(235 days)
Not Found
No
The document describes a critical care system for analyzing blood samples and does not mention any AI or ML capabilities. The focus is on the analytical measurements and a software operating system upgrade.
No
This device is a diagnostic tool that provides quantitative measurements of various blood parameters to aid in the diagnosis and monitoring of medical conditions, rather than directly treating them.
Yes
The device measures various parameters (e.g., pH, pCO2, pO2, electrolytes, glucose, lactate, hematocrit, total bilirubin, CO-Oximetry parameters) from whole blood samples, and the text explicitly states these parameters "aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity" and are "used in the diagnosis and treatment of" specific conditions.
No
The device description explicitly states it is a "portable critical care system" that "provides fast, accurate, quantitative measurements" of various blood parameters. This indicates a physical instrument that analyzes blood samples, not solely software. The 510(k) summary also mentions "Software Verification" related to an operating system upgrade, implying the software is part of a larger hardware system.
Based on the provided information, the GEM Premier 5000 is indeed an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the device is used to analyze "heparinized whole blood samples" and provides "quantitative measurements" of various parameters (pH, pCO2, pO2, electrolytes, metabolites, hematocrit, bilirubin, and CO-Oximetry). These measurements are used to "aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity." This aligns perfectly with the definition of an IVD, which is a device intended for use in the in vitro examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
- Sample Type: The device analyzes "heparinized whole blood samples," which are specimens derived from the human body.
- Purpose: The measurements obtained are used to "aid in the diagnosis" of various conditions and statuses.
Therefore, the GEM Premier 5000 fits the criteria of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of 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 plus deoxyhemoglobin plus deoxyhemoglobin.
-
pH, pCQ2, 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 (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.
Product codes
CHL, JGS, CEM, CGZ, JFP, CGA, KHP, MQM, GKF, GHS, GKR, GLY
Device Description
The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples.
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 / point of health care delivery in a 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)
Performance data is limited to Software Verification as the scope of this Special 510(k) is specific to an operating system upgrade from Fedora 17 Linux to WindRiver LTS 18 Linux.
All verification and validation activities were performed in accordance to established plans and protocols and Design Control procedures. Testing verified all acceptance criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K173403, K160415, K160402, K160225
Reference Device(s)
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
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
August 20, 2021
Instrumentation Laboratory Co. Gabriella Erdosy Sr. Regulatory Affairs Manager 180 Hartwell Road Bedford, Massachusetts 01730
Re: K203790
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, JGS, CEM, CGZ, JFP, CGA, KHP, MQM, GKF, GHS, GKR, GL Y Dated: December 23, 2020 Received: December 28, 2020
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-torres -S
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203790
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, pO2, sodium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MHb, 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 plus deoxyhemoglobin 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 (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 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.
3
· 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.
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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K203790 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
Sr. Regulatory Affairs Manager
Phone: 781-861-4571
Fax: 781-861-4207
Email: gerdosy@ilww.com |
| ---------------- | --------------------------------------------------------------------------------------------------------------------------- |
|---|
| Preparation Date | August 18, 2021 |
|---|---|
| ------------------ | ----------------- |
| Device Trade Name | GEM Premier 5000 |
|---|---|
| ------------------- | ------------------ |
| Predicate Devices | GEM Premier 5000 | K173403,K160415,
K160402, K160225 |
| ------------------- | ------------------ | -------------------------------------- |
|---|
| Regulatory Information | |||||
|---|---|---|---|---|---|
| GEM Premier 5000 | |||||
| Analyte | Regulation | ||||
| Section | Regulatory Description | Class | Product | ||
| Code | Panel | ||||
| pH, pCO2, pO2 | 862.1120 | Blood Gases (pCO2, pO2) and Blood | |||
| pH system | II | CHL | |||
| 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 |
5
| Regulatory Information | |||||
|---|---|---|---|---|---|
| GEM Premier 5000 | |||||
| Glucose | 862.1345 | Glucose test system | II | CGA | |
| Lactate | 862.1450 | Lactic acid test system | I | KHP | |
| Analyte | Regulation | ||||
| Section | Regulatory Description | Class | Product | ||
| Code | Panel | ||||
| Total Bilirubin | 862.1113 | Bilirubin (total and unbound) | |||
| in the neonate test system | I | ||||
| (Reserved) | MQM | 75 | |||
| Hematocrit | 864.5600 | Automated hematocrit instrument | II | GKF | |
| CO-Oximetry | 864.7425 | Carboxyhemoglobin assay | II | GHS | 81 |
| 864.5620 | Automated hemoglobin system | II | GKR | ||
| 864.7500 | Whole blood hemoglobin assays | II | GLY |
Device Description
The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples.
Indications for Use / 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 plus deoxyhemoglobin plus deoxyhemoglobin.
- pH, pCQ2, 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
6
Indications for Use / Intended Use
disorders, such as cystic fibrosis and diabetic acidosis.
- 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.
7
Reason for Submission
This Special 510(k) is being submitted to upgrade the operating system from Fedora 17 Linux to WindRiver LTS 18 Linux for the GEM Premier 5000 Instrument. The operating system is being upgraded to accommodate long-term support of resolutions for common vulnerability exposures.
The submission meets the criteria for a Special 510(k) based on the following:
- The proposed change is submitted by the manufacturer legally authorized to market the existing device.
- . Performance data is limited to Software Verification as the scope of this Special 510(k) is specific to an operating system upgrade from Fedora 17 Linux to WindRiver LTS 18 Linux.
- . There is a well-established method to evaluate the change:
- O General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11.2002
- o Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices O Guidance for Industry and Food and Drug Administration Staff, October 2, 2014
- Off-The-Shelf Software Use in Medical Devices, Guidance for Industry and Food and Drug o Administration Staff, September 2019
- The data can be reviewed in a summary or risk analysis format. ●
In addition, the changes in this submission do not introduce:
- Changes to indications for use or intended use
- Changes to the fundamental scientific technology ●
- . Changes to operating principle
- . Changes to labeled performance claims
Risk Management
The Risk Management was performed in compliance with EN ISO 14971:2012 (ISO 14971:2007) Medical Devices - Application of Risk Management to Medical Devices. A series of risk assessments were performed in order to identify and mitigate any potential risks associated to the design changes for the modified device.
Verification and Validation Summary
All verification and validation activities were performed in accordance to established plans and protocols and Design Control procedures. Testing verified all acceptance criteria were met.
8
Cybersecurity Information
Cybersecurity assessments for the GEM Premier 5000 were performed as part of the Quality Management procedures for software validation and risk analysis activities. Vulnerabilities were identified, assessed and compensating controls were implemented within the software/system, to mitigate potential security threats, system vulnerabilities, viral attacks and safeguard against unauthorized access to patient data.
| Comparison to Predicate | ||
|---|---|---|
| Item | Predicates | |
| (K173403, K160415, K160402, K160225) | Updated Device | |
| Subject of this Submission | ||
| Similarities | ||
| Trade Name | GEM Premier 5000 | Same |
| Indications for Use | See above | Same |
| Intended User | Central Laboratory and Point-of-Care | Same |
| Blood Gas Measurement | Potentiometry: pH and pCO2 | |
| Amperometry: pO2 | Same | |
| Electrolyte Measurement | Potentiometry: Na+, K+, Cl-, Ca++ | Same |
| Metabolite Measurement | Amperometry: Glucose and Lactate | Same |
| Hemoglobin Measurement | Spectrophotometry: tHb, O2Hb, COHb, MetHb, HHb, sO2 | Same |
| Total Bilirubin | Spectrophotometry | Same |
| Hematocrit Measurement | Conductivity | Same |
| Sample Introduction | Aspiration | Same |
| Sampling Modes | ||
| and | ||
| Sample Volumes | Normal Mode 150 μL Micro Mode 65 μL tBili/CO-Ox Mode 100 μL | Same |
| Test Principle | Potentiometry: pH, pCO2, Na+, K+, Ca++ Amperometry: pO2, Glu, Lac Conductivity: Hematocrit | Same |
| Sample Type | Heparinized whole blood for all analytes | Same |
| Dimensions | Height: 18.6 inches Width: 13.0 inches Depth: 16.4 inches | Same |
| Weight | 45.4 pounds | Same |
| System Operating Temperature | 12-32°C | Same |
| User Interface | Menu Driven Touch Screen | Same |
| Sample Introduction | Aspiration | Same |
| Differences | ||
| Operating System Software | Fedora 17 Linux | Wind River LTS 18 Linux |
9
| Conclusion | The GEM Premier 5000, with the change in its operating system from Fedora
17 Linux to WindRiver LTS 18 Linux is substantially equivalent to the legally
marketed predicate device last FDA cleared under K173403. |
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|