GEM Premier 5000

K173403 · Instrumentation Laboratory CO · CHL · Dec 29, 2017 · Clinical Chemistry

Device Facts

• Record ID: K173403
• Device Name: GEM Premier 5000
• Applicant: Instrumentation Laboratory CO
• Product Code: CHL · Clinical Chemistry
• Decision Date: Dec 29, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• 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 pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2*) parameters from arterial, venous or capillary heparinized whole blood. 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. *sO2 = ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin.

Device Story

Portable critical care system; analyzes heparinized whole blood samples (arterial, venous, capillary). System components: GEM Premier 5000 analyzer and GEM Premier 5000 PAK (disposable cartridge containing reagents, sensors, optical cell, sampler, waste bag). Principle of operation: potentiometric sensors (pCO2, K+, Cl-); electrical conductivity (hematocrit); spectrophotometric absorbance (total hemoglobin). Operator: healthcare professional at point-of-care or central lab. Workflow: sample aspiration into cartridge; automated analysis; results displayed on analyzer. Output: quantitative measurements of blood parameters; aids clinical decision-making regarding acid-base status, electrolyte balance, and oxygen delivery. Benefits: rapid diagnostic information for critical care patients.

Clinical Evidence

No clinical trials; performance established via bench and method comparison studies. Precision evaluated internally and at an external POC site using whole blood samples (n=56-120 per study). Method comparison against predicate (GEM Premier 4000) performed with 136-141 samples (native and contrived) spanning reportable ranges. Results showed high correlation (R=0.980-0.995) and acceptable bias at medical decision levels for pCO2, K+, Cl-, Hct, and tHb.

Technological Characteristics

System uses PVC-based ion-selective electrodes (potentiometry) for electrolytes, electrical conductivity for hematocrit, and LED-based spectrophotometry for total hemoglobin. Disposable GEM PAK cartridge contains sensors, optical cell, and reagents. Connectivity: standalone analyzer. Software: embedded firmware. Sterilization: not specified. Materials: PVC, Ag/AgCl electrodes.

Indications for Use

Indicated for health care professionals to analyze heparinized whole blood (arterial, venous, or capillary) for diagnosis of acid-base disturbances, electrolyte/metabolite balance, and oxygen delivery capacity in clinical and central laboratory settings. Used for patients requiring monitoring of pH, blood gases, electrolytes (Na, K, Ca, Cl), glucose, lactate, bilirubin, and CO-Oximetry parameters.

Regulatory Classification

Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Predicate Devices

• GEM Premier 4000 (k133407)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 29, 2017

Instrumentation Laboratory Co. Carol Marble Regulatory Affairs Director 180 Hartwell Road Bedford, MA 01730

Re: K173403

Trade/Device Name: GEM Premier 5000 Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (pCO2, pO2) and blood pH test system Regulatory Class: Class II Product Code: CHL, CEM, CGZ, GKF, GKR, GLY Dated: October 30, 2017 Received: October 31, 2017

Dear Carol 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 Part 801 and Part 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

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Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Kellie B. Kelm -S

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

Enclosure

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# Indications for Use

510(k) Number (if known)

#### k173403

Device Name

GEM Premier 5000

#### 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 pH, pCO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, MetHb, HHb, sO2*) parameters from arterial, venous or capillary heparinized whole blood. 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. *sO2 = ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin.

· pH, pCO2, and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.

· 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 treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.

· Hematocrit (Het) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells),

· 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 (tBili) measurement is used to aid in assessing the risk of kernicterus and hyperbilirulyinemia in neonates.

• CO-Oximetry (tHb, COHb, MetHb, O2Hb, HHb, and sO2) evaluates the ability of the blood to carry oxygen by measuring total hemoglobin and determining the percentage of functional hemoglobin species.

• Total Hemoglobin (tHb): Total hemoglobin measure the hemoglobin content of whole blood for the detection of anemia.

· COHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# Indications for Use

510(k) Number (if known)

Device Name

GEM Premier 5000

Indications for Use (Describe)

- · MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia.
- · HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to measure oxygen status.
- · O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with decxyhemoglobin to measure oxygen status.
- · sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygen status.

Type of Use (Select one or both, as applicable)

V Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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## k173403

## 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<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Preparation Date | December 19, 2017 |
| Device Trade Name | GEM Premier 5000 |

| Regulatory Information | | | | |
|------------------------|-----------------------|------------------------------------------------------|-------|-----------------|
| Analyte | Regulation<br>Section | Regulatory Description | Class | Product<br>Code |
| $pCO_2$ | 862.1120 | Blood Gases ( $pCO_2$ , $pO_2$ ) and Blood pH system | II | CHL |
| Potassium | 862.1600 | Potassium test system | II | CEM |
| Chloride | 862.1170 | Chloride test system | II | CGZ |
| Hematocrit | 864.5600 | Automated hematocrit instrument | II | GKF |
| Total Hemoglobin | 864.5620 | Automated hemoglobin system | II | GKR |
| | 864.7500 | Whole blood hemoglobin assays | II | GLY |

## Device Description

The GEM Premier 5000 system provides health care professionals with fast, accurate, quantitative measurements of pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O₂Hb, MetHb, HHb, sO₂*) parameters from arterial, venous or capillary heparinized whole blood in central laboratory or point-of-care clinical settings.

*sO2 = Ratio between the concentration of oxyhemoglobin plus deoxyhemoglobin plus deoxyhemoglobin.

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### Purpose for Submission

The purpose of this submission is to expand capillary heparinized whole blood claims on the GEM Premier 5000 system to include the following analytes: pCQz, potassium, chloride, hematocrit and total hemoglobin.

- Note: The other measured analytes on the GEM Premier 5000 were previously FDA cleared for capillary claims under their respective 510(k): K160225, K160402, K160412 and K160415.
To support the expanded claims, a combination of improved sample handling instructions in the labeling to avoid pre-analytical error and cartridge EEPROM coefficient adjustments (for pCO2, potassium and hematocrit) were implemented on the GEM Premier 5000.

## 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 pH, pCQ2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O₂Hb, COHb, MetHb, HHb, sO-*) parameters from arterial, venous or capillary heparinized whole blood. 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.

*s02 = ratio between the concentration of oxyhemoglobin plus deoxyhemoglobin plus deoxyhemoglobin.

- . pH, pCO2, and pO2 measurements in whole blood are used in the diagnosis and treatment of lifethreatening acid-base disturbances.
- . 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.

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## Intended Use / Indications for Use (Cont.)

- Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
- 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 (tBili) measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.
- CO-Oximetry (tHb, COHb, MetHb, O2Hb, HHb, and sO2) evaluates the ability of the blood to carry oxygen by measuring total hemoglobin and determining the percentage of functional and dysfunctional hemoglobin species.
- . Total Hemoglobin (tHb): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.
- . COHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
- . MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia.
- . HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to measure oxygen status.
- . O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure oxygen status.
- . sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygen status.

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## Substantial Equivalence

The following table compares the use of capillard whole blood samples with pCO2, potasium, chloride, hemoglobin on the GEM Premier 5000 to the predicate device, the GEM Premier 4000.

| ltem | Predicate Device | New Device | |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Trade Name | GEM Premier 4000 | GEM Premier 5000 | |
| 510(k) No. | K133407 | Pending | |
| Manufacturer | Instrumentation Laboratory Co. | Instrumentation Laboratory Co. | |
| Intended Use /<br>Indications for<br>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, glucose,<br>lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb,<br>COHb, MetHb, HHb) parameters. Total bilirubin can also be<br>quantitated from heparinized plasma samples when analyzed in the<br>tBili/CO-Ox mode.<br>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 pH, pCO2, pO2, sodium, potassium,<br>chloride, ionized calcium, glucose, lactate, hematocrit, total<br>bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2*)<br>parameters from arterial, venous or capillary heparinized whole<br>blood. These parameters, along with derived parameters, aid in<br>the diagnosis of a patient's acid/base status, electrolyte and<br>metabolite balance and oxygen delivery capacity.<br>*sO2 = ratio between the concentration of oxyhemoglobin and<br>oxyhemoglobin plus deoxyhemoglobin.<br>See previous pages for complete Intended Use/Indications for Use<br>for the GEM Premier 5000. | |
| Substantial Equivalence (Cont.) | | | |
| Item | Predicate Device | Modified Device | |
| Trade Name | GEM Premier 4000<br>K133407 | GEM Premier 5000 | |
| Intended Settings | Central Laboratory and Point-of-Care | Same | |
| Sample Type | Heparinized whole blood<br>(arterial, venous or capillary) | Same; expanding capillary<br>claims to pCO2, K+, Cl-, Hct<br>and tHb with this 510(k) | |
| Detection Method | Analyte | GEM Premier 4000 | GEM Premier 5000 |
| | pCO2 | Potentiometry | Same |
| | K+ | Potentiometry | Same |
| | Cl- | Potentiometry | Same |
| | Hct | Conductivity | Same |
| | tHb | 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 | |
| Reportable Range | Analyte | GEM Premier 4000 | GEM Premier 5000 |
| | pCO2 | 6 to 125 mmHg | 6 to 125 mmHg |
| | K+ | 0.2 to 19.0 mmol/L | 1.0 to 19.0 mmol/L |
| | Cl- | 40 to 158 mmol/L | 40 to 158 mmol/L |
| | Hct | 15 to 72% | 15 to 72% |
| | tHb | 3.0 to 23.0 g/dL | 3.0 to 23.0 g/dL |

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#### Performance Summary

- The linearity, limit of detection and analytical specificity performance for pCO₂, K*, Cl , Hct and tHb Note: on the GEM Premier 5000 were previously established under K160225, K160415 for heparinized whole blood and these studies are also applicable for capillary heparinized whole blood. Consequently, studies performed were limited to precision and method comparison to support substantial equivalence for these analytes with capillary samples.
#### Internal Precision - Capillary Transfer Samples

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 level for five (5) days, with one (1) run per day and eight (8) replicates measured per run per level (N=120 per analyte per level). Samples were transferred from syringe to a capillary device.

| Analyte | Level | Mean | N | Within Run<br>SD | Within Run<br>%CV | | | | | | | | | | | | | | | | | | | | |
|-----------------|-----------------|-------|-------|------------------|-------------------|------|------|-----|-----|------|---|------|-----|-----|------|---|-------|-----|-----|------|---|-------|-----|-----|------|
| pCO2<br>(mmHg) | 1 | 9.9 | 120 | 0.5 | 5.1% | | | | | | | | | | | | | | | | | | | | |
| | 2 | 34.5 | 120 | 0.6 | 1.9% | | | | | | | | | | | | | | | | | | | | |
| | 3 | 49.0 | 120 | 0.5 | 1.1% | | | | | | | | | | | | | | | | | | | | |
| | 4 | 68.9 | 120 | 1.6 | 2.3% | | | | | | | | | | | | | | | | | | | | |
| | 5 | 108.9 | 120 | 2.4 | 2.2% | | | | | | | | | | | | | | | | | | | | |
| K+<br>(mmol/L) | 1 | 1.46 | 120 | 0.05 | 3.2% | | | | | | | | | | | | | | | | | | | | |
| | 2 | 2.70 | 120 | 0.06 | 2.1% | | | | | | | | | | | | | | | | | | | | |
| | 3 | 5.43 | 120 | 0.04 | 0.8% | | | | | | | | | | | | | | | | | | | | |
| | 4 | 7.16 | 120 | 0.07 | 1.0% | | | | | | | | | | | | | | | | | | | | |
| | 5…