(69 days)
No
The summary describes a standard blood gas analyzer with various measurement capabilities and quality control systems. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The studies focus on method comparison and precision, which are typical for this type of device and do not indicate the use of AI/ML for analysis or interpretation.
No.
The device is an analyzer system used for quantitative determination of various blood components, which falls under diagnostic rather than therapeutic use.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is for "quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin in heparinized arterial and venous whole blood." This involves measuring specific biomarkers to provide information for diagnosis or treatment.
No
The device description explicitly states it consists of hardware components including an analyzer, sensor cartridges, and a thermal printer.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin in heparinized arterial and venous whole blood." This involves testing biological specimens (whole blood) in vitro (outside the body) to provide information for diagnostic purposes.
- Device Description: The device is described as an "analyzer" that performs tests on blood samples using "sensor cartridges." This aligns with the typical description of an IVD device used for laboratory analysis.
- Performance Studies: The document details performance studies like "Method Comparison Studies," "Precision/Reproducibility," and "Linearity Testing," which are standard evaluations for IVD devices to demonstrate their accuracy and reliability in measuring analytes in biological samples.
- Predicate Device: The predicate device is also an "Analyzer System," further indicating that this type of device falls under the category of IVDs.
The core function of the device is to analyze biological samples (blood) to provide quantitative results for specific analytes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stat Profile® Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, and Deoxyhemoglobin in heparinized arterial and venous whole blood.
Product codes
GGZ, GHS, GKK, GKR, JPI
Device Description
The Stat Profile Prime Plus Analyzer System is a low cost, low maintenance analyzer for hospital laboratory and point-of-care settings. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).
The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed.
Primary Sensor Card Port:
There are two options for the primary sensor card:
. Primary Sensor Card 1 shall enable and report the following listed analytes: . o Hct, tHb, SO2, O2Hb, COHb, MetHb, HHb
. Primary Sensor Card 2 shall enable and report the following listed analytes: . o Hct, tHb, SO2
As with the predicate, the Stat Profile Prime Plus Analyzer is a blood gas, co-oximetry, electrolyte, chemistry, and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control is available, as well as an on-board Quality Management System (QMS), and an electronic monitoring approach that insures the analyzer is working properly at all times.
The Stat Profile Prime Plus Analyzer accepts samples from syringes and open tubes. The minimum sample size for analysis is 135 µL.
Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.
Stat Profile Prime Plus Analyzer System Components:
The Stat Profile Prime Plus Analyzer System is comprised of the following components.
. Stat Profile Prime Plus Analyzer System
. Primary Sensor Cartridge
. Auxiliary Sensor Cartridge ●
. Stat Profile Prime Plus Auto-Cartridge Quality Control Pack ●
. Stat Profile Prime Plus Calibrator Cartridge ●
. Stat Profile Prime Plus External Ampuled Control
. IFU/Labeling
Sample Types:
The Stat Profile Prime Plus Analyzer System accepts lithium heparinized arterial and venous whole blood.
Measured Parameters:
The Stat Profile Prime Plus Analyzer measures:
. Hematocrit (Hct) ●
. Oxygen Saturation (SO2) ●
. Total Hemoglobin (tHb)
. Oxyhemoglobin (O2Hb) ●
. Carboxyhemoglobin (COHb) ●
. Methemoglobin (MetHb)
. Deoxyhemoglobin (HHb) ●
Calculated Parameters:
The Prime Plus Analyzer also provides the following parameter results calculated based on results of the directly measured parameters:
. Arterial Oxygen Content (CaO2) ●
. Arterial-Venous Oxygen Content Difference (C(a-v)O2)
. Base Excess of Blood (BE-b)
. Fractional Oxyhemoglobin (FO2Hb)
. Oxygen Capacity (O₂Cap)
. Oxygen Content (O2Ct)
. P50
. Qsp/Qt (Physiological Shunt)
. Standard Bicarbonate Concentration (SBC) .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals in clinical laboratory settings and for point-of-care usage
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was previously completed and summarized in K180186 to show that the Stat Profile Prime Plus Analyzer demonstrates substantial equivalence to the predicate submission.
The bench testing included:
- Method Comparison Studies ●
- Precision/Reproducibility Within Run and Run to Run Studies ●
- Linearity Testing
- Specificity/Interference Testing
- Detection Limit ●
The results of that testing confirmed that the performance of the Stat Profile Prime Plus Analyzer System is substantially equivalent to that of the Nova Stat Profile pHOx Ultra Analyzer System (predicate device).
Summary of Point-of-Care Testing:
A Point-of-Care (POC) study was conducted to show that the Stat Profile Prime Plus Analyzer demonstrates substantial equivalence to the predicate submission. The testing compared results obtained by trained Healthcare Professionals to results obtained by POC personnel on the same specimens using the same analyzer. The Stat Profile Prime Plus Analyzer was evaluated by point-of-care (POC) personnel in 3 POC sites including a Cardiothoracic Intensive Care Unit (CTICU), an Emergency Department (ED) and a Respiratory Therapy Lab (RT). A total of 61 Respiratory Care, 12 Nursing, and 1 Exercise Physiology POC personnel participated from the 3 POC settings over the course of the study. The personnel represent trained, qualified staff found in typical POC sites where blood gas analyzers are utilized. All testing was performed using quality control materials or discarded blood gas specimens.
Method Comparison studies on venous and arterial whole blood specimens were conducted using methods described in CLSI "Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline - Second Edition", CLSI EP9-A2. Combined method comparison data from all 3 POC settings is summarized in Table 1.
Key Results for Method Comparison (Venous and Arterial Whole Blood):
| analyte | N | # altered samples | range | Slope | Intercept | r | MDL | 95% Confidence Interval of Bias (Lower Limit-Upper Limit) |
|---|---|---|---|---|---|---|---|---|
| Hct | 417 | 3 | 18 - 69 | 0.9997 | 0.1315 | 0.9929 | 20 56 | 20-20 |
| SO2 | 398 | 1 | 30 - 100 | 1.0084 | -0.9664 | 0.9982 | 80 90 | 80-80 |
| tHb | 416 | 2 | 5.0 - 24.2 | 1.0042 | -0.0058 | 0.9923 | 7 22 | 6.9-7.1 |
| O2Hb | 422 | 8 | 7.1 - 98.4 | 1.0072 | -0.8636 | 0.9983 | 85 90 | 84.6-85.1 |
| COHb | 425 | 11 | 0.3 - 50.5 | 1.0024 | -0.0013 | 0.9986 | 3 10 | 3.0-3.0 |
| MetHb | 437 | 23 | 0.3 - 56.7 | 1.0040 | 0.0006 | 0.9993 | 5 10 | 5.0-5.0 |
| HHb | 322 | 7 | 0.4 - 39.7 | 1.0123 | 0.0882 | 0.9962 | 6 15 | 6.0-6.3 |
Total Imprecision Performance:
The estimates for total impression were obtained from different POC personnel running 3 levels of Stat Profile Prime Plus Quality Control/Linearity Materials in duplicate each day for a total of 20 runs on 3 Stat Profile Prime Plus analyzers. The protocol was based upon methods described in CLSI Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition, CLSI EP5-A2T. The total imprecision data from one representative POC site is shown in Table 2 is representative of the expected total imprecision performance obtainable by POC personnel using the Stat Profile Prime Plus analyzer using external quality control and linearity materials.
Within-Run Whole Blood Precision:
Whole blood with-run precision of the Stat Profile Prime Plus Analyzer System in the hands of point-of-care operators was assessed by a minimum of two (2) point-of-care operators at each of the three (3) POC sites for a total of nine (9) operators across the 3 testing locations. Each precision run consisted of ten (10) replicate measurements using both fresh, native and altered whole blood samples. A total of five (5) different native samples and two (2) altered samples were evaluated at each site. Each whole blood specimen was maintained in a syringe. The POC operator performed all sample analysis steps including sample analysis, removal of resultant air bubble(s) from the syringe, recapping of the syringe and mixing prior to the next sample analysis. The whole blood within-run precision data from one representative POC site is shown in Table 3 and is representative of the expected within-run precision obtainable by POC personnel using the Stat Profile Prime Plus analyzer using whole blood samples.
Conclusion:
The results of the POC clinical performance verification testing confirmed that the Stat Profile Prime Plus Analyzer is substantially equivalent to the predicate Stat Profile
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for Method Comparison (Slope, Intercept, r, 95% Confidence Interval of Bias) and Total Imprecision Performance (Mean, Within Run SD, Within Run %CV, Total SD, Total %CV) as well as Within-Run Whole Blood Precision (Mean, SD, %CV, 95% CI).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7500 Whole blood hemoglobin assays.
(a)
Identification. A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.(b)
Classification. Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
April 6, 2020
Nova Biomedical Corporation Rachel Gilbert Regulatory Affairs Specialist II 200 Prospect Street Waltham, MA 02454
Re: K200204
Trade/Device Name: Stat Profile® Prime Plus Analyzer System Regulation Number: 21 CFR 864.7500 Regulation Name: Whole Blood Hemoglobin Assays Regulatory Class: Class II Product Code: GGZ, GHS, GKK, GKR, JPI Dated: January 23, 2020 Received: January 28, 2020
Dear Rachel Gilbert:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, M.T., Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200204
Device Name
Stat Profile® Prime Plus Analyzer System
Indications for Use (Describe)
The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, and Deoxyhemoglobin in heparinized arterial and venous whole blood.
| Hct | Hematocrit (Hct) measurements of the packed red blood cell volume are used to distinguish normal from abnormal states, such as anemia and erythrocytosis. |
|---|---|
| SO2 | Oxygen Saturation (SO2) measurements are used to assess the oxygenation of the hemoglobin and the adequacy of tissue oxygenation in the evaluation of pulmonary function. Measurements are also used to diagnose and treat cyanosis. |
| tHb | Total Hemoglobin (tHb) measurements are used in the evaluation of chronic and acute anemia as well as the oxygen transport capability of the hemoglobin. |
| O2Hb | Oxyhemoglobin (O2Hb) measurements are used to assess pulmonary function in combination with Deoxyhemoglobin and are also used in the diagnosis and treatment of cyanosis. |
| COHb | Carboxyhemoglobin (COHb) measurements are used to determine if and to what level carbon monoxide has been inhaled by the patient. High levels of carbon monoxide can lead to tissue anoxia and death. |
| MetHb | Methemoglobin (MetHb) measurements are used to determine congenital methemoglobinemia or determine the ingestion of nitrates, chlorates, or any other drug or chemical that can cause methemoglobin formation. High levels of methemoglobin can lead to cyanosis and death. |
| HHb | Deoxyhemoglobin (HHb) measurements are used to assess pulmonary function in combination with Oxyhemoglobin. |
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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3
510(k) Summary K200204
| 510(K) Owner: | Nova Biomedical Corporation |
|---|---|
| Registration Number: | 1219029 |
| Address: | 200 Prospect St. |
| Waltham, MA 02454 | |
| Phone: | 781-894-0800 |
| Fax Number: | 784-891-4806 |
| Contact Person: | Rachel Gilbert, Regulatory Affairs Specialist |
| Date Prepared: | January 23, 2020 |
Proprietary Name: Stat Profile® Prime Plus Analyzer System
Common or Usual Name: Blood Analyzer
Classification Name: Multiple
| Regulation section | Classification | Product
code | Panel |
|-------------------------------------------------------------------------|----------------|-----------------|--------------------|
| 21 CFR § 864.7500 Whole blood hemoglobin assays (Oxyhemoglobin) | Class II | GGZ | |
| 21 CFR § 864.7500 Whole blood hemoglobin assays
(Cyanomethemoglobin) | Class II | GKK | Hematology
(81) |
| 21 CFR § 864.6400 Hematocrit measuring device | Class II | JPI | |
| 21 CFR § 864.7425 Carboxyhemoglobin assay | Class II | GHS | |
| 21 CFR § 864.5620 Automated hemoglobin system | Class II | GKR | |
Predicate Device:
K180186 – Stat Profile Prime Plus Analyzer System
Device Description:
The Stat Profile Prime Plus Analyzer System is a low cost, low maintenance analyzer for hospital laboratory and point-of-care settings. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).
The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed.
4
Primary Sensor Card Port:
There are two options for the primary sensor card:
- Primary Sensor Card 1 shall enable and report the following listed analytes: . o Hct, tHb, SO2, O2Hb, COHb, MetHb, HHb
- Primary Sensor Card 2 shall enable and report the following listed analytes: . o Hct, tHb, SO2
As with the predicate, the Stat Profile Prime Plus Analyzer is a blood gas, co-oximetry, electrolyte, chemistry, and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control is available, as well as an on-board Quality Management System (QMS), and an electronic monitoring approach that insures the analyzer is working properly at all times.
The Stat Profile Prime Plus Analyzer accepts samples from syringes and open tubes. The minimum sample size for analysis is 135 µL.
Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.
Stat Profile Prime Plus Analyzer System Components:
The Stat Profile Prime Plus Analyzer System is comprised of the following components.
- . Stat Profile Prime Plus Analyzer System
- . Primary Sensor Cartridge
- Auxiliary Sensor Cartridge ●
- Stat Profile Prime Plus Auto-Cartridge Quality Control Pack ●
- Stat Profile Prime Plus Calibrator Cartridge ●
- . Stat Profile Prime Plus External Ampuled Control
- IFU/Labeling
Sample Types:
The Stat Profile Prime Plus Analyzer System accepts lithium heparinized arterial and venous whole blood.
Measured Parameters:
The Stat Profile Prime Plus Analyzer measures:
- Hematocrit (Hct) ●
- Oxygen Saturation (SO2) ●
- Total Hemoglobin (tHb)
- Oxyhemoglobin (O2Hb) ●
- Carboxyhemoglobin (COHb) ●
- Methemoglobin (MetHb)
- Deoxyhemoglobin (HHb) ●
5
Calculated Parameters:
The Prime Plus Analyzer also provides the following parameter results calculated based on results of the directly measured parameters:
- Arterial Oxygen Content (CaO2) ●
- Arterial-Venous Oxygen Content Difference (C(a-v)O2)
- Base Excess of Blood (BE-b)
- . Fractional Oxyhemoglobin (FO2Hb)
- . Oxygen Capacity (O₂Cap)
- Oxygen Content (O2Ct)
- P50
- Qsp/Qt (Physiological Shunt)
- Standard Bicarbonate Concentration (SBC) .
Intended Use:
The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin in heparinized arterial and venous whole blood.
Indications for Use:
| Hct | Hematocrit (Hct) measurements of the packed red blood cell volume are used to
distinguish normal from abnormal states, such as anemia and erythrocytosis. |
|-------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SO2 | Oxygen Saturation (SO2) measurements are used to assess the oxygenation of the
hemoglobin and the adequacy of tissue oxygenation in the evaluation of pulmonary
function. Measurements are also used to diagnose and treat cyanosis. |
| tHb | Total Hemoglobin (tHb) measurements are used in the evaluation of chronic and
acute anemia as well as the oxygen transport capability of the hemoglobin. |
| O2Hb | Oxyhemoglobin (O2Hb) measurements are used to assess pulmonary function in
combination with Deoxyhemoglobin and are also used in the diagnosis and treatment
of cyanosis. |
| COHb | Carboxyhemoglobin (COHb) measurements are used to determine if and to what
level carbon monoxide has been inhaled by the patient. High levels of carbon
monoxide can lead to tissue anoxia and death. |
| MetHb | Methemoglobin (MetHb) measurements are used to determine congenital methe-
moglobinemia or determine the ingestion of nitrates, chlorates, or any other drug or
chemical that can cause methemoglobin formation. High levels of methemoglobin can
lead to cyanosis and death. |
| HHb | Deoxyhemoglobin (HHb) measurements are used to assess pulmonary function in
combination with Oxyhemoglobin. |
Summary of the Technological Characteristics:
The Stat Profile Prime Plus Analyzer is substantially equivalent to the previously cleared for market Stat Profile Prime Plus Analyzer in intended use. It uses the same sensor technology and measurement algorithms, and the formulations of the internal and external controls and the calibration cartridge are the same for the tested parameters.
6
Principles of Measurement:
Oxygen Saturation:
Oxygen saturation (SQ2%) represents the percent of hemoglobin bound to oxygen, expressed as a fraction of the amount of hemoglobin capable of binding to oxygen (oxyhemoglobin plus deoxyhemoglobin). As the level of SQ2% changes within a blood sample, the color of the whole blood changes. Oxygen Saturation is determined by using a standard equation.
Hematocrit:
Hematocrit is defined as the percentage of red blood cells to the total blood volume and can be obtained by measuring electrical resistance of the blood sample. Two standard solutions are used to calibrate the hematocrit sensor and to obtain the slope. The analyzer the electrical resistance of the blood sample to obtain the hematocrit value. The hematocrit value obtained is corrected for the concentration of the sodium ion.
Total Hemoglobin:
Hemoglobin is a protein found in red blood cells that carries oxygen from the lungs to the body's tissues and returns carbon dioxide from the tissues back to the lungs. Total Hemoglobin is the sum of all measured hemoglobin fractions expressed as the amount of hemoglobin in a specified volume of whole blood. Total Hemoglobin is calculated using a standard equation.
Oxyhemoglobin:
Oxyhemoglobin is the combined form of hemoglobin and oxygen is bound reversibly and is readily given up to the tissues because of the lower tissue oxygen tension. Conversely in the lungs, there is a higher oxygen tension and greater oxygen uptake by hemoglobin. The percentage of oxyhemoglobin is determined using a standard equation.
Carboxyhemoqlobin:
Carboxyhemoglobin is the combined form of carbon monoxide and hemoglobin. The affinity of hemoglobin for carbon monoxide is approximately 210 times greater than for oxygen. Because of this high affinity, inhalation of large amounts of carbon monoxide can lead to death if left undiagnosed. The percentage of carboxyhemoglobin is determined by using a standard equation.
Methemoglobin:
Methemoglobin is the form of hemoglobin in which the iron has been oxidized from the ferrous to the ferric state. Oxygen cannot bind with methemoglobin. Therefore, increased amounts can lead to cyanosis, tissue anoxia, and death. There are congenital and acquired forms of methemoglobinemia. The percentage of methemoglobin is determined by using a standard equation.
Deoxyhemoglobin:
Deoxyhemoglobin is the form of hemoglobin that is not combined with oxygen but can easily uptake oxygen in the lungs. The percentage of deoxyhemoglobin is determined by using a standard equation.
Summary of Performance Testing:
Bench testing was previously completed and summarized in K180186 to show that the Stat Profile Prime Plus Analyzer demonstrates substantial equivalence to the predicate submission.
The bench testing included:
- Method Comparison Studies ●
- Precision/Reproducibility Within Run and Run to Run Studies ●
- Linearity Testing
- Specificity/Interference Testing
- Detection Limit ●
7
The results of that testing confirmed that the performance of the Stat Profile Prime Plus Analyzer System is substantially equivalent to that of the Nova Stat Profile pHOx Ultra Analyzer System (predicate device).
Summary of Point-of-Care Testing:
A Point-of-Care (POC) study was conducted to show that the Stat Profile Prime Plus Analyzer demonstrates substantial equivalence to the predicate submission. The testing compared results obtained by trained Healthcare Professionals to results obtained by POC personnel on the same specimens using the same analyzer. The Stat Profile Prime Plus Analyzer was evaluated by point-of-care (POC) personnel in 3 POC sites including a Cardiothoracic Intensive Care Unit (CTICU), an Emergency Department (ED) and a Respiratory Therapy Lab (RT). A total of 61 Respiratory Care, 12 Nursing, and 1 Exercise Physiology POC personnel participated from the 3 POC settings over the course of the study. The personnel represent trained, qualified staff found in typical POC sites where blood gas analyzers are utilized. All testing was performed using quality control materials or discarded blood gas specimens.
Method Comparison studies on venous and arterial whole blood specimens were conducted using methods described in CLSI "Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline - Second Edition", CLSI EP9-A2. Combined method comparison data from all 3 POC settings is summarized in Table 1.
| analyte | N | # altered samples | range | Slope | Intercept | r | MDL | 95% Confidence Interval of Bias | |
|---|---|---|---|---|---|---|---|---|---|
| Lower Limit | Upper Limit | ||||||||
| Hct | 417 | 3 | 18 - 69 | 0.9997 | 0.1315 | 0.9929 | 20 | ||
| 56 | 20 | 20 | |||||||
| SO2 | 398 | 1 | 30 - 100 | 1.0084 | -0.9664 | 0.9982 | 80 | ||
| 90 | 80 | 80 | |||||||
| tHb | 416 | 2 | 5.0 - 24.2 | 1.0042 | -0.0058 | 0.9923 | 7 | ||
| 22 | 6.9 | 7.1 | |||||||
| O2Hb | 422 | 8 | 7.1 - 98.4 | 1.0072 | -0.8636 | 0.9983 | 85 | ||
| 90 | 84.6 | 85.1 | |||||||
| COHb | 425 | 11 | 0.3 - 50.5 | 1.0024 | -0.0013 | 0.9986 | 3 | ||
| 10 | 3.0 | 3.0 | |||||||
| MetHb | 437 | 23 | 0.3 - 56.7 | 1.0040 | 0.0006 | 0.9993 | 5 | ||
| 10 | 5.0 | 5.0 | |||||||
| HHb | 322 | 7 | 0.4 - 39.7 | 1.0123 | 0.0882 | 0.9962 | 6 | ||
| 15 | 6.0 | 6.3 |
Table 1: Venous and Aterial Whole Blood Method Comparison Results – Point of Care vs Lab (ED, RT and CTICU)
8
Total Imprecision Performance:
The estimates for total impression were obtained from different POC personnel running 3 levels of Stat Profile Prime Plus Quality Control/Linearity Materials in duplicate each day for a total of 20 runs on 3 Stat Profile Prime Plus analyzers. The protocol was based upon methods described in CLSI Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition, CLSI EP5-A2T. The total imprecision data from one representative POC site is shown in Table 2 is representative of the expected total imprecision performance obtainable by POC personnel using the Stat Profile Prime Plus analyzer using external quality control and linearity materials.
| Total Imprecision Data-Level 1 | |||||
|---|---|---|---|---|---|
| Mean | Within Run SD | Within Run %CV | Total SD | Total %CV | |
| Hct (%) | 61 | 0.5 | 0.8 | 0.6 | 0.9 |
| SO2 (%) | 47.5 | 0.6 | 1.2 | 0.7 | 1.4 |
| tHb (g/dL) | 19.8 | 0.2 | 0.9 | 0.2 | 1.0 |
| O2Hb (%) | 20.5 | 0.3 | 1.2 | 0.4 | 1.7 |
| COHb(%) | 29.2 | 0.1 | 0.5 | 0.2 | 0.7 |
| MetHb(%) | 27.7 | 0.1 | 0.4 | 0.1 | 0.4 |
| HHb (%) | 22.7 | 0.1 | 0.5 | 0.1 | 0.6 |
| Total Imprecision Data-Level 2 | |||||
| Hct (%) | 38 | 0.2 | 0.6 | 0.3 | 0.8 |
| SO2 (%) | 78.0 | 0.4 | 0.5 | 0.4 | 0.5 |
| tHb (g/dL) | 13.3 | 0.3 | 1.9 | 0.3 | 2.2 |
| O2Hb (%) | 47.1 | 0.4 | 0.8 | 0.4 | 0.9 |
| COHb(%) | 21.2 | 0.3 | 1.2 | 0.3 | 1.4 |
| MetHb(%) | 18.4 | 0.2 | 1.1 | 0.2 | 1.2 |
| HHb (%) | 13.2 | 0.2 | 1.2 | 0.2 | 1.2 |
| Total Imprecision Data-Level 3 | |||||
| Hct (%) | 27 | 0.4 | 1.6 | 0.4 | 1.6 |
| SO2 (%) | 91.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| tHb (g/dL) | 6.6 | 0.1 | 1.9 | 0.1 | 2.2 |
| O2Hb (%) | 80.1 | 0.1 | 0.2 | 0.2 | 0.2 |
| COHb(%) | 6.2 | 0.1 | 1.4 | 0.1 | 1.5 |
| MetHb(%) | 5.8 | 0.1 | 2.2 | 0.1 | 2.3 |
| HHb (%) | 7.9 | 0.1 | 1.5 | 0.1 | 1.7 |
| Table 2: Total Imprecision From ED Site | ||||
|---|---|---|---|---|
| Mean | SD | %CV | 95% CI | |
| Sample 1 | ||||
| Hct (%) | 48.4 | 1.43 | 2.95 | 46 - 51 |
| SO2 (%) | 80.0 | 0.00 | 0.00 | 80 - 80 |
| tHb (g/dL) | 15.0 | 0.31 | 2.06 | 14.4 - 15.6 |
| O2Hb (%) | 78.6 | 0.30 | 0.38 | 78.0 - 79.2 |
| COHb(%) | 1.28 | 0.25 | 19.42 | 0.8 - 1.8 |
| MetHb(%) | 0.54 | 0.08 | 15.62 | 0.4 - 0.7 |
| HHb (%) | 19.6 | 0.18 | 0.91 | 19.3 - 20.0 |
| Sample 2 | ||||
| Hct (%) | 20.8 | 0.42 | 2.03 | 20 - 22 |
| SO2 (%) | 89.4 | 0.70 | 0.78 | 88 - 91 |
| tHb (g/dL) | 7.2 | 0.22 | 3.03 | 6.7 - 7.6 |
| O2Hb (%) | 85.0 | 0.65 | 0.77 | 83.7 - 86.3 |
| COHb(%) | 4.11 | 0.17 | 4.05 | 3.8 - 4.4 |
| MetHb(%) | 0.81 | 0.22 | 27.58 | 0.4 - 1.3 |
| HHb (%) | 10.1 | 0.60 | 5.97 | 8.9 - 11.3 |
| Sample 3 | ||||
| Hct (%) | 49.6 | 0.70 | 1.41 | 48 - 51 |
| SO2 (%) | 95.9 | 0.32 | 0.33 | 95 - 97 |
| tHb (g/dL) | 16.2 | 0.05 | 0.33 | 16.0 - 16.3 |
| O2Hb (%) | 93.9 | 0.48 | 0.51 | 92.9 - 94.8 |
| COHb(%) | 1.60 | 0.19 | 11.79 | 1.2 - 2.0 |
| MetHb(%) | 0.58 | 0.09 | 15.84 | 0.4 - 0.8 |
| HHb (%) | 4.0 | 0.36 | 9.19 | 3.2 - 4.7 |
| Sample 4 | ||||
| Hct (%) | 49.8 | 0.63 | 1.27 | 49 - 51 |
| SO2 (%) | 99.4 | 0.52 | 0.52 | 98 - 100 |
| tHb (g/dL) | 16.1 | 0.05 | 0.32 | 16.0 - 16.2 |
| O2Hb (%) | 97.7 | 0.13 | 0.13 | 97.4 - 97.9 |
| COHb(%) | 1.08 | 0.17 | 15.62 | 0.7 - 1.4 |
| MetHb(%) | 0.71 | 0.07 | 10.39 | 0.6 - 0.9 |
| HHb (%) | 0.5 | 0.11 | 19.99 | 0.3 - 0.7 |
| Sample 5 | ||||
| Hct (%) | 26.7 | 0.48 | 1.81 | 26 - 28 |
| SO2 (%) | 92.5 | 0.53 | 0.57 | 91 - 94 |
| tHb (g/dL) | 8.2 | 0.05 | 0.59 | 8.1 - 8.3 |
| O2Hb (%) | 90.4 | 0.45 | 0.50 | 89.5 - 91.3 |
| COHb(%) | 1.53 | 0.27 | 17.44 | 1.0 - 2.1 |
| MetHb(%) | 0.88 | 0.15 | 16.77 | 0.6 - 1.2 |
| HHb (%) | 7.2 | 0.37 | 5.08 | 6.5 - 7.9 |
| Mean | SD | %CV | 95% Cl | |
| Sample 6 (Altered) | ||||
| Hct (%) | 38.1 | 0.57 | 1.49 | 37 - 39 |
| SO2 (%) | 99.4 | 0.52 | 0.52 | 98 - 100 |
| tHb (g/dL) | 11.0 | 0.12 | 1.06 | 10.7 - 11.2 |
| O2Hb (%) | 94.4 | 0.17 | 0.18 | 94.1 - 94.7 |
| COHb(%) | 4.74 | 0.15 | 3.18 | 4.4 - 5.0 |
| MetHb(%) | 0.38 | 0.08 | 20.76 | 0.2 - 0.5 |
| HHb (%) | 0.48 | 0.08 | 16.43 | 0.3 - 0.6 |
| Sample 7 (Altered) | ||||
| Hct (%) | 44.0 | 0.47 | 1.07 | 43 - 45 |
| SO2 (%) | 98.9 | 0.32 | 0.32 | 98 - 100 |
| tHb (g/dL) | 14.7 | 0.08 | 0.54 | 14.6 - 14.9 |
| O2Hb (%) | 60.5 | 1.01 | 1.67 | 58.4 - 62.5 |
| COHb(%) | 17.4 | 0.21 | 1.18 | 17.0 - 17.8 |
| MetHb(%) | 21.5 | 1.06 | 4.92 | 19.4 - 23.7 |
| HHb (%) | 0.61 | 0.18 | 29.38 | 0.3 - 1.0 |
Within-Run Whole Blood Precision:
Whole blood with-run precision of the Stat Profile Prime Plus Analyzer System in the hands of point-ofcare operators was assessed by a minimum of two (2) point-of-care operators at each of the three (3) POC sites for a total of nine (9) operators across the 3 testing locations. Each precision run consisted of ten (10) replicate measurements using both fresh, native and altered whole blood samples. A total of five (5) different native samples and two (2) altered samples were evaluated at each site. Each whole blood specimen was maintained in a syringe. The POC operator performed all sample analysis steps including sample analysis, removal of resultant air bubble(s) from the syringe, recapping of the syringe and mixing prior to the next sample analysis. The whole blood within-run precision data from one representative POC
9
site is shown in Table 3 and is representative of the expected within-run precision obtainable by POC personnel using the Stat Profile Prime Plus analyzer using whole blood samples.
Table 3: Within Run Precision with Whole Blood Samples (n=10) – ED
10
Conclusion:
The results of the POC clinical performance verification testing confirmed that the Stat Profile Prime Plus
Analyzer is substantially equivalent to the predicate Stat Profile
11
| Table 4: Comparison of Predicate and Proposed Devices | ||
|---|---|---|
| ------------------------------------------------------- | -- | -- |
| Characteristic | Predicate: | Proposed: |
|---|---|---|
| Indication For Use | The Stat Profile Prime Plus Analyzer System | |
| is indicated for use by healthcare | ||
| professionals in clinical laboratory settings for | ||
| quantitative determination of Hematocrit, | ||
| Oxygen Saturation, Total Hemoglobin, | ||
| Oxyhemoglobin, Carboxyhemoglobin, | ||
| Methemoglobin, and Deoxyhemoglobin in | ||
| heparinized arterial and venous whole blood. | The Stat Profile Prime Plus Analyzer System | |
| is indicated for use by healthcare | ||
| professionals in clinical laboratory settings | ||
| and for point-of care usage for quantitative | ||
| determination of Hematocrit, Oxygen | ||
| Saturation, Total Hemoglobin, | ||
| Oxyhemoglobin, Carboxyhemoglobin, | ||
| Methemoglobin, and Deoxyhemoglobin in | ||
| heparinized arterial and venous whole blood. | ||
| Acceptable Samples | ||
| Sample Types | Lithium heparin whole blood from syringes | |
| and open tubes | Same | |
| Sample Volumes | 135µL | Same |
| Measurement Range | ||
| Hct | 12-70% | Same |
| SO2 | 30-100% | Same |
| tHb | 5.0-25.0 g/dL | Same |
| O2Hb | 1.8-100% | Same |
| COHb | 0.3-60% | Same |
| MetHb | 0.3-60% | Same |
| HHb | 0.4-40% | Same |
| Principles of | ||
| Measurement | ||
| Hct | Impedance sensor | Same |
| SO2 | Spectrophotometric | Same |
| tHb | Spectrophotometric | Same |
| O2Hb | Spectrophotometric | Same |
| COHb | Spectrophotometric | Same |
| MetHb | Spectrophotometric | Same |
| HHb | Spectrophotometric | Same |
| Touch Screen | 10.1" WXGA 1280 x 800 color touch screen | Same |
| Menu | Fully configurable test menu based on | |
| available sensors | Same | |
| Bar Code Scanner | Internal Integrated 1D/2D | Same |
| Printer | 2" Roll, Thermal Transfer | Same |
| Pump | Peristaltic Pump w/ Pressure Plate, TPE | |
| Tubing (Pharmed BPT) | Same | |
| Analog Board | Precision low level analog front end w/ | |
| amperometric and potentiometric amplifiers, | ||
| air detector circuitry and temperature control | ||
| circuitry | Same |