(59 days)
No
The summary describes a standard critical care blood analyzer and its performance characteristics. There is no mention of AI, ML, or any technology that would suggest the use of such algorithms for analysis or interpretation.
No.
The device is used to analyze blood samples to aid in diagnosis, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the parameters measured by the device "aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity." It further details how specific measurements (e.g., Sodium, Potassium, Glucose, Lactate, Carboxyhemoglobin) "are used in the diagnosis" of various conditions.
No
The device description clearly states it is a "portable critical care system" and an "instrument" that analyzes blood samples, indicating it is a physical hardware device. The performance studies also describe testing on "analyzers" and "instruments," further confirming it is not software-only.
Yes, the GEM Premier 5000 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "rapidly analyze heparinized whole blood samples" and provides "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, pO2, electrolytes, glucose, lactate, hematocrit, total bilirubin, and CO-Oximetry) that are commonly used in clinical laboratories and at the point of care for diagnostic and monitoring purposes. The description of the clinical significance of each parameter further reinforces its diagnostic role.
- Specimen Type: The device analyzes "heparinized whole blood samples," which are specimens derived from the human body.
- Clinical Setting: The device is intended for use in a "clinical setting and in a central laboratory," which are typical environments for IVD testing.
- Performance Studies: The provided information includes details about performance studies (precision and method comparison) conducted using human blood samples, which are standard requirements for demonstrating the analytical performance of an IVD device.
- Predicate Device: The mention of a predicate device (GEM Premier 4000, K133407) which is also a blood gas and critical care analyzer, further indicates that this device falls within the category of IVDs.
Based on the intended use, the type of measurements performed on human specimens, and the clinical context of its use, the GEM Premier 5000 clearly fits the definition 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.
*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.
- 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, CEM, CGZ, GKF, GKR, 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.
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, point-of-care
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
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
- Study Type: Internal precision study
- Sample Size: 5 different concentrations of whole blood per analyte, N=120 per analyte per level.
- Data Source: Whole blood samples transferred from syringe to a capillary device.
- Key Results: All results met specification.
Internal Precision – Capillary Finger-stick Samples
- Study Type: Internal precision study
- Sample Size: 28 donor samples
- Data Source: Finger-stick samples drawn and run by two (2) point-of-care (POC) operators. Samples collected into two (2) capillary tubes via capillary puncture.
- Key Results: All results met specification.
External POC Precision – Capillary Transfer Samples
- Study Type: Precision study
- Sample Size: minimum of 20 residual whole blood samples run over five (5) days, each run in triplicate.
- Data Source: Heparinized whole blood patient samples transferred from syringe to a capillary device and run by three (3) POC operators at an external point-of-care (POC) site.
- Key Results: All results met specification.
Point-of-Care (POC) Method Comparison
- Study Type: Method comparison study
- Sample Size: Not explicitly stated for all, but for pooled data:
- pCO2, K+, Hct: N=130
- Cl-: N=129
- tHb: N=131
- Pooled data with additional contrived capillary results: N=139 for pCO2, N=140 for K+, N=141 for Cl-, N=136 for Hct, N=137 for tHb.
- Data Source: Native capillary finger-stick samples collected by six (6) POC operators at an external POC site (minimum of 40 samples) and three (3) POC operators in the IL internal Customer Simulation Laboratory (CSL) (minimum of 80 samples). These were run in singlicate on both the test (GEM Premier 5000) and predicate (GEM Premier 4000) instruments. Data was then pooled with contrived whole blood samples (
§ 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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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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.
4
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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.
180 Hartwell Road
Bedford, MA 01730, USA |
|-------------------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person | Carol Marble, Regulatory Affairs Director
Phone: 781-861-4467
Fax: 781-861-4207
Email: cmarble@ilww.com |
| Preparation Date | December 19, 2017 |
| Device Trade Name | GEM Premier 5000 |
Regulatory Information | ||||
---|---|---|---|---|
Analyte | Regulation | |||
Section | Regulatory Description | Class | Product | |
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.
6
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.
7
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.
8
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 / | |||
Indications for | |||
Use | The GEM Premier 4000 is a portable critical care system for use by | ||
health care professionals to rapidly analyze 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) parameters. Total bilirubin can also be | |||
quantitated from heparinized plasma samples when analyzed in the | |||
tBili/CO-Ox mode. | |||
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. | |||
Total bilirubin measurements are used in the diagnosis and | |||
management of biliary tract obstructions, liver disease and various | |||
hemolytic diseases and disorders involving the metabolism of | |||
bilirubin. In neonates, the level of total bilirubin is used to aid in | |||
assessing the risk of kernicterus. | 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. | |||
See previous pages for complete Intended Use/Indications for Use | |||
for the GEM Premier 5000. | |||
Substantial Equivalence (Cont.) | |||
Item | Predicate Device | Modified Device | |
Trade Name | GEM Premier 4000 | ||
K133407 | GEM Premier 5000 | ||
Intended Settings | Central Laboratory and Point-of-Care | Same | |
Sample Type | Heparinized whole blood | ||
(arterial, venous or capillary) | Same; expanding capillary | ||
claims to pCO2, K+, Cl-, Hct | |||
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 |
9
10
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
SD | Within Run
%CV | | | | | | | | | | | | | | | | | | | | |
|-----------------|-----------------|-------|-------|------------------|-------------------|------|------|-----|-----|------|---|------|-----|-----|------|---|-------|-----|-----|------|---|-------|-----|-----|------|
| pCO2
(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+
(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 | 17.29 | 120 | 0.15 | 0.9% | | | | | | | | | | | | | | | | | | | | |
| Cl-
(mmol/L) | 1 | 53.4 | 120 | 0.4 | 0.8% | 2 | 75.8 | 120 | 0.4 | 0.5% | 3 | 89.8 | 120 | 0.4 | 0.4% | 4 | 110.7 | 120 | 0.4 | 0.4% | 5 | 152.8 | 120 | 0.7 | 0.4% |
| | Cl-
(mmol/L) | 1 | 53.4 | 120 | 0.4 | 0.8% | | | | | | | | | | | | | | | | | | | |
| | | 2 | 75.8 | 120 | 0.4 | 0.5% | | | | | | | | | | | | | | | | | | | |
| | | 3 | 89.8 | 120 | 0.4 | 0.4% | | | | | | | | | | | | | | | | | | | |
| | | 4 | 110.7 | 120 | 0.4 | 0.4% | | | | | | | | | | | | | | | | | | | |
| 5 | | 152.8 | 120 | 0.7 | 0.4% | | | | | | | | | | | | | | | | | | | | |
All results met specification.
11
Analyte | Level | Mean | N | Within Run SD | Within Run %CV |
---|---|---|---|---|---|
Hct | |||||
(%) | 1 | 19.3 | 120 | 0.6 | 2.9% |
2 | 32.8 | 120 | 0.6 | 1.9% | |
3 | 44.7 | 120 | 0.6 | 1.3% | |
4 | 55.0 | 120 | 0.8 | 1.5% | |
5 | 63.7 | 120 | 1.3 | 2.0% | |
tHb | |||||
(g/dL) | 1 | 7.02 | 120 | 0.16 | 2.3% |
2 | 11.06 | 120 | 0.09 | 0.8% | |
3 | 14.47 | 120 | 0.10 | 0.7% | |
4 | 17.34 | 120 | 0.09 | 0.5% | |
5 | 19.92 | 120 | 0.25 | 1.3% |
Internal Precision – Capillary Transfer Samples (Cont.):
12
Internal Precision – Capillary Finger-stick Samples
An internal precision study was performed on a single GEM Premier 5000 in the IL Customer Simulation Laboratory (CSL), using finger-stick samples drawn and run by two (2) point-of-care (POC) operators brought on site for the study.
The study used twenty-eight (28) donor samples, collected into two (2) capillary tubes via capillary puncture. Each capillary tube was run in singlicate.
Results were analyzed separately for samples with mean within the fixed acceptance criteria range (SD) and those in the variable acceptance criteria range (%CV).
All results met specification.
| Analyte | N | Mean | Within Sample
SD | Within Sample
%CV |
|-----------------|----|------|---------------------|----------------------|
| pCO2
(mmHg) | 56 | 39 | 1.3 | 3.3 |
| K+
(mmol/L) | 56 | 4.1 | 0.11 | 2.6 |
| Cl-
(mmol/L) | 56 | 106 | 0.3 | 0.3 |
| Hct
(%) | 56 | 43 | 0.7 | 1.7 |
| tHb
(g/dL) | 56 | 14.2 | 0.14 | 1.0 |
13
External POC Precision – Capillary Transfer Samples
A precision study was performed on a GEM Premier 5000 at an external point-of-care (POC) site, using heparinized whole blood patient samples transferred from syringe to a capillary device and run by three (3) POC operators.
The study used a minimum of twenty (20) residual whole blood samples run over five (5) days. Each sample was run in triplicate.
Results were analyzed separately for samples with mean within the fixed acceptance criteria range (SD) and those in the variable acceptance criteria range (%CV).
All results met specification.
| Analyte | N | Mean | Within Sample
SD | Within Sample
%CV |
|-----------------|----|------|---------------------|----------------------|
| pCO2
(mmHg) | 63 | 42 | 0.9 | 2.0 |
| pCO2
(mmHg) | 3 | 88 | 0.6 | 0.7 |
| K+
(mmol/L) | 66 | 4.0 | 0.05 | 1.2 |
| Cl-
(mmol/L) | 66 | 107 | 0.5 | 0.5 |
| Hct
(%) | 66 | 30 | 0.7 | 2.4 |
| tHb
(g/dL) | 60 | 11.0 | 0.29 | 2.6 |
14
Point-of-Care (POC) Method Comparison
A method comparison study was conducted comparing the GEM Premier 5000 to the GEM Premier 4000 (predicate device) with native capillary finger-stick samples were collected via finger-stick by six (6) POC operators at an external POC site (minimum of 40 native capillary samples) and three (3) POC operators in the IL internal Customer Simulation Laboratory (CSL) (minimum of 80 native samples), and then run in singlicate on both the test and predicate instruments.
Pooled Point-of-Care Site and CSL Data with Native Capillary Samples | |||||||
---|---|---|---|---|---|---|---|
Analyte | N | Range | |||||
Min | Range | ||||||
Max | MDL | Bias at | |||||
MDL | 95% CI of Bias at MDL | TEa | |||||
pCO2 | |||||||
(mmHg) | 130 | 26 | 50 | 35 | 1.0 | 1.0 to 2.0 | ± 5.0 |
50 | 1.0 | 1.0 to 2.0 | ± 5.0 | ||||
70 | 1.4% | 1.4% to 3.1% | ± 8% | ||||
K+ | |||||||
(mmol/L) | 130 | 3.1 | 6.7 | 3.0 | 0.1 | -0.03 to 0.19 | ± 0.5 |
5.8 | 0.1 | 0.05 to 0.30 | ± 0.5 | ||||
7.5 | 1.3% | 0.7% to 6.8% | ± 7% | ||||
Cl | |||||||
(mmol/L) | 129 | 90 | 111 | 90 | -1.1% | -1.1% to 0.0% | ± 5% |
112 | -0.9% | -0.9% to 0.0% | ± 5% | ||||
Hct | |||||||
(%) | 130 | 24 | 51 | 21 | -0.4 | -1.3 to 0.5 | ± 4 |
33 | -0.3 | -0.7 to 0.1 | ± 4 | ||||
56 | -0.1 | -0.7 to 0.5 | ± 4 | ||||
tHb | |||||||
(g/dL) | 131 | 6.9 | 17.3 | 7.0 | -0.27 | -0.43 to -0.12 | ± 0.7 |
10.5 | -0.17 | -0.25 to -0.09 | ± 0.7 | ||||
18.0 | 0.05 | -0.07 to 0.16 | ± 1.0 |
The observed biases at the medical decision levels are shown below:
15
Point-of-Care (POC) Method Comparison (Cont.)
The data from the native capillary samples (finger-stick samples) previously presented were pooled with contrived whole blood samples (