(456 days)
No
The summary describes a standard laboratory analyzer for measuring various blood parameters using sensor cartridges. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the analytical methods and equivalence to a predicate device.
No
This device is an analyzer that determines the quantitative levels of various substances in blood to aid in diagnosis and treatment, rather than directly treating a disease or condition.
Yes
The device quantitatively determines various analytes (e.g., pH, pCO2, pO2, Hematocrit, Glucose, Lactate, Sodium) in blood, and the Indications for Use explicitly state that these measurements are "used in the diagnosis and treatment of life-threatening acid base disturbances" and "diagnosis and treatment of carbohydrate metabolism," among other diagnostic purposes.
No
The device description explicitly states that the system consists of an analyzer, sensor cartridges, and thermal paper, which are all hardware components. The software is part of a larger hardware system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the system is "indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of pH, Partial Pressure of Carbon Dioxide (pCO2), Partial Pressure of Oxygen (pO2), Hematocrit, Sodium, Chloride, Ionized Calcium, Ionized Magnesium, Gucose, and Lactate in heparinized capillary whole blood." It then details how these measurements are used in the "diagnosis and treatment" of various medical conditions. This directly aligns with the definition of an IVD, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Sample Type: The device analyzes "heparinized capillary whole blood," which is a specimen taken from the human body.
- Device Description: The description details an "analyzer" that performs "quantitative determination" of various analytes in blood. This is characteristic of an IVD instrument.
- Performance Studies: The document describes "clinical performance" studies and "method comparison" studies comparing the device to a predicate device, which are standard requirements for demonstrating the performance of an IVD.
The entire context of the document points to the device being used to perform tests on human biological samples to aid in medical decision-making, which is the core function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 pH, Partial Pressure of Carbon Dioxide (pCO2), Partial Pressure of Oxygen (pO2), Hematocrit, Sodium, Potassium, Chloride, Ionized Calcium, Ionized Magnesium, Glucose, and Lactate in heparinized capillary whole blood.
Indication for Use:
pH, pCO2, pO2 measurements are used in the diagnosis and treatment of life-threatening acid base disturbances.
Hematocrit (Hct) measurements of the packed red blood cell volume are used to distinguish normal from abnormal states, such as anemia and erythrocytosis.
Glucose (Glu) measurement is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis.
Sodium (Na) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.
Potassium (K) measurements are used in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.
Chloride (Cl) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Ionized Calcium (iCa) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Ionized Magnesium (iMg) measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).
Product codes (comma separated list FDA assigned to the subject device)
CHL, JPI, CGA, KHP, JGS, CEM, CGZ, JFP, CFA
Device Description
The Stat Profile Prime Plus Analyzer System is an analyzer for use in 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: PO2, PCO2, pH, Hct, tHb, SO2, O2Hb, COHb, MetHb, HHb, Glu, Lactate, Sodium, Potassium, Chloride, Calcium, Ionized Magnesium
- Primary Sensor Card 2 shall enable and report the following listed analytes: PO2, PCO2, pH, Hct, tHb, SO2, Glu, Lactate, Sodium, Chloride, Calcium, Ionized Magnesium
Auxiliary Sensor Card Port:
The reporting of Creatinine and BUN parameters (or not reporting them) shall be determined by the selection of the Auxiliary Sensor Card
- Auxiliary Sensor Card 1 shall enable the Creatinine and BUN parameters
- Auxiliary Sensor Card 2 shall be a "dummy" sensor card and will not report any parameters.
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 ensures the analyzer is working properly.
The Stat Profile Prime Plus Analyzer accepts samples from syringes, open tubes, and capillary tubes. The sample size for analysis is 135 µL for the complete test panel or 90 µL for the capillary panel.
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 Ampule Control
- IFU/Labeling
Sample Types:
The Stat Profile Prime Plus Analyzer System accepts lithium heparinized arterial, venous, and capillary whole blood.
Measured Parameters:
The Stat Profile Prime Plus Analyzer measures:
- pH
- Partial Pressure of Carbon Dioxide (pCO2)
- Partial Pressure of Oxygen (pO2)
- Hematocrit (Hct)
- Glucose (Glu)
- Lactate (Lac)
- Sodium (Na)
- Potassium (K)
- Chloride (Cl)
- Ionized Calcium (iCa)
- Ionized Magnesium (iMg)
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
Point-of-Care testing for arterial and venous whole blood samples was previously completed and summarized in the following Prime Plus Analyzer System bundled 510(k)s K193246, K200349, K200403 to demonstrate that the system is safe and effective for use in the POC setting.
The testing included method comparison studies in 3 POC sites, including a Cardiothoracic Intensive Care Unit (CTICU), an Emergency Department (ED) and a Respiratory Therapy Lab (RT).
A separate clinical study was conducted in Point-of-Care (POC) settings to demonstrate the clinical performance of capillary whole blood specimens on the Stat Profile Prime Plus analyzers. The study was conducted to demonstrate the clinical performance of capillary whole blood specimens on the Stat Profile Prime Plus analyzers. The study compared the Stat Profile Prime Plus analyzers to the Nova Stat Profile pHOx Ultra analyzers (predicate device) to assess the equivalence of the analyzers in the measurement of pH, blood gases, hematocrit, electrolytes, and metabolites in capillary whole blood specimens. The method comparison study was performed at two (2) external POC sites. The study was conducted in the Emergency Room (ER) with five (5) POC nurses and within a Hemodialysis Unit with four (4) POC nurses over a minimum of 20 days. Each site used a single Prime Plus analyzer and a single pHOx Ultra analyzer. Some of the specimens were altered (less than 10%) to cover the full dynamic range.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing: Previously completed and summarized in 510(k)s K173797, K180186, K180340, K180428, K200349. Confirmed substantial equivalence in performance, safety, and efficacy to the Nova Stat Profile pHOx Ultra Analyzer System.
Point-of-Care Testing (Arterial and Venous Whole Blood): Previously completed and summarized in 510(k)s K193246, K200349, K200403. Included method comparison studies in 3 POC sites (Cardiothoracic Intensive Care Unit, Emergency Department, Respiratory Therapy Lab). Confirmed safety and effectiveness for POC use and substantial equivalence to the predicate.
Capillary Mode Testing - Method Comparison:
- Study Type: Clinical method comparison study in Point-of-Care (POC) settings.
- Sample Size:
- ER site: N=122 for pH, N=123 for pO2, N=120 for pCO2, N=118 for Hct, N=119 for Na, N=120 for K, N=119 for Cl, N=121 for Ca, N=122 for Mg, N=120 for Glu, N=119 for Lac.
- Hemodialysis site: N=127 for pH, N=128 for pO2, N=125 for pCO2, N=123 for Hct, N=124 for Na, N=125 for K, N=124 for Cl, N=126 for Ca, N=127 for Mg, N=125 for Glu, N=124 for Lac.
- Combined results: N=249 for pH, N=251 for pO2, N=245 for pCO2, N=241 for Hct, N=243 for Na, N=245 for K, N=243 for Cl, N=247 for Ca, N=249 for Mg, N=245 for Glu, N=243 for Lac.
- Key Results: The capillary blood comparison data for all test parameters for the Stat Profile Prime Plus analyzers met the clinical accuracy acceptance criteria for correlation coefficient (r) and bias at the medical decision levels.
- ER (r-values): pH (0.9914), pO2 (0.9965), pCO2 (0.9958), Hct (0.9864), Na (0.9907), K (0.9984), Cl (0.9810), Ca (0.9932), Mg (0.9808), Glu (0.9959), Lac (0.9988).
- Hemodialysis (r-values): pH (0.9971), pO2 (0.9987), pCO2 (0.9975), Hct (0.9864), Na (0.9866), K (0.9990), Cl (0.9897), Ca (0.9935), Mg (0.9813), Glu (0.9979), Lac (0.9991).
- Combined (r-values): pH (0.9942), pO2 (0.9976), pCO2 (0.9968), Hct (0.9876), Na (0.9885), K (0.9987), Cl (0.9856), Ca (0.9932), Mg (0.9811), Glu (0.9969), Lac (0.9989).
Total Imprecision Performance - Within Run Precision (Internal Study):
- Study Type: Evaluation of within-run and between-analyzer precision using venous blood transferred to capillary tubes.
- Sample Size: 20 replicates for each analyte at targeted concentrations on two Prime Plus analyzers.
- Key Results: Precision data for all samples met within-run and between-analyzer imprecision specifications.
Total Imprecision Performance - Within Sample Precision (Internal Study):
- Study Type: Evaluation of within-sample precision for whole blood.
- Sample Size: Two replicates of capillary whole blood from 30 different donors.
- Key Results: Precision data met within-run imprecision specifications.
Within-Run Imprecision - Capillary Mode Fingerstick (External POC):
- Study Type: Precision study using discarded arterial blood specimens transferred to capillary tubes by POC operators.
- Sample Analysis: Each whole blood specimen transferred to three balanced heparin capillary tubes and analyzed in Capillary Micro mode.
- Key Results: The device exhibits clinically acceptable imprecision specifications for all measured analytes in Capillary mode.
Within-Sample Imprecision - Capillary Mode Fingerstick (Internal POC):
- Study Type: Internal precision study using capillary whole blood collected via fingerstick puncture.
- Sample Size: 60 samples.
- Key Results: The analyzer met the performance criteria for within-sample precision on capillary fingerstick specimens run by POC operators.
Within-Run Imprecision - Capillary Samples (Internal Study):
- Study Type: Internal precision study using different concentrations of deidentified venous whole blood specimens.
- Sample Size: 120 (8 replicates per run, 5 days, 3 analyzers for 5 different concentrations) for each analyte.
- Key Results: The analyzers provided consistently reliable performance and met the acceptance criteria for precision.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficient (r), Slope, Intercept, Mean, Standard Deviation (SD), Coefficient of Variation (CV%) are reported for precision studies.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K193246, K200204, K200349, K200403, K173797, K180186, K180340, K180428
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
September 29, 2023
Nova Biomedical Corporation Bobby Zinck Sr. Regulatory Affairs Manager 200 Prospect St. Waltham, Massachusetts 02454
Re: K221900
Trade/Device Name: Stat Profile Prime Plus Analyzer System Regulation Number: 21 CFR 862.1120 Regulation Name: Blood Gases (pCO2, pO2) and Blood pH Test System Regulatory Class: Class II Product Code: CHL, JPI, CGA, KHP, JGS, CEM, CGZ, JFP, CFA Dated: February 17, 2023 Received: February 21, 2023
Dear Bobby Zinck:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Paula V. Caposino -2
Paula Caposino, Ph.D. Acting Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221900
Device Name Stat Profile Prime Plus Analyzer System
Indications for Use (Describe)
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 pH, Partial Pressure of Carbon Dioxide (pCO2), Partial Pressure of Oxygen (pO2), Hematocrit, Sodium, Chloride, Ionized Calcium, Ionized Magnesium, Gucose, and Lactate in heparinized capillary whole blood.
Indication for Use: pH, pCO2, pO2 measurements are used in the diagnosis and treatment of life-threatening acid base disturbances.
Hematocrit (Hct) measurements of the packed red blood cell volume are used to distinguish normal states, such as anemia and erythrocytosis.
Glucose (Glu) measurement is used in the diagnosis and treatment of carbohydrate metabolism distuding diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis.
Sodium (Na) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.
Potassium (K) measurements are used in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.
Chloride (Cl) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Ionized Calcium (iCa) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Ionized Magnesium (iMg) measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
K221900 510(k) Summary
510(K) Owner: Nova Biomedical Corporation
Registration Number: 1219029
Address: 200 Prospect St. Waltham, MA 02454
Phone: 781-894-0800
784-891-4806 Fax Number:
Contact Person: Bobby Zinck
Date Prepared: September 28, 2023
Proprietary Name:
Stat Profile Prime Plus Analyzer System
Common or Usual Name:
Blood and Blood Gas Analyzer
Classification Name: Multiple
| Classification Name | Regulation # | Class | Product Code | Panel |
|---|---|---|---|---|
| Blood Gases and Blood pH System | 862.1120 | II | CHL | Chemistry (75) |
| Hematocrit measuring device | 864.6400 | II | JPI | Hematology (81) |
| Glucose Test System | 864.1345 | II | CGA | Hematology (81) |
| Lactic Acid Test System* | 862.1450 | I | KHP | Chemistry (75) |
| Sodium Test System | 862.1665 | II | JGS | Chemistry (75) |
| Potassium Test System | 862.1600 | II | CEM | Chemistry (75) |
| Chloride Test System | 862.1170 | II | CGZ | Chemistry (75) |
| Calcium Test System | 862.1145 | II | JFP | Chemistry (75) |
| Magnesium Test System | 862.1495 | Class I, reserved | CFA | Chemistry (75) |
- Meets Limitations to Exemptions 21 CFR § 862.9(c)(9)
Predicate Device: The predicate device for this submission is the Nova Biomedical Stat Profile pHOx Ultra Analyzer which received clearance through 510(k) K110648.
Purpose for Submission:
The purpose of this submission is to expand the indication for use to include capillary whole blood specimen testing for the following analytes tested on the Stat Profile Prime Plus Analyzer System, pH, pCO2, pO2, sodium (Nat), potassium (Kt), chloride (Cl-), ionized calcium (Ca2+), ionized magnesium (Mg2*), glucose, lactate, and hematocrit. The full panel of analytes measured on the Stat Profile Prime Plus including the ones listed in this submission previously received FDA clearance for point-of-care testing with arterial and venous whole blood specimens as a part of a bundled submission under the 510(k)s: K193246, K200204, K200349, K200403.
To support the expanded claims, a point-of-care study at 2 clinical sites was conducted using capillary specimens tested on the Stat Profile Prime Plus Analyzer and compared to the predicate device, Stat Profile pHOx Ultra Analyzer.
5
Device Description:
Stat Profile Prime Plus Analyzer
The Stat Profile Prime Plus Analyzer System is an analyzer for use in 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: .
- PO2, PCO2, pH, Hct, tHb, SO2, O2Hb, COHb, MetHb, HHb, Glu, Lactate, Sodium, o Potassium, Chloride, Calcium, Ionized Magnesium
- Primary Sensor Card 2 shall enable and report the following listed analytes: .
- PO2, PCO2, pH, Hct, tHb, SO2, Glu, Lactate, Sodium, Chloride, Calcium, Ionized o Magnesium
Auxiliarv Sensor Card Port:
The reporting of Creatinine and BUN parameters (or not reporting them) shall be determined by the selection of the Auxiliary Sensor Card
- . Auxiliary Sensor Card 1 shall enable the Creatinine and BUN parameters
- Auxiliary Sensor Card 2 shall be a "dummy" sensor card and will not report any parameters. .
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 ensures the analyzer is working properly.
The Stat Profile Prime Plus Analyzer accepts samples from syringes, open tubes, and capillary tubes. The sample size for analysis is 135 µL for the complete test panel or 90 µL for the capillary panel.
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 Ampule Control
- . IFU/Labeling
Sample Types:
The Stat Profile Prime Plus Analyzer System accepts lithium heparinized arterial, venous, and capillary whole blood.
Measured Parameters:
The Stat Profile Prime Plus Analyzer measures:
- . pH
- . Partial Pressure of Carbon Dioxide (pCO2)
6
- Partial Pressure of Oxygen (pO2) ●
- Hematocrit (Hct) ●
- . Glucose (Glu)
- . Lactate (Lac)
- Sodium (Na) ●
- Potassium (K)
- Chloride (CI)
- . Ionized Calcium (iCa)
- . lonized Magnesium (iMg)
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 pH, Partial Pressure of Carbon Dioxide (pCO2), Partial Pressure of Oxygen (pO2), Hematocrit, Sodium, Potassium, Chloride, lonized Calcium, lonized Magnesium, Glucose, and Lactate in heparinized capillary whole blood.
Indication for Use:
| pH, pC02, pO2 | Measurements are used in the diagnosis and treatment of life-threatening acid base
disturbances. |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Hct | Hematocrit (Hct) measurements of the packed red blood cell volume are used to
distinguish normal from abnormal states, such as anemia and erythrocytosis. |
| Glucose (Glu) | Glucose measurement is used in the diagnosis and treatment of carbohydrate
metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and
idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. |
| Lactate (Lac) | Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients
suspected of having lactic acidosis. |
| Sodium (Na) | Sodium measurements are used in the diagnosis and treatment of aldosteronism,
diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or
diseases involving electrolyte imbalance. |
| Potassium (K) | Potassium measurements are used in the diagnosis and treatment of disease
conditions characterized by low or high potassium levels. |
| Chloride (CI) | Chloride measurements are used in the diagnosis and treatment of electrolyte and
metabolic disorders such as cystic fibrosis and diabetic acidosis. |
| lonized Calcium
(iCa) | lonized calcium measurements are used in the diagnosis and treatment of
parathyroid disease, a variety of bone diseases, chronic renal disease and tetany
(intermittent muscular contractions or spasms). |
| lonized
Magnesium
(iMg) | lonized magnesium measurements are used in the diagnosis and treatment of
hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia
(abnormally high levels of magnesium). |
7
Principle of Measurement:
pH:
pH is measured using a hydrogen ion selective glass membrane. One side of the glass is in contact with a solution of constant pH. The other side is in contact with a solution of unknown pH. A change in potential develops which is proportional to the pH difference of these solutions. This change in potential is measured against a reference electrode of constant potential. The magnitude of the potential difference is a measure, then, of the pH of the unknown solution.
pCO2:
PCO2 is measured with a modified pH sensor. Carbon dioxide in the unknown solution makes contact with a gas permeable membrane mounted on a combination measuring/ reference electrode. CO2 diffuses across the membrane into a thin layer of electrolyte solution in response to partial pressure difference. This solution then becomes equilibrated with the external gas pressure. CO2 in the solution becomes hydrated producing carbonic acid. which results in a change in hydrogen ion activity.
pO2:
PO2 is measured amperometrically by the generation of a current at the sensor surface. As oxygen diffuses through a gas permeable membrane, the oxygen molecules are reduced at the cathode, consuming 4 electrons for every molecule of oxygen reduced. This flow of electrons is then measured by the sensor and is directly proportional to the partial pressure of oxygen.
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.
Glucose:
Glucose measurement is based on the level of H₂O₂ produced during the enzymatic reaction between glucose and oxygen molecules in the presence of the glucose oxidase enzyme. At a constant potential of 0.70 volts, electroactive H2O2 is oxidized at the surface of the platinum anode. The current generated by the flow of electrons at the surface of the platinum electrode is proportional to the glucose concentration of the sample.
Lactate:
Lactate measurement is based on the level of HzOz produced during the enzymatic reaction between lactate and oxygen molecules in the presence of the lactate oxidase enzyme. At a constant potential of 0.70 volts, electroactive H2O2 is oxidized at the surface of the platinum anode. The current generated by the flow of electrons at the surface of the platinum electrode is proportional to the lactate concentration of the sample.
Sodium, Potassium, Chloride, Ionized Calcium, Ionized Magnesium:
The parameters are measured by an Ion-Selective Electrode (ISE) that selectively measures the activity of ionic species. When the ISE is contacted with a sample, potential is developed. The potential is proportional to the logarithm of the ionic activity and is measured versus a reference electrode.
Summary of Technological Characteristics:
The Stat Profile Prime Plus Analyzer System is substantially equivalent to the previously cleared for market Stat Profile pHOx Ultra Analyzer System (K110648). It uses the same sensor technology, measurement algorithms, formulations of the internal and external controls, and callbrator cartridge for the tested parameters.
Summary of Performance Testing:
Bench testing was previously completed and summarized in the following Prime Plus Analyzer System bundled 510(k)s K173797, K180186, K180340, K180428, K200349 to demonstrate that the Stat Profile Prime Plus Analyzer is substantially equivalent in performance, safety, and efficacy in the predicate submission.
The results of that testing confirmed that the performance of the Stat Profile Prime Plus Analyzer System Page 4 of 15
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is substantially equivalent to the Nova Stat Profile pHOx Ultra Analyzer System (predicate device),
Summary of Point-of-Care Testing:
Point-of-Care testing for arterial and venous whole blood samples was previously completed and summarized in the following Prime Plus Analyzer System bundled 510(k)s K193246, K200349, K200403 to demonstrate that the system is safe and effective for use in the POC setting.
The testing included method comparison studies in 3 POC sites, including a Cardiothoracic Intensive Care Unit (CTICU), an Emergency Department (ED) and a Respiratory Therapy Lab (RT).
The results of the POC clinical performance verification testing confirmed that the Stat Profile Prime Plus Analyzer is safe and effective for its intended purpose in POC settings and that the Stat Profile Prime Plus Analyzer System is substantially equivalent to that of the predicate Stat Profile Prime Plus Analyzer System.
Summary of Capillary Mode Testing: Method Comparison:
A separate clinical study was conducted in Point-of-Care (POC) settings to demonstrate the clinical performance of capillary whole blood specimens on the Stat Profile Prime Plus analyzers. The study was conducted to demonstrate the clinical performance of capillary whole blood specimens on the Stat Profile Prime Plus analyzers. The study compared the Stat Profile Prime Plus analyzers to the Nova Stat Profile pHOx Ultra analyzers (predicate device) to assess the equivalence of the analyzers in the measurement of pH, blood gases, hematocrit, electrolytes, and metabolites in capillary whole blood specimens. The method comparison study was performed at two (2) external POC sites. The study was conducted in the Emergency Room (ER) with five (5) POC nurses and within a Hemodialysis Unit with four (4) POC nurses over a minimum of 20 days. Each site used a single Prime Plus analyzer and a single pHOx Ultra analyzer. Some of the specimens were altered (less than 10%) to cover the full dynamic range.
| Capillary Mode Method Comparison | ||||||
|---|---|---|---|---|---|---|
| Stat Profile Prime Plus vs pHOx Ultra (ER) | ||||||
| Parameter | N | Altered | ||||
| Samples | Whole Blood | |||||
| Range | Slope | Intercept | r | |||
| pH | 122 | 9 | 6.790-7.729 | 0.9949 | 0.0321 | 0.9914 |
| pO2, (mmHg) | 123 | 10 | 7.5-562.2 | 1.0109 | -1.3281 | 0.9965 |
| pCO2, (mmHg) | 120 | 7 | 7.4-183.0 | 1.0003 | -0.3135 | 0.9958 |
| Hct, (%) | 118 | 5 | 18-54 | 0.9944 | 0.7831 | 0.9864 |
| Na, (mM) | 119 | 6 | 83.0-194.8 | 1.0158 | -2.7473 | 0.9907 |
| K, (mM) | 120 | 7 | 1.34-18.47 | 0.9924 | 0.0461 | 0.9984 |
| Cl, (mM) | 119 | 6 | 64.5-191.1 | 0.9561 | 4.7910 | 0.9810 |
| Ca, (mM) | 121 | 8 | 0.37-2.44 | 0.9871 | 0.0222 | 0.9932 |
| Mg, (mM) | 122 | 9 | 0.13-1.17 | 0.9690 | 0.0187 | 0.9808 |
| Glu, (mg/dL) | 120 | 7 | 28.0-427.5 | 0.9955 | 0.4436 | 0.9959 |
| Lac, (mM) | 119 | 6 | 0.5-16.9 | 1.0148 | -0.0108 | 0.9988 |
Table 1: Capillary Mode Method Comparison: ER
9
| Capillary Mode Method Comparison | ||||||
|---|---|---|---|---|---|---|
| Stat Profile Prime Plus vs pHOx Ultra (Hemodialysis) | ||||||
| Parameter | N | Altered | ||||
| Samples | Whole Blood | |||||
| Range | Slope | Intercept | r | |||
| pH | 127 | 9 | 6.790-7.655 | 0.9839 | 0.1148 | 0.9971 |
| pO2, (mmHg) | 128 | 10 | 8.1-567.1 | 0.9936 | 2.3980 | 0.9987 |
| pCO2, (mmHg) | 125 | 7 | 7.4-183.1 | 1.0125 | -0.8197 | 0.9975 |
| Hct, (%) | 123 | 5 | 18-55 | 0.9944 | 0.7831 | 0.9864 |
| Na, (mM) | 124 | 6 | 85.0-195.6 | 1.0097 | -1.6583 | 0.9866 |
| K, (mM) | 125 | 7 | 1.43-18.53 | 0.9956 | 0.0369 | 0.9990 |
| Cl, (mM) | 124 | 6 | 67.2-191.6 | 1.0235 | -3.0725 | 0.9897 |
| Ca, (mM) | 126 | 8 | 0.38-2.46 | 0.9935 | 0.0082 | 0.9935 |
| Mg, (mM) | 127 | 9 | 0.16-1.22 | 0.9627 | 0.0241 | 0.9813 |
| Glu, (mg/dL) | 125 | 7 | 28.5-452.0 | 0.9948 | 1.3066 | 0.9979 |
| Lac, (mM) | 124 | 6 | 0.4-17.6 | 0.9867 | 0.0307 | 0.9991 |
Table 2: Capillary Mode Method Comparison: Hemodialysis
Table 3: Capillary Mode Method Comparison: Combined Results
| Capillary Mode Method Comparison | ||||||
|---|---|---|---|---|---|---|
| Stat Profile Prime Plus vs pHOx Ultra (Combined) | ||||||
| Parameter | N | Altered | ||||
| Samples | Whole Blood | |||||
| Range | Slope | Intercept | r | |||
| pH | 249 | 18 | 6.790-7.729 | 0.9894 | 0.0736 | 0.9942 |
| p02, (mmHg) | 251 | 20 | 7.5-567.1 | 1.0006 | 0.8320 | 0.9976 |
| pCO2, (mmHg) | 245 | 14 | 7.4-183.1 | 1.0075 | -0.5969 | 0.9968 |
| Hct, (%) | 241 | 10 | 18-55 | 0.9900 | 0.8011 | 0.9876 |
| Na, (mM) | 243 | 12 | 83.0-195.6 | 1.0129 | -2.2244 | 0.9885 |
| K, (mM) | 245 | 14 | 1.34-18.53 | 0.9940 | 0.0416 | 0.9987 |
| Cl, (mM) | 243 | 12 | 64.5-191.6 | 0.9944 | 0.3494 | 0.9856 |
| Ca, (mM) | 247 | 16 | 0.37-2.46 | 0.9900 | 0.0155 | 0.9932 |
| Mg, (mM) | 249 | 18 | 0.13-1.22 | 0.9659 | 0.0214 | 0.9811 |
| Glu, (mg/dL) | 245 | 14 | 28-452 | 0.9950 | 0.9041 | 0.9969 |
| Lac, (mM) | 243 | 12 | 0.4-17.6 | 1.0001 | 0.0119 | 0.9989 |
Conclusion: The Nova Biomedical Stat Profile Prime Plus analyzer provided consistently reliable performance throughout the POC clinical evaluation study. The capillary blood comparison data for all test parameters for the Stat Profile Prime Plus analyzers met the clinical accuracy acceptance criteria for correlation coefficient (r) and bias at the medical decision levels.
Total Imprecision Performance:
Within Run Precision:
Estimates for total imprecision for within run precision were obtained from running 20 replicates of venous blood transferred to capillary tubes at targeted sample concentrations on two Prime Plus analyzers in a Customer Simulation Laboratory at Nova Biomedical. The average SD and CV% for each analyzer for each sample type and level was calculated and compared to the defined within run imprecision specifications. The Between Analyzer mean, SD, and CV% from two (2) analyzers for each level was calculated and compared to the defined
10
between analyzer imprecision specifications. Within run data are summarized in Tables 3 to 5.
| Prime Plus Capillary Mode | ||||
|---|---|---|---|---|
| Whole Blood Within Run Precision | ||||
| Parameter | n = 20 | Analyzer 1 | Analyzer 2 | Between Analyzer |
| pH | Mean | 7.358 | 7.342 | 7.350 |
| SD | 0.006 | 0.006 | 0.009 | |
| pH | Mean | 7.252 | 7.246 | |
| SD | 0.004 | 0.004 | 0.005 | |
| pH | Mean | 7.142 | 7.144 | |
| SD | 0.004 | 0.005 | 0.005 | |
| pCO2, mmHg | Mean | 25.0 | 24.7 | |
| SD | 0.6 | 0.5 | 0.6 | |
| CV% | 2.4 | 1.9 | 2.2 | |
| pCO2, mmHg | Mean | 54.8 | 59.6 | 57.2 |
| SD | 1.1 | 0.8 | 2.6 | |
| CV% | 2.0 | 1.3 | 4.5 | |
| pCO2, mmHg | Mean | 70.2 | 73.7 | 72.0 |
| SD | 1.8 | 1.3 | 2.4 | |
| CV% | 2.6 | 1.8 | 3.3 | |
| pO2, mmHg | Mean | 54.3 | 56.0 | 55.2 |
| SD | 0.7 | 0.6 | 1.1 | |
| CV% | 1.3 | 1.0 | 2.0 | |
| pO2, mmHg | Mean | 178.4 | 174.3 | 176.4 |
| SD | 1.8 | 1.6 | 2.7 | |
| CV% | 1.0 | 0.9 | 1.5 | |
| pO2, mmHg | Mean | 95.0 | 100.7 | 97.9 |
| SD | 1.7 | 1.5 | 3.3 | |
| CV% | 1.7 | 1.5 | 3.4 |
Table 4: Capillary Mode Within Run Precision: Blood Gas Summary
Table 5: Capillary Mode Within Run Precision: Electrolytes Summary
| Prime Plus Capillary Mode | ||||
|---|---|---|---|---|
| Whole Blood Within Run Precision | ||||
| Parameter | n = 20 | Analyzer 1 | Analyzer 2 | Between Analyzer |
| Na+, mmol/L | Mean | 87.2 | 86.2 | 86.7 |
| SD | 0.5 | 0.8 | 0.8 | |
| CV% | 0.6 | 1.0 | 1.0 | |
| Na+, mmol/L | Mean | 155.0 | 155.6 | 155.3 |
| SD | 0.4 | 1.0 | 0.8 | |
| Prime Plus Capillary Mode | ||||
| Whole Blood Within Run Precision | ||||
| Parameter | n = 20 | Analyzer 1 | Analyzer 2 | Between Analyzer |
| CV% | 0.3 | 0.6 | 0.5 | |
| Na+, mmol/L | Mean | 134.5 | 135.9 | 135.2 |
| SD | 0.4 | 0.6 | 0.9 | |
| CV% | 0.3 | 0.4 | 0.6 | |
| K+, mmol/L | Mean | 1.92 | 1.93 | 1.92 |
| SD | 0.02 | 0.02 | 0.02 | |
| CV% | 1.1 | 1.1 | 1.1 | |
| K+, mmol/L | Mean | 6.17 | 6.11 | 6.14 |
| SD | 0.11 | 0.11 | 0.11 | |
| CV% | 1.8 | 1.8 | 1.8 | |
| K+, mmol/L | Mean | 4.57 | 4.59 | 4.58 |
| SD | 0.04 | 0.03 | 0.04 | |
| CV% | 0.9 | 0.7 | 0.8 | |
| Cl-, mmol/L | Mean | 72.1 | 71.7 | 71.9 |
| SD | 0.5 | 0.9 | 0.8 | |
| CV% | 0.7 | 1.2 | 1.0 | |
| Cl-, mmol/L | Mean | 130.8 | 131.5 | 131.2 |
| SD | 1.2 | 1.0 | 1.2 | |
| CV% | 0.9 | 0.7 | 0.9 | |
| Cl-, mmol/L | Mean | 102.7 | 102.0 | 102.3 |
| SD | 0.4 | 0.5 | 0.6 | |
| CV% | 0.4 | 0.5 | 0.6 | |
| iCa, mmol/L | Mean | 0.31 | 0.29 | 0.30 |
| SD | 0.01 | 0.01 | 0.01 | |
| CV% | 2.2 | 3.0 | 3.9 | |
| iCa, mmol/L | Mean | 2.59 | 2.62 | 2.61 |
| SD | 0.03 | 0.06 | 0.05 | |
| CV% | 1.1 | 2.2 | 1.8 | |
| iCa, mmol/L | Mean | 1.33 | 1.35 | 1.34 |
| SD | 0.01 | 0.01 | 0.02 | |
| CV% | 0.6 | 0.7 | 1.3 | |
| iMg, mmol/L | Mean | 0.13 | 0.13 | 0.13 |
| SD | 0.01 | 0.00 | 0.00 | |
| CV% | 4.3 | 1.7 | 3.4 | |
| iMg, mmol/L | Mean | 0.91 | 1.00 | 0.95 |
| SD | 0.02 | 0.01 | 0.05 | |
| CV% | 1.7 | 1.3 | 5.2 | |
| iMg, mmol/L | Mean | 0.58 | 0.60 | 0.59 |
| Prime Plus Capillary Mode | ||||
| Whole Blood Within Run Precision | ||||
| Parameter | n = 20 | Analyzer 1 | Analyzer 2 | Between Analyzer |
| SD | 0.01 | 0.01 | 0.01 | |
| CV% | 1.3 | 1.2 | 2.4 |
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Table 6: Capillary Mode Within Run Precision: Hematology and Chemistry Summary
| Prime Plus Capillary Mode | ||||
|---|---|---|---|---|
| Whole Blood Within Run Precision | ||||
| Parameter | n = 20 | Analyzer 1 | Analyzer 2 | Between Analyzer |
| Hct, % | Mean | 28 | 28 | 28 |
| Hct, % | SD | 0.7 | 0.6 | 0.6 |
| Hct, % | Mean | 60 | 63 | 61 |
| Hct, % | SD | 0.3 | 1.3 | 1.6 |
| Hct, % | Mean | 42 | 43 | 42 |
| Hct, % | SD | 0.9 | 0.7 | 0.9 |
| Glu, mg/dL | Mean | 91 | 93 | 92.4 |
| Glu, mg/dL | SD | 2.3 | 2.2 | 2.4 |
| Glu, mg/dL | CV% | 2.5 | 2.4 | 2.5 |
| Glu, mg/dL | Mean | 282 | 279 | 280.5 |
| Glu, mg/dL | SD | 4.2 | 2.6 | 3.8 |
| Glu, mg/dL | CV% | 1.5 | 0.9 | 1.3 |
| Glu, mg/dL | Mean | 36 | 36 | 36.1 |
| Glu, mg/dL | SD | 0.4 | 0.4 | 0.4 |
| Glu, mg/dL | CV% | 1.0 | 1.1 | 1.1 |
| Lac, mmol/L | Mean | 1.8 | 1.8 | 1.79 |
| Lac, mmol/L | SD | 0.1 | 0.1 | 0.07 |
| Lac, mmol/L | CV% | 3.8 | 4.3 | 4.0 |
| Lac, mmol/L | Mean | 4.2 | 4.4 | 4.3 |
| Lac, mmol/L | SD | 0.1 | 0.1 | 0.1 |
| Lac, mmol/L | CV% | 3.4 | 2.0 | 3.2 |
| Lac, mmol/L | Mean | 9.6 | 9.7 | 9.6 |
| Lac, mmol/L | SD | 0.3 | 0.3 | 0.3 |
| Lac, mmol/L | CV% | 2.7 | 2.7 | 2.7 |
Within Sample Precision:
Sample within run precision in capillary mode was assessed for whole blood by measuring two replicates of capillary whole blood from thirty (30) different donors in a Customer Simulation Laboratory at Nova Biomedical. The mean, SD, and CV% for all samples were calculated and compared to the defined withinrun imprecision specifications. Sample within run data is summarized in Table 7.
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| Prime Plus Capillary Mode
| Whole Blood Within Sample Precision | |||||
|---|---|---|---|---|---|
| Analyte | SD | ||||
| %CV | n | Mean | SD | %CV | |
| pH | 0.010 | 60 | 7.322 | 0.003 | -------- |
| pCO2 (mmHg) | 1.0 | ||||
| 3.0 | 60 | 31.0 | 0.7 | 2.1 | |
| pO2 (mmHg) | 2.0 | ||||
| 3.0 | 60 | 127.9 | 0.8 | 0.6 | |
| Hct (%) | 1.0 | 60 | 32 | 0.4 | -------- |
| Na+ (mM) | 1.0 | ||||
| 1.0 | 60 | 137.9 | 0.1 | 0.1 | |
| K+ (mM) | 0.2 | ||||
| 1.5 | 60 | 4.03 | 0.01 | 0.21 | |
| Cl- (mM) | 1.5 | ||||
| 2.0 | 60 | 109.5 | 0.5 | 0.5 | |
| iCa (mM) | 0.07 | ||||
| 2.5 | 60 | 1.11 | 0.00 | 0.44 | |
| iMg (mM) | 0.03 | ||||
| 2.0 | 60 | 0.63 | 0.01 | 1.58 | |
| Glu (mg/dL) | 2.0 | ||||
| 3.0 | 60 | 108 | 0.5 | 0.5 | |
| Lac (mM) | 0.3 | ||||
| 3.0 | 60 | 4.1 | 0.0 | 0.6 |
Table 7: Capillary Mode Within Sample Precision: Summary
Conclusion: The precision data for all samples in capillary mode met the within run and between analyzer imprecision specifications for the Prime Plus analyzers. Each Prime Plus analyzer provided a consistently reliable performance throughout the evaluation study. The analyzers used for this evaluation met all performance criteria for precision.
Within-Run Imprecision - Capillary Mode Fingerstick (External POC):
A precision study was performed at an external site using discarded specimens transferred from a lithium heparin syringe to a capillary tube by POC (Point-of-Care) operators. The study used one Stat Profile Prime Plus Analyzer, and de-identified and discarded arterial blood specimens.
Sample Analysis
Each whole blood specimen was transferred from a syringe to three balanced heparin capillary tubes and analyzed in Capillary Micro mode on the Stat Profile Prime Plus Analyzer by one POC operator.
14
Data Analysis
The mean, SD, and CV% of the triplicate results of each sample were calculated.
| Analyte | Unit | Grand Mean | Grand SD | Grand CV% |
|---|---|---|---|---|
| pH | pH units | 7.357 | 0.008 | N/A |
| pCO2 | mmHg | 37.2 | 0.7 | 1.9 |
| pO2 | mmHg | 145.6 | 2.1 | 1.5 |
| Hct | % | 31.5 | 1.2 | N/A |
| Na+ | mmol/L | 135.1 | 0.8 | 0.6 |
| K+ | mmol/L | 3.94 | 0.04 | 0.9 |
| Cl- | mmol/L | 110.1 | 0.8 | 0.8 |
| Ca2+ | mmol/L | 1.14 | 0.01 | 1.2 |
| Mg2+ | mmol/L | 0.51 | 0.01 | 2.5 |
| Glu | mg/dL | 128 | 1.8 | 1.4 |
| Lac | mmol/L | 3.1 | 0.1 | 4.6 |
Table 8: Within-Run Imprecision - Capillary Mode Fingerstick Data Summary
Conclusion
This study demonstrates the Stat Profile Prime Plus analyzer exhibits clinically acceptable imprecision specifications for pH, pCO2, pO2, sodium (Na+), chloride (C1-), potassium (K+), ionized calcium (Ca2+), ionized magnesium (Mg2+), glucose, lactate, and hematocrit measured by the Stat Profile Prime Plus Analyzer System in Capillary mode.
Within-Sample Imprecision - Capillary Mode Fingerstick (Internal POC):
An internal precision study was performed in the Nova Customer Simulation Laboratory using a single Stat Profile Prime Plus analyzer. Capillary whole blood was collected via fingerstick puncture and run on the Stat Profile Prime Plus Analyzer in capillary mode by two (2) point-of-care (POC) operators (Nurse and Respiratory Therapist) in duplicate.
The mean, SD, and CV% for all sample pairs was calculated and compared to the defined imprecision specifications.
Table 9: Within-Sample Imprecision - Capillary Mode Fingerstick Data Summary
| Analyte | Mean | N | Within Sample (SD) | Within Sample (%CV) |
|---|---|---|---|---|
| pH | 7.403 | 60 | 0.008 | N/A |
| p02 (mmHg) | 81.8 | 60 | 2.2 | 2.7 |
| pCO2 (mmHg) | 32.0 | 60 | 1.0 | 3.0 |
| Hct (%) | 41 | 60 | 1.0 | N/A |
| Na (mM) | 139.5 | 60 | 0.8 | 0.6 |
| K (mM) | 4.75 | 60 | 0.17 | 3.5 |
| Cl (mM) | 109.9 | 60 | 0.6 | 0.6 |
| Ca (mM) | 1.20 | 60 | 0.01 | 0.9 |
| Mg (mM) | 0.54 | 60 | 0.01 | 1.1 |
| Glu (mg/dl) | 109 | 60 | 1.6 | 1.5 |
| Lac (mM) | 1.7 | 60 | 0.2 | 12.4 |
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Conclusion
The Stat Profile Prime Plus analyzer provided a consistently reliable performance throughout the evaluation study. The analyzer used for this evaluation met the performance criteria for within sample precision on capillary fingerstick specimens run by POC operators.
Within-Run Imprecision - Capillary Samples (Internal Study)
An internal precision study was performed in the Nova Customer Simulation Laboratory using five (5) different concentrations of deidentified venous whole blood specimens per analyte, each run on three (3) Stat Profile Prime Plus analyzers, for five (5) days, with one (1) run performed each day and eight (8) replicates measured per run per level.
The mean, SD, and CV% for all samples were calculated and compared to the defined within-run imprecision specifications.
Table 10: Within-Run Imprecision - Capillary Mode
| Analyte | Level | Mean | N | Within Run (SD) | Within Run (%CV) |
|---|---|---|---|---|---|
| pH | 1 | 7.133 | 120 | 0.003 | N/A |
| 2 | 7.341 | 120 | 0.003 | N/A | |
| 3 | 7.465 | 120 | 0.004 | N/A | |
| 4 | 6.933 | 120 | 0.004 | N/A | |
| 5 | 7.652 | 120 | 0.009 | N/A | |
| pO2 | |||||
| (mmHg) | 1 | 47.9 | 120 | 0.4 | 0.9% |
| 2 | 205.4 | 120 | 0.8 | 0.4% | |
| 3 | 415.4 | 120 | 2.5 | 0.6% | |
| 4 | 146.6 | 120 | 0.7 | 0.5% | |
| 5 | 521.6 | 120 | 3.3 | 0.6% | |
| pCO2 | |||||
| (mmHg) | 1 | 84.0 | 120 | 1.3 | 1.5% |
| 2 | 39.5 | 120 | 0.7 | 1.7% | |
| 3 | 21.9 | 120 | 0.2 | 0.9% | |
| 4 | 161.0 | 120 | 2.3 | 1.4% | |
| 5 | 117.9 | 120 | 1.6 | 1.3% | |
| Hct (%) | 1 | 40 | 120 | 0.8 | N/A |
| 2 | 64 | 120 | 0.7 | N/A | |
| 3 | 20 | 120 | 0.6 | N/A | |
| 4 | 30 | 120 | 0.7 | N/A | |
| 5 | 57 | 120 | 0.8 | N/A | |
| Na | |||||
| (mM) | 1 | 107.7 | 120 | 0.8 | 0.7% |
| 2 | 167.3 | 120 | 1.1 | 0.7% | |
| 3 | 181.2 | 120 | 1.5 | 0.8% | |
| 4 | 152.2 | 120 | 0.6 | 0.4% | |
| 5 | 128.9 | 120 | 0.6 | 0.5% |
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| Analyte | Level | Mean | N | Within Run (SD) | Within Run (%CV) | ||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| K (mM) | 1 | 3.34 | 120 | 0.04 | 1.2% | ||||||||||||||||||||||||||||||||||||||||||||||
| 2 | 8.80 | 120 | 0.13 | 1.4% | |||||||||||||||||||||||||||||||||||||||||||||||
| 3 | 1.79 | 120 | 0.05 | 2.7% | |||||||||||||||||||||||||||||||||||||||||||||||
| 4 | 14.95 | 120 | 0.17 | 1.1% | |||||||||||||||||||||||||||||||||||||||||||||||
| 5 | 6.10 | 120 | 0.05 | 0.8% | |||||||||||||||||||||||||||||||||||||||||||||||
| Cl (mM) | 1 | 95.9 | 120 | 0.7 | 0.8% | ||||||||||||||||||||||||||||||||||||||||||||||
| 2 | 161.2 | 120 | 1.8 | 1.1% | |||||||||||||||||||||||||||||||||||||||||||||||
| 3 | 186.3 | 120 | 2.0 | 1.1% | |||||||||||||||||||||||||||||||||||||||||||||||
| 4 | 81.2 | 120 | 0.9 | 1.1% | |||||||||||||||||||||||||||||||||||||||||||||||
| 5 | 131.7 | 120 | 1.2 | 0.0% | |||||||||||||||||||||||||||||||||||||||||||||||
| Ca (mM) | 1 | 0.95 | 120 | 0.01 | 1.4% | ||||||||||||||||||||||||||||||||||||||||||||||
| 2 | 1.50 | 120 | 0.02 | 1.3% | |||||||||||||||||||||||||||||||||||||||||||||||
| 3 | 1.82 | 120 | 0.02 | 1.4% | |||||||||||||||||||||||||||||||||||||||||||||||
| 4 | 0.78 | 120 | 0.01 | 1.1% | |||||||||||||||||||||||||||||||||||||||||||||||
| 5 | 2.22 | 120 | 0.03 | 1.3% | |||||||||||||||||||||||||||||||||||||||||||||||
| Mg (mM) | 1 | 0.80 | 120 | 0.01 | 1.7% | ||||||||||||||||||||||||||||||||||||||||||||||
| 2 | 1.13 | 120 | 0.02 | 1.4% | |||||||||||||||||||||||||||||||||||||||||||||||
| 3 | 0.30 | 120 | 0.01 | 2.1% | |||||||||||||||||||||||||||||||||||||||||||||||
| 4 | 0.56 | 120 | 0.01 | 1.9% | |||||||||||||||||||||||||||||||||||||||||||||||
| 5 | 1.38 | 120 | 0.02 | 1.6% | |||||||||||||||||||||||||||||||||||||||||||||||
| Glu (mg/dl) | 1 | 87 | 120 | 0.9 | 1.0% | 2 | 198 | 120 | 3.5 | 1.8% | 3 | 429 | 120 | 3.9 | 0.9% | 4 | 117 | 120 | 1.6 | 1.4% | 5 | 34 | 120 | 0.7 | 2.0% | Lac (mM) | 1 | 10.8 | 120 | 0.2 | 2.3% | 2 | 2.1 | 120 | 0.1 | 5.4% | 3 | 5.9 | 120 | 0.1 | 2.4% | 4 | 13.6 | 120 | 0.3 | 2.5% | 5 | 16.1 | 120 | 0.3 | 1.9% |
| Glu (mg/dl) | 1 | 87 | 120 | 0.9 | 1.0% | ||||||||||||||||||||||||||||||||||||||||||||||
| 2 | 198 | 120 | 3.5 | 1.8% | |||||||||||||||||||||||||||||||||||||||||||||||
| 3 | 429 | 120 | 3.9 | 0.9% | |||||||||||||||||||||||||||||||||||||||||||||||
| 4 | 117 | 120 | 1.6 | 1.4% | |||||||||||||||||||||||||||||||||||||||||||||||
| 5 | 34 | 120 | 0.7 | 2.0% | |||||||||||||||||||||||||||||||||||||||||||||||
| Lac (mM) | 1 | 10.8 | 120 | 0.2 | 2.3% | 2 | 2.1 | 120 | 0.1 | 5.4% | 3 | 5.9 | 120 | 0.1 | 2.4% | 4 | 13.6 | 120 | 0.3 | 2.5% | 5 | 16.1 | 120 | 0.3 | 1.9% | ||||||||||||||||||||||||||
| Lac (mM) | 1 | 10.8 | 120 | 0.2 | 2.3% | ||||||||||||||||||||||||||||||||||||||||||||||
| 2 | 2.1 | 120 | 0.1 | 5.4% | |||||||||||||||||||||||||||||||||||||||||||||||
| 3 | 5.9 | 120 | 0.1 | 2.4% | |||||||||||||||||||||||||||||||||||||||||||||||
| 4 | 13.6 | 120 | 0.3 | 2.5% | |||||||||||||||||||||||||||||||||||||||||||||||
| 5 | 16.1 | 120 | 0.3 | 1.9% |
Table 10: Within-Run Imprecision - Capillary Mode (continued)
Conclusion
The Stat Profile Prime Plus analyzers provided consistently reliable performance throughout the evaluation study. The analyzers used for this evaluation met the acceptance criteria for precision.
17
Table 11: Comparison of Predicate and Proposed Devices
| Characteristic | Predicate: | Proposed: |
|---|---|---|
| Indication For Use | The Stat Profile pHOx Ultra Analyzer without | |
| CO-Oximeter is intended for in vitro diagnostic | ||
| use by health care professionals and/or point- | ||
| of-care usage in the quantitative | ||
| determination of pH, PCO2, PO2, SO2%, | ||
| Hematocrit (Hct), Hemoglobin (Hb) in | ||
| heparinized whole blood; Na+, K'-, Cl-, Ca++, | ||
| Mg++, Glucose (Glu), Lactate (Lac), BUN | ||
| (Urea), and Creatinine (Great) in heparinized | ||
| whole blood, serum, or plasma. | ||
| The Stat Profile pHOx Ultra Analyzer with CO- | ||
| Oximeter is intended for in vitro diagnostic use | ||
| by health care professionals and for point-of- | ||
| care usage in the quantitative determination of | ||
| pH, PCO2, PO2, SO2%, Hematocrit (Hct), | ||
| total Hemoglobin (tHb), Oxyhemoglobin | ||
| (O2Hb), Carboxyhemoglobin (COHb), | ||
| Methemoglobin (MetHb), Deoxyhemoglobin | ||
| (HHb), and total bilirubin (tBil) in heparinized | ||
| whole blood; Nat, K'-, Cl-, Ca++, Mg++, | ||
| Glucose (Glu), Lactate (Lac), BUN (Urea), | ||
| and Creatinine (Creat) in Heparinized whole | 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 pH, Partial Pressure of | ||
| Carbon Dioxide (pCO2), Partial Pressure of | ||
| Oxygen (pO2), Hematocrit, Sodium, | ||
| Potassium, Chloride, Ionized Calcium, | ||
| Ionized Magnesium, Glucose, and Lactate in | ||
| heparinized capillary whole blood. | ||
| blood, serum, or plasma. Total Bilirubin (tBil) | ||
| was not evaluated on neonatal samples. | ||
| Acceptable Samples | ||
| Sample Types | Sodium or lithium heparinized whole blood, | |
| serum, or plasma samples from syringes, | ||
| open tubes, small cups, and capillary tubes. | Lithium heparin whole blood from syringes, | |
| open tubes, and capillary tubes. | ||
| Sample Volumes | 60-200µL (dependent on panel selected) | 135µL (Syringes and open tubes) |
| 90µL (Capillary tubes) | ||
| Measurement Range | ||
| pH | 6.500 - 8.000 | Same |
| PCO2 | 3.0 – 200 mmHg | Same |
| PO2 | 0 - 800 mmHg | 5.0 - 765.0 mmHg |
| Hct | 12% - 70% | Same |
| Glu | 15 - 500 mg/dL | Same |
| Lac | 0.3 - 20.0 mmol/L | Same |
| Sodium | 80 - 200 mmol/L | Same |
| Potassium | 1.0 - 20.0 mmol/L | Same |
| Chloride | 50 - 200 mmol/L | Same |
| lonized Calcium | 0.1 - 2.7 mmol/L | Same |
| lonized Magnesium | 0.1 - 1.5 mmol/L | Same |
| Principles of | ||
| Measurement | ||
| pH | Hydrogen ion-selective glass sensor | Same |
| PCO2 | Severinghaus-type sensor | Same |
| PO2 | Polarographic Clark-type sensor | Same |
| Hct | Impedance sensor | Same |
| Glu | Enzymatic sensor | Same |
| Lac | Enzymatic sensor | Same |
| Sodium | Ion-Selective Electrode | Same |
| Potassium | Ion-Selective Electrode | Same |
| Chloride | Ion-Selective Electrode | Same |
| Ionized Calcium | Ion-Selective Electrode | Same |
| Ionized Magnesium | Ion-Selective Electrode | Same |
| Touch Screen | 12.1" LCD, 1024x768 pixel, Resistive Touch | 10.1" WXGA 1280 x 800 color touch screen |
| 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 |
18
Conclusion
The performance of pH, Partial Pressure of Carbon Dioxide (pCO2), Partial Pressure of Oxygen (pO2), Hematocrit, Sodium, Potassium, Chloride, lonized Calcium, lonized Magnesium, Glucose, and Lactate in heparinized capillary whole blood on the Stat Profile Prime Plus Analyzer System is substantially equivalent to the Stat Profile pHOx Ultra Analyzer.