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K Number
K183549
Device Name
GEM Premier ChemSTAT
Manufacturer
Instrumentation Laboratory Co.
Date Cleared
2019-02-16

(58 days)

Product Code
JGSCEMCGZJFPJJE
Regulation Number
862.1665
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of Sodium (Na+), Ionized Calcium (Ca++) and Chloride (C1-) from arterial and venous heparinized whole blood. These parameters. along with derived parameters, aid in the diagnosis of a patient's electrolyte balance. Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes: - · Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance. - · Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. - Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. - · Chloride (Cl-) measurements are used in the diagnosis and metabolic and metabolic disorders, such as, cystic fibrosis and diabetic acidosis.
Device Description
The GEM Premier ChemSTAT is a portable system that analyzes arterial and venous lithium heparinized whole blood at the point of health care delivery in a clinical setting and in a central laboratory for Na*, K*, Ca** and Cl . All tests are included in a single self-contained, disposable GEM Premier ChemSTAT PAK (cartridge). Key Components: Analyzer: The GEM Premier ChemSTAT analyzer has the internal logic and processing power necessary to perform analysis. It employs a unique touch-sensitive color screen and a simple set of menus and buttons for user interaction. The analyzer guides operators through the sampling process with simple, clear messages and prompts. PAK (Cartridge): The disposable, multi-use GEM Premier ChemSTAT PAK is a completely closed cartridge that houses all components necessary to operate the instrument once the GEM PAK is validated. These components include the sensors, Process Control (PC) Solutions, sampler, and waste bag. The values of all PC Solutions are read from the GEM PAK Electronically Erasable Programmable Read Only Memory (EEPROM) chip. The components and processes used to manufacture the PC Solutions in the GEM PAK are traceable to National Institute of Standards and Technology (NIST) standards, Clinical & Laboratory Standards Institute (CLSI) procedures or other internal standards, where available and appropriate. The GEM Premier ChemSTAT PAK has flexible menus to assist facilities in maximizing efficiency. As part of this program, GEM ChemSTAT CVP (Calibration Valuation Products) are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up. Intelligent Quality Management (iQM): Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier ChemSTAT system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process before and after sample measurement with real-time, automatic error detection, automatic correction and automatic documentation of all corrective actions. iQM performs 4 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, and reagents throughout the cartridge use-life. These checks include System, Sensor, Pattern Recognition (PR) and Stability Checks.
More Information

K133407

Not Found

Unknown
The document mentions "Pattern Recognition (PR)" as part of the Intelligent Quality Management (iQM) system. While pattern recognition can be a component of AI/ML, the description is not detailed enough to definitively confirm the use of AI/ML technology. It could refer to simpler statistical pattern matching or more complex ML algorithms.

No

The device is an in vitro diagnostic device used to measure electrolytes in whole blood samples, which aids in diagnosis and treatment, but it does not directly provide therapeutic treatment.

Yes
The "Intended Use / Indications for Use" section explicitly states that the parameters measured by the device "aid in the diagnosis of a patient's electrolyte balance" and that measurements are "used in the diagnosis and treatment of" specific medical conditions.

No

The device description clearly outlines hardware components like the "Analyzer" and the "PAK (Cartridge)" which house sensors, solutions, and a waste bag. While software is mentioned for user interaction and quality management (iQM), the device is fundamentally a physical system for analyzing blood samples.

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 lithium heparinized whole blood samples" and provides "quantitative measurements of Sodium (Na+), Ionized Calcium (Ca++) and Chloride (C1-) from arterial and venous heparinized whole blood." It also states that these parameters "aid in the diagnosis of a patient's electrolyte balance." Analyzing human samples (whole blood) to provide information for diagnosis is the core definition of an IVD.
  • Sample Type: The device analyzes "lithium heparinized whole blood samples," which are biological specimens taken from the human body.
  • Parameters Measured: The device measures specific analytes (Na+, Ca++, Cl-) in these samples.
  • Diagnostic Aid: The results of the analysis are used to "aid in the diagnosis of a patient's electrolyte balance" and specific disease conditions related to electrolyte levels.

All of these points align with the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of Sodium (Na+), Ionized Calcium (Ca++) and Chloride (C1-) from arterial and venous heparinized whole blood. These parameters. along with derived parameters, aid in the diagnosis of a patient's electrolyte balance.

Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:

  • Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
  • Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
  • Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
  • Chloride (Cl-) measurements are used in the diagnosis and metabolic and metabolic disorders, such as, cystic fibrosis and diabetic acidosis.

Product codes (comma separated list FDA assigned to the subject device)

JGS, CEM, JFP, CGZ, JJE

Device Description

The GEM Premier ChemSTAT is a portable system that analyzes arterial and venous lithium heparinized whole blood at the point of health care delivery in a clinical setting and in a central laboratory for Na+, K+, Ca++ and Cl. All tests are included in a single self-contained, disposable GEM Premier ChemSTAT PAK (cartridge).

Key Components:

  • Analyzer: The GEM Premier ChemSTAT analyzer has the internal logic and processing power necessary to perform analysis. It employs a unique touch-sensitive color screen and a simple set of menus and buttons for user interaction. The analyzer guides operators through the sampling process with simple, clear messages and prompts.
  • PAK (Cartridge): The disposable, multi-use GEM Premier ChemSTAT PAK is a completely closed cartridge that houses all components necessary to operate the instrument once the GEM PAK is validated. These components include the sensors, Process Control (PC) Solutions, sampler, and waste bag. The values of all PC Solutions are read from the GEM PAK Electronically Erasable Programmable Read Only Memory (EEPROM) chip. The components and processes used to manufacture the PC Solutions in the GEM PAK are traceable to National Institute of Standards and Technology (NIST) standards, Clinical & Laboratory Standards Institute (CLSI) procedures or other internal standards, where available and appropriate. The GEM Premier ChemSTAT PAK has flexible menus to assist facilities in maximizing efficiency. As part of this program, GEM ChemSTAT CVP (Calibration Valuation Products) are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up.
  • Intelligent Quality Management (iQM): Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier ChemSTAT system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process before and after sample measurement with real-time, automatic error detection, automatic correction and automatic documentation of all corrective actions. iQM performs 4 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, and reagents throughout the cartridge use-life. These checks include System, Sensor, Pattern Recognition (PR) and Stability Checks.

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

Not Found

Intended User / Care Setting

health care professionals / clinical setting and in a central 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 – Whole Blood:
    • Type: Precision study
    • Sample Size: N=120 per level for 5 levels for each analyte (Na+, K+, Ca++, Cl-)
    • Key Results: All results were within specification. Data provided for Within Run SD and %CV, Analyzer-to-Analyzer SD and %CV, and Total SD and %CV for each analyte level.
  • Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting:
    • Type: Reproducibility study
    • Sample Size: N=90 per control level (pooled across 3 sites)
    • Data Source: Controls at three (POC) sites, using a single Intern PAKs (cartridges).
    • Annotation Protocol: Studies run by a total of nine (9) different operators on six (6) different GEM Premier ChemSTAT instruments. Each site used seven (7) levels of quality control material for each analyte (2 levels of GEM ChemSTAT PVP), running each control level in triplicate, twice a day for 5 days.
    • Key Results: All results at all sites were within specification. Data provided for Repeatability, Between-Run, Between-Day, Between-Site, and Reproducibility (SD and %CV) for each control level for all analytes.
  • External Precision – Whole Blood:
    • Type: Precision study
    • Sample Size: Total N=195 (Pooled) for the main range, and N=9 (Pooled) for extreme values for each analyte (Na+, K+, Ca++, Cl-).
    • Data Source: Whole blood patient samples at three (3) external clinical point-of-care (POC) sites.
    • Annotation Protocol: Studies run by six (6) different operators on three (3) different GEM Premier ChemSTAT instruments, using a single lot of GEM Premier ChemSTAT PAKs (cartridges). Less than 10% of samples included in the study were contrived. Data analyzed by partitioning into Fixed Acceptance Range (Constant SD) or Variable Acceptance Range (Constant %CV).
    • Key Results: All results at all sites were within specification. Data presented for Mean and Within Sample SD or %CV for each site and pooled.
  • LoB, LoD and LoQ:
    • Type: Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) establishment.
    • Data Source: Three (3) lots of GEM Premier ChemSTAT PAKs (cartridges).
    • Key Results: LoB, LoD, and LoQ values established for Na+, K+, Ca++, and Cl-.
  • Linearity:
    • Type: Linearity study
    • Sample Size: 9 levels per analyte, 18 replicates per level.
    • Data Source: Whole blood (spiked or diluted).
    • Annotation Protocol: Each blood level was analyzed in triplicate on six (6) GEM Premier ChemSTAT test analyzers and results compared to the reference analyzer.
    • Key Results: Linear relationship demonstrated for Na+, K+, Ca++, and Cl- across claimed reportable ranges with R2 values between 0.9984 and 0.9998.
  • Analytical Specificity:
    • Type: Interference study.
    • Key Results: Several test substances screened showed no observed interference. Hemoglobin (Hemolysis) and Triglyceride (Intralipid) showed interference with Potassium, and Perchlorate showed interference with Chloride, with specific biases reported.
  • Clinical Testing:
    • Type: Method comparison study.
    • Sample Size: 435 to 444 patient samples per analyte.
    • Data Source: Lithium heparinized whole blood patient samples from the intended use population at three (3) point-of-care (POC) sites. Less than 10% of samples included in the study were contrived.
    • Key Results: The pooled results showed slopes close to 1.0 and R values close to 1.0 (ranging from 0.987 to 0.999) when compared to the predicate device, indicating substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found (For classification of device)
Precision metrics (SD, %CV) and Linearity metrics (Slope, Intercept, R2) are reported in the performance studies.

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.

K133407

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

§ 862.1665 Sodium test system.

(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.

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February 16, 2019

Instrumentation Laboratory Co. Gabriella Erdosy Regulatory Affairs Manager 180 Hartwell Road Bedford. MA 01730

Re: K183549

Trade/Device Name: GEM Premier ChemSTAT Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Code: JGS, CEM, JFP, CGZ, JJE Dated: December 19, 2018 Received: December 20, 2018

Dear Gabriella Erdosy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, vou may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Kellie B. Kelm -S

Courtney H. Lias, Ph.D. for Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183549

Device Name GEM Premier ChemSTAT

Indications for Use (Describe)

The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of Sodium (Na+), Ionized Calcium (Ca++) and Chloride (C1-) from arterial and venous heparinized whole blood. These parameters. along with derived parameters, aid in the diagnosis of a patient's electrolyte balance.

Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:

  • · Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
  • · Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
  • Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
  • · Chloride (Cl-) measurements are used in the diagnosis and metabolic and metabolic disorders, such as, cystic fibrosis and diabetic acidosis.

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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K183549: GEM Premier ChemSTAT with Na*, K*, Ca** and Cl

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 | Gabriella Erdosy
Phone: 781-861-4571
Fax: 781-861-4207
Email: gerdosy@ilww.com |
| Preparation Date | February 15, 2019 |
| Device Trade Name | GEM Premier ChemSTAT |

Predicate DeviceGEM Premier 4000K133407
---------------------------------------------
Regulatory Information
DeviceRegulation
SectionRegulatory DescriptionClassificationProduct
CodePanel
Analyzer862.2160Analyzer, chemistry
(photometric, discrete), for
clinical useClass I
(Exempt)JJE
Sodium862.1665Sodium test systemClass IIJGSChemistry
(75)
Potassium862.1600Potassium test systemClass IICEM
Ionized Calcium862.1145Calcium test systemClass IIJFP
Chloride862.1170Chloride test systemClass IICGZ

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Device Description

The GEM Premier ChemSTAT is a portable system that analyzes arterial and venous lithium heparinized whole blood at the point of health care delivery in a clinical setting and in a central laboratory for Na*, K*, Ca** and Cl . All tests are included in a single self-contained, disposable GEM Premier ChemSTAT PAK (cartridge).

Key ComponentsDescription
AnalyzerThe GEM Premier ChemSTAT analyzer has the internal logic and
processing power necessary to perform analysis. It employs a
unique touch-sensitive color screen and a simple set of menus and
buttons for user interaction. The analyzer guides operators through
the sampling process with simple, clear messages and prompts.
PAK (Cartridge)The disposable, multi-use GEM Premier ChemSTAT PAK is a
completely closed cartridge that houses all components necessary
to operate the instrument once the GEM PAK is validated. These
components include the sensors, Process Control (PC) Solutions,
sampler, and waste bag.
The values of all PC Solutions are read from the GEM PAK
Electronically Erasable Programmable Read Only
Memory
(EEPROM) chip. The components and processes used to
manufacture the PC Solutions in the GEM PAK are traceable to
National Institute of Standards and Technology (NIST) standards,
Clinical & Laboratory Standards Institute (CLSI) procedures or other
internal standards, where available and appropriate.
The GEM Premier ChemSTAT PAK has flexible menus to assist
facilities in maximizing efficiency.
As part of this program, GEM ChemSTAT CVP (Calibration Valuation
Products) are external solutions intended to complete the
calibration process and final accuracy assessment of the iQM
cartridge calibration following warm-up.

5

Device Description (Cont.)
Intelligent Quality Management
(iQM)Intelligent Quality Management (iQM) is used as the quality
control and assessment system for the GEM Premier ChemSTAT
system. iQM is an active quality process control program
designed to provide continuous monitoring of the analytical
process before and after sample measurement with real-time,
automatic error detection, automatic correction and automatic
documentation of all corrective actions.

iQM performs 4 types of continuous, quality checks to monitor
the performance of the GEM PAK, sensors, and reagents
throughout the cartridge use-life. These checks include System,
Sensor, Pattern Recognition (PR) and Stability Checks. |

6

Indications for Use / Intended Use

The GEM Premier ChemSTAT is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of Sodium (Na*), Potassium (K*), Ionized Calcium (Ca*) and Chloride (Cl) from arterial and venous heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's electrolyte balance.

Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:

  • . Sodium (Na*) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
  • . Potassium (K*) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
  • lonized calcium (Ca*) measurements are used in the diagnosis and treatment of parathyroid . disease, a variety of bone diseases, chronic renal disease and tetany.
  • . Chloride (Cl) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as, cystic fibrosis and diabetic acidosis.

Special Conditions for Use Statement

  • For prescription use only.
  • . For clinical laboratory and point-of-care use

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Substantial Equivalency
ItemCandidate Device:
GEM Premier ChemSTATPredicate Device:
GEM Premier 4000
510(k) No.PendingK133407
ManufacturerInstrumentation Laboratory Co.Same
Intended UseA portable critical care system for use by
health care professionals to rapidly
analyze lithium heparinized whole
blood samples at the point of health
care delivery in a clinical setting and in a
central laboratory. The instrument
provides quantitative measurements of
Sodium (Na+), Potassium (K+), Ionized
Calcium (Ca++) and Chloride (Cl-) from
arterial and venous heparinized whole
blood. These parameters, along with
derived parameters, aid in the diagnosis
of a patient's electrolyte balance.Same
Intended UserCentral Laboratory and Point-of-CareSame
Measurement PrincipleNa+PotentiometrySame
K+PotentiometrySame
Ca++PotentiometrySame
Cl-PotentiometrySame
Sample Volume150 μL65 to 150 μL
(dependent on sample mode)
Sample TypeLithium heparinized whole blood
(arterial and venous)Same
(arterial, venous and capillary)
Reportable RangeNa+100 to 180 mmol/LSame
K+0.3 to 19.0 mmol/L0.2 to 19.0 mmol/L
Ca++0.10 to 4.25 mmol/LSame
Cl-40 to 158 mmol/LSame
Substantial Equivalency (Cont.)
ItemCandidate Device:
GEM Premier ChemSTATPredicate Device:
GEM Premier 4000
PAK Storage Temperature15-25°CSame
Calibration2-point calibrationSame
Instrument Sample IntroductionAspirationSame
Instrument Operating Temperature12-32°CSame
Software Operating SystemLinux-basedSame
Instrument User InterfaceMenu Driven Touch ScreenSame

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Performance Summary

Internal Precision Study – Whole Blood

In accordance with CLS EPO5-A3, an internal precisions of ve (5) different concentrations of whole blood per analyte, each un on three (3) GEM Premier ChemSTAT analyzers for five (5) days, with one (1) run per day and eight (8) replicates measured per run per level (N=120).

All results were within specification.

| Analyte | Whole
Blood
Level | N | Mean | Within Run
SD | Within Run
%CV | Analyzer-
to-
Analyzer
SD | Analyzer-
to-
Analyzer
%CV | Total
SD | Total
%CV |
|-----------------|-------------------------|-----|------|------------------|-------------------|------------------------------------|-------------------------------------|-------------|--------------|
| Na+
(mmol/L) | Level 1 | 120 | 106 | 0.5 | 0.5% | 0.4 | 0.3% | 0.6 | 0.6% |
| | Level 2 | 120 | 118 | 0.4 | 0.4% | 0.4 | 0.4% | 0.6 | 0.5% |
| | Level 3 | 120 | 132 | 0.5 | 0.4% | 0.0 | 0.0% | 0.5 | 0.4% |
| | Level 4 | 120 | 152 | 0.7 | 0.4% | 0.3 | 0.2% | 0.8 | 0.5% |
| | Level 5 | 120 | 175 | 0.6 | 0.3% | 0.6 | 0.3% | 0.8 | 0.5% |
| K+
(mmol/L) | Level 1 | 120 | 1.5 | 0.03 | 2.2% | 0.01 | 0.8% | 0.04 | 2.3% |
| | Level 2 | 120 | 3.4 | 0.03 | 0.9% | 0.01 | 0.4% | 0.03 | 0.9% |
| | Level 3 | 120 | 5.8 | 0.04 | 0.7% | 0.02 | 0.4% | 0.04 | 0.7% |
| | Level 4 | 120 | 7.9 | 0.04 | 0.5% | 0.02 | 0.3% | 0.05 | 0.6% |
| | Level 5 | 120 | 18.1 | 0.04 | 0.2% | 0.11 | 0.6% | 0.12 | 0.6% |

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Internal Precision Study – Whole Blood (Cont.)

| Analyte | Whole
Blood
Level | N | Mean | Within Run
SD | Within Run
%CV | Analyzer-
to-
Analyzer
SD | Analyzer-
to-
Analyzer
%CV | Total
SD | Total
%CV |
|------------------|-------------------------|-----|------|------------------|-------------------|------------------------------------|-------------------------------------|-------------|--------------|
| Ca++
(mmol/L) | Level 1 | 120 | 0.19 | 0.003 | 1.7% | 0.004 | 2.3% | 0.005 | 2.8% |
| | Level 2 | 120 | 0.38 | 0.004 | 1.1% | 0.003 | 0.7% | 0.005 | 1.3% |
| | Level 3 | 120 | 0.82 | 0.007 | 0.8% | 0.3% | 0.3% | 0.007 | 0.8% |
| | Level 4 | 120 | 1.60 | 0.012 | 0.7% | 0.010 | 0.7% | 0.016 | 1.0% |
| | Level 5 | 120 | 3.79 | 0.029 | 0.8% | 0.039 | 1.0% | 0.048 | 1.3% |
| Cl-
(mmol/L) | Level 1 | 120 | 54 | 0.4 | 0.7% | 0.5 | 0.9% | 0.6 | 1.1% |
| | Level 2 | 120 | 75 | 0.3 | 0.4% | 0.6 | 0.8% | 0.7 | 0.9% |
| | Level 3 | 120 | 90 | 0.5 | 0.5% | 0.8 | 0.9% | 0.9 | 1.0% |
| | Level 4 | 120 | 118 | 0.6 | 0.5% | 1.4 | 1.2% | 1.5 | 1.3% |
| | Level 5 | 120 | 142 | 0.5 | 0.3% | 2.0 | 1.4% | 2.1 | 1.5% |

11

Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting

In accordance with CLSI EP05-A3, a reproducibility study was performed with controls at three (POC) sites. The studies were run by a total of nine (9) different operators on six (6) different GEM Premier ChemSTAT instruments, using a single Intern PAKs (cartridges). Each site used seven (7) levels of quality control material for each analyte (2 levels of GEM ChemSTAT PVP), running each control level in triplicate, twice a day for 5 days, for a total of 30 replicates per level (N=90 pooled across 3 sites).

Pooled Multi-Site POC Data
AnalyteControl
LevelNMeanRepeatabilityBetween-RunBetween-DayBetween-SiteReproducibility
SD%CVSD%CVSD%CVSD%CVSD%CV
Na+
(mmol/L)CVP Level 1901240.80.7%0.40.3%0.00.0%0.50.4%1.00.8%
CVP Level 2901560.70.4%0.40.2%0.20.1%0.00.0%0.80.5%
PVP Level 1901060.50.4%0.00.0%0.20.2%0.30.3%0.60.6%
PVP Level 2901250.40.3%0.30.2%0.00.0%0.40.3%0.60.5%
PVP Level 3901400.60.4%0.60.4%0.00.0%0.10.1%0.80.6%
PVP Level 4901550.60.4%0.30.2%0.20.1%0.20.1%0.70.5%
PVP Level 5901770.90.5%0.10.0%0.50.3%0.70.4%1.20.7%
Pooled Multi-Site POC Data
AnalyteControl
LevelNMeanRepeatabilityBetween-RunBetween-DayBetween-SiteReproducibility
SD%CVSD%CVSD%CVSD%CVSD%CV
K+
(mmol/L)CVP Level 1902.50.000.0%0.020.7%0.000.0%0.000.0%0.020.7%
CVP Level 2907.40.030.4%0.050.7%0.000.0%0.010.1%0.060.8%
K+
(mmol/L)PVP Level 1901.20.000.0%0.000.0%0.000.0%0.000.0%0.000.0%
PVP Level 2902.50.000.0%0.000.0%0.000.0%0.000.0%0.000.0%
PVP Level 3904.60.030.6%0.040.9%0.000.0%0.020.5%0.051.2%
PVP Level 4907.30.030.4%0.020.3%0.000.0%0.020.2%0.040.5%
PVP Level 5909.60.040.5%0.010.1%0.020.2%0.060.6%0.080.8%
Ca++
(mmol/L)CVP Level 1900.890.0091.0%0.0010.1%0.0000.0%0.0020.3%0.0101.1%
CVP Level 2901.540.0090.6%0.0070.4%0.0000.0%0.0020.1%0.0110.7%
PVP Level 1900.370.0041.1%0.0030.9%0.0000.0%0.0030.9%0.0061.7%
PVP Level 2900.900.0060.6%0.0050.5%0.0000.0%0.0030.4%0.0080.9%
PVP Level 3901.100.0070.7%0.0080.7%0.0000.0%0.0000.0%0.0111.0%
Ca++
(mmol/L)PVP Level 4901.560.0090.6%0.0060.4%0.0000.0%0.0020.2%0.0110.7%
PVP Level 5902.230.0150.7%0.0110.5%0.0030.1%0.0000.0%0.0190.9%
Pooled Multi-Site POC Data
AnalyteControl
LevelNMeanRepeatabilityBetween-RunBetween-DayBetween-SiteReproducibility
SD%CVSD%CVSD%CVSD%CVSD%CV
Cl-
(mmol/L)CVP Level 190910.60.6%0.30.3%0.20.2%0.30.3%0.70.8%
CVP Level 2901350.40.3%0.10.1%0.10.1%2.11.5%2.11.6%
PVP Level 190720.30.5%0.00.0%0.30.4%2.33.2%2.33.3%
PVP Level 290920.50.6%0.20.2%0.20.2%0.30.3%0.70.8%
PVP Level 3901060.50.4%0.30.3%0.00.0%0.70.7%0.90.9%
PVP Level 4901350.60.4%0.40.3%0.10.1%2.11.5%2.21.6%
PVP Level 5901520.80.5%0.00.0%0.40.3%2.71.8%2.91.9%

All results at all sites were within specification.

12

Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting (Cont.)

13

Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting (Cont.)

14

External Precision – Whole Blood

A precision study was performed with whole blood patient samples at three (3) external clinical point-ofcare (POC) sites. The studies were run by six (6) different operators on three (3) different GEM Premier ChemSTAT instruments, using a single lot of GEM Premier ChemSTAT PAKs (cartridges). Less than 10% of samples included in the study were contrived.

For data analysis and acceptance criteria application, measured data for each analyte were partitioned into zones and identified as Fixed Acceptance Range (Constant SD) or Variable Acceptance Range (Constant %CV).

| Analyte | Fixed or Variable
Acceptance Range | Site | N | Mean | Within Sample
SD of %CV |
|-----------------|---------------------------------------|--------|-----|------|----------------------------|
| Na+
(mmol/L) | Fixed
(SD) | POC 1 | 69 | 139 | 1.0 |
| | | POC 2 | 63 | 140 | 1.0 |
| | | POC 3 | 63 | 140 | 1.3 |
| | | Pooled | 195 | 140 | 1.1 |
| Na+
(mmol/L) | Fixed
(SD) | POC 1 | 3 | 106 | 0.6 |
| | | POC 2 | 3 | 106 | 0.0 |
| | | POC 3 | 3 | 103 | 0.6 |
| | | Pooled | 9 | 105 | 0.5 |
| K+
(mmol/L) | Fixed
(SD) | POC 1 | 69 | 4.1 | 0.12 |
| | | POC 2 | 63 | 4.0 | 0.03 |
| | | POC 3 | 63 | 3.6 | 0.04 |
| | | Pooled | 195 | 3.9 | 0.08 |
| K+
(mmol/L) | Variable
(%CV) | POC 1 | 3 | 8.2 | 0.7% |
| | | POC 2 | 3 | 7.3 | 0.0% |
| | | POC 3 | 3 | 7.9 | 0.7% |
| | | Pooled | 9 | 7.8 | 0.5% |

All results at all sites were within specification.

15

| Analyte | Fixed or Variable
Acceptance Range | Site | N | Mean | Within Sample
SD of %CV |
|------------------|---------------------------------------|--------|-----|------|----------------------------|
| Ca++
(mmol/L) | Fixed
(SD) | POC 1 | 3 | 0.34 | 0.006 |
| | | POC 2 | 3 | 0.38 | 0.006 |
| | | POC 3 | 3 | 0.41 | 0.006 |
| | | Pooled | 9 | 0.38 | 0.006 |
| Ca++
(mmol/L) | Variable
(%CV) | POC 1 | 69 | 1.20 | 1.1% |
| | | POC 2 | 63 | 1.22 | 1.4% |
| | | POC 3 | 63 | 1.22 | 1.8% |
| | | Pooled | 195 | 1.21 | 1.4% |
| Cl-
(mmol/L) | Fixed
(SD) | POC 1 | 3 | 73 | 0.0 |
| | | POC 2 | 3 | 40 | 0.0 |
| | | POC 3 | 3 | 44 | 0.0 |
| | | Pooled | 9 | 52 | 0.0 |
| Cl-
(mmol/L) | Variable
(%CV) | POC 1 | 69 | 102 | 0.5% |
| | | POC 2 | 63 | 105 | 0.7% |
| | | POC 3 | 63 | 105 | 0.5% |
| | | Pooled | 195 | 104 | 0.6% |

External Precision – Whole Blood (Cont.)

16

LoB, LoD and LoQ

In accordance with CLSI EP17-A2, Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) were established for Na*, K*, Ca** and Cl*, using three (3) lots of GEM Premier ChemSTAT PAKs (cartridges).

Following are the combined data results for LoB, LoD and LoQ:

AnalyteLoBLoDLoQ
Na+ (mmol/L)697088
K+ (mmol/L)0.00.10.3
Ca++ (mmol/L)0.000.010.05
Cl- (mmol/L)4436

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 Nat, K*, Ca** and Cl*. Each blood level was analyzed in triplicate on six (6) GEM Premier ChemSTAT test analyzers and results compared to the reference analyzer.

Combined data from limit of quantitation (LoQ) and linearity were used to support the lower limits of the claimed reportable ranges.

| Analyte | # of
Levels | N per
Level | Slope | Intercept | R2 | Tested
Range | Reportable
Range |
|------------------|----------------|----------------|-------|-----------|--------|-----------------|---------------------|
| Na+
(mmol/L) | 9 | 18 | 1.023 | -1.189 | 0.9997 | 92 to 200 | 100 to 180 |
| K+
(mmol/L) | 9 | 18 | 0.995 | 0.057 | 0.9998 | 0.2 to 19.6 | 0.3 to 19.0 |
| Ca++
(mmol/L) | 9 | 18 | 0.986 | 0.019 | 0.9984 | 0.04 to 4.27 | 0.10 to 4.25 |
| Cl-
(mmol/L) | 9 | 18 | 1.011 | -1.909 | 0.9998 | 34 to 177 | 40 to 158 |

17

Analytical Specificity

In accordance with EP07 3d Edition, an interference study was conducted on the GEM Premier ChemSTAT for Na*, K*, Ca** and Cl¯.

The table below and on the next page lists the substances that were screened with no observed interference on Na*, K*, Ca** and/or Cl¯:

Test SubstanceTest ConcentrationTested analytes where interference was not observed
Atracurium50 mg/LSodium, Potassium, Ionized Calcium, Chloride
Benzalkonium (Chloride)5 mg/LSodium, Potassium, Ionized Calcium, Chloride
Bilirubin40 mg/dLSodium, Potassium, Ionized Calcium, Chloride
Ceftriaxone1510 µmol/LSodium, Potassium, Ionized Calcium, Chloride
Epinephrine0.5 µmol/LSodium, Potassium, Ionized Calcium, Chloride
Etomidate50 mg/LSodium, Potassium, Ionized Calcium, Chloride
Fentanyl0.03 µg/mLSodium, Potassium, Ionized Calcium, Chloride
Furosemide48.1 µmol/LSodium, Potassium, Ionized Calcium, Chloride
Gadodiamide1.4 mmol/LSodium, Potassium, Ionized Calcium, Chloride
Hemoglobin (Hemolysis)1000 mg/dLSodium, Ionized Calcium, Chloride
Heparin100,000 U/LSodium, Potassium, Ionized Calcium, Chloride
Ibuprofen1060 µmol/LSodium, Potassium, Ionized Calcium, Chloride
Leflunomide100 µg/mLSodium, Potassium, Ionized Calcium, Chloride
Lithium3.2 mmol/LSodium, Potassium
Methadone10.3 µmol/LSodium, Potassium, Ionized Calcium, Chloride
Midazolam0.376 mg/dLSodium, Potassium, Ionized Calcium, Chloride
Morphine27.3 µmol/LSodium, Potassium, Ionized Calcium, Chloride
N-Acetyl-L-cysteine920µmol/LSodium, Potassium, Ionized Calcium, Chloride
Perchlorate20 mg/dLSodium, Potassium, Ionized Calcium
Phenobarbital2970 µmol/LSodium, Potassium, Ionized Calcium, Chloride
Test SubstanceTest ConcentrationTested analytes where interference was not observed
Piperacillin110 mg/dLSodium, Potassium, Ionized Calcium, Chloride
Propofol4.8 mg/dLSodium, Potassium, Ionized Calcium, Chloride
Salicylic acid0.207 mmol/LSodium, Potassium, Ionized Calcium, Chloride
Suxamethonium68 µmol/LSodium, Potassium, Ionized Calcium, Chloride
Tazobactam3.05 mg/dLSodium, Potassium, Ionized Calcium, Chloride
Teriflunomide100 µg/mLSodium, Potassium, Ionized Calcium, Chloride
Thiocyanate898 µmol/LSodium, Potassium, Ionized Calcium, Chloride
Thiopental1660 µmol/LSodium, Potassium, Ionized Calcium, Chloride
Triglycerides (Intralipid)2000 mg/dL
(1% Intralipid)Sodium, Chloride, Ionized Calcium
Vancomycin82.8 µmol/LSodium, Potassium, Ionized Calcium, Chloride

18

Analytical Specificity (Cont.)

The table below lists substances that demonstrated interference with Na*, K*, Ca** and the concentration of the interfering substance, as well as the bias observed and its direction (positive / negative):

| Interfering
Substance | Affected
Analytes | Analyte
Concentration | Interfering
Concentration
Tested | Bias
Observed
(Mean) | Lowest
Interfering
Concentration
with Analyte
Impact | Bias Observed
at the Lowest
Concentration |
|------------------------------|----------------------|--------------------------|----------------------------------------|----------------------------|------------------------------------------------------------------|-------------------------------------------------|
| Hemoglobin
(Hemolysis) | Potassium | 3.5 mmol/L | 1000 mg/dL | +16 % | 155 mg/dL | +7% |
| Hemoglobin
(Hemolysis) | Potassium | 5.0 mmol/L | 1000 mg/dL | +15 % | 228 mg/dL | +7% |
| Perchlorate | Chloride | 100 mmol/L | 20 mg/dL | +6 % | 18 mg/dL | +5% |
| Perchlorate | Chloride | 110 mmol/L | 20 mg/dL | +5 % | 17 mg/dL | +5% |
| Triglyceride
(Intralipid) | Potassium | 3.5 mmol/L | 2000 mg/dL
(1 % Intralipid) | +11 % | 689 mg/dL
(0.34 %) | +7% |
| Triglyceride
(Intralipid) | Potassium | 5.0 mmol/L | 2000 mg/dL
(1 % Intralipid) | | No Interference Observed | |

19

AnalyteReference RangeUnit
$Na^+$136 to 145mmol/L
136 to 145mEq/L
$K^+$3.5 to 5.1mmol/L
3.5 to 5.1mEq/L
$Ca^{++}$1.15 to 1.33mmol/L
2.30 to 2.66mEq/L
4.60 to 5.32mg/dL
1.16 to 1.32 (venous)mmol/L
2.32 to 2.64 (venous)mEq/L
4.64 to 5.28 (venous)mg/dL
$Cl^-$98 to 107mmol/L
98 to 107mEq/L

Reference Ranges

Source: Burtis, Carl and David Bruns, Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, Elsevier Saunders, 7th Edition, 2015, pages 952-982.

20

Clinical Testing

In accordance with EP09c, a method comparison study was conducted at three (3) point-of-care (POC) sites on the GEM Premier ChemSTAT compared to the predicate device, the GEM Premier 4000 (K133407), using lithium heparinized whole blood patient samples from the intended use population. Less than 10% of samples included in the study were contrived.

Pooled Point-of-Care Sites
AnalyteNSlopeInterceptRSample Range
Na+ (mmol/L)4361.021-2.1570.987100 to 170
K+ (mmol/L)4421.0000.1000.9990.5 to 18.2
Ca++ (mmol/L)4441.0000.0150.9990.26 to 4.08
Cl- (mmol/L)4351.0001.0000.99445 to 154

The pooled results from the POC sites are presented below.

| Conclusion | The technological and functional characteristics of the new GEM
Premier ChemSTAT as described above are substantially equivalent to
that of the predicate device (GEM Premier 4000) for Sodium,
Potassium, Ionized Calcium and Chloride. |
|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The analytical and clinical study results demonstrate that the GEM
Premier ChemSTAT is safe and effective for its intended purpose and
equivalent in performance to the predicate device (K133407). |