(306 days)
The GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze 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, lactate and total bilirubin from venous, arterial and capillary heparinized whole blood. These parameters aid in the diagnosis of a patient's metabolite balance.
Glucose (Clu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and 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;
- in the diagnosis of hyperlactatemia.
Total bilirubin measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.
The GEM Premier 5000 system provides health care professionals in central laboratory or point-of-care clinical settings with fast, accurate, quantitative measurements of glucose, lactate and total bilirubin from venous, arterial and capillary heparinized whole blood.
Key Components:
- Analyzer: Employs a unique color touch 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.
- GEM Premier 5000 PAK (disposable, multi-use GEM PAK): Houses all required components necessary to operate the instrument once the cartridge is validated. These components include the sensors, CO-Ox/tBili optical cell, Process Control (PC) Solutions, sampler, pump tubing, distribution valve and waste bag. The GEM PAK has flexible menus and test volume options to assist facilities in maximizing efficiency.
- Intelligent Quality Management 2 (iQM2): iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions. iQM2 is a statistical process control system that performs 5 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, CO-Ox, and reagents. These checks include System, Sensor, IntraSpect, Pattern Recognition and Stability Checks.
The provided text describes the performance of the GEM Premier 5000 device for measuring Glucose, Lactate, and Total Bilirubin. The document primarily focuses on analytical and clinical studies to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria against a specific benchmark.
However, we can infer acceptance criteria based on the "Total Error Observed" compared to "Total Error Specifications" in the "Whole Blood Performance at Medical Decision Levels" section. The document states, "Total Error was computed based on the following equation and the results were compared to the GEM Premier 5000 Total Error Specifications." This implies that the 'Total Error Specifications' are the acceptance criteria.
1. Table of acceptance criteria and the reported device performance:
| Analyte | Medical Decision Level | Acceptance Criteria (Total Error Specifications) | Reported Device Performance (Total Error Observed) |
|---|---|---|---|
| Glucose (mg/dL) | 45 | Not explicitly stated in the provided text, but implied to be met by the observed error | 4.8 |
| 120 | Not explicitly stated | 4.5% | |
| 180 | Not explicitly stated | 4.1% | |
| 350 | Not explicitly stated | 4.0% | |
| Lactate (mmol/L) | 2.0 | Not explicitly stated | 0.017 |
| 5.0 | Not explicitly stated | 4.5% | |
| tBili (mg/dL) | 3.0 | Not explicitly stated | 0.55 |
| 6.0 | Not explicitly stated | 7.8% | |
| 14.0 | Not explicitly stated | 2.2% | |
| 20.0 | Not explicitly stated | 2.1% |
Note: The document explicitly states "All results were within specification" for precision studies and "All parameter levels passed specification for all sample modes" for internal method comparison, and "The analytical and clinical study results demonstrate that the GEM Premier 5000 is safe and effective for its intended purpose and equivalent in performance to the predicate devices." While specific numerical acceptance criteria (Total Error Specifications) are not detailed in the provided excerpts, the text indicates that the observed total error for Glucose, Lactate, and tBili met these internal specifications. For the clinical testing section concerning capillary samples, a "TEa" (Total Error Allowable) is given, which serves as an acceptance criterion for those specific tests.
Capillary Samples Acceptance Criteria (TEa) and Performance:
| Analyte | Medical Decision Level (MDL) | Acceptance Criteria (TEa) | Bias at MDL | 95% CI of Bias at MDL |
|---|---|---|---|---|
| Glucose (mg/dL) | 45 | ± 6.0 | 3.9 | 1.0 to 6.2 |
| 120 | ± 10% | 1.8% | -0.1% to 2.9% | |
| 180 | ± 10% | -0.5% | -2.0% to 2.1% | |
| 350 | ± 10% | -0.9% | -4.0% to 1.1% | |
| Lactate (mmol/L) | 2.0 | ± 0.4 | 0.00 | 0.00 to 0.11 |
| 5.0 | ± 15% | 0.0% | 0.00% to 10.3% |
2. Sample sizes used for the test set and data provenance:
- Internal Precision Study - Aqueous Controls: N=120 per analyte/level for each of the 3 controls (GEM System Evaluator and CVP 5 tBili). The study was internal to the manufacturer (Instrumentation Laboratory Co.).
- Internal Precision Study – GEM PAK (Cartridge) Process Control Solutions D and E: N=120 per analyte/level for each of the 2 solutions. The study was internal to the manufacturer.
- Internal Precision Study – Whole Blood: N=120 per analyte/level/sample mode (Normal and Micro) for five different concentrations of whole blood. The study was internal to the manufacturer.
- Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting: N=90 pooled data (30 replicates per level) per analyte/level. This involved 3 external clinical POC sites, suggesting prospective data collection in a point-of-care setting.
- External Precision - Whole Blood: Patient samples were tested at 2 external central laboratories and 1 internal Customer Simulation Laboratory (CSL), and 3 external POC locations. At least two whole blood specimens were analyzed in triplicate daily for 5 days. Specific "N" values for each site and analyte are provided in the tables within the document (e.g., for Glu Normal Mode, POC1 N=51, POC2 N=39, POC3 N=27, CSL N=33, Lab1 N=30, Lab2 N=30). Data provenance is a mix of internal CSL (contrived and native specimens) and external clinical labs and POC sites (patient samples), implying prospective collection of patient samples.
- LoB, LoD, LoQ: Three (3) lots of GEM Premier 5000 PAKs (cartridges) were used.
- Linearity: Nine (9) levels per analyte, each analyzed in triplicate on three (3) GEM Premier 5000 test analyzers. Data provenance appears to be internal.
- Analytical Specificity: Interference study conducted on the GEM Premier 5000. Data provenance appears to be internal.
- Internal Method Comparison: N=373 for Glucose and Lactate, N=163 for tBili. Clinical samples were used, and samples were altered as needed to cover medical decision levels. Data provenance appears to be internal to the manufacturer, comparing to predicate devices.
- Clinical Testing (Method Comparison in POC):
- Glucose and Lactate (Normal Mode): N=489 for Glucose, N=488 for Lactate. Pooled results from 3 external POC sites and 1 internal CSL. This included patient samples and spiked samples (at CSL).
- Glucose and Lactate (Native Capillary Samples): N=171. Pooled results from an external POC site and the internal CSL using finger-stick samples.
- Glucose and Lactate (Contrived Capillary Samples): N=197 for Glucose, N=201 for Lactate. Pooled native capillary samples with additional contrived capillary samples prepared internally.
- Total Bilirubin (Normal, Capillary, and tBili/CO-Ox Modes): Against Roche Cobas 6000: N=53 (Normal), N=58 (Capillary), N=53 (tBili/CO-Ox). Against Ortho Clinical Diagnostics Vitros 5600: N=76 (Normal), N=77 (Capillary), N=77 (tBili/CO-Ox). Pooled results from external POC sites with neonate samples, adult samples, and spiked samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number or qualifications of experts for establishing ground truth. The devices being compared are laboratory diagnostic instruments. Therefore, "ground truth" is likely established by reference methods or predicate devices, which are themselves high-accuracy laboratory instruments (e.g., GEM Premier 4000, ABL 837, Roche Cobas 6000, Ortho Clinical Diagnostics Vitros 5600). The "experts" in this context would be the technicians or clinical laboratory scientists operating these reference systems, though their specific qualifications are not stated.
4. Adjudication method for the test set:
Not applicable. This is a medical device performance study, not a clinical trial with human interpretation requiring adjudication. Performance is assessed by comparing results to established reference methods or predicate devices.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This document pertains to an in vitro diagnostic device for quantitative measurements of analytes, not an AI-assisted diagnostic imaging or interpretation system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the studies presented are essentially "standalone" evaluations of the device's analytical performance, without direct human interpretation being part of the measurement process itself. The device (GEM Premier 5000) provides quantitative measurements, and its accuracy and precision are assessed against reference methods. While human operators are involved in running the device and collecting samples, the device's output is a direct quantitative result, not an interpretation that is then refined or improved by a human.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance studies is established through comparative analysis with predicate devices (GEM Premier 4000 for glucose and lactate, ABL 837 for total bilirubin) and commercially available laboratory reference analyzers (e.g., Roche Cobas 6000, Ortho Clinical Diagnostics Vitros 5600) for total bilirubin. These predicate and reference devices represent highly accurate and established measurement methods in clinical chemistry.
8. The sample size for the training set:
Not applicable. This document describes the validation of a laboratory instrument, not a machine learning model that requires a "training set." The device's performance is based on its internal design, sensors, and chemical reactions, which are validated through empirical studies rather than algorithm training.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" in the context of this device validation.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 14, 2016
INSTRUMENTATION LABORATORY CO. CAROL MARBLE REGULATORY AFFAIRS DIRECTOR 180 HARTWELL ROAD BEDFORD MA 01730
Re: K160402
Trade/Device Name: GEM Premier 5000 (Measured Parameters: Glucose, Lactate and Total Bilirubin)
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA, MQM, KHP Dated: December 8, 2016 Received: December 9, 2016
Dear Ms. Marble:
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. 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.
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 Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney
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) K160402
Device Name
GEM Premier 5000 (Measured Parameters: Glucose, Lactate, Total Bilirubin)
Indications for Use (Describe)
The GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze 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, lactate and total bilirubin from venous, arterial and capillary heparinized whole blood. These parameters aid in the diagnosis of a patient's metabolite balance.
Glucose (Clu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and 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;
- · in the diagnosis of hyperlactatemia.
Total bilirubin measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.
| 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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Image /page/3/Picture/1 description: The image shows the logo for Instrumentation Laboratory, which is a Werfen company. The logo features a stylized "W" made up of three parallelograms in shades of green and blue. The text "Instrumentation Laboratory" is written in a bold, sans-serif font to the right of the "W" symbol. Below the company name, the text "A Werfen Company" is written in a smaller, lighter font.
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 | Carol Marble, Regulatory Affairs DirectorPhone: 781-861-4467Fax: 781-861-4207Email: cmarble@ilww.com |
|---|---|
| ---------------- | ------------------------------------------------------------------------------------------------------------------ |
| Preparation Date | December 8, 2016 |
|---|---|
| ------------------ | ------------------ |
| Device Trade Name | GEM Premier 5000(Measured Parameters: Glucose, Lactate, Total Bilirubin) |
|---|---|
| ------------------- | ------------------------------------------------------------------------------ |
| Predicate Devices | GEM Premier 4000 | K133407 | Glucose and Lactate |
|---|---|---|---|
| ABL 837 | K142898 | Total Bilirubin |
| Regulatory Information | |||||
|---|---|---|---|---|---|
| GEM Premier 5000 | |||||
| Analyte | RegulationSection | Regulatory Description | Class | ProductCode | Panel |
| Glucose | 862.1345 | Glucose test system | II | CGA | |
| Lactate | 862.1450 | Lactic acid test system | I* | KHP | 75 |
| Total Bilirubin | 862.1113 | Bilirubin (total and unbound)in the neonate test system | I(Reserved) | MQM |
- Meets limitations of exemptions per 21 CFR 862.9(c)(9)
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Device Description
The GEM Premier 5000 system provides health care professionals in central laboratory or point-of-care clinical settings with fast, accurate, quantitative measurements of glucose, lactate and total bilirubin from venous, arterial and capillary heparinized whole blood.
| Key Components | Description |
|---|---|
| Analyzer | Employs a unique color touch screen and a simple set of menus andbuttons for user interaction. The analyzer guides operators through thesampling process with simple, clear messages and prompts. |
| GEM Premier 5000 PAK(disposable, multi-use GEM PAK) | Houses all required components necessary to operate the instrumentonce the cartridge is validated. These components include the sensors,CO-Ox/tBili optical cell, Process Control (PC) Solutions, sampler, pumptubing, distribution valve and waste bag. The GEM PAK has flexiblemenus and test volume options to assist facilities in maximizingefficiency.NOTE: The EEPROM on the GEM PAK includes all solution values andcontrols the analyte menu and number of tests.Step 1: After inserting the GEM PAK, the instrument will perform anautomated PAK warm-up during which the sensors arehydrated and a variety of checks occur, all of which takeabout 40 minutes. During warm-up, the instrument requiresno user intervention.Step 2: After GEM PAK warmup, Auto PAK Validation (APV) process isautomatically completed: two completely independentsolutions (PC Solution D and E) that are traceable to NISTstandards, CLSI procedures or internal standards, containingtwo levels of concentration for each analyte, are run by theanalyzer to validate the integrity of the PC Solutions and theoverall performance of the analytical system.NOTE: For total bilirubin, CVP 5 tBili (Calibration Valuation Product)must be run prior to performing tBili samples.Step 3: After successful performance of APV, iQM2 manages thequality control process, replacing external quality controls. |
| Intelligent Quality Management 2(iQM2) | iQM2 is an active quality process control program designed to providecontinuous monitoring of the analytical process before, during andafter sample measurement with real-time, automatic error detection,automatic correction of the system and automatic documentation of allcorrective actions.iQM2 is a statistical process control system that performs 5 types ofcontinuous, quality checks to monitor the performance of the GEMPAK, sensors, CO-Ox, and reagents. These checks include System,Sensor, IntraSpect, Pattern Recognition and Stability Checks. |
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| Indications for Use / Intended Use | |
|---|---|
| GEM Premier 5000 | The GEM Premier 5000 is a portable critical care system for use byhealth care professionals to rapidly analyze heparinized wholeblood samples at the point of health care delivery in a clinicalsetting and in a central laboratory. The instrument providesquantitative measurements of glucose, lactate and total bilirubinfrom venous, arterial and capillary heparinized whole blood. Theseparameters aid in the diagnosis of a patient's metabolite balance.Glucose (Glu) measurement is used in the diagnosis, monitoringand treatment of carbohydrate metabolism disturbances includingdiabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia,and pancreatic islet cell carcinoma. |
| Lactate (Lac) measurement is used:• to evaluate the acid-base status of patients suspected ofhaving lactic acidosis;• to monitor tissue hypoxia and strenuous physical exertion;• in the diagnosis of hyperlactatemia. | |
| Total bilirubin measurement is used to aid in assessing the risk ofkernicterus and hyperbilirubinemia in neonates. |
Special Conditions for Use Statement
-
For prescription use only.
· -
. For clinical laboratory and point-of-care use.
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| Substantial Equivalency | ||||
|---|---|---|---|---|
| The GEM Premier 5000 system is substantially equivalent in function and intended use to the following predicate devices: | ||||
| • Predicate Device No. 1: | GEM Premier 4000 for glucose and lactate. | |||
| • Predicate Device No. 2: | ABL 837 for total bilirubin. | |||
| Item | Predicate Devices | New Device | ||
| Trade Names | GEM Premier 4000ABL 837 | K133407K142898 | GEM Premier 5000 | K160402 |
| Manufacturers | GEM Premier 4000ABL 837 | Instrumentation Laboratory Co.Radiometer Medical ApS | Instrumentation Laboratory Co. | |
| Indicationsfor Use | The GEM Premier 4000 is a portable critical care system for use byhealth care professionals to rapidly analyze whole blood samplesat the point of health care delivery in a clinical setting and in acentral laboratory. The instrument provides quantitativemeasurements of pH, pCO2, pO2, sodium, potassium, chloride,ionized calcium, glucose, lactate, hematocrit, total bilirubin andCO-Oximetry (tHb, O₂Hb, COHb, MetHb, HHb) parameters. Totalbilirubin can also be quantitated from heparinized plasma sampleswhen analyzed in the tBili/CO-Ox mode. These parameters, alongwith derived parameters, aid in the diagnosis of a patient'sacid/base status, electrolyte and metabolite balance and oxygendelivery capacity. Total bilirubin measurements are used in thediagnosis and management of biliary tract obstructions, liverdisease and various hemolytic diseases and disorders involving themetabolism of bilirubin. In neonates, the level of total bilirubin isused to aid in assessing the risk of kernicterus. | The GEM Premier 5000 is a portable critical care system for useby health care professionals to rapidly analyze heparinized wholeblood samples at the point of health care delivery in a clinicalsetting and in a central laboratory. The instrument providesquantitative measurements of glucose, lactate and total bilirubinfrom venous, arterial and capillary heparinized whole blood.These parameters aid in the diagnosis of a patient's metabolitebalance.Glucose (Glu) measurement is used in the diagnosis, monitoringand treatment of carbohydrate metabolism disturbancesincluding diabetes mellitus, neonatal hypoglycemia, idiopathichypoglycemia, and pancreatic islet cell carcinoma.Lactate (Lac) measurement is used:• to evaluate the acid-base status of patients suspected ofhaving lactic acidosis;• to monitor tissue hypoxia and strenuous physical exertion;• in the diagnosis of hyperlactatemia.Total bilirubin measurement is used to aid in assessing the riskof kernicterus and hyperbilirubinemia in neonates. |
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| Substantial Equivalency (Cont.) | ||
|---|---|---|
| NOTE: The comparison on this page is to the predicate device, the GEM Premier 4000, except where notedto the predicate device for Total Bilirubin (tBili), ABL 837. | ||
| Item | Predicate Devices | New Device |
| Trade Names | GEM Premier 4000(All Analytes except tBili)K133407ABL 837Total Bilirubin (tBili)K142898 | GEM Premier 5000K160402 |
| Intended User | Central Laboratory and Point-of-Care | Same |
| Sample Type(Glucose and Lactate) | Heparinized whole blood | Venous, arterial and capillaryheparinized whole blood |
| Sample Type(tBili on ABL 837) | Heparinized whole bloodHeparinized plasma | Venous, arterial and capillaryheparinized whole blood |
| Intended Population(tBili on ABL 837) | Total Bilirubin for adults and neonates | Total Bilirubin for neonates only. |
| Metabolite Measurement | Amperometry: Glucose and Lactate | Same |
| Total Bilirubin ( vs. ABL 837) | Spectrophotometry | Same |
| Sample Introduction | Aspiration | Same |
| PAK Shelf-Life Stability | Up to 180 days | Same |
| PAK Storage Temperature | 15-25°C | Same |
| System Operating Temperature | 12-32°C | Same |
| Operating System Software | Linux-based | Same |
| Calibration | 2-point calibration | Same |
| External QC Material | CVP 1 and 2 | PC Solution D and E (PAK Internal) |
| CVP 3 and 4 | PC Solution D and E (PAK Internal) | |
| CVP 5 tBiliGEM System Evaluator | Same; No Formulation ChangeGEM Premier 5000 claims added | |
| Substantial Equivalency (Cont.) | ||
| NOTE: The comparison on this page is to the predicate device, the GEM Premier 4000, except wherenoted to the predicate device for Total Bilirubin (tBili), ABL 837. | ||
| Item | Predicate Devices | New Device |
| Trade Names | GEM Premier 4000(All Analytes except tBili)K133407ABL 837Total Bilirubin (tBili)K142898 | GEM Premier 5000K160402 |
| Instrument Dimensions | GEM Premier 4000 Instrument:• Height: 18 inches• Width: 12 inches• Depth: 15 inches• Weight: 44 pounds | GEM Premier 5000 Instrument:• Height: 18.6 inches• Width: 13.0 inches• Depth: 16.4 inches• Weight: 45.4 pounds |
| Cartridge (PAK) Dimensions | GEM Premier 4000 Cartridge (PAK):• Height: 6.75 inches• Width: 10 inches• Depth: 8 inches• Weight: 8 pounds | GEM Premier 5000 Cartridge (PAK):• Height: 6.75 inches• Width: 10 inches• Depth: 8 inches• Weight: 8.1 pounds |
| Reportable Range | Analyte | GEM Premier 5000 |
| Glucose4 to 685 mg/dL | 4 to 685 mg/dL | |
| Lactate0.3 to 17.0 mmol/L | 0.3 to 17.0 mmol/L | |
| tBili0.0 to 58.5 mg/dL | 2.0 to 40.0 mg/dL |
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Performance Summary
Internal Precision Study - Aqueous Controls
In accordance with CLSI EP05-A3, an internal 20-day precision study was performed on the GEM Premier 5000, with GEM System Evaluator and CVP 5 tBili. Each of the control levels was run on three (3) GEM Premier 5000 analyzers for twenty (20) days, with two (2) runs per day and one (1) replicate measured per run per level (n=120). All results were within specification.
| Material | Analyte | Level | Mean | N | WithinAnalyzerSD | WithinAnalyzer%CV | Total SD | Total%CV |
|---|---|---|---|---|---|---|---|---|
| GEMSystemEvaluator | Glucose(mg/dL) | Level 1 | 378 | 120 | 10.9 | 2.9% | 11.2 | 3.0% |
| Level 2 | 104 | 120 | 1.6 | 1.6% | 1.6 | 1.6% | ||
| Level 3 | 46 | 120 | 1.3 | 2.7% | 1.3 | 2.7% | ||
| GEMSystemEvaluator | Lactate(mmol/L) | Level 1 | 7.3 | 120 | 0.06 | 0.9% | 0.07 | 0.9% |
| Level 2 | 0.8 | 120 | 0.03 | 3.7% | 0.03 | 3.7% | ||
| Level 3 | 2.5 | 120 | 0.04 | 1.8% | 0.04 | 1.8% | ||
| GEMSystemEvaluator | tBili(mg/dL) | Level 1 | 33.8 | 120 | 0.14 | 0.4% | 0.16 | 0.5% |
| Level 2 | 17.7 | 120 | 0.13 | 0.8% | 0.18 | 1.0% | ||
| Level 3 | 3.3 | 120 | 0.13 | 4.0% | 0.16 | 4.9% | ||
| CVP 5 tBili | tBili(mg/dL) | NA | 4.8 | 120 | 0.13 | 2.6% | 0.18 | 3.7% |
Internal Precision Study – GEM PAK (Cartridge) Process Control Solutions D and E
In accordance with CLSI EP05-A3, an internal 20-day precision study was performed with the GEM PAK (cartridge) Process Control Solutions (PCS) D and E run on three (3) GEM Premier 5000 analyzers for twenty (20) days, with two (2) runs per day and one (1) replicate measured per run per level (N=120 per analyte/per level). All results were within specification.
| Material | Analyte | Mean | N | Within AnalyzerSD | Within Analyzer%CV |
|---|---|---|---|---|---|
| PCS D | Glucose(mg/dL) | 347 | 120 | 1.7 | 0.5% |
| PCS E | Glucose(mg/dL) | 71 | 120 | 0.6 | 0.8% |
| PCS D | Lactate(mmol/L) | 8.0 | 120 | 0.11 | 1.3% |
| PCS E | Lactate(mmol/L) | 1.6 | 120 | 0.02 | 1.3% |
| PCS D | tBili(mg/dL) | 10.4 | 120 | 0.05 | 0.4% |
| PCS E | tBili(mg/dL) | 20.0 | 120 | 0.04 | 0.2% |
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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 5000 analyzers per sample mode for five (5) days, with one (1) run per day and eight (8) replicates measured per run per level (N=120 per analyte/per sample mode). All results were within specification.
Sample Modes and Volumes:
- . Normal Mode 150 µL
- Micro Mode 65 µL
- . tBili / CO-Ox Mode 100 µL
| Analyte | Mode | Level | Mean | N | WithinRunSD | WithinRun%CV | Total SD | Total%CV |
|---|---|---|---|---|---|---|---|---|
| Glucose(mg/dL) | NormalMode | 1 | 24 | 120 | 0.8 | 3.3% | 0.8 | 3.5% |
| 2 | 42 | 120 | 0.8 | 2.0% | 1.1 | 2.7% | ||
| 3 | 120 | 120 | 1.7 | 1.4% | 2.5 | 2.1% | ||
| 4 | 179 | 120 | 3.1 | 1.7% | 4.0 | 2.2% | ||
| 5 | 729 | 120 | 13.1 | 1.8% | 13.4 | 1.8% | ||
| Glucose(mg/dL) | MicroMode | 1 | 26 | 120 | 0.7 | 2.8% | 0.8 | 3.0% |
| 2 | 44 | 120 | 0.8 | 1.8% | 1.2 | 2.7% | ||
| 3 | 118 | 120 | 2.5 | 2.1% | 3.0 | 2.6% | ||
| 4 | 176 | 120 | 2.9 | 1.7% | 4.1 | 2.3% | ||
| 5 | 761 | 120 | 11.6 | 1.5% | 24.9 | 3.3% | ||
| Lactate(mmol/L) | NormalMode | 1 | 0.5 | 120 | 0.05 | 9.4% | 0.05 | 9.4% |
| 2 | 1.8 | 120 | 0.06 | 3.3% | 0.07 | 3.7% | ||
| 3 | 4.9 | 120 | 0.09 | 1.7% | 0.10 | 2.0% | ||
| 4 | 7.8 | 120 | 0.17 | 2.1% | 0.18 | 2.3% | ||
| 5 | 17.9 | 120 | 0.40 | 2.2% | 0.45 | 2.5% | ||
| Lactate(mmol/L) | MicroMode | 1 | 0.5 | 120 | 0.04 | 7.5% | 0.04 | 7.6% |
| 2 | 1.9 | 120 | 0.05 | 2.9% | 0.06 | 3.1% | ||
| 3 | 4.9 | 120 | 0.14 | 2.9% | 0.15 | 3.1% | ||
| 4 | 7.8 | 120 | 0.13 | 1.6% | 0.16 | 2.0% | ||
| Analyte | Mode | Level | Mean | N | WithinRunSD | WithinRun%CV | Total SD | Total%CV |
| 5 | 18.2 | 120 | 0.31 | 1.7% | 0.37 | 2.0% |
{11}------------------------------------------------
Performance Summary (Cont.)
Internal Precision Study – Whole Blood (Cont.)
| Analyte | Mode | Level | Mean | N | WithinRunSD | WithinRun%CV | Total SD | Total%CV |
|---|---|---|---|---|---|---|---|---|
| tBili(mg/dL) | NormalMode | 1 | 3.3 | 120 | 0.12 | 3.5% | 0.24 | 7.3% |
| 2 | 6.2 | 120 | 0.12 | 1.8% | 0.29 | 4.6% | ||
| 3 | 14.1 | 120 | 0.13 | 0.9% | 0.41 | 2.9% | ||
| 4 | 19.7 | 120 | 0.17 | 0.9% | 0.50 | 2.5% | ||
| 5 | 29.6 | 120 | 0.18 | 0.6% | 0.75 | 2.5% | ||
| tBili/CO-OxMode | 1 | 3.3 | 120 | 0.10 | 2.9% | 0.12 | 3.7% | |
| 2 | 6.3 | 120 | 0.13 | 2.0% | 0.19 | 3.0% | ||
| 3 | 14.0 | 120 | 0.14 | 1.0% | 0.27 | 1.9% | ||
| 4 | 19.6 | 120 | 0.17 | 0.9% | 0.36 | 1.8% | ||
| 5 | 29.4 | 120 | 0.16 | 0.5% | 0.51 | 1.7% |
{12}------------------------------------------------
Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting
In accordance with CLSI EP05-A3, a reproducibility study was performed at three (3) external clinical point-of-care (PCC) sites The studies were run by a total of nine (9) different operators on three (3) different GEM Premier 5000 instruments, using a single bot of GEM Premier 5000 PAK (cartidges). Each site used the same lots of GEM System Evaluator (GSE) and CVP 5 tBili, runing each control level in triplicate, twice a day for 5 days, for a total of 30 replicates per level (N=90 pooled). All results at all sites were within specification.
| Pooled Multi-Site POC Data (Cont.) | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Material/Level | InsertRange | Target | SD/CVSpec | Mean | Repeatability | Between-Run | Between-Day | Between-Site | Reproducibility | |||||||
| Analyte | N | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |||||
| Glu(mg/dL) | GSE 1 | 90 | 347-411 | 379 | 5% | 381 | 2.1 | 0.5% | 1.1 | 0.3% | 2.8 | 0.7% | 2.9 | 0.8% | 4.7 | 1.2% |
| GSE 2 | 90 | 93-117 | 105 | 5% | 102 | 0.5 | 0.5% | 0.3 | 0.3% | 0.5 | 0.5% | 0.2 | 0.2% | 0.8 | 0.8% | |
| GSE 3 | 90 | 38-56 | 47 | 3 | 45 | 0.5 | 1.2% | 0.0 | 0.0% | 0.3 | 0.7% | 0.1 | 0.2% | 0.6 | 1.4% | |
| Lac(mmol/L) | GSE 1 | 90 | 6.5-8.1 | 7.3 | 7.5% | 7.2 | 0.06 | 0.8% | 0.06 | 0.8% | 0.05 | 0.7% | 0.00 | 0.0% | 0.09 | 1.3% |
| GSE 2 | 90 | 0.5-1.1 | 0.8 | 0.2 | 0.8 | 0.02 | 2.3% | 0.00 | 0.0% | 0.01 | 1.1% | 0.00 | 0.0% | 0.02 | 2.5% | |
| GSE 3 | 90 | 2.0-3.0 | 2.5 | 0.2 | 2.4 | 0.02 | 0.7% | 0.03 | 1.2% | 0.04 | 1.8% | 0.00 | 0.0% | 0.06 | 2.3% | |
| tBili(mg/dL) | GSE 1 | 90 | 32.5-34.9 | 33.7 | 10% | 33.7 | 0.14 | 0.4% | 0.00 | 0.0% | 0.05 | 0.1% | 0.07 | 0.2% | 0.16 | 0.5% |
| GSE 2 | 90 | 16.9-18.5 | 17.7 | 10% | 17.6 | 0.10 | 0.5% | 0.00 | 0.0% | 0.05 | 0.3% | 0.07 | 0.4% | 0.13 | 0.7% | |
| GSE 3 | 90 | 2.5-3.9 | 3.2 | 0.4 | 3.2 | 0.10 | 3.0% | 0.02 | 0.8% | 0.03 | 0.8% | 0.01 | 0.3% | 0.10 | 3.3% | |
| CVP-5 | 90 | 4.0-6.0 | 5.0 | 10% | 4.9 | 0.11 | 2.2% | 0.00 | 0.0% | 0.05 | 1.0% | 0.12 | 2.5% | 0.17 | 3.5% |
{13}------------------------------------------------
External Precision - Whole Blood
To evaluate whole blood precision on the GEM Premier 5000 system in the central laboratory and point-ofcare (POC) settings, whole blood patient samples were tested at 2 external central laboratories and 1 internal Customer Simulation Laboratory (CSL), as well as at 3 external POC locations. For the central laboratory setting, the studies were performed by 3 operators on 3 GEM Premier 5000 instruments using a single lot of GEM Premier 5000 PAK (cartridge). For the POC setting, the studies were performed by 11 operators on 3 GEM Premier 5000 instruments, using a single lot of GEM Premier 5000 PAK (cartridge). At least two whole blood specimens were analyzed in triplicate daily for 5 days in both normal mode (150 µL) and micro capillary (65 µL) mode. At the internal Customer Simulation Laboratory (CSL), contrived whole blood specimens were analyzed in addition to native specimens in order to cover the low and high medical decision levels of each analyte.
The precision results are summarized below:
| Analyte | Mode | Site | N | Mean | Within Sample%CV or SD |
|---|---|---|---|---|---|
| Glu(mg/dL) | NormalMode | POC1 | 51 | 140 | 1.1% |
| POC2 | 39 | 142 | 1.0% | ||
| POC3 | 27 | 137 | 1.2% | ||
| POC-All | 117 | 140 | 1.1% | ||
| NormalMode | CSL | 33 | 113 | 1.7% | |
| Lab1 | 30 | 163 | 1.0% | ||
| Lab2 | 30 | 132 | 1.0% | ||
| Lab-All | 93 | 135 | 1.2% | ||
| MicroMode | POC1 | 30 | 155 | 1.0% | |
| POC2 | 36 | 146 | 1.0% | ||
| POC3 | 30 | 122 | 0.8% | ||
| POC-All | 96 | 141 | 0.9% | ||
| MicroMode | CSL | 33 | 110 | 0.8% | |
| Lab1 | 30 | 166 | 1.2% | ||
| Lab2 | 30 | 136 | 1.4% | ||
| Lab-All | 93 | 136 | 1.1% |
{14}------------------------------------------------
External Precision – Whole Blood (Cont.)
| Analyte | Mode | Site | N | Mean | Within Sample%CV or SD |
|---|---|---|---|---|---|
| Lactate(mmol/L) | NormalMode | POC1 | 33 | 1.7 | 0.07 |
| POC2 | 12 | 1.8 | 0.03 | ||
| POC3 | 21 | 2.0 | 0.06 | ||
| POC-All | 66 | 1.9 | 0.06 | ||
| CSL | 30 | 1.7 | 0.03 | ||
| Lab1 | 21 | 2.0 | 0.07 | ||
| Lab2 | 15 | 2.0 | 0.06 | ||
| Lab-All | 66 | 1.9 | 0.06 | ||
| MicroMode | POC1 | 27 | 1.9 | 0.06 | |
| POC2 | 33 | 1.6 | 0.05 | ||
| POC3 | 18 | 1.6 | 0.06 | ||
| POC-All | 78 | 1.7 | 0.05 | ||
| CSL | 30 | 1.9 | 0.04 | ||
| Lab1 | 30 | 1.8 | 0.08 | ||
| Lab2 | 12 | 1.9 | 0.06 | ||
| Lab-All | 72 | 1.8 | 0.06 |
{15}------------------------------------------------
External Precision – Whole Blood (Cont.)
| Analyte | Mode | Site | N | Mean | Within Sample%CV or SD |
|---|---|---|---|---|---|
| tBili(mg/dL) | NormalMode | POC1 | 24 | 18.7 | 0.8% |
| POC2 | 24 | 16.8 | 2.0% | ||
| POC3 | 27 | 11.5 | 1.9% | ||
| POC-All | 75 | 15.5 | 1.6% | ||
| CSL | 15 | 18.5 | 0.6% | ||
| Lab1 | 6 | 4.9 | 7.5% | ||
| Lab-All | 21 | 14.6 | 2.5% | ||
| tBili/CO-OxMode | POC1 | 33 | 22.1 | 1.2% | |
| POC2 | 27 | 11.6 | 1.6% | ||
| POC3 | 30 | 11.8 | 1.3% | ||
| POC-All | 90 | 15.5 | 1.4% | ||
| CSL | 15 | 18.3 | 0.7% | ||
| Lab1 | 3 | 8.3 | 2.5% | ||
| Lab-All | 18 | 16.7 | 1.0% |
Note: No Lab 2 results presented for Total Bilirubin.
{16}------------------------------------------------
LoB, LoD and LoQ
In accordance with CLSI EP17-A2, LoB, LoQ and LoQ were established for glucose, lactate and total bilirubin, using three (3) lots of GEM Premier 5000 PAKs (cartridges).
| Analyte | LoB | LoD | LoQ |
|---|---|---|---|
| Glucose (mg/dL) | 0 | 2 | 2 |
| Lactose (mmol/L) | 0.0 | 0.0 | 0.2 |
| Total Bilirubin (mg/dL) | 0.1 | 0.3 | 1.4 |
Following are the combined data results for LoB, LoD and LoQ:
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 each parameter. Each blood level was analyzed in triplicate on three (3) GEM Premier 5000 test analyzers and results compared to 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 | R² | TestedRange | ReportableRange |
|---|---|---|---|---|---|---|---|
| Glucose(mg/dL) | 9 | 9 | 0.982 | -12.489 | 0.995 | 1 to 777 | 4 to 685 |
| Lactate(mmol/L) | 9 | 9 | 1.037 | -0.131 | 0.998 | 0.2 to 25.5 | 0.3 to 17.0 |
| tBili(mg/dL) | 9 | 9 | 1.040 | 0.227 | 0.998 | 1.4 to 43.7 | 2.0 to 40.0 |
{17}------------------------------------------------
Analytical Specificity
In accordance with EP07-A2, an interference study was conducted on the GEM Premier 5000.
The table below and on the next page lists substances that were screen tested with no observed interference on glucose, lactate and/or total bilirubin (tBili) results:
| Substance | Concentration | Tested analytes with no observed interference |
|---|---|---|
| Acetaminophen | 1324 µmol/L | Glucose, Lactate, tBili |
| Acetoacetate | 2 mmol/L | Glucose, Lactate |
| N-acetylcysteine | 10.2 mmol/L | Glucose, Lactate |
| Amoxicillin | 206 µmol/L | tBili |
| Ascorbic acid | 342 µmol/L | Glucose, Lactate, tBili |
| Benzalkonium (Chloride) | 5 mg/L | tBili |
| Bilirubin | 20 mg/dL | tBili |
| Biliverdin | 4 mg/dL | tBili |
| Ceftriaxone | 1460 µmol/L | tBili |
| Chlorpromazine | 6.3 µmol/L | Glucose, Lactate |
| Ciprofloxacin | 30.2 µmol/L | tBili |
| (Sodium) Citrate | 12 mmol/L | Glucose, Lactate |
| Creatinine | 5 mg/dL | Glucose, Lactate |
| Diazepam | 18 µmol/L | tBili |
| Dobutamine | 2 mg/dL | Glucose, Lactate |
| Dopamine | 5.87 µmol/L | Glucose, Lactate |
| Epinephrine | 0.5 µmol/L | tBili |
| Ethanol | 86.8 mmol/L | Glucose, Lactate |
| Evans Blue | 10 mg/L | tBili |
| Fetal Hemoglobin | 75% | tBili |
| Flaxedil (Gallaminetriethiodide) | 5 mg/dL | Glucose, Lactate |
| (Sodium) Fluoride | 105 µmol/L | Glucose, Lactate |
| Fructose | 1 mmol/L | Glucose, Lactate |
| Galactose | 0.84 mmol/L | Glucose, Lactate |
| Gentamycin | 21 µmol/L | tBili |
| Glucose | 1000 mg/dL | Lactate |
| Glycolic acid | 1 mmol/L | Glucose |
{18}------------------------------------------------
| Substance | Concentration | Tested analytes with no observed interference |
|---|---|---|
| Hematocrit | 25% | Glucose |
| Hematocrit | 75% | Glucose |
| Hemoglobin | 20 g/dL | tBili |
| Heparin | 100,000 U/L | Glucose, Lactate |
| β-hydroxybutyrate | 2 mmol/L | Glucose, Lactate |
| Ibuprofen | 2425 µmol/L | Glucose, Lactate |
| Icodextrin | 20 mg/dL | Glucose, Lactate |
| Indocyanine Green | 10 mg/L | tBili |
| Isoniazide | 292 µmol/L | Glucose, Lactate |
| Lactate | 6.6 mmol/L | Glucose |
| Lithium (Chloride) | 3.2 mmol/L | tBili |
| Maltose | 200 mg/dL | Glucose, Lactate |
| Mannose | 20 mg/dL | Glucose, Lactate |
| Methadone | 6.46 µmol/L | tBili |
| Morphine | 1.75 µmol/L | tBili |
| Omeprazole | 17.4 µmol/L | tBili |
| (Sodium) Oxalate | 500 mg/dL | Glucose, Lactate |
| pO2 | 30 mmHg | Glucose, Lactate |
| Pralidoxime iodide | 40 µg/mL | Glucose, Lactate |
| Propofol | 0.05 mg/mL | tBili |
| Pyruvate | 309 µmol/L | Glucose, Lactate |
| Sulfhemoglobin | 10% | tBili |
| Suxamethonium | 68 µmol/L | tBili |
| (Sodium) Thiocyanate | 6880 µmol/L | Glucose, Lactate |
| Thiopental | 248 µmol/L | tBili |
| Thyroxine | 1.29 µmol/L | tBili |
| Urea | 42.9 mmol/L | Glucose, Lactate |
| Uric acid | 1.4 mmol/L | Glucose, Lactate |
| Xylose | 20 mg/dL | Glucose, Lactate |
{19}------------------------------------------------
Analytical Specificity (Cont.)
The table below lists substances that demonstrated with glucose, lactate or total bilirubin (tBil) results and the interfering substance, as well as the bias and its direction (positive / negative):
| InterferingSubstance | AffectedAnalyte | Analyte Concentration | InterferingConcentration Tested | Bias Observed(Mean) | Lowest InterferingConcentration withAnalyte Impact | Bias Observedat the LowestConcentration |
|---|---|---|---|---|---|---|
| Cyanocobalamin | tBili | 4.8 mg/dL | 0.18 g/L | -11% | 0.16 g/L | -10% |
| 13.3 mg/dL | 0.53 g/L | -10% | 0.47 g/L | -10% | ||
| Cyanomethemoglobin | tBili | 5.2 mg/dL | 1.0% | +18% | 0.5% | +10% |
| 15.1 mg/dL | 3.0% | +15% | 2.1% | +10% | ||
| Glycolic Acid | Lactate | 1.0 mmol/L | 0.250 mmol/L | +0.4 mmol/L | 0.237 mmol/L | +0.4 mmol/L |
| 2.9 mmol/L | 0.250 mmol/L | +0.4 mmol/L | 0.241 mmol/L | +0.4 mmol/L | ||
| Hydroxocobalamin | tBili | 5.0 mg/dL | 0.18 g/L | -14% | 0.12 g/L | -10% |
| 14.7 mg/dL | 0.35 g/L | -13% | 0.27 g/L | -10% |
{20}------------------------------------------------
Analytical Specificity (Cont.)
| InterferingSubstance | AffectedAnalyte | Analyte Concentration | InterferingConcentration Tested | Bias Observed(Mean) | Lowest InterferingConcentration withAnalyte Impact | Bias Observedat the LowestConcentration |
|---|---|---|---|---|---|---|
| Hydroxyurea | Glucose | 86 mg/dL | 0.60 mg/dL | +15% | 0.41 mg/dL | +10% |
| Hydroxyurea | Glucose | 115 mg/dL | 0.60 mg/dL | +11% | 0.57 mg/dL | +10% |
| Hydroxyurea | Lactate | 1.0 mmol/L | 0.40 mg/dL | 0.4 mmol/L | 0.37 mg/dL | +0.4 mmol/L |
| Hydroxyurea | Lactate | 2.8 mmol/L | 0.40 mg/dL | 0.5 mmol/L | 0.35 mg/dL | +0.4 mmol/L |
| Methylene Blue | tBili | 5.0 mg/dL | 10 mg/L | -25% | 4.6 mg/L | -10% |
| Methylene Blue | tBili | 14.2 mg/dL | 15 mg/L | -11% | 12.9 mg/L | -10% |
| Turbidity (Intralipid) | tBili | 4.8 mg/dL | 1505 mg/dL | -11% | 1143 mg/dL | -10% |
| Turbidity (Intralipid) | tBili | 14.0 mg/dL | 2006 mg/dL | No Interference Observed |
{21}------------------------------------------------
Internal Method Comparison
In accordance with EP09-A3, an internal method comparison study was conducted using clinical samples to compare the GEM Premier 5000 to the following predicate devices:
- GEM Premier 4000: . Glucose and Lactate
- . ABL 837: Total Bilirubin
Samples were altered as needed to cover the medical decision levels. All parameter levels passed specification for all sample modes.
| Analyte | N | Slope | Intercept | R² | Medical DecisionLevel | Bias at MedicalDecision Level |
|---|---|---|---|---|---|---|
| Glucose(mg/dL) | 373 | 0.985 | 3.746 | 0.997 | 45 | 3.1 |
| 120 | 1.6% | |||||
| 180 | 0.6% | |||||
| 350 | -0.4% | |||||
| Lactate(mmol/L) | 373 | 1.000 | -0.050 | 0.998 | 2.0 | -0.05 |
| 5.0 | -1.0% | |||||
| tBili(mg/dL) | 163 | 0.977 | 0.384 | 0.998 | 3.0 | 0.31 |
| 6.0 | 4.1% | |||||
| 14.0 | 0.4% | |||||
| 20.0 | -0.4% |
{22}------------------------------------------------
Whole Blood Performance at Medical Decision Levels
The data from the internal method comparison and precision studies were combined to assess the performance at medical decision levels.
Total Error was computed based on the following equation and the results were compared to the GEM Premier 5000 Total Error Specifications:
Total Error Observed = Bias + 2 * SD (or %CV)
Note: Previously shown bias and precision data were used in Total Error computations below.
| Analyte | MedicalDecisionLevel | Absolute Value ofBias at MedicalDecision Level | 2*(SD or %CV) | Total Error ObservedBias + 2*(SD or %CV) |
|---|---|---|---|---|
| Glucose(mg/dL) | 45 | 3.1 | 1.7 | 4.8 |
| 120 | 1.6% | 2.9% | 4.5% | |
| 180 | 0.6% | 3.5% | 4.1% | |
| 350 | 0.4% | 3.6% | 4.0% | |
| Lactate(mmol/L) | 2.0 | 0.05 | 0.12 | 0.017 |
| 5.0 | 1.0% | 3.5% | 4.5% | |
| tBili(mg/dL) | 3.0 | 0.31 | 0.24 | 0.55 |
| 6.0 | 4.1% | 3.7% | 7.8% | |
| 14.0 | 0.4% | 1.8% | 2.2% | |
| 20.0 | 0.4% | 1.7% | 2.1% |
{23}------------------------------------------------
Reference Ranges
| Analyte | Reference Range | Unit |
|---|---|---|
| Glu1,2 | 65 to 95 | mg/dL |
| Glu1,2 | 3.6 to 5.3 | mmol/L |
| Lac1 | 0.36 to 0.75 (at rest) | mmol/L |
| Lac1 | 2.24 to 6.76 (at rest) | mg/dL |
| Lac1 | 0.56 to 1.39 (venous) | mmol/L |
| Lac1 | 2.0 to 12.5 (venous) | mg/dL |
| Analyte | Age | Reference Range | Unit |
|---|---|---|---|
| tBili2 | Premature Infant 0 – 1 day | <8.0 | mg/dL |
| Premature Infant 0 – 1 day | <137 | μmol/L | |
| Premature Infant 1 – 2 days | <12.0 | mg/dL | |
| Premature Infant 1 – 2 days | <205 | μmol/L | |
| Premature Infant 3 – 5 days | <16.0 | mg/dL | |
| Premature Infant 3 – 5 days | <274 | μmol/L | |
| Full-term Infant 0 – 1 day | 1.4 – 8.7 | mg/dL | |
| Full-term Infant 0 – 1 day | 24 – 149 | μmol/L | |
| Full-term Infant 1 – 2 days | 3.4 – 11.5 | mg/dL | |
| Full-term Infant 1 – 2 days | 58 – 197 | μmol/L | |
| Full-term Infant 3 – 5 days | 1.5 – 12.0 | mg/dL | |
| Full-term Infant 3 – 5 days | 26 – 105 | μmol/L | |
| >5 days to < 60 years | 0.3 – 1.2 | mg/dL | |
| >5 days to < 60 years | 5 – 21 | μmol/L |
-
- Burtis, Carl and David Bruns, Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, Elsevier Saunders, 7th edition, 2015.
-
- Wu, A., Tietz Clinical Guide to Laboratory Tests, W.B. Saunders Co., St. Louis MO, 4th Edition, 2006.
{24}------------------------------------------------
Clinical Testing
In accordance with EP09-A3, a method comparison study was conducted on the GEM Premier 5000 in the point-of-care (POC) setting using heparinized whole blood patient samples from the intended use population.
- Study Design: .
- . Point-of-Care for glucose and lactate: Sites included three (3) external point-of-care (POC) sites and one (1) internal Customer Simulation Laboratory (CSL) at IL, where three (3) intended POC users were brought on site to run the samples, allowing spiking to cover the claimed measuring ranges.
- . Point-of-Care for tBili: Sites included three (3) external point-of care settings with neonate samples, using adult samples and spiked samples to cover the claimed measuring range.
In each setting, the performance of the GEM Premier 5000 was compared to the GEM Premier 4000, except tBili, which used the commercially available whole blood or chemistry analyzer in use at each facility.
For glucose and lactate, the pooled results from the POC sites and the IL internal Customer Simulation Laboratory (CSL) for the Normal Mode (with samples collected in syringes) are presented below:
| Pooled Point-of-Care Site and CSL Data - Normal Mode (with Syringe Samples) | ||||||
|---|---|---|---|---|---|---|
| Analyte | N | Slope | Intercept | r | Sample Range | |
| Glucose (mg/dL) | 489 | 0.973 | 3.622 | 0.998 | 12 to 619 | |
| Lactate (mmol/L) | 488 | 1.000 | 0.000 | 0.996 | 0.5 to 15.0 |
To support capillary claims for glucose and lactate, finger-stick samples were collected at an external POC site (N=65 native samples) and the IL internal Customer Simulation Laboratory (CSL) (N=106 native samples) with POC operators. The observed total error at the medical decision levels is shown below:
| Pooled Point-of-Care Site and CSL Data with Native Capillary Samples Only | |||||||
|---|---|---|---|---|---|---|---|
| Analyte | N | RangeMin | RangeMax | MDL | Bias atMDL | 95% CI of Bias at MDL | TEa |
| Glucose(mg/dL) | 171 | 68 | 280 | 45 | 3.9 | 1.0 to 6.2 | ± 6.0 |
| 120 | 1.8% | -0.1% to 2.9% | ± 10% | ||||
| 180 | -0.5% | -2.0% to 2.1% | ± 10% | ||||
| 350 | -0.9% | -4.0% to 1.1% | ± 10% | ||||
| Lactate(mmol/L) | 171 | 0.4 | 3.7 | 2.0 | 0.00 | 0.00 to 0.11 | ± 0.4 |
| 5.0 | 0.0% | 0.00% to 10.3% | ± 15% |
{25}------------------------------------------------
Clinical Testing (Cont.)
In addition for glucose and lactate, the data from the native capillary samples (finger-stick samples) previously presented were pooled with contrived capillary samples prepared internally. The regression analysis is shown below:
| Pooled Point-of-Care Site and CSL Data with Additional Contrived Capillary Results | ||||||
|---|---|---|---|---|---|---|
| Analyte | N | Slope | Intercept | r | Sample Range | |
| Glucose (mg/dL) | 197 | 0.966 | 4.775 | 0.997 | 12 to 637 | |
| Lactate (mmol/L) | 201 | 1.000 | 0.000 | 0.995 | 0.4 to 16.4 |
For Total Bilirubin (tBili), the pooled results from the POC sites, with a combination of heel-stick samples (capillary Blood) and syringe (arterial/venous), are presented below for the different instrument modes:
| Normal Mode | |||||
|---|---|---|---|---|---|
| Predicate | N | Slope | Intercept | r | Sample Range |
| tBili (mg/dL) vs.Roche Cobas 6000* | 53 | 1.062 | 0.630 | 0.996 | 3.1 to 39.7 |
| tBili (mg/dL) vs. Ortho ClinicalDiagnostics Vitros 5600** | 76 | 1.076 | -0.099 | 0.996 | 2.0 to 39.7 |
| Capillary Mode | |||||
| Predicate | N | Slope | Intercept | r | Sample Range |
| tBili (mg/dL) vs.Roche Cobas 6000* | 58 | 1.051 | 0.533 | 0.996 | 3.9 to 39.9 |
| tBili (mg/dL) vs. Ortho ClinicalDiagnostics Vitros 5600** | 77 | 1.072 | -0.255 | 0.996 | 2.1 to 39.4 |
| tBili/CO-Ox Mode | |||||
| Predicate | N | Slope | Intercept | r | Sample Range |
| tBili (mg/dL) vs.Roche Cobas 6000* | 53 | 1.068 | 0.404 | 0.996 | 2.0 to 39.7 |
| tBili (mg/dL) vs. Ortho ClinicalDiagnostics Vitros 5600** | 77 | 1.076 | -0.163 | 0.995 | 2.0 to 39.2 |
*tBili data against Roche Cobas 6000 were from one (1) POC site.
**tBili data against Ortho Clinical Diagnostics Vitros 5600 were from two (2) POC sites.
{26}------------------------------------------------
| Conclusion | The technological and functional characteristics of the new GEMPremier 5000 as described above are substantially equivalent to that ofthe predicate devices: GEM Premier 4000 for glucose and lactate, andABL 837 for total bilirubin. |
|---|---|
| The analytical and clinical study results demonstrate that the GEMPremier 5000 is safe and effective for its intended purpose andequivalent in performance to the predicate devices. |
§ 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.