CV) | Within specification (not explicitly stated, but < 1.4% for variable range) | 0.6% - 1.4% (POC 1-3, Pooled_N=54 for variable range) | |
| Limit of Blank (LoB) | Established | 0.04 mg/dL | |
| Limit of Detection (LoD) | Established | 0.07 mg/dL | |
| Limit of Quantification (LoQ) | Established | 0.10 mg/dL | |
| Linearity (R²) | Ideally close to 1 (0.9976 is excellent) | 0.9976 | |
| Reportable Range | To be met | 0.20 to 15.00 mg/dL (after testing up to 16.40 mg/dL) | |
| Analytical Specificity | No observed interference (for non-interfering substances) or acceptable bias (for interfering substances) | No interference for numerous substances. Specific biases for Creatine and Hydroxyurea detailed. | |
| Method Comparison (Slope) | Close to 1.0 (1.009 is excellent) | 1.009 | |
| Method Comparison (Intercept) | Close to 0 (-0.027 is excellent) | -0.027 | |
| Method Comparison (R) | Close to 1 (0.997 is excellent) | 0.997 | |
| Method Comparison (Sample Range) | To be covered by testing | 0.20 to 14.18 mg/dL | |
| BUN (mg/dL) | Internal Precision (Total %CV) | Within specification (not explicitly stated, but < 1.8% for all levels is good) | 1.1% - 1.8% (Levels 1-5, N=120) |
| Reproducibility (CVP) | Within specification (not explicitly stated, but < 3.1% for CVP Level 2 is good) | 2.0% - 3.1% (Levels 1-2, N=90) | |
| Reproducibility (PVP) | Within specification (not explicitly stated, but < 3.0% for PVP Level 5 is good) | 1.7% - 3.0% (Levels 1-5, N=90) | |
| External Precision (SD) | Within specification (not explicitly stated, but < 0.18 for fixed range) | 0.12 - 0.18 (POC 1-3, Pooled_N=132 for fixed range) | |
| External Precision (%CV) | Within specification (not explicitly stated, but < 2.8% for variable range) | 0.7% - 2.8% (POC 1-3, Pooled_N=66 for variable range) | |
| Limit of Blank (LoB) | Established | 0.3 mg/dL | |
| Limit of Detection (LoD) | Established | 0.3 mg/dL | |
| Limit of Quantification (LoQ) | Established | 1.2 mg/dL | |
| Linearity (R²) | Ideally close to 1 (0.9997 is excellent) | 0.9997 | |
| Reportable Range | To be met | 3.0 to 112.0 mg/dL (after testing up to 122.0 mg/dL) | |
| Analytical Specificity | No observed interference (for non-interfering substances) or acceptable bias (for interfering substances) | No interference for numerous substances. No explicit interfering substances for BUN shown in the table. | |
| Method Comparison (Slope) | Close to 1.0 (0.965 is good) | 0.965 | |
| Method Comparison (Intercept) | Close to 0 (0.441 is small) | 0.441 | |
| Method Comparison (R) | Close to 1 (0.997 is excellent) | 0.997 | |
| Method Comparison (Sample Range) | To be covered by testing | 3.0 to 109.7 mg/dL | |
| tCO2 (mmol/L) | Internal Precision (Total %CV) | Within specification (not explicitly stated, but < 2.0% for all levels is good) | 1.4% - 2.0% (Levels 1-5, N=120) |
| Reproducibility (CVP) | Within specification (not explicitly stated, but < 4.5% for CVP Level 2 is good) | 2.5% - 4.5% (Levels 1-2, N=90) | |
| Reproducibility (PVP) | Within specification (not explicitly stated, but < 5.5% for PVP Level 5 is good) | 1.1% - 5.5% (Levels 1-5, N=90) | |
| External Precision (SD) | Within specification (not explicitly stated, but < 0.12 for fixed range) | 0.11 - 0.12 (POC 1-3, Pooled_N=81 for fixed range) | |
| External Precision (%CV) | Within specification (not explicitly stated, but < 1.1% for variable range) | 0.5% - 1.1% (POC 1-3, Pooled_N=120 for variable range) | |
| Limit of Blank (LoB) | Established | 0.0 mmol/L | |
| Limit of Detection (LoD) | Established | 0.2 mmol/L | |
| Limit of Quantification (LoQ) | Established | 2.0 mmol/L | |
| Linearity (R²) | Ideally close to 1 (0.9986 is excellent) | 0.9986 | |
| Reportable Range | To be met | 5.0 to 50.0 mmol/L (after testing up to 51.3 mmol/L) | |
| Analytical Specificity | No observed interference (for non-interfering substances) or acceptable bias (for interfering substances) | No interference for numerous substances. No explicit interfering substances for tCO2 shown in the table. | |
| Method Comparison (Slope) | Close to 1.0 (0.979 is good) | 0.979 | |
| Method Comparison (Intercept) | Close to 0 (0.535 is small) | 0.535 | |
| Method Comparison (R) | Close to 1 (0.986 is good) | 0.986 | |
| Method Comparison (Sample Range) | To be covered by testing | 5.5 to 47.2 mmol/L |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes several studies, and the test sets are detailed separately for each:
-
Internal Precision Study – Whole Blood:
- Sample Size: 5 different concentrations of whole blood per analyte, with 8 replicates per run, 1 run per day for 5 days on 3 analyzers. Total N = 120 (5 concentrations * 8 replicates * 5 days * 3 analyzers).
- Data Provenance: Not explicitly stated, implied as internal lab data ("internal precision study"). No country of origin mentioned. Likely prospective, as it's a controlled study.
-
Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting:
- Sample Size: 9 levels for Creatinine (4 CVP, 5 PVP) and 7 levels for BUN and tCO2 (2 CVP, 5 PVP). Each control level run in triplicate, twice a day for 5 days. Total N = 90 (3 replicates * 2 times/day * 5 days * 3 sites) pooled across 3 sites per level for each analyte.
- Data Provenance: Conducted at "control clinical point-of-care (POC) sites." No specific country of origin mentioned. Likely prospective, as it's a controlled study.
-
External Precision – Whole Blood:
- Sample Size: Patients samples (whole blood). N = 147 for Creatinine (fixed), 54 for Creatinine (variable), 132 for BUN (fixed), 66 for BUN (variable), 81 for tCO2 (fixed), 120 for tCO2 (variable). Less than 10% of samples were "contrived."
- Data Provenance: Conducted at "three (3) external clinical point-of-care (POC) sites." No specific country of origin mentioned. Likely a mix of prospective (as part of the study) and retrospective (existing patient samples) given the mention of "patient samples" and "contrived" samples.
-
LoB, LoD, and LoQ:
- Sample Size: 3 lots of GEM Premier ChemSTAT PAKs (cartridges). Specific number of measurements not detailed but implied to be sufficient for CLSI EP17-A2.
- Data Provenance: Internal laboratory study. Likely prospective.
-
Linearity:
- Sample Size: 9 levels per analyte, prepared by spiking or diluting whole blood. Each blood level analyzed in triplicate on 6 GEM Premier ChemSTAT test analyzers. Total N per level = 18 (3 replicates * 6 analyzers).
- Data Provenance: "whole blood" samples, but could be internal or simulated. Likely prospective.
-
Analytical Specificity (Interference Study):
- Sample Size: Various test substances at specified concentrations mentioned in tables. Specific number of replications or blood samples not detailed.
- Data Provenance: Not explicitly stated, implied as internal lab study. Likely prospective.
-
Clinical Testing (Method Comparison Study):
- Sample Size: N = 405 for Creatinine and BUN, N = 416 for tCO2. These were "lithium heparinized whole blood patient samples." Less than 10% of samples were "contrived."
- Data Provenance: Conducted at "three (3) point-of-care (POC) sites." No specific country of origin mentioned. This is a clinical study, likely a mix of prospective and retrospective patient samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The device is an in-vitro diagnostic (IVD) for quantitative measurements of analytes (Creatinine, BUN, tCO2) using established laboratory methods. For such devices, "ground truth" is typically established by comparative analysis against a reference method or predicate device, which are themselves considered gold standards in laboratory medicine. There is no mention of human experts establishing a "ground truth" through interpretation or consensus for these quantitative measurements, as would be the case for image-based diagnostic AI.
The method comparison study compares the candidate device to legally marketed predicate devices:
- Cobas Integra Creatinine Plus Ver. 2 (K024098)
- Cobas Integra Urea/BUN (K954000)
- Cobas Integra Bicarbonate Liquid (K031879)
These predicate devices serve as the reference standard for the "ground truth" in the clinical method comparison.
4. Adjudication Method for the Test Set:
Not applicable. For this type of quantitative IVD device, ground truth for patient samples is typically established by measurement on a reference method/predicate device, not through expert adjudication in the way it's done for qualitative interpretations (e.g., radiology reads). The comparison involves statistical analyses (slope, intercept, R-value) rather than an adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. This device is an automated in-vitro diagnostic (IVD) system that provides direct quantitative measurements. It does not involve human "readers" interpreting cases with or without AI assistance, nor is it an AI-powered diagnostic aid to human interpretation. Therefore, an MRMC study is not relevant here.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done:
Yes, the studies presented (internal precision, external precision, LoB/LoD/LoQ, linearity, analytical specificity) all demonstrate the standalone performance of the GEM Premier ChemSTAT device. The device operates automatically to provide quantitative measurements without human intervention in the measurement process itself, beyond sample loading and initiation. The "clinical testing" (method comparison) also evaluates the device's performance against predicate devices as a standalone instrument.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance studies of the GEM Premier ChemSTAT is established by:
- Reference Methods/Predicate Devices: For the method comparison study, the measurements obtained from the predicate devices (Cobas Integra Creatinine Plus Ver. 2, Cobas Integra Urea/BUN, Cobas Integra Bicarbonate Liquid) served as the reference standard for patient samples.
- Prepared Standards/Controls: For precision, linearity, LoB/LoD/LoQ, and analytical specificity studies, the ground truth is established by precisely prepared control materials, aqueous solutions, or spiked/diluted whole blood samples with known concentrations of the analytes. These are traceable to national or international standards (e.g., NIST, CLSI).
8. The Sample Size for the Training Set:
This document describes a pre-market notification (510(k)) for a medical device (IVD analyzer). It does not explicitly mention a "training set" in the context of machine learning or AI models. The performance studies detailed are for verification and validation of the device's analytical and clinical performance against predicate devices and controlled materials, not for training a model. Therefore, this information is not provided because the device is not an AI/ML-driven product in the described context.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as a "training set" in the context of AI/ML is not described or implied for this device. The development process for such IVD devices typically involves rigorous analytical characterization and clinical validation against reference methods, rather than machine learning training.
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February 16, 2019
Instrumentation Laboratory Co. Gabriella Erdosy Regulatory Affairs Manager 180 Hartwell Road Bedford, MA 01730
Re: K183555
Trade/Device Name: GEM Premier ChemSTAT Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: JFY, CDQ, KHS 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.
Please note that if you modify your IVD in the future to exceed any of the limitations to the exemption found in 21 CFR 862.9(c), your device will require a new 510(k) prior to marketing this device in the United States and will not be exempt from the premarket notification requirements so long as it exceeds the limitations to the exemption found in 21 CFR 862.9.
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 (OS) 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 (Sections 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 medical devices and radiation-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
Courtney H. Lias, Ph.D. for 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) K183555
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 Creatinine (Crea), Blood Urea Nitrogen (BUN) and Total Carbon Dioxide (tCO2) 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.
- · Creatinine (Crea) measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
- · Blood Urea Nitrogen (BUN) or urea measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.
- · Total carbon dioxide/tCO2 (also referred to as bicarbonate/HCO3-) is used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
| 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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K183555: GEM Premier ChemSTAT with Creatinine, BUN and tCO2
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 ErdosyPhone: 781-861-4571Fax: 781-861-4207Email: gerdosy@ilww.com |
| Preparation Date | February 11, 2019 |
|---|---|
| Device Trade Name | GEM Premier ChemSTAT |
| Cobas Integra Creatinine Plus Ver. 2 | K024098 | |
|---|---|---|
| Predicate Devices | Cobas Integra Urea/BUN | K954000 |
| Cobas Integra Bicarbonate Liquid | K031879 |
| Regulatory Information | |||||
|---|---|---|---|---|---|
| Analyte | RegulationSection | Regulatory Description | Classification | ProductCode | Panel |
| Creatinine | 862.1225 | Creatinine test system | Class II | JFY | |
| Blood UreaNitrogen | 862.1770 | Urea nitrogen test system | Class II | CDQ | Chemistry(75) |
| tCO2 | 862.1160 | Bicarbonate/carbon dioxidetest system | Class II | KHS |
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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 Creatinine, BUN and tCO₂. 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 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. |
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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 programdesigned to provide continuous monitoring of the analyticalprocess before and after sample measurement with real-time,automatic error detection, automatic correction and automaticdocumentation of all 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 Creatinine (Crea), Blood Urea Nitrogen (BUN) and Total Carbon Dioxide (tCO₂) 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.
- Creatinine (Crea) measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
- Blood Urea Nitrogen (BUN) or urea measurements are used for the diagnosis, monitoring, and ● treatment of certain renal and metabolic diseases.
- Total carbon dioxide/tCO₂ (also referred to as bicarbonate/HCO₃`) is used in the diagnosis, . monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Special Conditions for Use Statement
- For prescription use only.
- For clinical laboratory and point-of-care use
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Substantial Equivalency Discussion
The GEM Premier ChemSTAT system is substantially equivalent in function and intended use to the following predicate devices for Creatinine, Urea Nitrogen (BUN) and tCO2:
- Creatinine Cobas Integra Creatinine Plus Ver. 2 K024098
- Urea Nitrogen ● Cobas Integra Urea/BUN
- tCO2 Cobas Integra Bicarbonate Liquid .
A comparison to the above predicate devices follow for Creatinine, Urea Nitrogen (BUN) and tCO₂.
| Creatinine (Crea) | ||
|---|---|---|
| Item | Candidate Device:GEM Premier ChemSTAT | Predicate Device:Cobas Integra Creatinine Plus Ver.2 |
| 510(k) No. | K183555 | K024098 |
| Manufacturer | Instrumentation Laboratory Co. | Roche Diagnostics |
| Intended Use | A portable critical care system for useby health care professionals to rapidlyanalyze lithium heparinized wholeblood samples at the point of healthcare delivery in a clinical setting and ina central laboratory. The instrumentprovides quantitative measurementsof Creatinine (Crea), Blood UreaNitrogen (BUN) and Total CarbonDioxide (tCO2) from arterial andvenous heparinized whole blood.These parameters, along with derivedparameters, aid in the diagnosis of apatient's acid/base status andmetabolite balance. | In vitro test for the quantitativedetermination of creatinineconcentration in human serum,plasma and urine on Roche/Hitachicobas c systems. |
| Intended User | Central Laboratory and Point-of-Care | Central Laboratory Only |
| Measurement Principle | Enzymatic Amperometry | Enzymatic Colorimetry |
| Sample Volume | 150 μL | 2-5 μL |
| Sample Type | Lithium heparinized whole blood(arterial and venous) | Serum, Plasma and Urine |
| Reportable Range | 0.20 to 15.00 mg/dL | 0.06 to 30.5 mg/dL |
| Calibration | 3-point calibration | 2-point calibration |
| Storage Temperature | 15-25°C (PAK) | 2-8°C (Reagents) |
| Substantial Equivalency Discussion (Cont.) | ||
| Blood Urea Nitrogen (BUN) | ||
| Item | Candidate Device:GEM Premier ChemSTAT | Predicate Device:Cobas Integra Urea/BUN |
| 510(k) No. | K183555 | K954000 |
| Manufacturer | Instrumentation Laboratory Co. | Roche Diagnostics |
| Intended Use | A portable critical care system for useby health care professionals to rapidlyanalyze lithium heparinized wholeblood samples at the point of healthcare delivery in a clinical setting and ina central laboratory. The instrumentprovides quantitative measurementsof Creatinine (Crea), Blood UreaNitrogen (BUN) and Total CarbonDioxide (tCO2) from arterial andvenous heparinized whole blood.These parameters, along with derivedparameters, aid in the diagnosis of apatient's acid/base status andmetabolite balance. | In vitro test for the quantitativedetermination of urea/urea nitrogenconcentration in human serum,plasma and urine on Roche/Hitachicobas c systems. |
| Intended User | Central Laboratory and Point-of-Care | Central Laboratory Only |
| Measurement Principle | Enzymatic Potentiometry | Enzymatic Colorimetry |
| Sample Volume | 150 µL | 2 µL |
| Sample Type | Lithium heparinized whole blood(arterial and venous) | Serum, Plasma and Urine |
| Reportable Range | 3.0 to 112.0 mg/dL | 1.4 to 112 mg/dL |
| Calibration | 2-point calibration | 2-point calibration |
| Storage Temperature | 15-25°C (PAK) | 2-8°C (Reagents) |
| Substantial Equivalency Discussion (Cont.) | ||
| Total Carbon Dioxide (tCO2) | ||
| Item | Candidate Device:GEM Premier ChemSTAT | Predicate Device:Cobas Integra Bicarbonate Liquid |
| 510(k) No. | K183555 | K031879 |
| Manufacturer | Instrumentation Laboratory Co. | Roche Diagnostics |
| Intended Use | A portable critical care system for useby health care professionals to rapidlyanalyze lithium heparinized wholeblood samples at the point of healthcare delivery in a clinical setting and ina central laboratory. The instrumentprovides quantitative measurementsof Creatinine (Crea), Blood UreaNitrogen (BUN) and Total CarbonDioxide (tCO2) from arterial andvenous heparinized whole blood.These parameters, along with derivedparameters, aid in the diagnosis of apatient's acid/base status andmetabolite balance. | In vitro test for the quantitativedetermination of bicarbonate (HCO3-)concentration in human serum andplasma on Roche/Hitachi cobas csystems. |
| Intended User | Central Laboratory and Point-of-Care | Central Laboratory Only |
| Measurement Principle | Potentiometry | Enzymatic Colorimetry |
| Sample Volume | 150 μL | 2 μL |
| Sample Type | Lithium heparinized whole blood(arterial and venous) | Serum and Plasma |
| Reportable Range | 5.0 to 50.0 mmol/L | 2 to 50 mmol/L |
| Calibration | 2-point calibration | 2-point calibration |
| Storage Temperature | 15-25°C (PAK) | 2-8°C (Reagents) |
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
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 |
|---|---|---|---|---|---|---|---|
| Creatinine(mg/dL) | Level 1 | 120 | 0.48 | 0.014 | 2.9% | 0.017 | 3.6% |
| Level 2 | 120 | 1.53 | 0.016 | 1.0% | 0.032 | 2.1% | |
| Level 3 | 120 | 2.83 | 0.019 | 0.7% | 0.067 | 2.4% | |
| Level 4 | 120 | 5.67 | 0.028 | 0.5% | 0.121 | 2.1% | |
| Level 5 | 120 | 9.36 | 0.056 | 0.6% | 0.235 | 2.5% | |
| BUN(mg/dL) | Level 1 | 120 | 6.5 | 0.06 | 1.0% | 0.08 | 1.1% |
| Level 2 | 120 | 25.7 | 0.24 | 0.9% | 0.27 | 1.1% | |
| Level 3 | 120 | 50.0 | 0.88 | 1.8% | 0.88 | 1.8% | |
| Level 4 | 120 | 81.9 | 1.37 | 1.7% | 1.37 | 1.7% | |
| Level 5 | 120 | 102.4 | 1.44 | 1.4% | 1.57 | 1.5% | |
| tCO2(mmol/L) | Level 1 | 120 | 8.0 | 0.11 | 1.3% | 0.12 | 1.5% |
| Level 2 | 120 | 14.8 | 0.22 | 1.5% | 0.22 | 1.5% | |
| Level 3 | 120 | 21.2 | 0.23 | 1.1% | 0.30 | 1.4% | |
| Level 4 | 120 | 32.8 | 0.23 | 0.7% | 0.54 | 1.7% | |
| Level 5 | 120 | 43.5 | 0.30 | 0.7% | 0.88 | 2.0% |
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Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting
In accordance with CLSI EP05-A3, a reproducibility study was performed with control 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 nine (9) levels of quality control mor Creatinine (4 levels of GEM ChemSTAT PVP) and seven (7) levels for BUN and tCO2 (2 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 | Mean | Repeatability | Between-Run | Between-Day | Between-Site | Reproducibility | ||||||
| N | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |||
| Creatinine(mg/dL) | CVP Level 1 | 90 | 0.96 | 0.016 | 1.6% | 0.025 | 2.7% | 0.020 | 2.1% | 0.054 | 5.7% | 0.065 | 6.8% |
| CVP Level 2 | 90 | 5.17 | 0.105 | 2.0% | 0.116 | 2.2% | 0.000 | 0.0% | 0.048 | 0.9% | 0.164 | 3.2% | |
| CVP Level 3 | 90 | 0.98 | 0.015 | 1.6% | 0.023 | 2.3% | 0.000 | 0.0% | 0.014 | 1.4% | 0.031 | 3.1% | |
| CVP Level 4 | 90 | 0.62 | 0.011 | 1.8% | 0.032 | 5.2% | 0.000 | 0.0% | 0.052 | 8.4% | 0.063 | 10.1% | |
| PVP Level 1 | 90 | 0.46 | 0.011 | 2.3% | 0.011 | 2.3% | 0.010 | 2.1% | 0.037 | 7.9% | 0.041 | 8.8% | |
| PVP Level 2 | 90 | 1.03 | 0.017 | 1.7% | 0.015 | 1.5% | 0.029 | 2.8% | 0.068 | 6.6% | 0.077 | 7.5% | |
| PVP Level 3 | 90 | 3.02 | 0.036 | 1.2% | 0.041 | 1.4% | 0.000 | 0.0% | 0.102 | 3.4% | 0.116 | 3.8% | |
| PVP Level 4 | 90 | 5.37 | 0.093 | 1.7% | 0.054 | 1.0% | 0.000 | 0.0% | 0.073 | 1.4% | 0.130 | 2.4% | |
| PVP Level 5 | 90 | 8.31 | 0.083 | 1.0% | 0.094 | 1.1% | 0.039 | 0.5% | 0.045 | 0.5% | 0.139 | 1.7% | |
| Pooled Multi-Site POC Data | |||||||||||||
| Analyte | Control Level | N | Mean | Repeatability | Between-Run | Between-Day | Between-Site | Reproducibility | |||||
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | ||||
| BUN(mg/dL) | CVP Level 1 | 90 | 15.5 | 0.26 | 1.7% | 0.14 | 0.9% | 0.00 | 0.0% | 0.08 | 0.5% | 0.31 | 2.0% |
| CVP Level 2 | 90 | 57.2 | 0.44 | 0.8% | 0.18 | 0.3% | 1.14 | 2.0% | 1.31 | 2.3% | 1.80 | 3.1% | |
| BUN(mg/dL) | PVP Level 1 | 90 | 5.7 | 0.10 | 1.9% | 0.00 | 0.0% | 0.01 | 0.1% | 0.08 | 1.5% | 0.13 | 2.4% |
| PVP Level 2 | 90 | 15.5 | 0.24 | 1.6% | 0.05 | 0.3% | 0.00 | 0.0% | 0.09 | 0.6% | 0.26 | 1.7% | |
| PVP Level 3 | 90 | 38.2 | 0.33 | 0.9% | 0.19 | 0.5% | 0.67 | 1.8% | 0.68 | 1.8% | 1.03 | 2.7% | |
| PVP Level 4 | 90 | 56.5 | 0.61 | 1.1% | 0.00 | 0.0% | 1.08 | 1.9% | 1.21 | 2.1% | 1.73 | 3.1% | |
| PVP Level 5 | 90 | 96.2 | 1.26 | 1.3% | 0.00 | 0.0% | 1.78 | 1.9% | 1.93 | 2.0% | 2.91 | 3.0% | |
| tCO2(mmol/L) | CVP Level 1 | 90 | 25.4 | 0.15 | 0.6% | 0.10 | 0.4% | 0.25 | 1.0% | 0.55 | 2.2% | 0.63 | 2.5% |
| CVP Level 2 | 90 | 13.0 | 0.13 | 1.0% | 0.00 | 0.0% | 0.21 | 1.6% | 0.53 | 4.0% | 0.58 | 4.5% | |
| tCO2(mmol/L) | PVP Level 1 | 90 | 41.1 | 0.42 | 1.0% | 0.00 | 0.0% | 0.50 | 1.2% | 1.05 | 2.6% | 1.23 | 3.0% |
| PVP Level 2 | 90 | 25.7 | 0.25 | 1.0% | 0.00 | 0.0% | 0.14 | 0.5% | 0.52 | 2.0% | 0.60 | 2.3% | |
| PVP Level 3 | 90 | 18.7 | 0.18 | 1.0% | 0.00 | 0.0% | 0.04 | 0.2% | 0.08 | 0.4% | 0.20 | 1.1% | |
| PVP Level 4 | 90 | 13.0 | 0.12 | 0.9% | 0.00 | 0.0% | 0.18 | 1.4% | 0.53 | 4.1% | 0.57 | 4.4% | |
| PVP Level 5 | 90 | 8.0 | 0.10 | 1.2% | 0.00 | 0.0% | 0.15 | 1.9% | 0.40 | 5.0% | 0.44 | 5.5% |
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Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting (Cont.)
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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 |
|---|---|---|---|---|---|
| Creatinine(mg/dL) | Fixed(SD) | POC 1 | 33 | 0.91 | 0.011 |
| POC 2 | 60 | 0.88 | 0.014 | ||
| Fixed(SD) | POC 3 | 54 | 0.72 | 0.013 | |
| Fixed(SD) | Pooled | 147 | 0.83 | 0.013 | |
| Creatinine(mg/dL) | Variable(%CV) | POC 1 | 36 | 3.50 | 1.4% |
| POC 2 | 6 | 5.13 | 1.4% | ||
| Variable(%CV) | POC 3 | 12 | 3.52 | 0.6% | |
| Variable(%CV) | Pooled | 54 | 3.69 | 1.2% | |
| BUN(mg/dL) | Fixed(SD) | POC 1 | 36 | 15.2 | 0.18 |
| POC 2 | 54 | 12.4 | 0.18 | ||
| Fixed(SD) | POC 3 | 42 | 11.8 | 0.12 | |
| Fixed(SD) | Pooled | 132 | 13.0 | 0.16 | |
| BUN(mg/dL) | Variable(%CV) | POC 1 | 33 | 45.6 | 2.8% |
| POC 2 | 12 | 36.4 | 0.7% | ||
| Variable(%CV) | POC 3 | 21 | 52.1 | 0.9% | |
| Variable(%CV) | Pooled | 66 | 46.0 | 1.9% |
All results at all sites were within specification.
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| Analyte | Fixed or VariableAcceptance Range | Site | N | Mean | Within SampleSD of %CV |
|---|---|---|---|---|---|
| tCO2(mmol/L) | Fixed(SD) | POC 1 | 33 | 14.8 | 0.11 |
| POC 2 | 30 | 17.4 | 0.12 | ||
| POC 3 | 18 | 15.4 | 0.12 | ||
| Pooled | 81 | 15.9 | 0.12 | ||
| tCO2(mmol/L) | Variable(%CV) | POC 1 | 39 | 24.6 | 1.1% |
| POC 2 | 36 | 22.9 | 0.9% | ||
| POC 3 | 45 | 23.2 | 0.5% | ||
| Pooled | 120 | 23.6 | 0.9% |
External Precision – Whole Blood (Cont.)
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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 Creatinine, BUN and tCO₂, using three (3) lots of GEM Premier ChemSTAT PAKs (cartridges).
Following are the combined data results for LoB, LoD and LoQ:
| Analyte | LoB | LoD | LoQ |
|---|---|---|---|
| Creatinine (mg/dL) | 0.04 | 0.07 | 0.10 |
| BUN (mg/dL) | 0.3 | 0.3 | 1.2 |
| tCO2 (mmol/L) | 0.0 | 0.2 | 2.0 |
Linearity
In accordance with CLSI EP06-A, nine (9) levels per analyte were prepared by spiking or diluting whole blood to challenge the claimed reportable range for Creatinine, BUN and tCQ₂. Each blood level was analyzed in triplicate on six (6) GEM Premier ChemSTAT test analyzers and results compared to the reference analyzers.
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 | R 2 | TestedRange | ReportableRange |
|---|---|---|---|---|---|---|---|
| Creatinine(mg/dL) | 9 | 18 | 1.005 | -0.034 | 0.9976 | 0.10 to 16.40 | 0.20 to 15.00 |
| BUN(mg/dL) | 9 | 18 | 1.018 | -0.194 | 0.9997 | 2.4 to 122.0 | 3.0 to 112.0 |
| tCO2(mmol/L) | 9 | 18 | 1.002 | -0.798 | 0.9986 | 3.6 to 51.3 | 5.0 to 50.0 |
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Analytical Specificity
In accordance with EP07 3d Edition, an interference study was conducted on the GEM Premier ChemSTAT for Creatinine, BUN and tCO2.
The table below and on the next two pages lists the substances that were screened with no observed interference on Creatinine, BUN and/or tCO₂:
| Test Substance | Test Concentration | Tested analytes where interference was not observed |
|---|---|---|
| Acetaminophen | 1030 µmol/L | Creatinine |
| Acetoacetate | 2 mmol/L | Creatinine |
| Ammonium (Chloride) | 151 µmol/L | BUN |
| Ascorbic acid | 298 µmol/L | Creatinine |
| Atracurium | 50 mg/L | Creatinine, BUN, tCO2 |
| Benzalkonium (Chloride) | 5 mg/L | BUN |
| Bilirubin | 40 mg/dL | Creatinine, BUN, tCO2 |
| Ceftriaxone | 1510 µmol/L | Creatinine, BUN, tCO2 |
| Chlorpromazine | 10.3 µmol/L | Creatinine |
| Diatrizoate Sodium | 301 µmol/L | Creatinine, BUN |
| Dobutamine | 0.121 mg/dL | Creatinine |
| Dopamine | 4.06 µmol/L | Creatinine |
| Epinephrine | 0.5 µmol/L | Creatinine, BUN, tCO2 |
| Ethanol | 130 mmol/L | Creatinine |
| Ethylene glycol | 8.8 mmol/L | Creatinine |
| Etomidate | 50 mg/L | Creatinine, BUN, tCO2 |
| Fentanyl | 0.03 µg/mL | Creatinine, BUN, tCO2 |
| Furosemide | 48.1 µmol/L | Creatinine, BUN, tCO2 |
| Gadodiamide | 1.4 mmol/L | Creatinine, BUN, tCO2 |
| Test Substance | Test Concentration | Tested analytes where interference was not observed |
| Glycolic acid | 1.0 mmol/L | Creatinine |
| Hematocrit | 25% | Creatinine |
| Hematocrit | 60% | Creatinine |
| Hemoglobin (Hemolysis) | 1000 mg/dL | Creatinine, BUN, tCO2 |
| Heparin | 100,000 U/L | Creatinine, BUN |
| β-hydroxybutyrate | 2 mmol/L | Creatinine |
| Hydroxyurea | 3.08 mg/dL | BUN |
| Ibuprofen | 1060 µmol/L | Creatinine, BUN, tCO2 |
| Icodextrin | 20 mg/dL | Creatinine |
| Isoniazid | 438 µmol/L | Creatinine |
| Leflunomide | 100 µg/mL | BUN |
| Methadone | 10.3 µmol/L | Creatinine, BUN, tCO2 |
| Midazolam | 0.376 mg/dL | Creatinine, BUN, tCO2 |
| Morphine | 27.3 µmol/L | Creatinine, BUN, tCO2 |
| N-Acetyl-L-cysteine | 920µmol/L | Creatinine, BUN, tCO2 |
| Perchlorate | 20 mg/dL | BUN |
| Phenobarbital | 2970 µmol/L | Creatinine, BUN, tCO2 |
| Piperacillin | 110 mg/dL | Creatinine, BUN, tCO2 |
| pO2 | 30 mmHg | Creatinine |
| Pralidoxime iodide | 4 mg/dL | Creatinine |
| Propofol | 4.8 mg/dL | Creatinine, BUN, tCO2 |
| Salicylic acid | 0.207 mmol/L | BUN |
| Suxamethonium | 68 µmol/L | Creatinine, BUN, tCO2 |
| Tazobactam | 3.05 mg/dL | Creatinine, BUN, tCO2 |
| Test Substance | Test Concentration | Tested analytes where interference was not observed |
| Teriflunomide | 100 µg/mL | BUN |
| Thiocyanate | 898 µmol/L | BUN, Creatinine |
| Thiopental | 1660 µmol/L | BUN, tCO2 |
| Triglyceride (Intralipid) | 2000 mg/dL(1% Intralipid) | Creatinine, BUN, tCO2 |
| Uric acid | 1.4 mmol/L | Creatinine |
| Vancomycin | 82.8 µmol/L | Creatinine, BUN, tCO2 |
{17}------------------------------------------------
Analytical Specificity (Cont.)
{18}------------------------------------------------
Analytical Specificity (Cont.)
The table below lists substance that demonstrated interference with Creatinine, BUN and/or tCO₂ 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 |
|---|---|---|---|---|---|---|
| Creatine | Creatinine | 0.60 mg/dL | 0.382 mmol/L | +0.23 mg/dL | 0.33 mmol/L | +0.20 mg/dL |
| 2.00 mg/dL | No Interference Observed | |||||
| Hydroxyurea | Creatinine | 0.60 mg/dL | 0.77 mg/dL | +1.06 mg/dL | 0.15 mg/dL | 0.20 mg/dL |
| 2.00 mg/dL | +1.08 mg/dL | 0.12 mg/dL | 0.20 mg/dL |
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| Analyte | Reference Range | Unit |
|---|---|---|
| Crea* | 0.04-0.33 (0-1 yr) | mg/dL |
| 0.04-0.45 (2-5 yr) | mg/dL | |
| 0.20-0.52 (6-9 yr) | mg/dL | |
| 0.22-0.59 (10 yr) | mg/dL | |
| 0.62-1.10 (male adult) | mg/dL | |
| 0.45-0.75 (female adult) | mg/dL | |
| Crea* | 4-29 (0-1 yr) | μmol/L |
| 4-40 (2-5 yr) | μmol/L | |
| 18-46 (6-9 yr) | μmol/L | |
| 19-52 (10 yr) | μmol/L | |
| 55-96 (male adult) | μmol/L | |
| 40-66 (female adult) | μmol/L | |
| BUN* | 3-25 (1 wk) | mg/dL |
| 4-19 (< 1 yr) | mg/dL | |
| 5-18 (infant/child) | mg/dL | |
| 6-20 (18-60 yr) | mg/dL | |
| 8-23 (60-90 yr) | mg/dL | |
| 10-31 (> 90 yr) | mg/dL | |
| Urea* | 1.1-8.9 (1 wk) | mmol/L |
| 1.4-6.8 (< 1 yr) | mmol/L | |
| 1.8-6.4 (infant/child) | mmol/L | |
| 2.1-7.1 (18-60 yr) | mmol/L | |
| 2.9-8.2 (60-90 yr) | mmol/L | |
| 3.6-11.1 (> 90 yr) | mmol/L | |
| tCO2** | 19.0-24.0 | mmol/L |
| 22.0-26.0 (venous) | mmol/L |
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 316 and 1096.
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Clinical Testing
In accordance with EP09c, a method comparison study was conducted at three (3) point-of-care (POC) sites on the GEM Premier ChemSTAT compared to the respective predicate devices, using lithium heparinized whole blood patient samples from the intended use population. Less than 10% of samples included in the study were contrived.
| Pooled Point-of-Care Sites | |||||
|---|---|---|---|---|---|
| Analyte | N | Slope | Intercept | R | Sample Range |
| Creatinine (mg/dL) | 405 | 1.009 | -0.027 | 0.997 | 0.20 to 14.18 |
| BUN (mg/dL) | 405 | 0.965 | 0.441 | 0.997 | 3.0 to 109.7 |
| tCO2 (mmol/L) | 416 | 0.979 | 0.535 | 0.986 | 5.5 to 47.2 |
The pooled results from the POC sites are presented below.
| Conclusion | The technological and functional characteristics of the new GEMPremier ChemSTAT as described above are substantially equivalent tothat of the predicate devices: Cobas Integra Creatinine Plus Ver. 2(K024098), Cobas Integra Urea/BUN (K954000) and Cobas IntegraBicarbonate Liquid (K031879).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 devices: Cobas IntegraCreatinine Plus Ver. 2 (K024098), Cobas Integra Urea/BUN (K954000)and Cobas Integra Bicarbonate Liquid (K031879). |
|---|---|
| ------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.