(251 days)
Not Found
No
The summary describes an automated quality control system (iQM3) and hemolysis detection, but does not mention the use of AI or ML algorithms for analysis, interpretation, or decision-making beyond standard automated processes.
No
The device is an in vitro diagnostic (IVD) device that provides quantitative measurements of various parameters in blood samples to aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance, and oxygen delivery capacity. It is not used for treating or preventing disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device's parameters "aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity" and lists various conditions for which the measurements are "used in the diagnosis and treatment." This directly indicates its role as a diagnostic device.
No
The device is a critical care system that includes an instrument and a cartridge (PAK) with sensors, optical cells, and other hardware components for analyzing blood samples. While it includes software (iQM3), it is not solely software.
Based on the provided information, the GEM Premier 7000 with iQM3 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the device is used to analyze lithium heparinized whole blood samples to provide quantitative measurements of various parameters. These parameters "aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity." This aligns directly with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Parameters Measured: The device measures a wide range of parameters (pH, pCO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin, and CO-Oximetry) that are commonly used in clinical laboratories for diagnostic and monitoring purposes. The description of how each parameter is used further reinforces its diagnostic role.
- Specimen Type: The device analyzes "lithium heparinized whole blood samples," which are specimens derived from the human body.
- Care Setting: The device is intended for use "at the point of health care delivery in a clinical setting and in a central laboratory," both of which are typical environments for IVD testing.
- Predicate Device: The mention of a predicate device (K203790; GEM Premier 5000) which is also a critical care analyzer, strongly suggests that this device falls under the same regulatory category, which is IVD.
In summary, the GEM Premier 7000 with iQM3 meets the criteria of an In Vitro Diagnostic device as it is intended for the examination of human specimens to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The GEM Premier 7000 with iQM3 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 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 lithium 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 (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, 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.
- 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 (comma separated list FDA assigned to the subject device)
CHL, JGS, CEM, CGZ, JFP, CGA, KHP, MQM, GKF, GKR, GHS, GLY
Device Description
The GEM Premier 7000 with iQMs system provides health care professionals with quantitative measurements of lithium heparinized whole blood pH, pCO2, pO2, Na*, K*, Ch, Ca**, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO₂*) from arterial, venous or capillary samples at the point of health care delivery in a clinical setting and in a central laboratory.
*sO₂ = Ratio between the concentration of oxyhemoglobin plus deoxyhemoglobin plus deoxyhemoglobin.
Key Components:
Instrument: 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): All required components for sample analysis are contained in the GEM PAK, including sensors, optical cell for CO-Oximetry and total bilirubin, sampler, pump tubing, distribution valve, waste container and Process Control Solutions. The GEM PAK is an entirely closed analytical system. The operator cannot introduce changes to the analytical process before or during the GEM PAK's use-life on board the instrument. The GEM PAK has flexible menus and test volume options to assist facilities in maximizing efficiency. The EEPROM on the GEM PAK includes all solution values and controls the analyte menu and number of tests. The setup of the instrument consists of inserting the GEM PAK into the instrument. The instrument will perform an automated GEM PAK start-up during which the following is performed: warm-up (15 minutes), sensor conditioning (10 minutes), Process Control Solution (PCS) performance (15 minutes), all of which take about 40 minutes. After GEM PAK start-up, Auto PAK Validation (APV) process is automatically completed: two completely independent solutions traceable to NIST standards, CLSI procedures or internal standards, containing two levels of concentration for each analyte (PC Solution D and E), are run by the analyzer to validate the integrity of the PC Solutions and the overall performance of the analytical system. Note: GEM PAKs that include tBili analyte will require the successful performance of CVP 5 tBili. Includes all necessary components for hemolysis detection, such as an acoustofluidic flow cell, an LED light source and an optical detector, for appropriate flagging of potassium measurements in whole blood samples without additional sample volume or sample processing steps.
Intelligent Quality Management (iQM3): iQM3 is used as the quality control and assessment system for the GEM Premier 7000 system. iQM3 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external QC. iQM3 introduces hemolysis detection in whole blood samples, enhancing quality assessment in the pre-analytical phase of testing.
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, 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)
Verification (Internal Method Comparison, Internal Whole Blood Precision, Hemolysis Interference on Potassium, Hemolysis Verification), Shelf-life and Use-life studies were performed to establish that the modifications introduced with the addition of the new iQM quality check (Hemolysis detection module) of the GEM Premier 7000 with IQMs do not impact the performance data represented in the Operators Manual. These studies followed recognized guidelines:
- CLSI EP05-A3
- CLSI EP07, 3rd Ed
- CLSI EP09c, 3rd Ed
- CLSI EP25-A
- CLSI EP37, 1st Ed
All verification activities were performed in accordance to established plans and protocols and design control procedures. Testing verified that all acceptance criteria were met.
The analytical study results demonstrate that the GEM Premier 7000 with iQM3 is safe and effective for its intended purpose and equivalent in performance to the predicate device (K203790).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 862.1120 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
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August 10, 2023
Instrumentation Laboratory Company Gabriella Erdosy Director of Regulatory Affairs 180 Hartwell Road Bedford, Massachusetts 01730
Re: K223608
Trade/Device Name: GEM Premier 7000 with iQM3 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, GKR, GHS, GLY Dated: July 10, 2023 Received: July 11, 2023
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 medical devices and radiation-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,
Paula V. Caposino -S
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223608
Device Name
GEM Premier 7000 with iQM3
Indications for Use (Describe)
The GEM Premier 7000 with iQM3 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 pH, pCO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin, and CO-Oximetry (tHb, O2Hb, MetHb, HHb, sO2*) parameters from arterial, venous, or capillary lithium 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 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 insividus, 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.
- COHo: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human
3
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.
| 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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Image /page/4/Picture/0 description: The image contains the logo for Instrumentation Laboratory, a Werfen Company. The logo features a stylized graphic of three overlapping shapes in shades of green and blue. To the right of the graphic, the text "Instrumentation Laboratory" is displayed in a clear, sans-serif font. Below this, the words "A Werfen Company" are written in a smaller font size.
K223608: GEM Premier 7000 with IQM3
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 |
| Gabriella Erdosy | |
|---|---|
| Contact Person | Director of Regulatory Affairs |
| Phone: 781-861-4571 | |
| Fax: 781-861-4207 | |
| Email: gerdosy@werfen.com |
| Preparation Date | August 10, 2023 |
|---|---|
| ------------------ | ----------------- |
| Device Trade Name | GEM Premier 7000 with iQM3 |
|---|---|
| ------------------- | ---------------------------- |
| Predicate Device | GEM Premier 5000 | K203790 |
|---|---|---|
| ------------------ | ------------------ | --------- |
5
| Regulatory Information | |||||
|---|---|---|---|---|---|
| GEM Premier 7000 with iQM3 | |||||
| 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 | |
| Glucose | 862.1345 | Glucose test system | II | CGA | |
| Lactate | 862.1450 | Lactic acid test system | I* | KHP | |
| Total Bilirubin | 862.1113 | Bilirubin (total and unbound) | |||
| in the neonate test system | I | ||||
| (Reserved) | MQM | ||||
| Hematocrit | 864.5600 | Automated hematocrit instrument | II | GKF | |
| 864.7425 | Carboxyhemoglobin assay | II | GHS | ||
| CO-Oximetry | 864.5620 | Automated hemoglobin system | II | GKR | 81 |
| 864.7500 | Whole blood hemoglobin assays | II | GLY |
- Meets limitations of exemptions per 21 CFR 862.9(c)(9)
Special Conditions for Use Statement
- . For prescription use only.
- For clinical laboratory and point-of-care use. .
6
Device Description
The GEM Premier 7000 with iQM3
The GEM Premier 7000 with iQMs system provides health care professionals with quantitative measurements of lithium heparinized whole blood pH, pCO2, pO2, Na*, K*, Ch, Ca**, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO₂*) from arterial, venous or capillary samples at the point of health care delivery in a clinical setting and in a central laboratory.
*sO₂ = Ratio between the concentration of oxyhemoglobin plus deoxyhemoglobin plus deoxyhemoglobin.
| Key Components | Description |
|---|---|
| Instrument | 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) | All required components for sample analysis are contained in the GEM PAK, |
| including sensors, optical cell for CO-Oximetry and total bilirubin, sampler, | |
| pump tubing, distribution valve, waste container and Process Control | |
| Solutions. The GEM PAK is an entirely closed analytical system. The operator | |
| cannot introduce changes to the analytical process before or during the | |
| GEM PAK's use-life on board the instrument. | |
| The GEM PAK has flexible menus and test volume options to assist facilities | |
| in maximizing efficiency. The EEPROM on the GEM PAK includes all solution | |
| values and controls the analyte menu and number of tests. | |
| The setup of the instrument consists of inserting the GEM PAK into the | |
| instrument. The instrument will perform an automated GEM PAK start-up | |
| during which the following is performed: warm-up (15 minutes), sensor | |
| conditioning (10 minutes), Process Control Solution (PCS) performance (15 | |
| minutes), all of which take about 40 minutes. | |
| After GEM PAK start-up, Auto PAK Validation (APV) process is automatically | |
| completed: two completely independent solutions traceable to NIST | |
| standards, CLSI procedures or internal standards, containing two levels of | |
| concentration for each analyte (PC Solution D and E), are run by the analyzer | |
| to validate the integrity of the PC Solutions and the overall performance of | |
| the analytical system. | |
| Note: GEM PAKs that include tBili analyte will require the successful | |
| performance of CVP 5 tBili. | |
| Includes all necessary components for hemolysis detection, such as an | |
| acoustofluidic flow cell, an LED light source and an optical detector, for | |
| appropriate flagging of potassium measurements in whole blood samples | |
| without additional sample volume or sample processing steps. | |
| Intelligent Quality Management | |
| (iQM3) | iQM3 is used as the quality control and assessment system for the GEM |
| Premier 7000 system. iQM3 is an active quality process control program | |
| designed to provide continuous monitoring of the analytical process | |
| before, during and after sample measurement with real-time, automatic | |
| error detection, automatic correction of the system and automatic | |
| documentation of all corrective actions, replacing the use of traditional | |
| external QC. | |
| iQM3 introduces hemolysis detection in whole blood samples, enhancing | |
| quality assessment in the pre-analytical phase of testing. |
7
Indications for Use / Intended Use
The GEM Premier 7000 with iQM3 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 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 lithium 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:
- l 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.
- . 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, 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.
- 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.
8
Comparison to Predicate
The GEM Premier 7000 with iQM3 system is substantially equivalent in function and intended use to the following predicate device:
Predicate Device: GEM Premier 5000 ●
| Item | Predicate Device | New Device | |
|---|---|---|---|
| Trade Names | GEM Premier 5000 | K203790 | GEM Premier 7000 with iQM3 |
| Manufacturers | Instrumentation Laboratory Co. | Instrumentation Laboratory Co. | |
| 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 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. | Same | |
| Indications for Use | |||
| (Continued) | - | 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. |
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| - HHb: Deoxyhemoglobin, as a fraction | |
|---|---|
| of total hemoglobin, is used in | |
| combination with oxyhemoglobin to | |
| measure oxygen status. | |
| - O2Hb: Oxyhemoglobin, as a fraction of | |
| hemoglobin, is used in | |
| total | |
| combination with deoxyhemoglobin to | |
| measure oxygen status. | |
| sO2: Oxygen saturation, more | |
| l | |
| specifically the ratio between the | |
| concentration of oxyhemoglobin and | |
| oxyhemoglobin plus | |
| deoxyhemoglobin, is used to measure | |
| oxygen status. |
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| Comparison to Predicate (Cont.) | ||
|---|---|---|
| NOTE: The comparison on this page is to the predicate device, the GEM Premier 5000. | ||
| Item | Predicate Device | New Device |
| Trade Names | GEM Premier 5000 | |
| K203790 | GEM Premier 7000 with iQM3 | |
| Similarities | ||
| 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 | |
| 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 |
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| Comparison to Predicate (Cont.) | |||
|---|---|---|---|
| NOTE: The comparison on this page is to the predicate device, the GEM Premier 5000. | |||
| Item | Predicate Device | New Device | |
| Trade Names | GEM Premier 5000 | ||
| K203790 | GEM Premier 7000 with iQM3 | ||
| Similarities (Continued) | |||
| Sample Type | Heparinized whole blood (venous, arterial or capillary) | Same | |
| pH | 7.00 to 7.92 | Same | |
| pCO2 | 6 to 125 mmHg | Same | |
| pO2 | 6 to 690 mmHg | Same | |
| Na+ | 100 to 180 mmol/L | Same | |
| K+ | 1.0 to 19.0 mmol/L | Same | |
| Ca++ | 0.11 to 4.25 mmol/L | Same | |
| Cl- | 40 to 158 mmol/L | Same | |
| Reportable Range | Glucose | 4 to 685 mg/dL | Same |
| Lactate | 0.3 to 17.0 mmol/L | Same | |
| Hematocrit | 15 to 72% | Same | |
| tBili | 2.0 to 40.0 mg/dL | Same | |
| tHb | 3.0 to 23.0 g/dL | Same | |
| O2Hb | 0.7 to 100.0% | Same | |
| COHb | 0.3 to 75.0% | Same | |
| MetHb | 0.7 to 30.0% | Same | |
| HHb | 1.0 to 100.0% | Same | |
| SO2 | 0.7 to 100.0% | Same | |
| Comparison to Predicate (Cont.) | |||
| NOTE: The comparison on this page is to the predicate device, the GEM Premier 5000 | |||
| Item | Predicate Device | New Device | |
| Trade Names | GEM Premier 5000 | ||
| K203790 | GEM Premier 7000 with iQM3 | ||
| Differences | |||
| Instrument Dimensions | GEM Premier 5000 Instrument: | ||
| Height: 18.6 inchesWidth: 13.0 inchesDepth: 16.4 inchesWeight: 45.4 pounds | GEM Premier 7000 with iQM3 Instrument: | ||
| Height: 18.9 inchesWidth: 12.9 inchesDepth: SameWeight: 45.3 pounds | |||
| Cartridge (PAK) Dimensions | GEM Premier 5000 PAK (Cartridge): | ||
| Height: 6.75 inchesWidth: 10 inchesDepth: 8 inchesWeight: 8.1 pounds | GEM Premier 7000 PAK with iQM3 (Cartridge): | ||
| Height: 6.6 inchesWidth: 10.2 inchesDepth: 7.6 inchesWeight: Same | |||
| Fluidic Pathway | The fluidic pathway directly connects Sensor Card and CO-Ox module | Addition of the new iQM quality check module between Sensor Card and CO-Ox module | |
| Sample Fluidic Process | Micro Mode (65 $ μ $ L) | Additional time (11s) for the new iQM quality check before analyte measurements | |
| PAK (Reagent) Bags | Process Control Solution Bag (PCS) B | Addition of Heparin | |
| Cartridge-Analyzer Interface | Cartridge fluidic components interface with hardware components on the analyzer | Modification to existing analyzer connection to support the iQM quality check module | |
| Instrument | An analyzer capable of supporting the GEM Premier 5000 Cartridge (PAK) | An analyzer capable of supporting the GEM Premier 7000 with iQM3 Cartridge (PAK) | |
| PAK Compatibility | GEM Premier 5000 only | GEM Premier 7000 with iQM3 only |
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| Comparison to Predicate (Cont.) | ||
|---|---|---|
| NOTE: The following table compares iQM2 on the GEM Premier 5000 to iQM3 on the GEM Premier 7000. | ||
| Item | Predicate Device | New Device |
| Trade Names | iQM2 (Intelligent Quality Management 2) | iQM3 (Intelligent Quality Management 3) |
| Instrument | GEM Premier 5000 | GEM Premier 7000 with iQM3 |
| 510(k) No. | K203790 | K223608 |
| Quality Control | ||
| Principle | Active quality process control program using | |
| a combination of internal Auto PAK | ||
| Validation (APV) and one level of external | ||
| Calibration Valuation Product (CVP 5), five | ||
| internal Process Control Solutions (PCSs) | ||
| Pattern Recognition (PR) software and | ||
| IntraSpect sample integrity quality checks, | ||
| all of which are designed to provide | ||
| immediate error detection and automatic | ||
| remedial action, replacing the use of | ||
| traditional external quality controls. | Same | |
| Error | ||
| Detection | ||
| Scheme | Multi-level checks for detecting cartridge | |
| errors. | ||
| • System checks | ||
| • Sensor/CO-Oximetry checks | ||
| • IntraSpect checks | ||
| • Pattern Recognition (PR checks) | ||
| • Process Control Solution (PCS) Stability | Same except addition of Hemolysis | |
| detection. | ||
| • Same, except addition of | ||
| Hemolysis detection | ||
| functionality | ||
| • Same except the addition of | ||
| Hemolysis Module Checks | ||
| • Same | ||
| • Same | ||
| • Same | ||
| • Hemolysis detection | ||
| Error Mitigation | Automatic error handling: | |
| • Performing special rinse cycle after | ||
| detecting micro-clots and verifying the | ||
| cartridge function after clot removal. | ||
| • Permanently disabling failed sensor if | ||
| its functionality could not be | ||
| recovered. | ||
| • Rejecting cartridge for process stability | ||
| failure. | ||
| • Alerting the user if interferences are | ||
| detected in a sample. | ||
| • Automatically documenting the failure | ||
| and action taken. | ||
| • IntraSpect | Same | |
| Documentation | Automatic documentation: | |
| • Process Control Solutions delta charts. | ||
| • Error reporting and corrective action | ||
| report. | ||
| • GEM CVP report. | Same |
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Comparison to Predicate (Cont.)
| NOTE: The following table compares internal Process Control (PC) Solutions in the GEM Premier 5000 PAK
| (cartridge) to internal Process Control (PC) Solutions in the GEM Premier 7000 with iQM3 PAK (cartridge). | ||
|---|---|---|
| Category | Predicate Device | New Device |
| Trade Names | Process Control (PC) Solutions | Process Control (PC) Solutions |
| Instrument | GEM Premier 5000 | GEM Premier 7000 with iQM3 |
| 510(k) No. | K203790 | K223608 |
| PC Solution B is the primary Process Control Solution measured at a minimum of every half hour or after every sample. Furthermore, Solution B is monitored every 30 seconds while residing in the sensor card between measurements. Further, PC Solution B is used as a reference blank for CO-Oximetry. PC Solution A is measured at a minimum of every 4 hours. All sensor slope values are also measured and checked. Slope, which is an indicator of sensor sensitivity and drift, must be within allowable limits. PC Solution A also contains dyes that are used for checking functionality of the optical cell and the CO-Oximetry. | PC Solution B – Same, except the addition of Heparin PC Solution A – Same | |
| PC Solutions | PC Solution C is measured at a minimum of once every 24 hours. PC Solution C is primarily used for measuring low-level oxygen; however, PC Solution C is also used to provide an additional measurement of pH, pCO2 and K+ sensor functionality. | PC Solution C – Same |
| PC Solution D is measured every 12 hours. PC Solution D provides additional measurement for all analytes including CO-Oximetry. Reference values for analytes in PC Solution D are assigned at time of manufacturing. The D sensor check starts after the successful completion of Auto PAK Validation (APV). | PC Solution D – Same | |
| PC Solution E is measured every 12 hours. PC Solution E provides additional measurement for all analytes including CO-Oximetry. Reference values for analytes in PC Solution E are assigned at time of manufacturing. The E sensor check starts after the successful completion of Auto PAK Validation (APV). | PC Solution E – Same |
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Performance Summary
Verification (Internal Method Comparison, Internal Whole Blood Precision, Hemolysis Interference on Potassium, Hemolysis Verification), Shelf-life and Use-life studies were performed to establish that the modifications introduced with the addition of the new iQM quality check (Hemolysis detection module) of the GEM Premier 7000 with IQMs do not impact the performance data represented in the Operators Manual. These studies followed recognized guidelines:
- . CLSI EP05-A3
- . CLSI EP07, 3rd Ed
- CLSI EP09c, 3rd Ed ●
- CLSI EP25-A
- . CLSI EP37, 1st Ed
All verification activities were performed in accordance to established plans and protocols and design control procedures. Testing verified that all acceptance criteria were met.
| Conclusion | The technological and functional characteristics of the new GEM Premier 7000
with iQM3 as described above are substantially equivalent to that of the predicate
device GEM Premier 5000. The analytical study results demonstrate that the GEM
Premier 7000 with iQM3 is safe and effective for its intended purpose and
equivalent in performance to the predicate device (K203790). |
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