(306 days)
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 and pO2 from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of pCO2 from venous and arterial heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status.
pH, pCO2 and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.
The GEM Premier 5000 system provides health care professionals in central laboratory or point-of-care clinical settings with fast, accurate, quantitative measurements of pH and pQ2 from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of pCO₂ from venous and arterial heparinized whole blood.
Key Components:
Analyzer: Employs a unique color touch 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.
GEM Premier 5000 PAK (disposable, multi-use GEM PAK): Houses all required components necessary to operate the instrument once the cartridge is validated. These components include the sensors, CO-Ox optical cell, Process Control (PC) Solutions, sampler, pump tubing, distribution valve and waste bag. The GEM PAK has flexible menus and test volume options to assist facilities in maximizing efficiency. NOTE: The EEPROM on the GEM PAK includes all solution values and controls the analyte menu and number of tests.
Step 1: After inserting the GEM PAK, the instrument will perform an automated PAK warm-up during which the sensors are hydrated and a variety of checks occur, all of which take about 40 minutes. During warm-up, the instrument requires no user intervention.
Step 2: After GEM PAK warmup, Auto PAK Validation (APV) process is automatically completed: two completely independent solutions (PC Solution D and E) that are traceable to NIST standards, CLSI procedures or internal standards, containing two levels of concentration for each analyte, are run by the analyzer to validate the integrity of the PC Solutions and the overall performance of the analytical system.
Step 3: After successful performance of APV, iQM2 manages the quality control process, replacing external quality controls.
Intelligent Quality Management 2 (iQM2): iQM2 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. iQM2 is a statistical process control system that performs 5 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, CO-Ox, and reagents. These checks include System, Sensor, IntraSpect, Pattern Recognition and Stability Checks.
The GEM Premier 5000 is a medical device designed for the rapid analysis of heparinized whole blood samples for pH, pCO2, and pO2 measurements. The provided document is a 510(k) summary, which demonstrates substantial equivalence to a predicate device (GEM Premier 4000) for these parameters.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct numerical targets in the document. Instead, the studies aim to demonstrate that the device performs "within specification" or shows "substantial equivalency" to the predicate device and recognized standards (CLSI guidelines). The reported performance is summarized below, with an implied acceptance that these values fall within expected clinical or analytical ranges and compare favorably to the predicate.
The reported performance values are presented as part of precision studies, linearity studies, analytical specificity (absence of interference), and method comparison against predicate devices or reference methods. The "acceptance criteria" are implicitly met if the reported values demonstrate acceptable precision, linearity, and agreement with reference methods/predicate devices.
| Metric (Analyte) | Acceptance Criteria (Implied / Contextual) | Reported Device Performance (GEM Premier 5000) | Study Reference |
|---|---|---|---|
| pH Precision (Aqueous Controls) | Low SD/CV (within specification) | Level 1: Mean 7.14, Total SD 0.008, Total %CV 0.1%Level 2: Mean 7.38, Total SD 0.006, Total %CV 0.1%Level 3: Mean 7.57, Total SD 0.003, Total %CV 0.0% | Internal Precision Study - Aqueous Controls |
| pCO2 Precision (Aqueous Controls) | Low SD/CV (within specification) | Level 1: Mean 87, Total SD 2.3, Total %CV 2.7%Level 2: Mean 35, Total SD 0.8, Total %CV 2.3%Level 3: Mean 14, Total SD 0.3, Total %CV 2.3% | Internal Precision Study - Aqueous Controls |
| pO2 Precision (Aqueous Controls) | Low SD/CV (within specification) | Level 1: Mean 31, Total SD 2.4, Total %CV 7.9%Level 2: Mean 88, Total SD 2.2, Total %CV 2.4%Level 3: Mean 370, Total SD 5.9, Total %CV 1.6% | Internal Precision Study - Aqueous Controls |
| pH Precision (Whole Blood) | Low SD/CV (within specification) | Normal Mode: Total SD 0.005-0.014, Total %CV 0.1-0.2%Micro Mode: Total SD 0.007-0.015, Total %CV 0.1-0.2% | Internal Precision Study - Whole Blood |
| pCO2 Precision (Whole Blood) | Low SD/CV (within specification) | Normal Mode: Total SD 0.8-2.9, Total %CV 1.5-7.7% | Internal Precision Study - Whole Blood |
| pO2 Precision (Whole Blood) | Low SD/CV (within specification) | Normal Mode: Total SD 0.9-32.7, Total %CV 1.2-4.3%Micro Mode: Total SD 0.9-34.0, Total %CV 1.4-4.8% | Internal Precision Study - Whole Blood |
| pH Reproducibility (POC) | Low SD/CV (within specification) | GSE 1: Reproducibility SD 0.002, %CV 0.0%GSE 2: Reproducibility SD 0.008, %CV 0.1%GSE 3: Reproducibility SD 0.003, %CV 0.0% | Reproducibility Study - POC Setting |
| pCO2 Reproducibility (POC) | Low SD/CV (within specification) | GSE 1: Reproducibility SD 1.1, %CV 1.2%GSE 2: Reproducibility SD 0.9, %CV 2.7%GSE 3: Reproducibility SD 0.5, %CV 3.5% | Reproducibility Study - POC Setting |
| pO2 Reproducibility (POC) | Low SD/CV (within specification) | GSE 1: Reproducibility SD 1.9, %CV 6.7%GSE 2: Reproducibility SD 1.9, %CV 2.2%GSE 3: Reproducibility SD 9.3, %CV 2.6% | Reproducibility Study - POC Setting |
| Linearity (pH) | R² close to 1, slope close to 1, small intercept | Slope: 0.972, Intercept: 0.191, R²: 0.998 | Linearity Study |
| Linearity (pCO2) | R² close to 1, slope close to 1, small intercept | Slope: 1.045, Intercept: -2.027, R²: 0.998 | Linearity Study |
| Linearity (pO2) | R² close to 1, slope close to 1, small intercept | Slope: 1.028, Intercept: -4.069, R²: 0.995 | Linearity Study |
| Analytical Specificity | No observed interference | No interference with listed substances at specified concentrations for pH, pCO2, pO2. | Analytical Specificity |
| Method Comparison (pH vs. Predicate) | Good correlation with predicate (GEM Premier 4000) or reference (Tonometry) | Slope: 0.953, Intercept: 0.344, R²: 0.993 | Internal Method Comparison |
| Method Comparison (pCO2 vs. Predicate) | Good correlation with predicate (GEM Premier 4000) or reference (Tonometry) | Slope: 1.026, Intercept: -0.991, R²: 0.997 | Internal Method Comparison |
| Method Comparison (pO2 vs. Predicate) | Good correlation with predicate (GEM Premier 4000) or reference (Tonometry) | Slope: 1.027, Intercept: -1.266, R²: 0.999 | Internal Method Comparison |
| Clinical Testing (POC vs. Predicate) - Normal Mode | High correlation (r close to 1) | pH: r=0.991; pCO2: r=0.991; pO2: r=0.996 | Clinical Testing |
| Clinical Testing (POC capillary) - Total Error | Bias within 95% CI of Bias, Total Error (TEa) within specification | pH: MDL 7.30 Bias 0.002, 95% CI (-0.015 to 0.020), TEa $\pm$0.04pCO2: Not provided for capillarypO2: MDL 30 Bias 6.1, 95% CI (1.3 to 11.6), TEa $\pm$9.0 | Clinical Testing |
The total error calculations are compared against "GEM Premier 5000 Total Error Specifications," which are not explicitly provided in the document but are indicated as having been met.
2. Sample Sizes and Data Provenance
The document provides sample sizes for various tests:
- Internal Precision Study - Aqueous Controls: n=120 per analyte per level (3 analyzers, 20 days, 2 runs/day, 1 replicate/run). Data provenance is internal (Instrumentation Laboratory Co.).
- Internal Precision Study - GEM PAK Process Control Solutions D and E: n=120 per analyte per level (3 analyzers, 20 days, 2 runs/day, 1 replicate/run). Data provenance is internal (Instrumentation Laboratory Co.).
- Internal Precision Study - Whole Blood: n=120 per analyte per sample mode per level (3 analyzers, 5 days, 1 run/day, 8 replicates/run). Data provenance is internal (Instrumentation Laboratory Co.).
- Reproducibility Study with Aqueous Controls – POC Setting: n=90 per material/level (3 external POC sites, 9 operators, 3 instruments, 5 days, 2 runs/day, 3 replicates/run). Data provenance is external Point-of-Care sites within the USA (implied as no other country explicitly mentioned). This was a prospective study.
- External Precision – Whole Blood:
- POC Setting: n=30 to 54 per site (various N given per analyte/mode/site) for pH, pCO2, pO2. Pooled POC data: pH (N=102-126), pCO2 (N=117), pO2 (N=45-51). Performed by 11 operators on 3 instruments. Data provenance is 3 external POC locations, prospective.
- Central Lab Setting: n=24 to 30 per site. Pooled lab data: pH (N=90), pCO2 (N=78), pO2 (N=66-72). Performed by 3 operators on 3 instruments. Data provenance is 2 external central laboratories and 1 internal Customer Simulation Laboratory (CSL). It includes native and contrived specimens. This was a prospective study.
- LoB, LoD, and LoQ: LoB, LoD, LoQ were established using three (3) lots of GEM Premier 5000 PAKs (cartridges). Specific sample sizes for individual measurements within the establishment process are not detailed, but the method used is CLSI EP17-A2. Data provenance is internal (Instrumentation Laboratory Co.).
- Linearity: 8 or 9 levels per analyte, 9 replicates per level (on 3 test analyzers). Total N per analyte: 72-81. Data provenance is internal (Instrumentation Laboratory Co.).
- Analytical Specificity: Interference study with various substances. Specific N for each substance not detailed, but it involves screening tests at two different analyte concentrations. Data provenance is internal (Instrumentation Laboratory Co.).
- Internal Method Comparison:
- pH: N=373 clinical samples.
- pCO2: N=150 clinical samples.
- pO2: N=148 clinical samples.
Data provenance is internal, using clinical samples. These were retrospective or prospective, but likely prospective as samples were "altered as needed to cover the medical decision levels."
- Clinical Testing (Method Comparison):
- Normal Mode (Syringe Samples): pH: N=479; pCO2: N=492; pO2: N=506. Pooled data from 3 external POC sites and 1 internal Customer Simulation Laboratory (CSL). Data includes patient samples. This was a prospective study.
- Native Capillary Samples: N=171 for pH, N=167 for pO2. Collected at an external POC site (N=65) and an internal CSL (N=106). Data provenance is external POC site and internal CSL. This was a prospective study.
- Pooled Capillary Results (Native + Contrived): pH: N=189; pO2: N=218. The contrived samples were prepared internally. Data provenance is external POC site, internal CSL, and internal contrived samples. This was a prospective study.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of human "experts" in the traditional sense (e.g., radiologists, pathologists) to establish ground truth for the device's performance. Instead, ground truth for quantitative measurements of blood gases and pH is established using:
- Reference materials/standards: NIST standards, CLSI procedures, internal standards (for calibration and control solutions).
- Predicate devices: The GEM Premier 4000 serves as the predicate for method comparison studies.
- Reference methods: Tonometry is used as a reference for pO2 and pCO2 in Linearity and Internal Method Comparison studies due to instability of blood gases.
The quality control process (iQM2) also uses "Process Control (PC) Solutions" whose values are traceable to NIST standards, CLSI procedures, or internal standards.
4. Adjudication Method
No adjudication method (e.g., 2+1, 3+1 consensus) is described because the ground truth is established through quantitative measurements against reference materials, reference methods, or comparison to a predicate device, rather than subjective expert interpretation requiring consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The device measures quantitative laboratory parameters (pH, pCO2, pO2) and does not involve human readers interpreting images or data where "AI assistance" would be relevant in the context of diagnostic performance improvement. The studies focus on analytical performance metrics like precision, accuracy, and linearity.
6. Standalone Performance Study
Yes, standalone performance was done. All the precision, linearity, LoB/LoD/LoQ, analytical specificity, and method comparison studies described are standalone performance studies. These studies evaluate the device's ability to accurately and precisely measure pH, pCO2, and pO2 in various conditions (aqueous controls, whole blood, different modes) independently. The "method comparison" studies compare the device's readings directly against a predicate device or a reference method.
7. Type of Ground Truth Used
The ground truth used for the studies is based on:
- Calibration and Control Solutions: Values traceable to NIST standards, CLSI procedures, or internal standards.
- Reference Methods: Tonometry for pCO2 and pO2 in linearity and method comparison studies.
- Predicate Device: The GEM Premier 4000 for method comparison studies for pH.
- Clinical Samples: Patient samples (heparinized whole blood, native capillary samples) are used for precision and method comparison studies, with their "true" values established by the reference methods or predicate device for comparison. For some internal precision studies and clinical testing, contrived samples are also used to extend the tested range.
8. Sample Size for the Training Set
The document describes premarket validation studies for a medical device that performs quantitative measurements, not a machine learning or AI model that requires a "training set." Therefore, there is no "training set" in the context of AI model development mentioned or implied in this document. The studies are validation studies demonstrating the device's performance against established analytical standards.
9. How Ground Truth for the Training Set Was Established
As noted above, this device does not involve a "training set" in the context of AI/ML. The measurements and comparisons are against established analytical methodologies and reference values.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 14, 2016
INSTRUMENTATION LABORATORY CO. CAROL MARBLE REGULATORY AFFAIRS DIRECTOR 180 HARTWELL ROAD BEDFORD MA 01730
Re: K160412
Trade/Device Name: GEM Premier 5000 (Measured Parameters: pH. pCO2, pO2) Regulation Number: 21 CFR 862. 1120 Regulation Name: Blood gases (pCO2 and pO2) and blood pH test system Regulatory Class: II Product Code: CHL Dated: December 7, 2016 Received: December 8, 2016
Dear Ms. Marble:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160412
Device Name
GEM Premier 5000 (Measured Parameters: pH, pCO2, pO2)
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 and pO2 from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of pCO2 from venous and arterial heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status.
pH, pCO2 and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.
| 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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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 RoadBedford, MA 01730, USA |
|---|---|
| ------------------------- | ------------------------------------------------------------------------------------ |
| Contact Person | Carol Marble, Regulatory Affairs DirectorPhone: 781-861-4467Fax: 781-861-4207Email: cmarble@ilww.com |
|---|---|
| ---------------- | ------------------------------------------------------------------------------------------------------------------ |
| Preparation Date | December 7, 2016 |
|---|---|
| ------------------ | ------------------ |
| Device Trade Name | GEM Premier 5000(Measured Parameters: pH, pCO2 and pO2) |
|---|---|
| ------------------- | ------------------------------------------------------------- |
| Predicate Device | GEM Premier 4000 | K133407 |
|---|---|---|
| ------------------ | ------------------ | --------- |
| Regulatory Information | |||||
|---|---|---|---|---|---|
| Analyte | Regulation Section | Regulatory Description | Class | Product Code | Panel |
| pH, pCO₂, pO₂, | 862.1120 | Blood Gases (pCO₂, pO₂) and Blood pH system | II | CHL | 75 |
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Device Description
The GEM Premier 5000 system provides health care professionals in central laboratory or point-of-care clinical settings with fast, accurate, quantitative measurements of pH and pQ2 from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of pCO₂ from venous and arterial heparinized whole blood.
| Key Components | Description |
|---|---|
| Analyzer | Employs a unique color touch screen and a simple set of menus andbuttons for user interaction. The analyzer guides operators through thesampling process with simple, clear messages and prompts. |
| GEM Premier 5000 PAK(disposable, multi-use GEM PAK) | Houses all required components necessary to operate the instrumentonce the cartridge is validated. These components include the sensors,CO-Ox optical cell, Process Control (PC) Solutions, sampler, pumptubing, distribution valve and waste bag. The GEM PAK has flexiblemenus and test volume options to assist facilities in maximizingefficiency.NOTE: The EEPROM on the GEM PAK includes all solution values andcontrols the analyte menu and number of tests. |
| Step 1: | After inserting the GEM PAK, the instrument will perform anautomated PAK warm-up during which the sensors arehydrated and a variety of checks occur, all of which takeabout 40 minutes. During warm-up, the instrument requiresno user intervention. |
| Step 2: | After GEM PAK warmup, Auto PAK Validation (APV) process isautomatically completed: two completely independentsolutions (PC Solution D and E) that are traceable to NISTstandards, CLSI procedures or internal standards, containingtwo levels of concentration for each analyte, are run by theanalyzer to validate the integrity of the PC Solutions and theoverall performance of the analytical system. |
| Step 3: | After successful performance of APV, iQM2 manages thequality control process, replacing external quality controls. |
| Intelligent Quality Management 2(iQM2) | iQM2 is an active quality process control program designed to providecontinuous monitoring of the analytical process before, during andafter sample measurement with real-time, automatic error detection,automatic correction of the system and automatic documentation of allcorrective actions.iQM2 is a statistical process control system that performs 5 types ofcontinuous, quality checks to monitor the performance of the GEMPAK, sensors, CO-Ox, and reagents. These checks include System,Sensor, IntraSpect, Pattern Recognition and Stability Checks. |
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| Indications for Use / Intended Use | ||
|---|---|---|
| GEM Premier 5000 | The GEM Premier 5000 is a portable critical care system for use byhealth care professionals to rapidly analyze heparinized wholeblood samples at the point of health care delivery in a clinicalsetting and in a central laboratory. The instrument providesquantitative measurements of pH and pO2 from venous, arterialand capillary heparinized whole blood, as well as quantitativemeasurements of pCO2 from venous and arterial heparinized wholeblood. These parameters, along with derived parameters, aid in thediagnosis of a patient's acid/base status.pH, pCO2, pO2 measurements in whole blood are used in thediagnosis and treatment of life-threatening acid-base disturbances. | |
| Substantial Equivalency | ||
| The GEM Premier 5000 system is substantially equivalent in function and intended use to the following predicate device for pH, pCO2, pO2: | ||
| Item | Predicate Device | New Device |
| Trade Name | GEM Premier 4000 | GEM Premier 5000 |
| 510(k) No. | K133407 | K160412 |
| Manufacturer | Instrumentation Laboratory Co. | Instrumentation Laboratory Co. |
| Indicationsfor Use | The GEM Premier 4000 is a portable critical care system for use byhealth care professionals to rapidly analyze whole blood samples atthe point of health care delivery in a clinical setting and in a centrallaboratory. The instrument provides quantitative measurements ofpH, 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 bequantitated from heparinized plasma samples when analyzed in thetBili/CO-Ox mode. These parameters, along with derivedparameters, 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 andmanagement of biliary tract obstructions, liver disease and varioushemolytic diseases and disorders involving the metabolism ofbilirubin. In neonates, the level of total bilirubin is used to aid inassessing the risk of kernicterus. | The GEM Premier 5000 is a portable critical care system for useby health care professionals to rapidly analyze heparinizedwhole blood samples at the point of health care delivery in aclinical setting and in a central laboratory. The instrumentprovides quantitative measurements of pH and pO2 fromvenous, arterial and capillary heparinized whole blood, as wellas quantitative measurements of pCO2 from venous and arterialheparinized whole blood. These parameters, along with derivedparameters, aid in the diagnosis of a patient's acid/base status.pH, pCO2, pO2 measurements in whole blood are used in thediagnosis and treatment of life-threatening acid-basedisturbances. |
| Substantial Equivalency (Cont.) | ||
| Item | Predicate Device | New Device |
| Trade Names | GEM Premier 4000K133407 | GEM Premier 5000K160412 |
| Intended User | Central Laboratory and Point-of-Care | Same |
| Sample Type | Heparinized whole blood | $pH, pO2$ Arterial, venous or capillary heparinized whole blood$pCO2$ Arterial or venous heparinized whole blood |
| Blood Gas Measurement | Potentiometry: $pH$ and $pCO2$Amperometry: $pO2$ | 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 |
| QC Material | CVP 1 and 2 | PC Solution D and E (PAK Internal) |
| CVP 3 and 4 | PC Solution D and E (PAK Internal) | |
| CVP 5 tBili | Same; No Formulation Change |
Special Conditions for Use Statement
- . For prescription use only.
- For clinical laboratory and point-of-care use. .
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| Substantial Equivalency (Cont.) | ||||
|---|---|---|---|---|
| Item | Predicate Device | New Device | ||
| Trade Name | GEM Premier 4000 | K133407 | GEM Premier 5000 | K160412 |
| Instrument Dimensions | GEM Premier 4000 Instrument:• Height: 18 inches• Width: 12 inches• Depth: 15 inches• Weight: 44 pounds | GEM Premier 5000 Instrument:• Height: 18.6 inches• Width: 13.0 inches• Depth: 16.4 inches• Weight: 45.4 pounds | ||
| Cartridge (PAK) Dimensions | GEM Premier 4000 Cartridge (PAK):• Height: 6.75 inches• Width: 10 inches• Depth: 8 inches• Weight: 8 pounds | GEM Premier 5000 Cartridge (PAK):• Height: 6.75 inches• Width: 10 inches• Depth: 8 inches• Weight: 8.1 pounds | ||
| Reportable Range | Analyte | GEM Premier 4000 | GEM Premier 5000 | |
| pH | 7.00 to 8.00 | 7.00 to 7.92 | ||
| pCO2 | 6 to 125 mmHg | 6 to 125 mmHg | ||
| pO2 | 5 to 690 mmHg | 6 to 690 mmHg |
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Performance Summary
Internal Precision Study - Aqueous Controls
In accordance with CLSI EP05-A3, an internal 20-day precision study was performed on the GEM Premier 5000, with GEM System Evaluator. Each of the control levels was run on three (3) GEM Premier 5000 analyzers for twenty (20) days, with two (2) runs per day and one (1) replicate measured per run per level (n=120). All results were within specification.
| Material | Analyte | Level | Mean | N | WithinAnalyzerSD | WithinAnalyzer%CV | Total SD | Total%CV |
|---|---|---|---|---|---|---|---|---|
| GEM SystemEvaluator | pH | Level 1 | 7.14 | 120 | 0.008 | 0.1% | 0.008 | 0.1% |
| Level 2 | 7.38 | 120 | 0.004 | 0.1% | 0.006 | 0.1% | ||
| Level 3 | 7.57 | 120 | 0.003 | 0.0% | 0.003 | 0.0% | ||
| pCO2(mmHg) | Level 1 | 87 | 120 | 2.3 | 2.7% | 2.3 | 2.7% | |
| Level 2 | 35 | 120 | 0.7 | 1.9% | 0.8 | 2.3% | ||
| Level 3 | 14 | 120 | 0.3 | 2.2% | 0.3 | 2.3% | ||
| pO2(mmHg) | Level 1 | 31 | 120 | 1.9 | 6.1% | 2.4 | 7.9% | |
| Level 2 | 88 | 120 | 1.2 | 1.4% | 2.2 | 2.4% | ||
| Level 3 | 370 | 120 | 4.8 | 1.3% | 5.9 | 1.6% |
Internal Precision Study – GEM PAK (Cartridge) Process Control Solutions D and E
In accordance with CLSI EP05-A3, an internal 20-day precision study was performed with the GEM PAK (cartridge) Process Control Solutions (PCS) D and E run on three (3) GEM Premier 5000 analyzers for twenty (20) days, with two (2) runs per day and one (1) replicate measured per run per level (N=120 per analyte/per level). All results were within specification.
| Material | Analyte | Mean | N | Within AnalyzerSD | Within Analyzer%CV |
|---|---|---|---|---|---|
| PCS D | pH | 7.35 | 120 | 0.001 | 0.0% |
| PCS E | pH | 7.21 | 120 | 0.001 | 0.0% |
| PCS D | $pCO_2$ (mmHg) | 25 | 120 | 0.1 | 0.4% |
| PCS E | $pCO_2$ (mmHg) | 68 | 120 | 0.3 | 0.5% |
| PCS D | $pO_2$ (mmHg) | 55 | 120 | 1.1 | 1.9% |
| PCS E | $pO_2$ (mmHg) | 98 | 120 | 1.1 | 1.1% |
{10}------------------------------------------------
Internal Precision Study – Whole Blood
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 mode for five (5) days, with one (1) run per day and eight (8) replicates measured per run per level (N=120 per analyte/per sample mode). All results were within specification.
Sample Modes and Volumes:
- . Normal Mode 150 µL
- . Micro Mode 65 µL
| Analyte | Mode | Level | Mean | N | Within RunSD | Within Run%CV | Total SD | Total %CV |
|---|---|---|---|---|---|---|---|---|
| pH | NormalMode | 1 | 7.11 | 120 | 0.004 | 0.1% | 0.005 | 0.1% |
| 2 | 7.33 | 120 | 0.007 | 0.1% | 0.007 | 0.1% | ||
| 3 | 7.35 | 120 | 0.004 | 0.1% | 0.005 | 0.1% | ||
| 4 | 7.42 | 120 | 0.005 | 0.1% | 0.006 | 0.1% | ||
| 5 | 7.68 | 120 | 0.012 | 0.1% | 0.014 | 0.2% | ||
| MicroMode | 1 | 7.10 | 120 | 0.006 | 0.1% | 0.007 | 0.1% | |
| 2 | 7.32 | 120 | 0.004 | 0.1% | 0.006 | 0.1% | ||
| 3 | 7.35 | 120 | 0.004 | 0.1% | 0.005 | 0.1% | ||
| 4 | 7.41 | 120 | 0.005 | 0.1% | 0.006 | 0.1% | ||
| 5 | 7.67 | 120 | 0.013 | 0.2% | 0.015 | 0.2% | ||
| pCO2(mmHg) | NormalMode | 1 | 112 | 120 | 2.7 | 2.4% | 2.9 | 2.3% |
| 2 | 70 | 120 | 1.1 | 1.5% | 1.5 | 2.0% | ||
| 3 | 50 | 120 | 0.6 | 1.2% | 0.8 | 1.5% | ||
| 4 | 36 | 120 | 0.5 | 1.3% | 0.8 | 1.9% | ||
| 5 | 10 | 120 | 0.5 | 4.6% | 0.8 | 7.7% |
{11}------------------------------------------------
| Analyte | Mode | Level | Mean | N | Within Run SD | Within Run %CV | Total SD | Total %CV |
|---|---|---|---|---|---|---|---|---|
| pO2(mmHg) | NormalMode | 1 | 32 | 120 | 0.4 | 1.2% | 0.9 | 2.7% |
| 2 | 62 | 120 | 0.7 | 1.1% | 0.9 | 1.2% | ||
| 3 | 204 | 120 | 2.3 | 1.1% | 3.1 | 1.4% | ||
| 4 | 415 | 120 | 8.6 | 2.1% | 13.0 | 2.8% | ||
| 5 | 722 | 120 | 18.6 | 2.6% | 32.7 | 4.3% | ||
| MicroMode | 1 | 31 | 120 | 0.9 | 3.0% | 1.6 | 5.3% | |
| 2 | 62 | 120 | 0.7 | 1.1% | 0.9 | 1.4% | ||
| 3 | 204 | 120 | 4.3 | 2.1% | 5.5 | 2.5% | ||
| 4 | 402 | 120 | 15.3 | 3.8% | 16.4 | 3.8% | ||
| 5 | 693 | 120 | 26.5 | 3.8% | 34.0 | 4.8% |
Internal Precision Study – Whole Blood (Cont.)
{12}------------------------------------------------
Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting
In accordance with CLSI EP05-A3, a reproducibility study was performed at three (3) external clinical point-of-care (PCC) sites. The studies were run by a total of nine (9) different operators on three (3) different GEM Premier 5000 instruments, using a single lot of GEM Premier 5000 PAKs (cartridges). Each site used the same lots of GEM System Evaluator (GSE), running each control level in triplicate, twice a day for 5 days, for a total of 30 poled). All results at all sites were within specification.
| Pooled Multi-Site POC Data | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Analyte | Material/Level | N | InsertRange | Target | SD/CVSpec | Mean | Repeatability | Between-Run | Between-Day | Between-Site | Reproducibility | |||||
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |||||||
| pH | GSE 1 | 90 | 7.10-7.18 | 7.14 | 0.02 | 7.14 | 0.002 | 0.0% | 0.001 | 0.0% | 0.000 | 0.0% | 0.000 | 0.0% | 0.002 | 0.0% |
| GSE 2 | 90 | 7.35-7.43 | 7.39 | 0.02 | 7.39 | 0.007 | 0.1% | 0.003 | 0.0% | 0.003 | 0.0% | 0.002 | 0.0% | 0.008 | 0.1% | |
| GSE 3 | 90 | 7.53-7.61 | 7.57 | 0.02 | 7.57 | 0.002 | 0.0% | 0.000 | 0.0% | 0.003 | 0.0% | 0.000 | 0.0% | 0.003 | 0.0% | |
| pCO2(mmHg) | GSE 1 | 90 | 78-96 | 87 | 4% | 87 | 0.4 | 0.5% | 0.7 | 0.9% | 0.6 | 0.7% | 0.0 | 0.0% | 1.1 | 1.2% |
| GSE 2 | 90 | 29-39 | 34 | 2.5 | 34 | 0.9 | 2.5% | 0.0 | 0.0% | 0.3 | 0.9% | 0.0 | 0.0% | 0.9 | 2.7% | |
| GSE 3 | 90 | 10-16 | 13 | 2.5 | 13 | 0.4 | 3.3% | 0.0 | 0.0% | 0.2 | 1.2% | 0.0 | 0.0% | 0.5 | 3.5% | |
| pO2(mmHg) | GSE 1 | 90 | 21-41 | 31 | 5 | 28 | 0.7 | 2.3% | 0.4 | 1.4% | 0.6 | 2.2% | 1.6 | 5.8% | 1.9 | 6.7% |
| GSE 2 | 90 | 77-97 | 87 | 5 | 87 | 1.4 | 1.7% | 0.0 | 0.0% | 0.6 | 0.7% | 1.0 | 1.2% | 1.9 | 2.2% | |
| GSE 3 | 90 | 325-389 | 357 | 5% | 357 | 7.9 | 2.2% | 0.0 | 0.0% | 0.0 | 0.0% | 4.8 | 1.3% | 9.3 | 2.6% |
{13}------------------------------------------------
External Precision – Whole Blood
To evaluate whole blood precision on the GEM Premier 5000 system in the central laboratory and point-ofcare (POC) settings, whole blood patient samples were tested at 2 external central laboratories and 1 internal Customer Simulation Laboratory (CSL), as well as at 3 external POC locations. For the central laboratory setting, the studies were performed by 3 operators on 3 GEM Premier 5000 instruments using a single lot of GEM Premier 5000 PAK (cartridge). For the POC setting, the studies were performed by 11 operators on 3 GEM Premier 5000 instruments, using a single lot of GEM Premier 5000 PAK (cartridge). At least two whole blood specimens were analyzed in triplicate daily for 5 days in both normal mode (150 µL) for pH, pCO2 and pO2, and micro capillary (65 µL) mode for pH and pO2. At the internal Customer Simulation Laboratory (CSL), contrived whole blood specimens were analyzed in addition to native specimens in order to cover the low and high medical decision levels of each analyte.
The precision results are summarized below:
| Analyte | Mode | Site | N | Mean | Within SampleSD |
|---|---|---|---|---|---|
| pH | NormalMode | POC1 | 54 | 7.36 | 0.008 |
| POC2 | 42 | 7.33 | 0.009 | ||
| POC3 | 30 | 7.35 | 0.008 | ||
| POC-All | 126 | 7.35 | 0.008 | ||
| CSL | 30 | 7.32 | 0.009 | ||
| Lab1 | 30 | 7.36 | 0.009 | ||
| Lab2 | 30 | 7.32 | 0.007 | ||
| Lab-All | 90 | 7.33 | 0.008 | ||
| MicroMode | POC1 | 30 | 7.29 | 0.009 | |
| POC2 | 36 | 7.32 | 0.012 | ||
| POC3 | 36 | 7.28 | 0.012 | ||
| POC-All | 102 | 7.30 | 0.011 | ||
| CSL | 30 | 7.30 | 0.008 | ||
| Lab1 | 30 | 7.33 | 0.007 | ||
| Lab2 | 30 | 7.26 | 0.009 | ||
| Lab-All | 90 | 7.30 | 0.008 | ||
| Analyte | Mode | Site | N | Mean | Within SampleSD |
| pCO2(mmHg) | NormalMode | POC1 | 48 | 43 | 1.1 |
| POC2 | 39 | 42 | 0.8 | ||
| POC3 | 30 | 49 | 1.7 | ||
| POC-All | 117 | 44 | 1.2 | ||
| NormalMode | CSL | 24 | 53 | 1.3 | |
| Lab1 | 30 | 46 | 1.3 | ||
| Lab2 | 24 | 46 | 0.8 | ||
| Lab-All | 78 | 48 | 1.2 | ||
| pO2(mmHg) | NormalMode | POC1 | 27 | 52 | 1.5 |
| POC2 | 12 | 63 | 0.4 | ||
| POC3 | 12 | 71 | 2.0 | ||
| POC-All | 51 | 59 | 1.5 | ||
| CSL | 30 | 52 | 0.6 | ||
| MicroMode | Lab1 | 21 | 55 | 0.8 | |
| Lab2 | 15 | 50 | 3.9 | ||
| Lab-All | 66 | 53 | 0.8 | ||
| POC1 | 21 | 53 | 1.5 | ||
| MicroMode | POC2 | 6 | 45 | 1.2 | |
| POC3 | 18 | 58 | 1.1 | ||
| POC-All | 45 | 54 | 1.3 | ||
| CSL | 30 | 54 | 0.8 | ||
| MicroMode | Lab1 | 24 | 60 | 1.0 | |
| Lab2 | 18 | 52 | 1.1 | ||
| Lab-All | 72 | 56 | 1.0 |
{14}------------------------------------------------
External Precision – Whole Blood (Cont.)
{15}------------------------------------------------
LoB, LoD and LoQ
In accordance with CLSI EP17-A2, LoB, LoD and LoQ were established for pH, pCO2 and pO2 using three (3) lots of GEM Premier 5000 PAKs (cartridges).
| Analyte | LoB | LoD | LoQ |
|---|---|---|---|
| pH* | 8.90 | 8.87 | 8.04 |
| pCO2 (mmHg) | 0 | 1 | 4 |
| pO2 (mmHg) | NA | NA | 2 |
Following are the combined data results for LoB, LoD and LoQ:
- *Note: By definition, LoQ must be ≥ LoD except for pH. Since pH is measured on a negative log scale, larger pH values represent lower analyte levels. Thus, for pH, LoQ must be ≤ LoD.
Linearity
In accordance with CLSI EP06-A, eight (8) or nine (9) levels per analyte were prepared by tonometering whole blood to challenge the claimed reportable range for each parameter. Each blood level was analyzed in triplicate on three (3) GEM Premier 5000 test analyzers and results compared to standard reference procedures (i.e. tonometry for gases).
Combined data from limit of quantitation (LOQ) and linearity were used to support the lower limits of the claimed reportable ranges.
| Analyte | # ofLevels | N perLevel | Slope | Intercept | R2 | TestedRange | ReportableRange |
|---|---|---|---|---|---|---|---|
| pH | 8 | 9 | 0.972 | 0.191 | 0.998 | 6.67 to 7.97 | 7.00 to 7.92 |
| pCO2(mmHg) | 8 | 9 | 1.045 | -2.027 | 0.998 | 1 to 149 | 6 to 125 |
| pO2(mmHg) | 9 | 9 | 1.028 | -4.069 | 0.995 | 5 to 727 | 6 to 690 |
{16}------------------------------------------------
Analytical Specificity
In accordance with EP07-A2, an interference study was conducted on the GEM Premier 5000. A screening test was used to identify substances that produce a clinically significant interference based on measurement at two different analyte concentrations. The table below lists substances that were screen tested with no observed interference on pH, pCO₂ and pO₂ results:
| No Observed Interference with pH, pCO2 and pO2 | |
|---|---|
| Substance | Concentration |
| Acetaminophen | 1324 µmol/L |
| Albumin (Human) | 60 g/L |
| Amoxicillin | 206 µmol/L |
| Aprotinin | 50 mg/L |
| Atracurium | 50 mg/L |
| Benzalkonium (Chloride) | 5 mg/L |
| Bilirubin | 20 mg/dL |
| Ceftriaxone | 1460 µmol/L |
| Ciprofloxin | 30.2 µmol/L |
| Diazepam | 18 µmol/L |
| Epinephrine | 0.5 µmol/L |
| Ethanol | 86.8 mmol/L |
| Etomidate | 50 mg/L |
| Fentanyl | 0.02 µg/ml |
| Gentamycin | 21 µmol/L |
| Halothane | 759 µmol/L |
| Hematocrit | 25%75% |
| Hemoglobin (Hemolysis) | 2 g/dL (20%) |
| Lithium (Chloride) | 3.2 mmol/L |
| Methadone | 6.46 µmol/L |
| Midazolam | 0.5 µg/mL |
| Morphine | 1.75 µmol/L |
| Omeprazole | 17.4 µmol/L |
| Phenobarbital | 431 µmol/L |
| Propofol | 0.05 mg/mL |
| Suxamethonium | 68 µmol/L |
| Thiopental | 248 µmol/L |
| Thyroxine | 1.29 µmol/L |
| Triglycerides (Intralipids) | 2% or 4012 mg/dL |
{17}------------------------------------------------
Internal Method Comparison
In accordance with EP09-A3, an internal method comparison study was conducted using clinical samples to compare the GEM Premier 5000 to the following predicate devices:
- Tonometry: pO2, pCO2 (tonometry used due to instability of blood gases)
- . GEM Premier 4000: pH
Samples were altered as needed to cover the medical decision levels. All parameter levels passed specification for all sample modes.
| Analyte | N | Slope | Intercept | R² | Medical DecisionLevel | Bias at MedicalDecision Level |
|---|---|---|---|---|---|---|
| pH | 373 | 0.953 | 0.344 | 0.993 | 7.30 | 0.001 |
| 7.35 | -0.001 | |||||
| 7.45 | -0.006 | |||||
| pCO2(mmHg) | 150 | 1.026 | -0.991 | 0.997 | 35 | -0.1 |
| 50 | 0.3 | |||||
| 70 | 1.2% | |||||
| pO2(mmHg) | 148 | 1.027 | -1.266 | 0.999 | 30 | -0.5 |
| 45 | 0.0 | |||||
| 60 | 0.4 |
{18}------------------------------------------------
Whole Blood Performance at Medical Decision Levels
The data from the internal method comparison and precision studies were combined to assess the performance at medical decision levels.
Total Error was computed based on the following equation and the results were compared to the GEM Premier 5000 Total Error Specifications:
Total Error Observed = Bias + 2 * SD (or %CV)
Note: Previously shown bias and precision data were used in Total Error computations below.
| Analyte | MedicalDecisionLevel | Absolute Value ofBias at MedicalDecision Level | 2*(SD or %CV) | Total Error ObservedBias + 2*(SD or %CV) |
|---|---|---|---|---|
| pH | 7.30 | 0.001 | 0.013 | 0.014 |
| 7.35 | 0.001 | 0.008 | 0.009 | |
| 7.45 | 0.006 | 0.010 | 0.016 | |
| pCO2(mmHg) | 35 | 0.1 | 0.9 | 1.0 |
| 50 | 0.3 | 1.2 | 1.5 | |
| 70 | 1.2% | 3.0% | 4.2% | |
| pO2(mmHg) | 30 | 0.5 | 0.7 | 1.2 |
| 45 | 0.0 | 1.4 | 1.4 | |
| 60 | 0.4 | 1.4 | 1.8 |
{19}------------------------------------------------
Reference Ranges
| Analyte | Reference Range | Unit |
|---|---|---|
| pH | 7.35 to 7.45 | pH |
| cH | 35.5 to 44.7 | nmol/L |
| cH | 35.5 to 44.7 | nEq/L |
| pH | 7.32 to 7.43 (venous) | pH |
| pCO₂ | Arterial blood: 35 to 48 (male) and 32 to 35 (female)Arterial blood: 4.6 to 6.4 (male) and 4.3 to 6.0 (female)Venous blood (right atrium) - 6-7 mmHg (0.80-0.93 kPa) higher than arterial pCO₂ | mmHgkPa |
| pO₂ | 83 to 10811.0 to 14.4 | mmHgkPa |
| TCO₂ | 19.0 to 24.022.0 to 26.0 (venous) | mmol/L |
| BE | -2.0 to 3.0 | mmol/L |
| HCO₃⁻ | 21 to 28 | mmol/L |
| 21 to 28 | mEq/L | |
| 22 to 29 (venous) | mmol/L | |
| 22 to 29 (venous) | mEq/L |
Sources: Burtis, Carl and David Bruns, Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, Elsevier Saunders, 7th edition, 2015, pp 952-982
Wu, A., Tietz Clinical Guide to Laboratory Tests, W.B. Saunders Co., St. Louis MO, 4th Edition, 2006: 951-982
TCO₂, HCO₃ and BE (Base Excess) are derived parameters. Note:
{20}------------------------------------------------
Clinical Testing
In accordance with EPO9-A3, a method comparison study was conducted on the GEM Premier 5000 compared to the predicate device, the GEM Premier 4000, in the point-of-care (POC) setting using heparinized whole blood patient samples from the intended use population.
- Study Design:
- Three (3) external point-of-care (POC) sites.
- One (1) internal Customer Simulation Laboratory (CSL) at IL, where three (3) intended POC users were brought on site to run the samples, allowing spiking to cover the reportable ranges.
The pooled results from the POC sites and the IL internal Customer Simulation Laboratory (CSL) for the Normal Mode (with samples collected in syringes) are presented below.
| Pooled Point-of-Care Site and CSL Data - Normal Mode (with Syringe Samples) | |||||
|---|---|---|---|---|---|
| Analyte | N | Slope | Intercept | r | Sample Range |
| pH | 479 | 0.941 | 0.427 | 0.991 | 7.01 to 7.92 |
| pCO2 (mmHg) | 492 | 0.955 | 3.545 | 0.991 | 11 to 117 |
| pO2 (mmHg) | 506 | 0.992 | 5.093 | 0.996 | 6 to 685 |
To support capillary claims, finger-stick samples were collected at an external POC site (N=65 native samples) and the IL internal Customer Simulation Laboratory (CSL) (N=106 native samples) with POC operators. The observed total error at the medical decision levels is shown below:
| Pooled Point-of-Care Site and CSL Data with Native Capillary Samples Only | |||||||
|---|---|---|---|---|---|---|---|
| Analyte | N | RangeMin | RangeMax | MDL | Bias at MDL | 95% CI of Bias at MDL | TEa |
| pH | 171 | 7.36 | 7.59 | 7.30 | 0.002 | -0.015 to 0.020 | $\pm$ 0.04 |
| 7.35 | 0.005 | -0.006 to 0.016 | $\pm$ 0.04 | ||||
| 7.45 | 0.010 | 0.005 to 0.014 | $\pm$ 0.04 | ||||
| pO2(mmHg) | 167 | 52 | 105 | 30 | 6.1 | 1.3 to 11.6 | $\pm$ 9.0 |
| 45 | 5.1 | 2.0 to 8.6 | $\pm$ 9.0 | ||||
| 60 | 4.1 | 2.0 to 5.7 | $\pm$ 9.0 |
{21}------------------------------------------------
Clinical Testing
In addition, the data from the native capillary samples (finger-stick samples) previously presented were pooled with contrived capillary samples prepared internally. The regression analysis is shown below:
| Pooled Point-of-Care Site and CSL Data with Additional Contrived Capillary Results | |||||
|---|---|---|---|---|---|
| Analyte | N | Slope | Intercept | r | Sample Range |
| pH | 189 | 0.935 | 0.494 | 0.975 | 7.07 to 7.89 |
| pO2 (mmHg) | 218 | 1.008 | 2.545 | 0.996 | 6 to 676 |
| Conclusion | |
|---|---|
| The technological and functional characteristics of the new GEM Premier5000 as described above are substantially equivalent to that of thepredicate device (GEM Premier 4000) for pH, pCO2, pO2.The analytical and clinical study results demonstrate that the GEMPremier 5000 is safe and effective for its intended purpose and equivalentin performance to the predicate device. |
§ 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.