(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 Hematocrit and Total Hemoglobin from venous and arterial heparinized whole blood, as well as quantitative measurements of O2Hb. COHb. MetHb. HHb. sO2 from venous, arterial and capillary heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's oxygen delivery capacity.
- 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).
- 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.
- · 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 oxygenation status.
· O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure oxygenation status.
· sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygenation status.
The GEM Premier 5000 system provides health care professionals in central laboratory or point-of-care clinical settings with fast, accurate, quantitative measurements of Hematocrit and Total Hemoglobin from venous and arterial heparinized whole blood, as well as quantitative measurements of O₂Hb, COHb, MetHb, HHb, sO2 from venous, arterial and capillary 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.
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.
The provided text describes the GEM Premier 5000, a portable critical care system for analyzing heparinized whole blood samples. It focuses on the device's technical specifications and performance studies to demonstrate substantial equivalence to a predicate device (GEM Premier 4000) for Hematocrit and CO-Oximetry measurements.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for precision or method comparison studies in a single table with target values. Instead, it presents the "Within Analyzer SD/CV" and "Total SD/CV" or "Bias" for various analytes and compares them to specifications which are indirectly implied to be the acceptance criteria. For the purpose of this response, I will interpret "SD/CV Spec" as the acceptance criteria for reproducibility and "Medical Decision Levels" with a calculated "Total Error Observed" compared to an unstated "GEM Premier 5000 Total Error Specifications" as acceptance criteria for accuracy.
Here's a table summarizing the reported device performance based on the precision and method comparison studies:
Table 1: Summary of Device Performance against Implicit Criteria
| Analyte | Test Type | Performance Metric | Reported Performance | Implicit Acceptance Criteria (based on provided data) |
|---|---|---|---|---|
| All Analytes (tHb, O2Hb, COHb, MetHb, HHb, sO2, Hct) | Internal Precision (Aqueous Controls) | Within Analyzer %CV / SD | All results were within specification. (Specific values are provided in the table on page 10) | Not explicitly stated, but the values reported meet the internal specifications. |
| All Analytes (tHb, O2Hb, COHb, MetHb, HHb, sO2, Hct) | Internal Precision (GEM PAK PCS) | Within Analyzer %CV / SD | All results were within specification. (Specific values are provided in the table on page 11) | Not explicitly stated, but the values reported meet the internal specifications. |
| All Analytes (Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2) | Internal Precision (Whole Blood) | Within Run %CV / SD, Total %CV / SD | All results were within specification. (Specific values are provided in the tables on pages 12-14) | Not explicitly stated, but the values reported meet the internal specifications. |
| Hct (%) | Reproducibility (Aqueous Controls - POC) | Reproducibility SD / %CV | Level 1: 0.0 SD / 0.0%Level 2: 0.0 SD / 0.0%Level 3: 0.6 SD / 0.9% | SD/CV Spec: 2 |
| tHb (g/dL) | Reproducibility (Aqueous Controls - POC) | Reproducibility SD / %CV | Level 1: 0.16 SD / 0.8%Level 2: 0.13 SD / 0.9%Level 3: 0.10 SD / 1.4% | SD/CV Spec: 0.5 (Level 1), 0.35 (Level 2), 0.35 (Level 3) |
| O2Hb (%) | Reproducibility (Aqueous Controls - POC) | Reproducibility SD / %CV | Level 1: 0.01 SD / 0.0%Level 2: 0.05 SD / 0.1%Level 3: 0.04 SD / 0.0% | SD/CV Spec: 1.5 |
| COHb (%) | Reproducibility (Aqueous Controls - POC) | Reproducibility SD / %CV | Level 1: 0.05 SD / 0.2%Level 2: 0.04 SD / 0.3%Level 3: 0.07 SD / 2.1% | SD/CV Spec: 1.0 |
| MetHb (%) | Reproducibility (Aqueous Controls - POC) | Reproducibility SD / %CV | Level 1: 0.06 SD / 0.7%Level 2: 0.06 SD / 2.4% | SD/CV Spec: 1.0 |
| HHb (%) | Reproducibility (Aqueous Controls - POC) | Reproducibility SD / %CV | Level 1: 0.06 SD / 0.2%Level 2: 0.06 SD / 0.8%Level 3: 0.08 SD / 2.3% | SD/CV Spec: 1.5 |
| sO2 (%) | Reproducibility (Aqueous Controls - POC) | Reproducibility SD / %CV | Level 1: 0.06 SD / 0.1%Level 2: 0.07 SD / 0.1%Level 3: 0.08 SD / 0.1% | SD/CV Spec: 1.5 |
| Hct (%) | Total Error (Medical Decision Levels) | Total Error Observed | LDL: 1.1MDL: 0.9HDL: 1.3 | "GEM Premier 5000 Total Error Specifications" - Not explicitly provided. |
| tHb (g/dL) | Total Error (Medical Decision Levels) | Total Error Observed | LDL: 0.22MDL: 0.36HDL: 0.70 | "GEM Premier 5000 Total Error Specifications" - Not explicitly provided. |
| O2Hb (%) | Total Error (Medical Decision Levels) | Total Error Observed | MDL: 0.96 | TEa (Acceptable Total Error) = ± 3.0 (from Clinical Testing for Capillary) |
| COHb (%) | Total Error (Medical Decision Levels) | Total Error Observed | LDL: 0.64MDL: 0.72 | TEa (Acceptable Total Error) = ± 2.0 (from Clinical Testing for Capillary) |
| MetHb (%) | Total Error (Medical Decision Levels) | Total Error Observed | LDL: 0.54MDL: 0.58 | TEa (Acceptable Total Error) = ± 3.0 (from Clinical Testing for Capillary) |
| HHb (%) | Total Error (Medical Decision Levels) | Total Error Observed | MDL: 0.89 | TEa (Acceptable Total Error) = ± 3.0 (from Clinical Testing for Capillary) |
| sO2 (%) | Total Error (Medical Decision Levels) | Total Error Observed | MDL: 0.79 | TEa (Acceptable Total Error) = ± 3.0 (from Clinical Testing for Capillary) |
| O2Hb (%) | Clinical Testing (Capillary Samples) | Bias at MDL / 95% CI | Bias at 90.0: 1.19 / (0.48 to 1.89) | TEa: $\pm$ 3.0 |
| COHb (%) | Clinical Testing (Capillary Samples) | Bias at MDL / 95% CI | Bias at 3.0: -0.31 / (-0.49 to -0.12) | TEa: $\pm$ 2.0 |
| HHb (%) | Clinical Testing (Capillary Samples) | Bias at MDL / 95% CI | Bias at 6.0: -0.56 / (-1.07 to -0.04) | TEa: $\pm$ 3.0 |
| sO2 (%) | Clinical Testing (Capillary Samples) | Bias at MDL / 95% CI | Bias at 90.0: 1.20 / (-0.06 to 2.45) | TEa: $\pm$ 3.0 |
Note: For the Total Error Observed, the document states these were compared to "GEM Premier 5000 Total Error Specifications," but these specifications are not explicitly provided in the text for all analytes. However, for capillary clinical testing, specific TEa values are given for some analytes, which are used here as proxies for acceptance criteria where available.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Internal Precision Study (Aqueous Controls):
- Sample Size: 120 per analyte/level (3 analyzers, 20 days, 2 runs/day, 1 replicate/run).
- Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective.
- Internal Precision Study (GEM PAK Process Control Solutions):
- Sample Size: 120 per analyte/level (3 analyzers, 20 days, 2 runs/day, 1 replicate/run).
- Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective.
- Internal Precision Study (Whole Blood):
- Sample Size: 120 per analyte/sample mode (3 analyzers, 5 days, 1 run/day, 8 replicates/run).
- Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective. Origin of whole blood samples likely internal or procured, not specified by country.
- Reproducibility Study (Aqueous Controls – Point-of-Care (POC) Setting):
- Sample Size: 90 per analyte/level (3 external POC sites, 3 different GEM Premier 5000 instruments, triplicate measurements, twice a day, total 30 replicates per level, pooled).
- Data Provenance: External clinical POC settings, prospective. Country of origin not specified, but likely USA based on the FDA submission.
- External Precision (Whole Blood - Central Lab and POC settings):
- Sample Size: Varies by analyte and site (e.g., Hct Normal Mode POC-All N=126, CSL N=36, Lab1 N=30, Lab2 N=30). The overall study involved multiple whole blood specimens (at least two per day) analyzed in triplicate daily for 5 days.
- Data Provenance: 2 external central laboratories, 1 internal Customer Simulation Laboratory (CSL), and 3 external POC locations. Prospective, "contrived whole blood specimens were analyzed in addition to native specimens" in the CSL. Country of origin not specified, but likely USA based on the FDA submission.
- Analytical Specificity (Interference Study):
- Sample Size: Not explicitly stated as a single "test set" size for all substances, but experiments were conducted with various concentrations of interfering substances.
- Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective.
- Internal Method Comparison (Clinical Samples):
- Sample Size: Varies by analyte (N=376 for Hct, N=373 for O2Hb, etc.).
- Data Provenance: Clinical samples (heparinized whole blood) altered as needed to cover medical decision levels. Internal study, retrospective/prospective hybrid (samples altered to cover ranges).
- Clinical Testing (Point-of-Care Setting - Normal Mode):
- Sample Size: Varies by analyte (e.g., N=490 for Hct, N=485 for COHb).
- Data Provenance: Three (3) external point-of-care (POC) sites and one (1) internal Customer Simulation Laboratory (CSL) at IL. Heparinized whole blood patient samples from the intended use population. Samples spiked in CSL to cover reportable ranges. Provenance likely USA, prospective.
- Clinical Testing (Capillary Samples):
- Sample Size: Native capillary samples: N=52 (external POC), N=100 (IL CSL) for a total of 152 native samples for O2Hb, HHb, sO2. Total N becomes 180-182 when pooled with additional internally prepared contrived capillary samples for specific analytes (pages 29-30).
- Data Provenance: One external POC site and the IL internal Customer Simulation Laboratory (CSL). Native finger-stick samples and contrived capillary samples. Provenance likely USA, prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document relates to an in-vitro diagnostic device measuring blood parameters. Ground truth in this context is typically established by comparative measurements against a recognized reference method or a predicate device, not by expert consensus in the same way an imaging AI would use expert radiologist reads.
For the Internal Method Comparison and Clinical Testing studies, the GEM Premier 5000 was compared to the predicate device, the GEM Premier 4000. The predicate device itself serves as the "reference standard" or "ground truth" for demonstrating substantial equivalence. The document does not specify human experts establishing ground truth for the test set; rather, the predicate device and established analytical methods (e.g., CNMetHb procedure - CLSI H15-A3 for tHb) are used as comparators.
The Linearity study also mentions comparing results to "reference analyzers or standard reference procedures (i.e. CNMetHb procedure - CLSI H15-A3 for tHb)".
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of in-vitro diagnostic device. "Adjudication" typically refers to the process of resolving discrepancies between human readers or between human readers and an AI output, especially in imaging studies where subjective interpretation is involved. For this device, ground truth is established through quantitative comparisons against established reference methods or a predicate device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an in-vitro diagnostic device that provides quantitative measurements of blood parameters, not an AI-based imaging or diagnostic aid that assists human readers/clinicians in interpretation. Therefore, no MRMC study or assessment of human reader improvement with/without AI assistance was conducted or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies presented evaluate the performance of the device itself in a standalone capacity. The GEM Premier 5000 provides quantitative measurements directly. Operators interact with the device to load samples and retrieve results, but the analytical process and result generation are entirely performed by the instrument's internal "algorithm" (i.e., its measurement and data processing capabilities).
The device description on page 5 highlights its autonomy:
- "The analyzer guides operators through the sampling process with simple, clear messages and prompts."
- "After inserting the GEM PAK, the instrument will perform an automated PAK warm-up..."
- "Auto PAK Validation (APV) process is automatically completed..."
- "iQM2 manages the quality control process, replacing external quality controls."
This indicates that the device operates autonomously for its core measurements, with human intervention for sample loading and result review, but not for interpreting the raw measurement signals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance studies was established through:
- Comparison to a Legally Marketed Predicate Device: The GEM Premier 4000 served as the primary comparator for method comparison studies, demonstrating substantial equivalence.
- Standard Reference Procedures/Analyzers: For linearity studies and potentially for other analytical performance aspects, comparison to "reference analyzers or standard reference procedures (i.e. CNMetHb procedure - CLSI H15-A3 for tHb)" was used.
- Certified Control Materials: Aqueous controls and GEM PAK Process Control Solutions that are "traceable to NIST standards, CLSI procedures or internal standards" were used for precision and reproducibility studies. These materials have known, certified values which serve as ground truth for assessing device accuracy and precision.
8. The sample size for the training set
The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms as the primary focus is on proving the analytical performance of an in-vitro diagnostic instrument through traditional analytical validation studies (precision, linearity, method comparison, etc.).
However, the device incorporates "Intelligent Quality Management 2 (iQM2)" which is described as "an active quality process control program designed to provide continuous monitoring of the analytical process... with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions." While iQM2 itself would have been developed and "trained" or calibrated using extensive internal data during the device's R&D phase, the public 510(k) summary does not provide details on a specific training set size for the iQM2 component. The studies presented are for the validation of the final device's performance, not the internal development of iQM2.
The "internal precision study" and "internal method comparison" are validation studies of the final device. The data shown in these tables is for testing the device's performance, not training it.
9. How the ground truth for the training set was established
As noted in point 8, a "training set" in the context of typical AI/ML models is not explicitly described or relevant for the approval justification in this 510(k) summary. The document validates the measurement accuracy and precision of the device against predicate devices and reference methods, not an AI model that learns from data in the field.
If "training set" refers to the data used to initially calibrate the instrument's sensors and algorithms during development, this ground truth would have been established through:
- Primary Reference Methods: Employing highly accurate and precise laboratory methods (e.g., gas chromatography, certified spectrophotometric methods, gravimetric/volumetric methods) to determine the true concentration of analytes in reference materials and clinical samples.
- Reference Materials/Standards: Calibrating the device using NIST-traceable standards and other certified reference materials with known analyte concentrations.
- Extensive Internal Testing and Optimization: Using a large array of characterized samples (e.g., blood samples with varying analyte concentrations, interfering substances) to optimize the device's measurement algorithms and ensure accurate performance across its claimed reportable range.
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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: K160415
Trade/Device Name: GEM Premier 5000 (Measured Parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) Regulation Number: 21 CFR 864.5600 Regulation Name: Automated hematocrit instrument Regulatory Class: Class II Product Code: GKF, GHS, GKR, GLY Dated: 12/7/2016 Received: 12/8/2016
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
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as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
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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,
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) K160415
Device Name
GEM Premier 5000 (Measured Parameters: Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
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 Hematocrit and Total Hemoglobin from venous and arterial heparinized whole blood, as well as quantitative measurements of O2Hb. COHb. MetHb. HHb. sO2 from venous, arterial and capillary heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's oxygen delivery capacity.
- 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).
- 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.
- · 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 oxygenation status.
· O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure oxygenation status.
· sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygenation 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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 8, 2016 |
|---|---|
| ------------------ | ------------------ |
| Device Trade Name | GEM Premier 5000(Measured Parameters: Hematocrit, Total Hemoglobin,Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin,Oxyhemoglobin, Oxygen Saturation) |
|---|---|
| ------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Predicate Device | GEM Premier 4000 | K133407 |
|---|---|---|
| ------------------ | ------------------ | --------- |
| Regulatory Information | |||||
|---|---|---|---|---|---|
| GEM Premier 5000 | |||||
| Analyte | RegulationSection | Regulatory Description | Class | ProductCode | Panel |
| Hematocrit | 864.5600 | Automated hematocrit instrument | II | GKF | 81 |
| CO-Oximetry | 864.7425 | Carboxyhemoglobin assay | II | GHS | |
| 864.5620 | Automated hemoglobin system | II | GKR | ||
| 864.7500 | Whole blood hemoglobin assays | II | GLY |
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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 Hematocrit and Total Hemoglobin from venous and arterial heparinized whole blood, as well as quantitative measurements of O₂Hb, COHb, MetHb, HHb, sO2 from venous, arterial and capillary 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, |
*sO2 = Ratio between the concentration of oxyhemoglobin plus deoxyhemoglobin plus deoxyhemoglobin.
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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 Hematocrit and Total Hemoglobinfrom venous and arterial heparinized whole blood, as well asquantitative measurements of O₂Hb, COHb, MetHb, HHb, sO₂ fromvenous, arterial and capillary heparinized whole blood. Theseparameters, along with derived parameters, aid in the diagnosis ofa patient's oxygen delivery capacity. |
| • Hematocrit (Hct) measurements in whole blood of the packedred cell volume of a blood sample are used to distinguishnormal from abnormal states, such as anemia anderythrocytosis (an increase in the number of red cells). | |
| • Total Hemoglobin (tHb): Total hemoglobin measurements areused to measure the hemoglobin content of whole blood forthe detection of anemia. | |
| • COHb: Carboxyhemoglobin measurements are used todetermine the carboxyhemoglobin content of human blood asan aid in the diagnosis of carbon monoxide poisoning. | |
| • MetHb: Methemoglobin measurements are used to determinedifferent conditions of methemoglobinemia. | |
| • HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, isused in combination with oxyhemoglobin to measureoxygenation status. | |
| • O₂Hb: Oxyhemoglobin, as a fraction of total hemoglobin, isused in combination with deoxyhemoglobin to measureoxygenation status. | |
| • sO₂: Oxygen saturation, more specifically the ratio between theconcentration of oxyhemoglobin and oxyhemoglobin plusdeoxyhemoglobin, is used to measure oxygenation status. |
Special Conditions for Use Statement
- For prescription use only.
- For clinical laboratory and point-of-care use. .
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| Substantial Equivalency | ||
|---|---|---|
| The GEM Premier 5000 system is substantially equivalent in function and intended use to the following predicate device for Hematocrit and CO-Oximetry: | ||
| Item | Predicate Device | New Device |
| Trade Name | GEM Premier 4000 | GEM Premier 5000 |
| 510(k) No. | K133407 | K160415 |
| Manufacturer | Instrumentation Laboratory Co. | Instrumentation Laboratory Co. |
| Indicationsfor 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.NOTE: The GEM Premier 4000 also reports SO₂ results as a ratio result. | 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 Hematocrit and Total Hemoglobin from venous and arterial heparinized whole blood, as well as quantitative measurements of O₂Hb, COHb, MetHb, HHb, sO₂ from venous, arterial and capillary heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's oxygen delivery capacity. 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). 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 oxygenation status. O₂Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure oxygenation status. sO₂: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygenation status. |
{8}------------------------------------------------
| Substantial Equivalency (Cont.) | ||||
|---|---|---|---|---|
| Item | Predicate Device | New Device | ||
| Trade Names | GEM Premier 4000 | K133407 | GEM Premier 5000 | K160415 |
| Intended User | Central Laboratory and Point-of-Care | Same | ||
| Sample Type | Heparinized Whole Blood | Hct, tHb | Arterial or venous heparinized whole blood | |
| O₂Hb, COHb, MetHb, HHb, SO₂ | Arterial, venous or capillary heparinized whole blood | |||
| Hemoglobin Measurement | Spectrophotometry: tHb, O₂Hb, COHb, MetHb, HHb, SO₂ | Same | ||
| Hematocrit Measurement | Conductivity | 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 | |||
| Substantial Equivalency (Cont.) | ||||
| Item | Predicate Device | New Device | ||
| Trade Name | GEM Premier 4000 K133407 | GEM Premier 5000 K160415 | ||
| 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 | |
| Hematocrit | 15 to 72% | 15 to 72% | ||
| tHb | 3.0 to 23.0 g/dL | 3.0 to 23.0 g/dL | ||
| O₂Hb | 0.0 to 98.0% | 0.7 to 100.0% | ||
| COHb | 0.0 to 99.0% | 0.3 to 75.0% | ||
| MetHb | 0.0 to 28.0% | 0.7 to 30.0% | ||
| HHb | 0.0 to 96.0% | 1.0 to 100.0% | ||
| SO₂ | 0.0 to 100.0% | 0.7 to 100.0% |
{9}------------------------------------------------
{10}------------------------------------------------
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 and GEM Hematocrit. 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 |
|---|---|---|---|---|---|---|---|---|
| GEMSystemEvaluator | tHb(g/dL) | Level 1 | 20.8 | 120 | 0.14 | 0.7% | 0.16 | 0.8% |
| Level 2 | 14.6 | 120 | 0.13 | 0.9% | 0.18 | 1.2% | ||
| Level 3 | 7.8 | 120 | 0.13 | 1.7% | 0.16 | 2.1% | ||
| O2Hb(%) | Level 1 | 37.3 | 120 | 0.00 | 0.0% | 0.00 | 0.0% | |
| Level 2 | 73.7 | 120 | 0.04 | 0.1% | 0.05 | 0.1% | ||
| Level 3 | 93.0 | 120 | 0.04 | 0.0% | 0.05 | 0.1% | ||
| COHb(%) | Level 1 | 31.7 | 120 | 0.03 | 0.1% | 0.04 | 0.1% | |
| Level 2 | 16.8 | 120 | 0.05 | 0.3% | 0.06 | 0.3% | ||
| Level 3 | 3.1 | 120 | 0.07 | 2.3% | 0.09 | 2.8% | ||
| MetHb(%) | Level 1 | 8.3 | 120 | 0.05 | 0.6% | 0.06 | 0.7% | |
| Level 2 | 2.6 | 120 | 0.06 | 2.5% | 0.08 | 3.1% | ||
| Level 3 | Not Applicable | |||||||
| HHb(%) | Level 1 | 22.6 | 120 | 0.05 | 0.2% | 0.05 | 0.2% | |
| Level 2 | 6.9 | 120 | 0.05 | 0.7% | 0.06 | 0.9% | ||
| Level 3 | 3.3 | 120 | 0.09 | 2.6% | 0.11 | 3.2% | ||
| sO2(%) | Level 1 | 62.2 | 120 | 0.05 | 0.1% | 0.05 | 0.1% | |
| Level 2 | 91.4 | 120 | 0.06 | 0.1% | 0.07 | 0.1% | ||
| Level 3 | 96.6 | 120 | 0.09 | 0.1% | 0.11 | 0.1% | ||
| GEMHematocritEvaluator | Hct(%) | Level 1 | 21 | 120 | 0.2 | 1.2% | 0.3 | 1.3% |
| Level 2 | 41 | 120 | 0.2 | 0.6% | 0.2 | 0.6% | ||
| Level 3 | 65 | 120 | 0.4 | 0.6% | 0.4 | 0.6% |
{11}------------------------------------------------
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 Analyzer SD | Within Analyzer %CV |
|---|---|---|---|---|---|
| PCS D | Hct(%) | 27 | 120 | 0.2 | 0.6% |
| PCS E | Hct(%) | 37 | 120 | 0.0 | 0.1% |
| PCS D | tHb(g/dL) | 7.4 | 120 | 0.05 | 0.6% |
| PCS E | tHb(g/dL) | 16.5 | 120 | 0.04 | 0.2% |
| PCS D | O2Hb(%) | 79.9 | 120 | 0.13 | 0.2% |
| PCS E | O2Hb(%) | 49.8 | 120 | 0.06 | 0.1% |
| PCS D | COHb(%) | 4.0 | 120 | 0.11 | 2.7% |
| PCS E | COHb(%) | 10.1 | 120 | 0.04 | 0.4% |
| PCS D | MetHb(%) | 3.9 | 120 | 0.12 | 3.0% |
| PCS E | MetHb(%) | 8.0 | 120 | 0.05 | 0.6% |
| PCS D | HHb(%) | 12.2 | 120 | 0.35 | 2.9% |
| PCS E | HHb(%) | 32.1 | 120 | 0.14 | 0.4% |
| PCS D | sO2(%) | 86.8 | 120 | 0.35 | 0.4% |
| PCS E | sO2(%) | 60.8 | 120 | 0.13 | 0.2% |
{12}------------------------------------------------
Internal Precision Study – Whole Blood
In accordance with CLSI EP05-A3, an internal precision study was performed using four (4) or 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
- tBili/CO-Ox Mode 100 µL .
NOTE: Capillary not claimed for Hct and tHb on the GEM Premier 5000.
| Analyte | Mode | Level | Mean | N | WithinRunSD | WithinRun%CV | Total SD | Total%CV |
|---|---|---|---|---|---|---|---|---|
| Hct(%) | NormalMode | 1 | 18 | 120 | 0.3 | 1.9% | 0.4 | 2.5% |
| 2 | 33 | 120 | 0.3 | 1.0% | 0.6 | 1.9% | ||
| 3 | 45 | 120 | 0.5 | 1.0% | 0.8 | 1.8% | ||
| 4 | 57 | 120 | 0.6 | 1.1% | 1.0 | 1.8% | ||
| 5 | 65 | 120 | 0.7 | 1.1% | 0.9 | 1.4% | ||
| tHb(g/dL) | NormalMode | 1 | 6.2 | 120 | 0.04 | 0.6% | 0.07 | 1.1% |
| 2 | 11.2 | 120 | 0.04 | 0.4% | 0.14 | 1.3% | ||
| 3 | 15.1 | 120 | 0.05 | 0.3% | 0.20 | 1.3% | ||
| 4 | 18.8 | 120 | 0.06 | 0.3% | 0.23 | 1.2% | ||
| 5 | 21.7 | 120 | 0.08 | 0.4% | 0.23 | 1.1% | ||
| Analyte | Mode | Level | Mean | N | WithinRunSD | WithinRun%CV | Total SD | Total%CV |
| O₂Hb(%) | NormalMode | 1 | 9.1 | 120 | 0.21 | 2.4% | 0.22 | 2.4% |
| 2 | 38.4 | 120 | 0.26 | 0.7% | 0.26 | 0.7% | ||
| 3 | 77.0 | 120 | 0.20 | 0.3% | 0.21 | 0.3% | ||
| 4 | 90.6 | 120 | 0.21 | 0.2% | 0.23 | 0.3% | ||
| 5 | 96.4 | 120 | 0.18 | 0.2% | 0.20 | 0.2% | ||
| O₂Hb(%) | tBili/CO-OxMode | 1 | 8.7 | 120 | 0.20 | 2.3% | 0.25 | 2.9% |
| 2 | 38.0 | 120 | 0.27 | 0.7% | 0.29 | 0.8% | ||
| 3 | 76.5 | 120 | 0.23 | 0.3% | 0.34 | 0.4% | ||
| 4 | 90.2 | 120 | 0.22 | 0.2% | 0.33 | 0.4% | ||
| 5 | 96.0 | 120 | 0.21 | 0.2% | 0.31 | 0.3% | ||
| COHb(%) | NormalMode | 1 | 1.6 | 120 | 0.14 | 8.6% | 0.22 | 13.4% |
| 2 | 5.6 | 120 | 0.16 | 2.9% | 0.21 | 3.7% | ||
| 3 | 15.3 | 120 | 0.17 | 1.1% | 0.23 | 1.5% | ||
| 4 | 30.3 | 120 | 0.21 | 0.7% | 0.26 | 0.9% | ||
| 5 | 64.3 | 120 | 0.26 | 0.4% | 0.31 | 0.5% | ||
| COHb(%) | tBili/CO-OxMode | 1 | 1.8 | 120 | 0.18 | 9.9% | 0.29 | 15.6% |
| 2 | 5.8 | 120 | 0.16 | 2.7% | 0.24 | 4.2% | ||
| 3 | 15.4 | 120 | 0.20 | 1.3% | 0.26 | 1.7% | ||
| 4 | 30.4 | 120 | 0.23 | 0.8% | 0.31 | 1.0% | ||
| 5 | 64.3 | 120 | 0.31 | 0.5% | 0.46 | 0.7% | ||
| MetHb(%) | NormalMode | 1 | 5.0 | 120 | 0.17 | 3.4% | 0.22 | 4.4% |
| 2 | 9.9 | 120 | 0.19 | 1.9% | 0.21 | 2.1% | ||
| 3 | 14.5 | 120 | 0.27 | 1.9% | 0.29 | 2.0% | ||
| 4 | 25.5 | 120 | 0.28 | 1.1% | 0.32 | 1.2% | ||
| MetHb(%) | tBili/CO-OxMode | 1 | 5.1 | 120 | 0.16 | 3.2% | 0.19 | 3.7% |
| 2 | 10.0 | 120 | 0.21 | 2.1% | 0.23 | 2.2% | ||
| 3 | 14.8 | 120 | 0.34 | 2.3% | 0.36 | 2.4% | ||
| 4 | 25.6 | 120 | 0.21 | 0.8% | 0.21 | 0.8% | ||
| Analyte | Mode | Level | Mean | N | WithinRun SD | WithinRun %CV | Total SD | Total%CV |
| HHb(%) | NormalMode | 1 | 6.6 | 120 | 0.23 | 3.5% | 0.30 | 4.6% |
| NormalMode | 2 | 20.5 | 120 | 0.24 | 1.2% | 0.42 | 2.1% | |
| NormalMode | 3 | 59.9 | 120 | 0.29 | 0.5% | 0.46 | 0.8% | |
| NormalMode | 4 | 90.0 | 120 | 0.22 | 0.2% | 0.32 | 0.4% | |
| HHb(%) | tBili/CO-OxMode | 1 | 6.8 | 120 | 0.26 | 3.8% | 0.51 | 7.4% |
| tBili/CO-OxMode | 2 | 20.9 | 120 | 0.25 | 1.2% | 0.48 | 2.3% | |
| tBili/CO-OxMode | 3 | 60.2 | 120 | 0.29 | 0.5% | 0.60 | 1.0% | |
| tBili/CO-OxMode | 4 | 90.1 | 120 | 0.23 | 0.3% | 0.53 | 0.6% | |
| sO2(%) | NormalMode | 1 | 9.2 | 120 | 0.21 | 2.3% | 0.21 | 2.3% |
| NormalMode | 2 | 39.0 | 120 | 0.27 | 0.7% | 0.30 | 0.8% | |
| NormalMode | 3 | 79.0 | 120 | 0.23 | 0.3% | 0.37 | 0.5% | |
| NormalMode | 4 | 93.2 | 120 | 0.24 | 0.3% | 0.29 | 0.3% | |
| NormalMode | 5 | 98.7 | 120 | 0.25 | 0.2% | 0.39 | 0.4% | |
| sO2(%) | tBili/CO-OxMode | 1 | 8.8 | 120 | 0.19 | 2.2% | 0.25 | 2.8% |
| tBili/CO-OxMode | 2 | 38.7 | 120 | 0.27 | 0.7% | 0.36 | 0.9% | |
| tBili/CO-OxMode | 3 | 78.6 | 120 | 0.24 | 0.3% | 0.43 | 0.6% | |
| tBili/CO-OxMode | 4 | 92.9 | 120 | 0.26 | 0.3% | 0.50 | 0.5% | |
| tBili/CO-OxMode | 5 | 98.5 | 120 | 0.27 | 0.3% | 0.35 | 0.4% |
{13}------------------------------------------------
Internal Precision Study – Whole Blood (Cont.)
{14}------------------------------------------------
Internal Precision Study – Whole Blood (Cont.)
{15}------------------------------------------------
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) stess 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 PAK (cartidges). Each site used the same lots of GEM System Evaluator (GSE) and GEM Hematorit Evaluator (GHE), running each control level in triplicate, twice a datal of 30 replicates per level (N=90 pooled). All results at all sites were within specification.
| Pooled Multi-Site POC Data | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Analyte | Material/Level | InsertRange | SD/CVSpec | Repeatability | Between-Run | Between-Day | Between-Site | Reproducibility | ||||||||
| N | Target | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | ||||
| Hct(%) | GHE 1 | 90 | 19-23 | 21 | 2 | 21 | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% |
| Hct(%) | GHE 2 | 90 | 38-44 | 41 | 2 | 41 | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% | 0.0 | 0.0% |
| Hct(%) | GHE 3 | 90 | 62-70 | 66 | 2 | 66 | 0.3 | 0.4% | 0.1 | 0.1% | 0.2 | 0.4% | 0.4 | 0.6% | 0.6 | 0.9% |
| tHb(g/dL) | GSE 1 | 90 | 19.5-21.9 | 20.7 | 0.5 | 20.7 | 0.14 | 0.7% | 0.00 | 0.0% | 0.05 | 0.2% | 0.07 | 0.3% | 0.16 | 0.8% |
| tHb(g/dL) | GSE 2 | 90 | 13.8-15.4 | 14.6 | 0.35 | 14.5 | 0.10 | 0.7% | 0.00 | 0.0% | 0.05 | 0.3% | 0.07 | 0.5% | 0.13 | 0.9% |
| tHb(g/dL) | GSE 3 | 90 | 7.0-8.4 | 7.7 | 0.35 | 7.7 | 0.10 | 1.3% | 0.02 | 0.3% | 0.03 | 0.4% | 0.01 | 0.1% | 0.10 | 1.4% |
| O₂Hb(%) | GSE 1 | 90 | 36.3-40.3 | 38.3 | 1.5 | 37.3 | 0.01 | 0.0% | 0.00 | 0.0% | 0.00 | 0.0% | 0.00 | 0.0% | 0.01 | 0.0% |
| O₂Hb(%) | GSE 2 | 90 | 72.6-76.6 | 74.6 | 1.5 | 73.7 | 0.04 | 0.0% | 0.00 | 0.0% | 0.00 | 0.0% | 0.03 | 0.0% | 0.05 | 0.1% |
| O₂Hb(%) | GSE 3 | 90 | 92.0-96.0 | 94.0 | 1.5 | 93.0 | 0.03 | 0.0% | 0.00 | 0.0% | 0.02 | 0.0% | 0.01 | 0.0% | 0.04 | 0.0% |
{16}------------------------------------------------
| 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 | |||||||||
| COHb(%) | GSE 1 | 90 | 28.7-32.7 | 30.7 | 1.0 | 31.7 | 0.04 | 0.1% | 0.02 | 0.1% | 0.00 | 0.0% | 0.02 | 0.1% | 0.05 | 0.2% | ||
| COHb(%) | GSE 2 | 90 | 13.5-17.5 | 15.5 | 1.0 | 16.8 | 0.04 | 0.2% | 0.00 | 0.0% | 0.01 | 0.1% | 0.01 | 0.1% | 0.04 | 0.3% | ||
| COHb(%) | GSE 3 | 90 | 0.0-4.0 | 2.0 | 1.0 | 3.2 | 0.06 | 1.9% | 0.00 | 0.0% | 0.03 | 0.8% | 0.01 | 0.4% | 0.07 | 2.1% | ||
| MetHb(%) | GSE 1 | 90 | 7.8-11.8 | 9.8 | 1.0 | 8.3 | 0.05 | 0.6% | 0.00 | 0.0% | 0.00 | 0.0% | 0.02 | 0.3% | 0.06 | 0.7% | ||
| MetHb(%) | GSE 2 | 90 | 2.2-6.2 | 4.2 | 1.0 | 2.5 | 0.04 | 1.7% | 0.02 | 0.6% | 0.02 | 0.7% | 0.04 | 1.5% | 0.06 | 2.4% | ||
| MetHb(%) | GSE 3 | Not Applicable | ||||||||||||||||
| HHb(%) | GSE 1 | 90 | 19.2-23.2 | 21.2 | 1.5 | 22.6 | 0.04 | 0.2% | 0.00 | 0.0% | 0.01 | 0.0% | 0.04 | 0.2% | 0.06 | 0.2% | ||
| HHb(%) | GSE 2 | 90 | 3.7-7.7 | 5.7 | 1.5 | 6.9 | 0.05 | 0.7% | 0.01 | 0.2% | 0.00 | 0.0% | 0.03 | 0.5% | 0.06 | 0.8% | ||
| HHb(%) | GSE 3 | 90 | 0.0-4.0 | 2.0 | 1.5 | 3.4 | 0.06 | 1.9% | 0.02 | 0.5% | 0.03 | 0.8% | 0.03 | 0.8% | 0.08 | 2.3% | ||
| SO2(%) | GSE 1 | 90 | 1.5 | 62.2 | 0.04 | 0.1% | 0.00 | 0.0% | 0.01 | 0.0% | 0.04 | 0.1% | 0.06 | 0.1% | ||||
| SO2(%) | GSE 2 | 90 | NA | NA | 1.5 | 91.4 | 0.05 | 0.1% | 0.01 | 0.0% | 0.00 | 0.0% | 0.04 | 0.0% | 0.07 | 0.1% | ||
| SO2(%) | GSE 3 | 90 | 1.5 | 96.5 | 0.06 | 0.1% | 0.02 | 0.0% | 0.03 | 0.0% | 0.03 | 0.0% | 0.08 | 0.1% |
Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting (Cont.)
{17}------------------------------------------------
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 all analytes, micro mode (65 µL) for Hct, and tBili/CO-Ox mode (100 µL) mode for the CO-Ox fractions. 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.
| Analyte | Mode | Site | N | Mean | Within Sample SD |
|---|---|---|---|---|---|
| Hct(%) | NormalMode | POC1 | 54 | 27 | 0.3 |
| POC2 | 42 | 26 | 0.6 | ||
| POC3 | 30 | 28 | 0.7 | ||
| POC-All | 126 | 27 | 0.5 | ||
| CSL | 36 | 44 | 0.5 | ||
| Lab1 | 30 | 28 | 0.4 | ||
| Lab2 | 30 | રે રેણવાડી તેમ જ દિવસ તાલુકામાં આવેલું એક ગામનાં મુખ્યત્વે ખેત-ઉપયોગના મધ્યમાં આવેલું એક ગામનાં મુખ્યત્વે ખેત-ઉપયોગના મધ્યમાં આવેલું એક ગામનાં મુખ્યત્વે ખેત-ઉપયોગના મધ્યમાં | 0.5 | ||
| Lab-All | ರಿಲ | 36 | 0.5 |
The precision results are summarized below:
{18}------------------------------------------------
| Analyte | Mode | Site | N | Mean | Within Sample SD |
|---|---|---|---|---|---|
| tHb(g/dL) | NormalMode | POC1 | 54 | 8.9 | 0.10 |
| POC2 | 42 | 9.4 | 0.15 | ||
| POC3 | 30 | 9.6 | 0.15 | ||
| POC-All | 126 | 9.2 | 0.13 | ||
| CSL | 33 | 13.5 | 0.05 | ||
| Lab1 | 30 | 9.5 | 0.07 | ||
| Lab2 | 30 | 11.5 | 0.05 | ||
| Lab-All | 93 | 11.6 | 0.06 | ||
| O₂Hb(%) | NormalMode | POC1 | 54 | 86.5 | 0.57 |
| POC2 | 42 | 93.2 | 0.31 | ||
| POC3 | 30 | 94.2 | 0.48 | ||
| POC-All | 126 | 90.6 | 0.48 | ||
| CSL | 30 | 76.7 | 0.27 | ||
| Lab1 | 30 | 81.4 | 0.73 | ||
| Lab2 | 30 | 81.7 | 0.65 | ||
| Lab-All | 90 | 79.9 | 0.59 | ||
| O₂Hb(%) | tBili/CO-OxMode | POC1 | 45 | 91.2 | 1.00 |
| POC2 | 39 | 88.5 | 0.49 | ||
| POC3 | 30 | 97.0 | 0.31 | ||
| POC-All | 114 | 91.8 | 0.71 | ||
| CSL | 30 | 77.2 | 0.30 | ||
| Lab1 | 30 | 74.6 | 0.49 | ||
| Lab2 | 30 | 87.6 | 0.96 | ||
| Lab-All | 90 | 79.8 | 0.65 | ||
| Analyte | Mode | Site | N | Mean | Within Sample SD |
| COHb (%) | Normal Mode | POC1 | 54 | 2.6 | 0.31 |
| POC2 | 42 | 1.8 | 0.19 | ||
| POC3 | 30 | 1.7 | 0.19 | ||
| POC-All | 126 | 2.1 | 0.25 | ||
| CSL | 36 | 3.3 | 0.15 | ||
| Lab1 | 30 | 1.6 | 0.16 | ||
| Lab2 | 30 | 1.3 | 0.16 | ||
| Lab-All | 96 | 2.2 | 0.16 | ||
| COHb (%) | tBili/CO-Ox Mode | POC1 | 45 | 2.6 | 0.32 |
| POC2 | 39 | 1.9 | 0.21 | ||
| POC3 | 30 | 1.6 | 0.20 | ||
| POC-All | 114 | 2.1 | 0.26 | ||
| CSL | 36 | 3.3 | 0.10 | ||
| Lab1 | 30 | 1.4 | 0.19 | ||
| Lab2 | 30 | 1.6 | 0.18 | ||
| Lab-All | 96 | 2.2 | 0.16 | ||
| MetHb (%) | Normal Mode | POC1 | 9 | 1.6 | 0.22 |
| POC2 | 36 | 1.2 | 0.16 | ||
| POC-All | 45 | 1.3 | 0.17 | ||
| tBili/CO-Ox Mode | POC1 | 21 | 1.3 | 0.25 | |
| POC2 | 33 | 1.5 | 0.27 | ||
| POC-All | 54 | 1.4 | 0.27 | ||
| Analyte | Mode | Site | N | Mean | Within Sample SD |
| HHb(%) | NormalMode | POC1 | 24 | 23.1 | 0.84 |
| POC2 | 15 | 10.0 | 0.41 | ||
| POC3 | 15 | 6.7 | 0.53 | ||
| POC-All | 54 | 13.3 | 0.66 | ||
| CSL | 30 | 21.1 | 0.34 | ||
| Lab1 | 27 | 18.4 | 0.69 | ||
| Lab2 | 15 | 32.6 | 0.81 | ||
| Lab-All | 72 | 24.0 | 0.60 | ||
| tBili/CO-OxMode | POC1 | 15 | 15.4 | 1.63 | |
| POC2 | 21 | 14.7 | 0.58 | ||
| POC-All | 36 | 15.0 | 1.14 | ||
| CSL | 30 | 20.5 | 0.30 | ||
| Lab1 | 24 | 29.2 | 1.32 | ||
| Lab2 | 21 | 14.9 | 0.60 | ||
| Lab-All | 75 | 21.5 | 0.80 | ||
| sO2(%) | NormalMode | POC1 | 54 | 89.4 | |
| POC2 | 42 | 96.0 | |||
| POC3 | 30 | 96.3 | |||
| POC-All | 126 | 93.2 | |||
| CSL | 30 | 78.5 | 0.34 | ||
| Lab1 | 30 | 83.0 | 0.70 | ||
| Lab2 | 30 | 83.3 | 0.61 | ||
| Lab-All | 90 | 81.6 | 0.57 | ||
| tBili/CO-OxMode | POC1 | 45 | 94.5 | 1.04 | |
| POC2 | 39 | 91.5 | |||
| POC3 | 30 | 99.1 | |||
| POC-All | 114 | 94.7 | |||
| CSL | 30 | 79.1 | 0.30 | ||
| Lab1 | 30 | 76.2 | 0.55 | ||
| Lab2 | 30 | 89.4 | 1.06 | ||
| Lab-All | 90 | 81.6 | 0.71 |
External Precision – Whole Blood (Cont.)
{19}------------------------------------------------
External Precision – Whole Blood (Cont.)
{20}------------------------------------------------
External Precision – Whole Blood (Cont.)
{21}------------------------------------------------
LoB, LoD and LoQ
In accordance with CLSI EP17-A2, LoB, LoQ were established using three (3) lots of GEM Premier 5000 PAKs (cartridges).
| Analyte | LoB | LoD | LoQ |
|---|---|---|---|
| Hematocrit (%) | 4 | 4 | 7 |
| Total Hemoglobin (g/dL) | 0.2 | 0.3 | 1.3 |
| O2Hb (%) | 0.5 | 0.7 | 0.7 |
| COHb (%) | 0.1 | 0.3 | 0.3 |
| MetHb (%) | 0.4 | 0.7 | 0.7 |
| HHb (%) | 0.5 | 1.0 | 1.0 |
Following are the combined data results for LoB, LoD and LoQ:
Linearity
In accordance with CLSI EP06-A, eight (8) or nine (9) levels per analyte were prepared by spiking or diluting 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 reference analyzers or standard reference procedures (i.e. CNMetHb procedure - CLSI H15-A3 for tHb).
NOTE: Combined data from limit of quantitation (LOQ) and linearity studies were used to support lower limit of the claimed reportable range.
| Analyte | # ofLevels | N perLevel | Slope | Intercept | R² | TestedRange | ReportableRange |
|---|---|---|---|---|---|---|---|
| Hct(%) | 9 | 9 | 0.970 | 1.904 | 0.998 | 7 to 82 | 15 to 72 |
| tHb(g/dL) | 9 | 9 | 1.015 | 0.130 | 0.999 | 2.1 to 27.0 | 3.0 to 23.0 |
| O₂Hb(%) | 8 | 9 | 1.002 | 0.918 | 1.000 | 0.3 to 99.3 | 0.7 to 100.0 |
| COHb(%)* | 8 | 9 | 1.016 | 1.532 | 1.000 | 7.4 to 98.5 | 0.3 to 75.0 |
| 5 | 120 | 1.004 | -0.109 | 1.000 | -0.08 to 10.2 | ||
| MetHb(%)* | 9 | 9 | 1.035 | 0.029 | 1.000 | 3.3 to 38.9 | 0.7 to 30.0 |
| 5 | 120 | 0.988 | -0.149 | 1.000 | 0.3 to 9.9 | ||
| HHb(%) | 8 | 9 | 1.004 | -0.384 | 1.000 | -0.01 to 99.6 | 1.0 to 100.0 |
*Additional results at the low-end against the predicate device.
{22}------------------------------------------------
Analytical Specificity
In accordance with EP07-A2, an interference study was conducted on the GEM Premier 5000.
The table below lists substances that were screen tested with no observed interference on hematocrit and CO-Oximetry results:
| Substance | Concentration | Tested analytes with no observed interference |
|---|---|---|
| Bilirubin | 20 mg/dL | tHb/Hb fractions and sO2 |
| Biliverdin | 4 mg/dL | tHb/Hb fractions and sO2 |
| Evans Blue | 10 mg/L | tHb/Hb fractions and sO2 |
| Fetal Hemoglobin | 78% | tHb/Hb fractions and sO2 |
| Indocyanine Green | 10 mg/L | tHb/Hb fractions and sO2 |
| Leukocytes | 44.43 x 10³/μL | Hematocrit |
| Methylene Blue | 20 mg/L | tHb/Hb fractions and sO2 |
| Platelets | 785.0 x 10³/μL | Hematocrit |
| Sulfhemoglobin | 10% | tHb/Hb fractions and sO2 |
| Turbidity (Intralipid) | 1% or 2006mg/dL | Hematocrit, tHb/Hb fractions and sO2 |
The table below lists substances that demonstrated interference with hematocrit results causing a clinically significant error (TEa) and the concentration of the interfering substance, as well as the bias and its direction (positive / negative):
| InterferingSubstance | AffectedAnalyte | AnalyteConcentration | InterferingConcentrationTested | BiasObserved(Mean) | LowestInterferingConcentrationwith AnalyteImpact | Bias Observedat the LowestConcentration |
|---|---|---|---|---|---|---|
| Albumin | Hematocrit | 30% | 45.00 g/L | +4% | 43.92 g/L | +4% |
| 62% | 60.00 g/L | +5% | 49.90 g/L | +4% | ||
| InterferingSubstance | AffectedAnalyte | AnalyteConcentration | InterferingConcentrationTested | BiasObserved(Mean) | LowestInterferingConcentrationwith AnalyteImpact | Bias Observedat the LowestConcentration |
| Cyanocobalamin | tHb | 10.2 g/dL | 0.53 g/L* | +0.7 g/dL | 0.45 g/L | < 0.7 g/dL |
| O₂Hb | 84.8% | -4.1% | -3.0% | |||
| COHb | 9.6% | -2.0% | < 2.0 % | |||
| MetHb | 5.0% | -2.0% | < 2.0 % | |||
| HHb | <1.0% | < 3.0 % | < 3.0 % | |||
| SO₂ | 99.3% | < 3.0 % | < 3.0 % | |||
| tHb | 19.0 g/dL | 0.7 g/L* | No Interference Observed | |||
| O₂Hb | 97.2% | |||||
| COHb | 1.5% | |||||
| MetHb | <0.7% | |||||
| HHb | <1.0% | |||||
| SO₂ | 99.2% | |||||
| Cyano-methemoglobin | tHb | 10.2 g/dL | 4.0%* | < 0.7 g/dL | 3.8% | < 0.7 g/dL |
| O₂Hb | 97.3% | < 3.0 % | < 3.0 % | |||
| COHb | 1.3% | < 2.0 % | < 2.0 % | |||
| MetHb | 0.7% | < 2.0 % | < 2.0 % | |||
| HHb | <1.0% | +3.5% | +3.0% | |||
| SO₂ | 99.3% | -3.1% | < 3.0 % | |||
| tHb | 20.1 g/dL | 4.0%* | No Interference Observed | |||
| O₂Hb | 97.5% | |||||
| COHb | 1.8% | |||||
| MetHb | <0.7% | |||||
| HHb | <1.0% | |||||
| SO₂ | 99.9% | |||||
| InterferingSubstance | AffectedAnalyte | AnalyteConcentration | InterferingConcentrationTested | BiasObserved(Mean) | LowestInterferingConcentrationwith AnalyteImpact | Bias Observedat the LowestConcentration |
| Hydroxocobalamin | tHb | 9.5 g/dL | 0.50 g/L* | +0.7 g/dL | 0.34 g/L | < 0.7 g/dL |
| O₂Hb | 84.8% | -5.2% | < 3.0 % | |||
| COHb | 10.0% | < 2.0 % | -2.0% | |||
| MetHb | 4.5% | +2.6% | < 2.0 % | |||
| HHb | <1.0% | -3.9% | < 3.0 % | |||
| sO₂ | 99.3% | +3.5 % | < 3.0 % | |||
| tHb | 19.6 g/dL | 1.00 g/L* | +0.8 g/dL | 0.83 g/L | +0.7 g/dL | |
| O₂Hb | 97.6% | -3.4% | < 3.0 % | |||
| COHb | 1.5% | < 2.0 % | < 2.0 % | |||
| MetHb | <0.7% | < 2.0 % | < 2.0 % | |||
| HHb | <1.0% | < 3.0 % | < 3.0 % | |||
| sO₂ | 99.9% | < 3.0 % | < 3.0 % |
Note: For Hematocrit, all biases are expressed in absolute % (i.e. measured units, not %CV).
{23}------------------------------------------------
Analytical Specificity (Cont.)
The table below lists substances that demonstrated interference with CO-Oximetry results causing a clinically significant error (TEa) and the concentration of the interfering substance, as well as the bias and its direction (positive / negative):
*Results are flagged by iQM2 at the concentrations noted.
Note: For CO-Oximetry fractions, all biases are expressed in absolute % (i.e. measured units, not %CV).
{24}------------------------------------------------
Analytical Specificity (Cont.)
*Results are flagged by iQM2 at the concentrations noted
Note: For CO-Oximetry fractions, all biases are expressed in absolute % (i.e. measured units, not %CV)
{25}------------------------------------------------
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 GEM Premier 4000.
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 | MedicalDecision Level | Bias at MedicalDecision Level |
|---|---|---|---|---|---|---|
| Hct(%) | 376 | 1.013 | -0.651 | 0.998 | 21 | -0.4 |
| 33 | -0.2 | |||||
| 56 | 0.1 | |||||
| tHb(g/dL) | 376 | 1.040 | -0.144 | 0.998 | 7.0 | 0.14 |
| 10.5 | 0.28 | |||||
| 18.0 | 0.58 | |||||
| O2Hb(%) | 373 | 0.998 | 0.700 | 1.000 | 90.0 | 0.54 |
| COHb(%) | 374 | 0.997 | -0.349 | 1.000 | 3.0 | -0.36 |
| 10.0 | -0.38 | |||||
| MetHb(%) | 270 | 1.000 | 0.200 | 0.998 | 5.0 | 0.20 |
| 10.0 | 0.20 | |||||
| HHb(%) | 195 | 1.000 | -0.426 | 0.999 | 6.0 | -0.43 |
| SO2(%) | 373 | 0.995 | 0.783 | 0.999 | 90.0 | 0.31 |
NOTE: Capillary not claimed for Hct and tHb on the GEM Premier 5000.
{26}------------------------------------------------
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) |
|---|---|---|---|---|
| Hct(%) | 21 | 0.4 | 0.7 | 1.1 |
| Hct(%) | 33 | 0.2 | 0.7 | 0.9 |
| Hct(%) | 56 | 0.1 | 1.2 | 1.3 |
| tHb(g/dL) | 7.0 | 0.14 | 0.08 | 0.22 |
| tHb(g/dL) | 10.5 | 0.28 | 0.08 | 0.36 |
| tHb(g/dL) | 18.0 | 0.58 | 0.12 | 0.70 |
| O₂Hb(%) | 90.0 | 0.54 | 0.42 | 0.96 |
| COHb(%) | 3.0 | 0.36 | 0.28 | 0.64 |
| COHb(%) | 10.0 | 0.38 | 0.34 | 0.72 |
| MetHb(%) | 5.0 | 0.20 | 0.34 | 0.54 |
| MetHb(%) | 10.0 | 0.20 | 0.38 | 0.58 |
| HHb(%) | 6.0 | 0.43 | 0.46 | 0.89 |
| SO2(%) | 90.0 | 0.31 | 0.48 | 0.79 |
{27}------------------------------------------------
Reference Ranges
| Analyte | Reference Range | Unit |
|---|---|---|
| Hct1 | 40-50 (male) and 37-47 (female) | % |
| tHb1 | 12.6 -17.4 (male) and 11.7 -16.1 (female) | g/dL |
| tHb1 | 126-174 (male) and 117-161 (female) | g/L |
| tHb1 | 7.8 -10.8 (male) and 7.3 -10.0 (female) | mmol/L |
| O2Hb2 | 90.0 to 95.0 | % |
| COHb3-5 | <3.0 (nonsmoker)<10.0 (smokers) | % |
| MetHb6 | 0.0 to 1.5 | % |
| HHb7 | 1.0 to 5.0 | % |
| sO21 | 94 to 98 | % |
-
- Wu, A., Tietz Clinical Guide to Laboratory Tests, W.B. Saunders Co., St. Louis MO, 4th Edition, 2006: 951-982.
-
- Haymond, S., Oxygen Saturation, A guide to laboratory assessment, Clinical Laboratory News, February 2006: 10-12.
-
- Hampson, NB, et al. Practice Recommendations in the Diagnosis, Management and Prevention of Carbon Monoxide Poisoning, Am J Respir Crit Care Med, 2012:186:1095-1101
- Piantadosi, C.A, Carbon Monoxide Poisoning, New England Journal of Medicine 4. (2002), 347 (14): 1054-1055
-
- Radford, EP, Blood Carbon Monoxide Levels in Person 3-74 Years of Age: United States, 1976-1980. National Center for Health Statistics, 1982.
- Burtis, Carl and David Bruns, Tietz Textbook of Clinical Chemistry and Molecular 6. Diagnostics, Elsevier Saunders, 7th edition, 2015: 952-982
-
- American Environmental Laboratory: The Laboratory Assessment of Oxygenation: Robert F. Morgan 1993, 5(4), p. 147-153
{28}------------------------------------------------
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 |
| Hct (%) | 490 | 1.003 | -0.016 | 0.997 | 15 to 70 |
| tHb (g/dL) | 496 | 1.021 | -0.055 | 0.998 | 3.1 to 22.8 |
| O2Hb (%) | 496 | 1.003 | 0.338 | 0.999 | 12.2 to 99.0 |
| COHb (%) | 485 | 1.000 | -0.198 | 0.998 | 0.3 to 73.8 |
| MetHb (%) | 297 | 1.000 | -0.100 | 0.997 | 0.7 to 29.9 |
| HHb (%) | 258 | 1.007 | -0.303 | 0.999 | 1.0 to 98.7 |
| sO2 (%) | 494 | 0.998 | 0.355 | 0.999 | 12.3 to 100.0 |
{29}------------------------------------------------
Clinical Testing (Cont.)
To support capillary claims, finger-stick samples were collected at an external POC site (N=52 native samples) and the IL internal Customer Simulation Laboratory (CSL) (N=100 native samples) with POC operators. The observed total error at the medical decision levels is shown below:
NOTE: Capillary not claimed for Hct and tHb on the GEM Premier 5000.
| 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 |
| O2Hb (%) | 152 | 84.9 | 97.4 | 90.0 | 1.19 | 0.48 to 1.89 | $\pm$ 3.0 |
| 151 | 0.3 | 7.6 | 3.0 | -0.31 | -0.49 to -0.12 | $\pm$ 2.0 | |
| COHb (%) | 180 | 0.3 | 73.8 | 10.0* | NA | NA | NA |
| 15.0* | NA | NA | NA | ||||
| MetHb (%) | 98 | 0.7 | 29.7 | 5.0* | NA | NA | NA |
| 10.0* | NA | NA | NA | ||||
| HHb (%) | 151 | 1.3 | 13.9 | 6.0 | -0.56 | -1.07 to -0.04 | $\pm$ 3.0 |
| sO2 (%) | 152 | 86.0 | 99.1 | 90.0 | 1.20 | -0.06 to 2.45 | $\pm$ 3.0 |
- There were an insufficient number of native samples to cover these MDLs.
{30}------------------------------------------------
Clinical Testing (Cont.)
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 |
| O2Hb (%) | 182 | 1.000 | 0.802 | 0.997 | 13.7 to 98.6 |
| COHb (%) | 180 | 0.988 | -0.269 | 0.999 | 0.3 to 73.8 |
| MetHb (%) | 98 | 1.000 | -0.100 | 0.998 | 0.7 to 29.7 |
| HHb (%) | 181 | 1.001 | -0.279 | 0.998 | 1.3 to 98.5 |
| sO2 (%) | 180 | 0.994 | 0.930 | 0.997 | 13.9 to 100.0 |
NOTE: Capillary not claimed for Hct and tHb on the GEM Premier 5000.
| 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 hematocrit andCO-Oximetry. |
|---|---|
| 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. |
§ 864.5600 Automated hematocrit instrument.
(a)
Identification. An automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).(b)
Classification. Class II (performance standards).