GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator

K160225 · Instrumentation Laboratory CO · JGS · Dec 14, 2016 · Clinical Chemistry

Device Facts

• Record ID: K160225
• Device Name: GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator
• Applicant: Instrumentation Laboratory CO
• Product Code: JGS · Clinical Chemistry
• Decision Date: Dec 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Intended 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 sodium from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of potassium and chloride from venous and arterial heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of electrolyte balance. 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. Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis. Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. GEM CVP 5 tBili is an external Calibration Valuation Product used to complete the calibration process of the GEM Premier 4000 and GEM Premier 5000 analyzers prior to use with patient samples for total bilirubin (tBili) testing. GEM System Evaluator is a three-level assayed quality control material for evaluating performance characteristics of pH, pCO2, pO2, Electrolytes, Metabolites, Total Bilirubin (tBili) and CO-Oximetry on the GEM Premier 4000 and GEM Premier 5000 analyzers. GEM Hematocrit Evaluator is a three-level assayed quality control material intended for evaluating performance characteristics of hematocrit on the GEM Premier 4000 and GEM Premier 5000 analyzers.

Device Story

Portable critical care system; analyzes heparinized whole blood samples (venous, arterial, capillary) for electrolytes (Na+, K+, Cl-, Ca++). Uses ion-selective electrode (ISE) technology; PVC-based sensors with internal Ag/AgCl reference electrodes. System includes analyzer and GEM Premier 5000 PAK (cartridge containing reagents, sensors, and process control solutions). Operated by clinicians at point-of-care or central labs. Features Intelligent Quality Management 2 (iQM2) for continuous monitoring, automatic error detection, and corrective actions. Output provides quantitative electrolyte concentrations to aid clinical decision-making regarding electrolyte balance and metabolic disorders. Benefits include rapid, real-time diagnostic data for critical care patients.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated per CLSI EP05-A3; linearity per CLSI EP06-A; interference per CLSI EP07-A2; method comparison per CLSI EP09-A3; detection limits per CLSI EP17-A2. Method comparison against predicate (GEM Premier 4000) showed high correlation (r > 0.98) for all analytes across syringe and capillary samples. No clinical studies required.

Technological Characteristics

Potentiometric electrolyte measurement; disposable multi-use GEM PAK cartridge containing sensors, reagents, and waste. Dimensions: 18.6"H x 13.0"W x 16.4"D; Weight: 45.4 lbs. Connectivity: Standalone system with color touch screen. Software: Linux-based. Quality control: iQM2 (Intelligent Quality Management 2) statistical process control system with automated error detection/correction.

Indications for Use

Indicated for health care professionals to rapidly analyze heparinized whole blood samples (venous, arterial, capillary) for quantitative measurement of sodium, potassium, chloride, and ionized calcium to aid in diagnosis of electrolyte balance in clinical and central laboratory settings.

Regulatory Classification

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.

Predicate Devices

• GEM Premier 4000 (k133407)
• CVP 5 tBili (k112995)
• GEM System Evaluator (k093623)
• GEM Hematocrit Evaluator (k093623)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 14, 2016

INSTRUMENTATION LABORATORY CO. CAROL MARBLE REGULATORY AFFAIRS DIRECTOR 180 HARTWELL ROAD BEDFORD MA 01730

Re: K160225

Trade/Device Name: GEM Premier 5000 (Measured Parameters: Sodium, Potassium, Chloride, Ionized Calcium), GEM System Evaluator, GEM Hematocrit Evaluator, GEM CVP 5 tBili Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium Test System Regulatory Class: II Product Code: JGS, CEM, CGZ, JFP, JJY, JJE, GLK Dated: December 6, 2016 Received: December 7, 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 (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

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias -S

Courtney H. Lias, PhD 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) K160225

#### Device Name

GEM Premier 5000 (Measured Parameters: Sodium, Potassium, Chloride, Ionized Calcium) GEM System Evaluator, GEM Hematocrit Evaluator, GEM CVP 5 tBili

#### 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 sodium from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of potassium and chloride from venous and arterial heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of electrolyte balance.

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.

Chloride (Cl-) measurements are used in the diagnosis and metabolic disorders, such as cystic fibrosis and diabetic acidosis.

Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

GEM System Evaluator is a three-level assayed quality control material for evaluating performance characteristics of pH, pCO2, pO2, Electrolytes, Metabolites, Total Bilirubin (tBili) and CO-Oximetry on the GEM Premier 4000 and GEM Premier 5000 analyzers.

GEM Hematocrit Evaluator is a three-level assayed quality control material intended for evaluating performance characteristics of hematocrit on the GEM Premier 4000 and GEM Premier 5000 analyzers.

GEM CVP 5 tBili is an external Calibration Valuation Product used to complete the callbration process of the GEM Premier 4000 and GEM Premier 5000 analyzers prior to use with patient samples for total bilirubin (tBili) testing.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 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.<br>180 Hartwell Road<br>Bedford, MA 01730, USA |
|-------------------------|------------------------------------------------------------------------------------|
|-------------------------|------------------------------------------------------------------------------------|

| Contact Person | Carol Marble, Regulatory Affairs Director |
|----------------|-------------------------------------------|
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |

| Preparation Date | December 6, 2016 |
|------------------|------------------|
|------------------|------------------|

| Device Trade Names | GEM Premier 5000<br>(Measured Parameters: Sodium, Potassium, Chloride, Ionized Calcium) GEM CVP 5 tBili GEM System Evaluator GEM Hematocrit Evaluator |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|

| Predicate Devices | GEM Premier 4000 | K133407 |
|-------------------|------------------|--------------------------|
| | | GEM CVP 5 tBili |
| | | GEM System Evaluator |
| | | GEM Hematocrit Evaluator |

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| Regulatory Information | | | | | |
|---------------------------------------|--------------------------------------------------|-------------------------------------------------------------|-----------------|-----------------|-------|
| System | Regulation<br>Section | Regulatory Description | Class | Product<br>Code | Panel |
| Instrument | 862.2160 | Discrete photometric chemistry<br>analyzer for clinical use | I | JJE | 75 |
| Sodium | 862.1665 | Sodium test system | II | JGS | |
| Potassium | 862.1600 | Potassium test system | II | CEM | 75 |
| Chloride | 862.1170 | Chloride test system | II | CGZ | |
| Ionized Calcium | 862.1145 | Calcium test system | II | JFP | |
| Controls<br>(Internal<br>PCS D and E) | 862.1660 | Quality control material<br>(assayed and unassayed) | I<br>(Reserved) | JJY | 75 |
| | 864.8625 | Hematocrit Control | II | GLK | 81 |
| GEM CVP 5 tBili | | | | | |
| Regulation<br>Section | Regulatory Description | | Class | Product<br>Code | Panel |
| 862.1660 | Quality control material (assayed and unassayed) | | I<br>(Reserved) | JJY | 75 |
| GEM System Evaluator | | | | | |
| Regulation<br>Section | Regulatory Description | | Class | Product<br>Code | Panel |
| 862.1660 | Quality control material (assayed and unassayed) | | I<br>(Reserved) | JJY | 75 |
| GEM Hematocrit Evaluator | | | | | |
| Regulation<br>Section | Regulatory Description | | Class | Product<br>Code | Panel |
| 864.8625 | Hematocrit Control | | II | GLK | 81 |

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### Device Description

The GEM Premier 5000 system provides health care professionals in central laboratory or point-of-care clinical settings with fast, accurate, quantitative measurements of sodium and ionized calcium from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of potassium and chloride from venous and arterial heparinized whole blood.

| Key Components | Description |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyzer | Employs a unique color touch screen and a simple set of menus and<br>buttons for user interaction. The analyzer guides operators through the<br>sampling process with simple, clear messages and prompts. |
| GEM Premier 5000 PAK<br>(disposable, multi-use GEM PAK) | Houses all required components necessary to operate the instrument<br>once the cartridge is validated. These components include the sensors,<br>CO-Ox/tBili optical cell, Process Control (PC) Solutions, sampler, pump<br>tubing, distribution valve and waste bag. The GEM PAK has flexible<br>menus and test volume options to assist facilities in maximizing<br>efficiency.<br>NOTE: The EEPROM on the GEM PAK includes all solution values and<br>controls the analyte menu and number of tests.<br>Step 1: After inserting the GEM PAK, the instrument will perform an<br>automated PAK warm-up during which the sensors are<br>hydrated and a variety of checks occur, all of which take<br>about 40 minutes. During warm-up, the instrument requires<br>no user intervention.<br>Step 2: After GEM PAK warmup, Auto PAK Validation (APV) process is<br>automatically completed: two completely independent<br>solutions (PC Solution D and E) that are traceable to NIST<br>standards, CLSI procedures or internal standards, containing<br>two levels of concentration for each analyte, are run by the<br>analyzer to validate the integrity of the PC Solutions and the<br>overall performance of the analytical system.<br>NOTE: For total bilirubin, CVP 5 tBili (Calibration Valuation Product)<br>must be run prior to performing tBili samples.<br>Step 3: After successful performance of APV, iQM2 manages the<br>quality control process, replacing external quality controls. |
| Intelligent Quality Management 2<br>(iQM2) | iQM2 is an active quality process control program designed to provide<br>continuous monitoring of the analytical process before, <i>during</i> and<br>after sample measurement with real-time, automatic error detection,<br>automatic correction of the system and automatic documentation of all<br>corrective actions.<br>iQM2 is a statistical process control system that performs 5 types of<br>continuous, quality checks to monitor the performance of the GEM<br>PAK, sensors, CO-Ox, and reagents. These checks include System,<br>Sensor, IntraSpect, Pattern Recognition and Stability Checks. |

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| Indications for Use / Intended Use | |
|---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| GEM Premier 5000<br>with Intelligent Quality<br>Management 2 (iQM2) | The GEM Premier 5000 is a portable critical care system for use by<br>health care professionals to rapidly analyze heparinized whole<br>blood samples at the point of health care delivery in a clinical<br>setting and in a central laboratory. The instrument provides<br>quantitative measurements of sodium and ionized calcium from<br>venous, arterial and capillary heparinized whole blood, as well as<br>quantitative measurements of potassium and chloride from venous<br>and arterial heparinized whole blood. These parameters, along<br>with derived parameters, aid in the diagnosis of electrolyte<br>balance.<br><br>Sodium ( $Na^+$ ) measurements are used in the diagnosis and<br>treatment of aldosteronism, diabetes insipidus, adrenal<br>hypertension, Addison's disease, dehydration, inappropriate<br>antidiuretic secretion, or other diseases involving electrolyte<br>imbalance.<br><br>Potassium ( $K^+$ ) measurements are used to monitor electrolyte<br>balance in the diagnosis and treatment of disease conditions<br>characterized by low or high blood potassium levels.<br><br>Chloride ( $Cl^-$ ) measurements are used in the diagnosis and<br>treatment of electrolyte and metabolic disorders, such as cystic<br>fibrosis and diabetic acidosis.<br><br>Ionized calcium ( $Ca^{++}$ ) measurements are used in the diagnosis<br>and treatment of parathyroid disease, a variety of bone diseases,<br>chronic renal disease and tetany. |
| GEM CVP 5 tBili | GEM CVP 5 tBili is an external Calibration Valuation Product used to<br>complete the calibration process of the GEM Premier 4000 and<br>GEM Premier 5000 analyzers prior to use with patient samples for<br>total bilirubin (tBili) testing. |
| GEM System Evaluator | GEM System Evaluator is a three-level assayed quality control<br>material for evaluating performance characteristics of pH, pCO2,<br>pO2, Electrolytes, Metabolites, Total Bilirubin (tBili) and<br>CO-Oximetry on the GEM Premier 4000 and GEM Premier 5000<br>analyzers. |
| GEM Hematocrit Evaluator | GEM Hematocrit Evaluator is a three-level assayed quality control<br>material intended for evaluating performance characteristics of<br>hematocrit on the GEM Premier 4000 and GEM Premier 5000<br>analyzers. |

# Special Conditions for Use Statement

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

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| Substantial Equivalency | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| The GEM Premier 5000 system is substantially equivalent in function and intended use to the following predicate device for Na+, K+, Cl- and Ca++: | | | |
| Item | Predicate Device | New Device | |
| Trade Name | GEM Premier 4000 | GEM Premier 5000 | |
| 510(k) No. | K133407 | K160225 | |
| Manufacturer | Instrumentation Laboratory Co. | Instrumentation Laboratory Co. | |
| Indications<br>for Use | The GEM Premier 4000 is a portable critical care system for use by<br>health care professionals to rapidly analyze whole blood samples at<br>the point of health care delivery in a clinical setting and in a central<br>laboratory. The instrument provides quantitative measurements of<br>pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium,<br>glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb,<br>O₂Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be<br>quantitated from heparinized plasma samples when analyzed in the<br>tBili/CO-Ox mode. These parameters, along with derived<br>parameters, aid in the diagnosis of a patient's acid/base status,<br>electrolyte and metabolite balance and oxygen delivery capacity.<br>Total bilirubin measurements are used in the diagnosis and<br>management of biliary tract obstructions, liver disease and various<br>hemolytic diseases and disorders involving the metabolism of<br>bilirubin. In neonates, the level of total bilirubin is used to aid in<br>assessing the risk of kernicterus. | The GEM Premier 5000 is a portable critical care system for use<br>by health care professionals to rapidly analyze heparinized whole<br>blood samples at the point of health care delivery in a clinical<br>setting and in a central laboratory. The instrument provides<br>quantitative measurements of sodium and ionized calcium from<br>venous, arterial and capillary heparinized whole blood, as well as<br>quantitative measurements of potassium and chloride from<br>venous and arterial heparinized whole blood. These parameters,<br>along with derived parameters, aid in the diagnosis of electrolyte<br>balance.<br>Sodium (Na+) measurements are used in the diagnosis and<br>treatment of aldosteronism, diabetes insipidus, adrenal<br>hypertension, Addison's disease, dehydration, inappropriate<br>antidiuretic secretion, or other diseases involving electrolyte<br>imbalance.<br>Potassium (K+) measurements are used to monitor electrolyte<br>balance in the diagnosis and treatment of disease conditions<br>characterized by low or high blood potassium levels.<br>Chloride (Cl-) measurements are used in the diagnosis and<br>treatment of electrolyte and metabolic disorders, such as cystic<br>fibrosis and diabetic acidosis.<br>Ionized calcium (Ca++) measurements are used in the diagnosis<br>and treatment of parathyroid disease, a variety of bone diseases,<br>chronic renal disease and tetany. | |
| Substantial Equivalency (Cont.) | | | |
| Item | Predicate Device | New Device | |
| Trade Names | GEM Premier 4000<br>K133407 | GEM Premier 5000<br>K160225 | |
| Intended User | Central Laboratory and Point-of-Care | Same | |
| Sample Type | Heparinized whole blood | Na+, Ca++<br>Arterial, venous or capillary heparinized whole blood<br>K+, Cl-<br>Arterial or venous heparinized whole blood | |
| Electrolyte Measurement | Potentiometry | Same | |
| Sample Introduction | Aspiration | Same | |
| PAK Shelf-Life Stability | Up to 180 days | Same | |
| PAK Storage Temperature | 15-25°C…