(306 days)
Not Found
No
The description of the "Intelligent Quality Management 2 (iQM2)" mentions "Pattern Recognition" as one of its checks, but the overall description points to a statistical process control system rather than AI/ML. There is no mention of AI, ML, deep learning, neural networks, training data, or any other terms typically associated with AI/ML in the document.
No.
The device is an in vitro diagnostic (IVD) device used to quantitatively measure biomarkers, which aids in diagnosis and monitoring, rather than providing direct therapy.
Yes
The device measures glucose, lactate, and total bilirubin, and the stated "Intended Use / Indications for Use" explicitly states that these "parameters aid in the diagnosis of a patient's metabolite balance" and are "used in the diagnosis" of various conditions.
No
The device description clearly outlines hardware components like an analyzer, a disposable GEM PAK containing sensors and other physical elements, and mentions the analysis of whole blood samples, indicating a physical interaction with biological material. While it includes software for user interaction and quality control (iQM2), it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "rapidly analyze heparinized whole blood samples" and provides "quantitative measurements of glucose, lactate and total bilirubin". These measurements "aid in the diagnosis of a patient's metabolite balance" and are used in the "diagnosis, monitoring and treatment" of various conditions. This aligns directly with the definition of an in vitro diagnostic device, which is intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or other conditions.
- Sample Type: The device analyzes "heparinized whole blood samples", which are specimens taken from the human body.
- Parameters Measured: Glucose, lactate, and total bilirubin are all parameters measured in biological samples to provide diagnostic information.
- Clinical Setting: The device is intended for use in a "clinical setting and in a central laboratory", which are typical environments for IVD use.
- Performance Studies: The document details various performance studies (precision, reproducibility, linearity, analytical specificity, method comparison) which are standard requirements for demonstrating the analytical performance of an IVD.
- Predicate Devices: The mention of predicate devices (GEM Premier 4000 and ABL 837) further indicates that this device is being compared to other devices already classified as IVDs.
- Reference Devices: The comparison to reference devices (Roche Cobas 6000 and Ortho Clinical Diagnostics Vitros 5600) which are laboratory analyzers, reinforces its classification as an IVD.
The information provided clearly demonstrates that the GEM Premier 5000 is designed to perform diagnostic tests on human biological samples outside of the body, which is the core function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CGA, MQM, KHP
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:
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.
NOTE: The EEPROM on the GEM PAK includes all solution values and controls the analyte menu and number of tests.
Step 1: After inserting the GEM PAK, the instrument will perform an automated PAK warm-up during which the sensors are hydrated and a variety of checks occur, all of which take about 40 minutes. During warm-up, the instrument requires no user intervention.
Step 2: After GEM PAK warmup, Auto PAK Validation (APV) process is automatically completed: two completely independent solutions (PC Solution D and E) that are traceable to NIST standards, CLSI procedures or internal standards, containing two levels of concentration for each analyte, are run by the analyzer to validate the integrity of the PC Solutions and the overall 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 the quality control process, replacing external quality controls.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Total bilirubin measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.
Total Bilirubin for neonates only.
Intended User / Care Setting
health care professionals, clinical setting, central laboratory, Point-of-Care (POC) setting, clinical laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Internal Precision Study - Aqueous Controls:
Study type: Internal precision study in accordance with CLSI EP05-A3.
Sample size: Each of the control levels (GEM System Evaluator, CVP 5 tBili) 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).
Key results: All results were within specification.
Internal Precision Study – GEM PAK (Cartridge) Process Control Solutions D and E:
Study type: Internal precision study in accordance with CLSI EP05-A3.
Sample size: Process Control Solutions (PCS) D and E were 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).
Key results: All results were within specification.
Internal Precision Study – Whole Blood:
Study type: Internal precision study in accordance with CLSI EP05-A3.
Sample size: 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).
Key results: All results were within specification.
Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting:
Study type: Reproducibility study in accordance with CLSI EP05-A3.
Sample size: Performed at three (3) external clinical point-of-care (PCC) sites by nine (9) different operators on three (3) different GEM Premier 5000 instruments, using a single lot of GEM Premier 5000 PAK (cartridges). Each site ran each control level (GEM System Evaluator and CVP 5 tBili) in triplicate, twice a day for 5 days, for a total of 30 replicates per level (N=90 pooled).
Key results: All results at all sites were within specification.
External Precision - Whole Blood:
Study type: Evaluation of whole blood precision.
Sample size: Whole blood patient samples tested at 2 external central laboratories and 1 internal Customer Simulation Laboratory (CSL), as well as at 3 external POC locations. Central laboratory setting: 3 operators on 3 GEM Premier 5000 instruments using a single lot of GEM Premier 5000 PAK. POC setting: 11 operators on 3 GEM Premier 5000 instruments using a single lot of GEM Premier 5000 PAK. At least two whole blood specimens analyzed in triplicate daily for 5 days in both normal mode (150 µL) and micro capillary (65 µL) mode. CSL analyzed contrived whole blood specimens in addition to native specimens to cover low and high medical decision levels.
Key results: Precision results were summarized in tables.
LoB, LoD and LoQ:
Study type: Evaluation of Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) in accordance with CLSI EP17-A2.
Sample size: Established using three (3) lots of GEM Premier 5000 PAKs (cartridges). Combined data from LoQ and linearity used to support lower limits of claimed reportable ranges.
Linearity:
Study type: Linearity study in accordance with CLSI EP06-A.
Sample size: Nine (9) levels per analyte prepared by spiking or diluting whole blood. Each blood level analyzed in triplicate on three (3) GEM Premier 5000 test analyzers.
Analytical Specificity:
Study type: Interference study conducted in accordance with EP07-A2.
Key results: Screened substances listed with no observed interference. Substances demonstrating interference listed with bias and direction.
Internal Method Comparison:
Study type: Internal method comparison study in accordance with EP09-A3.
Sample size: N=373 for Glucose and Lactate, N=163 for tBili. Clinical samples used to compare GEM Premier 5000 to predicate devices (GEM Premier 4000 for Glucose and Lactate, ABL 837 for Total Bilirubin). Samples altered to cover medical decision levels.
Key results: All parameter levels passed specification for all sample modes. Slope, Intercept, R² and Bias at Medical Decision Levels were provided.
Whole Blood Performance at Medical Decision Levels:
Study type: Assessment of performance at medical decision levels by combining data from internal method comparison and precision studies.
Key results: Total Error Observed was computed and compared to GEM Premier 5000 Total Error Specifications.
Clinical Testing:
Study type: Method comparison study in accordance with EP09-A3.
Study Design:
Point-of-Care for glucose and lactate: Three (3) external POC sites and one (1) internal Customer Simulation Laboratory (CSL) at IL, where three (3) intended POC users ran samples, allowing spiking to cover claimed measuring ranges.
Point-of-Care for tBili: 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, performance compared to GEM Premier 4000 (except tBili, which used commercially available whole blood or chemistry analyzer).
Key results:
Pooled POC Site and CSL Data - Normal Mode (with Syringe Samples): Glucose (N=489), Lactate (N=488) showed strong correlation (r=0.998 for Glucose, 0.996 for Lactate).
Pooled POC Site and CSL Data with Native Capillary Samples Only: Glucose (N=171) and Lactate (N=171) showed observed total error at medical decision levels.
Pooled POC Site and CSL Data with Additional Contrived Capillary Results: Glucose (N=197), Lactate (N=201) showed strong correlation (r=0.997 for Glucose, 0.995 for Lactate).
For Total Bilirubin (tBili), pooled results from POC sites (heel-stick/capillary and syringe/arterial/venous) for different instrument modes showed strong correlation (r values of 0.995 or 0.996) compared to Roche Cobas 6000 and Ortho Clinical Diagnostics Vitros 5600.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Accuracy, precision, and linearity metrics are provided instead of traditional sensitivity/specificity for diagnostic tests.)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
GEM Premier 4000 K133407, ABL 837 K142898
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands and a bird-like figure at the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
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.
1
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
2
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 Road
Bedford, MA 01730, USA |
| ------------------------- | ------------------------------------------------------------------------------------ |
|---|
| Contact Person | Carol Marble, Regulatory Affairs Director
Phone: 781-861-4467
Fax: 781-861-4207
Email: 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 | Regulation | ||||
| Section | Regulatory Description | Class | Product | ||
| Code | 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)
4
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 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. | |
| NOTE: The EEPROM on the GEM PAK includes all solution values and | |
| controls the analyte menu and number of tests. | |
| Step 1: After inserting the GEM PAK, the instrument will perform an | |
| automated PAK warm-up during which the sensors are | |
| hydrated and a variety of checks occur, all of which take | |
| about 40 minutes. During warm-up, the instrument requires | |
| no user intervention. | |
| Step 2: After GEM PAK warmup, Auto PAK Validation (APV) process is | |
| automatically completed: two completely independent | |
| solutions (PC Solution D and E) that are traceable to NIST | |
| standards, CLSI procedures or internal standards, containing | |
| two levels of concentration for each analyte, are run by the | |
| analyzer to validate the integrity of the PC Solutions and the | |
| overall 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 the | |
| quality control process, replacing external quality controls. | |
| 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. |
5
| Indications for Use / Intended Use | |
|---|---|
| GEM Premier 5000 | 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 (Glu) 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. |
Special Conditions for Use Statement
-
For prescription use only.
· -
. For clinical laboratory and point-of-care use.
6
| 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 4000 | |||
| ABL 837 | K133407 | |||
| K142898 | GEM Premier 5000 | K160402 | ||
| Manufacturers | GEM Premier 4000 | |||
| ABL 837 | Instrumentation Laboratory Co. | |||
| Radiometer Medical ApS | Instrumentation Laboratory Co. | |||
| Indications | ||||
| for Use | The GEM Premier 4000 is a portable critical care system for use by | |||
| health care professionals to rapidly analyze 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 pH, pCO2, pO2, sodium, potassium, chloride, | ||||
| ionized calcium, glucose, lactate, hematocrit, total bilirubin and | ||||
| CO-Oximetry (tHb, O₂Hb, COHb, MetHb, HHb) parameters. Total | ||||
| bilirubin can also be quantitated from heparinized plasma samples | ||||
| when analyzed in the tBili/CO-Ox mode. These parameters, along | ||||
| with derived parameters, aid in the diagnosis of a patient's | ||||
| acid/base status, electrolyte and metabolite balance and oxygen | ||||
| delivery capacity. Total bilirubin measurements are used in the | ||||
| diagnosis and management of biliary tract obstructions, liver | ||||
| disease and various hemolytic diseases and disorders involving the | ||||
| metabolism of bilirubin. In neonates, the level of total bilirubin is | ||||
| used to aid in assessing the risk of kernicterus. | 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 (Glu) 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. |
7
| Substantial Equivalency (Cont.) | ||
|---|---|---|
| NOTE: The comparison on this page is to the predicate device, the GEM Premier 4000, except where noted | ||
| to the predicate device for Total Bilirubin (tBili), ABL 837. | ||
| Item | Predicate Devices | New Device |
| Trade Names | GEM Premier 4000 | |
| (All Analytes except tBili) | ||
| K133407 | ||
| ABL 837 | ||
| Total Bilirubin (tBili) | ||
| K142898 | GEM Premier 5000 | |
| K160402 | ||
| Intended User | Central Laboratory and Point-of-Care | Same |
| Sample Type | ||
| (Glucose and Lactate) | Heparinized whole blood | Venous, arterial and capillary |
| heparinized whole blood | ||
| Sample Type | ||
| (tBili on ABL 837) | Heparinized whole blood | |
| Heparinized plasma | Venous, arterial and capillary | |
| heparinized 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 tBili | ||
| GEM System Evaluator | Same; No Formulation Change | |
| GEM Premier 5000 claims added | ||
| Substantial Equivalency (Cont.) | ||
| NOTE: The comparison on this page is to the predicate device, the GEM Premier 4000, except where | ||
| noted to the predicate device for Total Bilirubin (tBili), ABL 837. | ||
| Item | Predicate Devices | New Device |
| Trade Names | GEM Premier 4000 | |
| (All Analytes except tBili) | ||
| K133407 |
ABL 837
Total Bilirubin (tBili)
K142898 | GEM Premier 5000
K160402 |
| 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 |
| | Glucose
4 to 685 mg/dL | 4 to 685 mg/dL |
| | Lactate
0.3 to 17.0 mmol/L | 0.3 to 17.0 mmol/L |
| | tBili
0.0 to 58.5 mg/dL | 2.0 to 40.0 mg/dL |
8
9
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 | Within
Analyzer
SD | Within
Analyzer
%CV | Total SD | Total
%CV |
|----------------------------|---------------------|---------|------|-----|--------------------------|---------------------------|----------|--------------|
| GEM
System
Evaluator | 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% |
| GEM
System
Evaluator | 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% |
| GEM
System
Evaluator | 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 Analyzer
SD | 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% |
10
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 | Within
Run
SD | Within
Run
%CV | Total SD | Total
%CV |
|---------------------|----------------|-------|------|-----|---------------------|----------------------|----------|--------------|
| Glucose
(mg/dL) | Normal
Mode | 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) | Micro
Mode | 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) | Normal
Mode | 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) | Micro
Mode | 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 | Within
Run
SD | Within
Run
%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 | Within
Run
SD | Within
Run
%CV | Total SD | Total
%CV |
|---------------------|----------------|-------|------|------|---------------------|----------------------|----------|--------------|
| tBili
(mg/dL) | Normal
Mode | 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-Ox
Mode | 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 | Insert | |||||||||||||||
| Range | Target | SD/CV | ||||||||||||||
| Spec | 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) | Normal
Mode | POC1 | 51 | 140 | 1.1% |
| | | POC2 | 39 | 142 | 1.0% |
| | | POC3 | 27 | 137 | 1.2% |
| | | POC-All | 117 | 140 | 1.1% |
| | Normal
Mode | CSL | 33 | 113 | 1.7% |
| | | Lab1 | 30 | 163 | 1.0% |
| | | Lab2 | 30 | 132 | 1.0% |
| | | Lab-All | 93 | 135 | 1.2% |
| | Micro
Mode | POC1 | 30 | 155 | 1.0% |
| | | POC2 | 36 | 146 | 1.0% |
| | | POC3 | 30 | 122 | 0.8% |
| | | POC-All | 96 | 141 | 0.9% |
| | Micro
Mode | 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) | Normal
Mode | 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 |
| | Micro
Mode | 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) | Normal
Mode | 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-Ox
Mode | 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 | # of
Levels | N per
Level | Slope | Intercept | R² | Tested
Range | Reportable
Range |
|---------------------|----------------|----------------|-------|-----------|-------|-----------------|---------------------|
| 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 (Gallamine | ||
| triethiodide) | 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):
| Interfering
Substance | Affected
Analyte | Analyte Concentration | Interfering
Concentration Tested | Bias Observed
(Mean) | Lowest Interfering
Concentration with
Analyte Impact | Bias Observed
at the Lowest
Concentration |
|--------------------------|---------------------|-----------------------|-------------------------------------|-------------------------|------------------------------------------------------------|-------------------------------------------------|
| 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.)
| Interfering
Substance | Affected
Analyte | Analyte Concentration | Interfering
Concentration Tested | Bias Observed
(Mean) | Lowest Interfering
Concentration with
Analyte Impact | Bias Observed
at the Lowest
Concentration |
|--------------------------|---------------------|-----------------------|-------------------------------------|--------------------------|------------------------------------------------------------|-------------------------------------------------|
| 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 Decision
Level | Bias at Medical
Decision 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 | Medical
Decision
Level | Absolute Value of
Bias at Medical
Decision Level | 2*(SD or %CV) | Total Error Observed
Bias + 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 | 5 days to 5 days to |