(55 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on standard analytical techniques and hardware.
No
The device is an analyzer system used for diagnostic purposes to measure various substances in blood, not for treating a condition.
Yes
The "Intended Use / Indications for Use" states that the device is "indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Sodium, Potassium, Chloride, Ionized Calcium, and Ionized Magnesium in heparinized arterial and venous whole blood." This quantitative determination of analytes in bodily fluids is inherently a diagnostic function, as it provides information used to diagnose conditions or monitor patient health.
No
The device description explicitly states that the system consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer, which are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for quantitative determination of Sodium, Potassium, Chloride, Ionized Calcium, and Ionized Magnesium in heparinized arterial and venous whole blood." This involves testing biological specimens (whole blood) in vitro (outside the body) to provide information about a patient's health status.
- Device Description: The device is an "analyzer" that uses "sensor cartridges" to perform these quantitative determinations on blood samples. This is a typical description of an IVD instrument.
- 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 analyzing biological samples.
- Care Setting: The device is intended for use in "clinical laboratory settings and for point-of-care usage," which are environments where IVD testing is performed.
The core function of the device is to analyze biological samples in vitro to provide diagnostic information, 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 Sodium, Chloride, Ionized Calcium, and Ionized Magnesium in heparinized arterial and venous whole blood.
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 measurements are used in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.
Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Ionized 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)
Ionized magnesium 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)
JGS, CEM, CGZ, JFP, CFA
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: Sodium, Potassium, Chloride, Calcium, Ionized Magnesium
- Primary Sensor Card 2 shall enable and report the following listed analytes: Sodium, Potassium, Chloride, Calcium, Ionized Magnesium
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 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
- Stat Profile Prime Plus Auto-Cartridge Quality Control Pack
- Stat Profile Prime Plus Calibrator Cartridge
- Stat Profile Prime Plus External Ampuled Control
- IFU/Labeling
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 (POC) study:
Sample size: A total of 61 Respiratory Care, 12 Nursing, and 1 Exercise Physiology POC personnel participated from the 3 POC settings over the study.
Data source: All testing was performed using quality control materials or discarded blood gas specimens.
Annotation protocol: Not Found (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). The personnel represent trained, qualified staff found in typical POC sites where blood gas analyzers are utilized.)
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing: Previously completed and summarized in K180428 to show that the Stat Profile Prime Plus Analyzer demonstrates substantial equivalence to the predicate submission.
Included:
- Method Comparison Studies
- Precision/Reproducibility Within Run and Run to Run Studies
- Linearity Testing
- Specificity/Interference Testing
- Detection Limit
Point-of-Care (POC) Study: A 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 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:
Type: Method Comparison studies on venous and arterial whole blood specimens.
Sample size: N varies per analyte (e.g., 432 for Na, 435 for K, 434 for Cl, 434 for iCa, 426 for iMg).
Key results: Combined method comparison data from all 3 POC settings. Slopes and intercepts for each analyte indicate correlation with predicate.
Sodium (Na): Slope 0.9964, Intercept 0.4488, r 0.9949. 95% Confidence Interval of Bias: 119.8-120.2 (Lower/Upper), 159.6-160.1 (Lower/Upper).
Potassium (K): Slope 1.0158, Intercept -0.0678, r 0.9993. 95% Confidence Interval of Bias: 2.77-2.81 (Lower/Upper), 5.98-6.04 (Lower/Upper).
Chloride (Cl): Slope 0.9963, Intercept 0.4416, r 0.9971. 95% Confidence Interval of Bias: 79.9-80.4 (Lower/Upper), 129.8-130.1 (Lower/Upper).
Ionized Calcium (iCa): Slope 0.9820, Intercept 0.0239, r 0.9871. 95% Confidence Interval of Bias: 0.80-0.82 (Lower/Upper), 1.53-1.54 (Lower/Upper).
Ionized Magnesium (iMg): Slope 1.0020, Intercept -0.0021, r 0.9910. 95% Confidence Interval of Bias: 0.29-0.30 (Lower/Upper), 0.80-0.80 (Lower/Upper).
Total Imprecision Performance:
Type: Estimates for total imprecision using quality control/linearity materials.
Sample size: 3 levels of quality control/linearity materials, run in duplicate each day for a total of 20 runs on 3 Stat Profile Prime Plus analyzers.
Key results: Total %CV for Na (Level 4: 0.6, Level 5: 0.8), K (Level 4: 2.2, Level 5: 1.9), Cl (Level 4: 0.6, Level 5: 0.6), Ca (Level 4: 2.1, Level 5: 2.7), Mg (Level 4: 4.4, Level 5: 6.5). For Linearity Level 4: Na 1.2, K 1.5, Cl 0.9, Ca 1.9, Mg 5.4.
Within-Run Whole Blood Precision:
Type: Within-run precision using fresh, native and altered whole blood samples.
Sample size: Ten (10) replicate measurements for each sample. Five (5) different native samples and two (2) altered samples evaluated at each site. 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.
Key results: Within-run %CV values for various samples. For example, Sample 1: Na 0.67, K 0.67, Cl 0.58, Ca 0.43, Mg 1.50. Sample 7 (Altered): Na 0.49, K 1.11, Cl 0.47, Ca 0.61, Mg 0.98.
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 Prime Plus Analyzer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Accuracy is expressed in Slope, Intercept, and r values in the Method Comparison Studies, and precision is expressed in SD and %CV in the Imprecision Performance 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.
Not Found
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
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.
0
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April 14, 2020
Nova Biomedical Corporation Rachel Gilbert Regulatory Affairs Specialist II 200 Prospect Street Waltham, MA 02454
Re: K200403
Trade/Device Name: Stat Profile® Prime Plus Analyzer System Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Code: JGS, CEM, CGZ, JFP, CFA Dated: February 12, 2020 Received: February 19, 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
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 mediation-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, 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) K200403
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 Sodium, Chloride, Ionized Calcium, and Ionized Magnesium in heparinized arterial and venous whole blood.
| 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 (Cl) | Chloride measurements are used in the diagnosis and treatment of electrolyte and
metabolic disorders such as cystic fibrosis and diabetic acidosis. |
| Ionized Calcium
(iCa) | Ionized 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) |
| Ionized
Magnesium (iMg) | Ionized magnesium 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)
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 K200403
| 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: | February 12, 2020 |
Proprietary Name: Stat Profile® Prime Plus Analyzer System
Common or Usual Name: Blood Analyzer
Classification Name: Multiple
| Regulation Section | Classification | Product Code |
|---|---|---|
| 21 CFR § 862.1665 Sodium Test System | Class II | JGS |
| 21 CFR § 862.1600 Potassium Test System | Class II | CEM |
| 21 CFR § 862.1170 Chloride Test System | Class II | CGZ |
| 21 CFR § 862.1145 Calcium Test System | Class II | JFP |
| 21 CFR § 862.1495 Magnesium Test System | Class I, reserved | CFA |
Product Code:
ിട്ടു
Predicate Device:
K180428 – 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.
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 Sodium, Potassium, Chloride, Calcium, Ionized Magnesium
- . Primary Sensor Card 2 shall enable and report the following listed analytes:
- o Sodium, Potassium, Chloride, Calcium, Ionized Magnesium
4
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 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
- 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:
- Sodium (Na) ●
- Potassium (K)
- . Chloride (CI)
- Ionized Calcium (iCa) ●
- lonized Magnesium (iMg) ●
Calculated Parameters:
The Prime Plus Analyzer also provides the following parameter results calculated based on results of the directly measured parameters:
- Anion Gap (Gap) ●
- Blood Osmolality (OSM) ●
- nCA to nMg Ratio (nCa/nMg)
- Normalized Calcium (nCa)
- Normalized Magnesium (nMq)
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 Sodium, Potassium, Chloride, lonized Calcium, and lonized Magnesium in heparinized arterial and venous whole blood.
5
Indications for Use:
| 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. |
| Ionized Calcium (iCa) | Ionized 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) |
| Ionized Magnesium (iMg) | Ionized magnesium measurements are used in the diagnosis and treatment of
hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia
(abnormally high levels of magnesium). |
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.
Principle of Measurement:
Sodium, Potassium, Chloride, Ionized Calcium, Ionized Magnesium:
The parameters are measured by an lon-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 Performance Testing:
Bench testing was previously completed and summarized in K180428 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 .
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 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.
6
Method Comparison Studies:
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 |
| Na | 432 | 18 | 90.0 - 187.0 | 0.9964 | 0.4488 | 0.9949 | 120
160 | 119.8 | 120.2 | |
| | | | | | | | | 159.6 | 160.1 | |
| K | 435 | 21 | 1.10 - 17.60 | 1.0158 | -0.0678 | 0.9993 | 2.8
6.0 | 2.77 | 2.81 | |
| | | | | | | | | 5.98 | 6.04 | |
| Cl | 434 | 20 | 56.0 - 173.0 | 0.9963 | 0.4416 | 0.9971 | 80
130 | 79.9 | 80.4 | |
| | | | | | | | | 129.8 | 130.1 | |
| iCa | 434 | 20 | 0.51 - 2.48 | 0.9820 | 0.0239 | 0.9871 | 0.80
1.54 | 0.80 | 0.82 | |
| | | | | | | | | 1.53 | 1.54 | |
| iMg | 426 | 13 | 0.24 - 1.36 | 1.0020 | -0.0021 | 0.9910 | 0.3
0.8 | 0.29 | 0.30 | |
| | | | | | | | | 0.80 | 0.80 | |
| Table 1: Venous and Aterial Whole Blood Method Comparison Results – Point of Care vs Lab (ED |
|---|
| RT and CTICU) |
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.
| | Mean | Within Run
SD | Within Run
%CV | Total SD | Total %CV |
|-------------|--------------------------------|------------------|-------------------|----------|-----------|
| | Total Imprecision Data-Level 4 | | | | |
| Na (mmol/L) | 136.2 | 0.8 | 0.6 | 0.9 | 0.6 |
| K (mmol/L) | 3.88 | 0.05 | 1.4 | 0.08 | 2.2 |
| Cl (mmol/L) | 123.2 | 0.6 | 0.5 | 0.7 | 0.6 |
| Ca (mmol/L) | 1.07 | 0.02 | 1.7 | 0.02 | 2.1 |
| Mg (mmol/L) | 0.60 | 0.02 | 3.6 | 0.03 | 4.4 |
| | Total Imprecision Data-Level 5 | | | | |
| Na (mmol/L) | 109.8 | 1.0 | 0.9 | 0.9 | 0.8 |
| K (mmol/L) | 6.24 | 0.06 | 1.0 | 0.12 | 1.9 |
| Cl (mmol/L) | 95.1 | 0.4 | 0.4 | 0.6 | 0.6 |
| Ca (mmol/L) | 1.56 | 0.04 | 2.8 | 0.04 | 2.7 |
| Mg (mmol/L) | 1.07 | 0.03 | 2.7 | 0.07 | 6.5 |
Table 2: Total Imprecision From ED Site
7
| | Mean | Within Run
SD | Within Run
%CV | Total SD | Total %CV |
|------------------------------------------|-------|------------------|-------------------|----------|-----------|
| Total Imprecision Data-Linearity Level 4 | | | | | |
| Na (mmol/L) | 168.6 | 1.5 | 0.9 | 2.0 | 1.2 |
| K (mmol/L) | 11.64 | 0.12 | 1.0 | 0.18 | 1.5 |
| Cl (mmol/L) | 132.7 | 1.0 | 0.8 | 1.2 | 0.9 |
| Ca (mmol/L) | 0.48 | 0.01 | 1.6 | 0.01 | 1.9 |
| Mg (mmol/L) | 0.24 | 0.01 | 2.3 | 0.01 | 5.4 |
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 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
| Mean | SD | %CV | 95% CI | |||
|---|---|---|---|---|---|---|
| Sample 1 | ||||||
| Na (mmol/L) | 123.7 | 0.82 | 0.67 | 122 - 125 | ||
| K (mmol/L) | 4.71 | 0.03 | 0.67 | 4.6 - 4.8 | ||
| Cl (mmol/L) | 88.6 | 0.52 | 0.58 | 88 - 90 | ||
| Ca (mmol/L) | 1.24 | 0.01 | 0.43 | 1.22 - 1.25 | ||
| Mg (mmol/L) | 0.56 | 0.01 | 1.50 | 0.55 - 0.58 | ||
| Sample 2 | ||||||
| Na (mmol/L) | 138.2 | 0.42 | 0.31 | 137 - 139 | ||
| K (mmol/L) | 1.94 | 0.05 | 2.66 | 1.8 - 2.0 | ||
| Cl (mmol/L) | 116.8 | 0.63 | 0.54 | 116 - 118 | ||
| Ca (mmol/L) | 0.75 | 0.01 | 1.13 | 0.73 - 0.76 | ||
| Mg (mmol/L) | 0.31 | 0.01 | 2.63 | 0.30 - 0.33 | ||
| Sample 3 | ||||||
| Na (mmol/L) | 141.1 | 0.32 | 0.22 | 140 - 142 | ||
| K (mmol/L) | 4.02 | 0.04 | 1.05 | 3.9 - 4.1 | ||
| Cl (mmol/L) | 103.8 | 0.42 | 0.41 | 103 - 105 | ||
| Ca (mmol/L) | 1.28 | 0.01 | 0.40 | 1.27 - 1.29 | ||
| Mg (mmol/L) | 0.61 | 0.00 | 0.52 | 0.60 - 0.62 | ||
| Sample 4 | ||||||
| Na (mmol/L) | 142.9 | 0.57 | 0.40 | 142 - 144 | ||
| K (mmol/L) | 4.11 | 0.03 | 0.77 | 4.0 - 4.2 | ||
| Cl (mmol/L) | 103.0 | 0.00 | 0.00 | 103 - 103 | ||
| Ca (mmol/L) | 1.31 | 0.01 | 0.54 | 1.29 - 1.32 | ||
| Mg (mmol/L) | 0.62 | 0.01 | 1.02 | 0.61 - 0.63 |
8
| Mean | SD | %CV | 95% CI | |
|---|---|---|---|---|
| Sample 5 | ||||
| Na (mmol/L) | 137.9 | 0.32 | 0.23 | 137 - 139 |
| K (mmol/L) | 3.30 | 0.00 | 0.00 | 3.3 - 3.3 |
| Cl (mmol/L) | 109.1 | 0.32 | 0.29 | 108 - 110 |
| Ca (mmol/L) | 0.98 | 0.01 | 0.52 | 0.97 - 0.99 |
| Mg (mmol/L) | 0.46 | 0.00 | 0.91 | 0.45 - 0.47 |
| Sample 6 (Altered) | ||||
| Na (mmol/L) | 133.6 | 0.70 | 0.52 | 132 - 135 |
| K (mmol/L) | 3.73 | 0.05 | 1.30 | 3.6 - 3.8 |
| Cl (mmol/L) | 104.4 | 0.70 | 0.67 | 103 - 106 |
| Ca (mmol/L) | 1.13 | 0.01 | 0.95 | 1.11 - 1.16 |
| Mg (mmol/L) | 0.48 | 0.01 | 2.29 | 0.46 - 0.50 |
| Sample 7 (Altered) | ||||
| Na (mmol/L) | 138.3 | 0.67 | 0.49 | 137 - 140 |
| K (mmol/L) | 7.91 | 0.09 | 1.11 | 7.7 - 8.1 |
| Cl (mmol/L) | 109.6 | 0.52 | 0.47 | 109 - 111 |
| Ca (mmol/L) | 1.22 | 0.01 | 0.61 | 1.20 - 1.23 |
| Mg (mmol/L) | 0.58 | 0.01 | 0.98 | 0.57 - 0.59 |
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
9
| 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 sodium, potassium, chloride, ionized calcium, and ionized magnesium 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 sodium, potassium, chloride ionized calcium, and ionized magnesium 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 | ||
| Sodium | 80-200 mmol/L | Same |
| Potassium | 1.0-20.0 mmol/L | Same |
| Chloride | 50-200 mmol/L | Same |
| Ionized Calcium | 0.4-10.8 mg/dL | Same |
| Ionized Magnesium | 0.24-3.65 mg/dL | Same |
| Principles of | ||
| Measurement | ||
| 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 | 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 |
| Table 4: Comparison of Predicate and Proposed Devices | ||||
|---|---|---|---|---|
| -- | -- | ------------------------------------------------------- | -- | -- |