(30 days)
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No
The document describes a standard laboratory analyzer using sensor cartridges and established analytical methods. There is no mention of AI, ML, or related technologies in the device description or performance studies.
No
This device is for diagnostic purposes (measuring analytes to aid in diagnosis and treatment monitoring), not for providing therapy or treatment.
Yes
The device quantitatively determines several biomarkers (Glucose, Lactate, Creatinine, and Blood Urea Nitrogen) which are explicitly stated as being "used in the diagnosis and treatment of" various medical conditions and for "monitoring adequacy of dialysis," indicating its role in the diagnostic process and patient management.
No
The device description explicitly states that the system consists of the 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: The intended use explicitly states that the system is for the "quantitative determination of Glucose, Lactate, Creatinine, and Blood Urea Nitrogen in heparinized arterial and venous whole blood." It also details how these measurements are used in the "diagnosis and treatment" of various conditions. This directly aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Specimen Type: The device analyzes "heparinized arterial and venous whole blood," which are specimens from the human body.
- Purpose: The measurements provide information used in the "diagnosis and treatment" of various medical conditions.
The device description and performance studies further support its classification as an IVD by detailing how it analyzes biological samples and the data collected to demonstrate its analytical performance.
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 Glucose, Lactate, Creatinine, and Blood Urea Nitrogen in heparinized arterial and venous whole blood.
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 (lactic acid) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis.
Creatinine measurement is used in the diagnosis and treatment of certain renal conditions and for monitoring adequacy of dialysis.
Blood Urea Nitrogen measurement is used in the diagnosis and treatment of certain renal and metabolic diseases.
Product codes (comma separated list FDA assigned to the subject device)
CGA, CGL, CDS, KHP
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 Glu. Lactate
- Primary Sensor Card 2 shall enable and report the following listed analytes: o Glu, Lactate
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 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 insures the analyzer is working properly at all times.
The Stat Profile Prime Plus Analyzer accepts samples from syringes and open tubes. The minimum sample size for analysis is 135 µL.
Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.
Stat Profile Prime Plus Analyzer System Components:
The Stat Profile Prime Plus Analyzer System is comprised of the following components.
- Stat Profile Prime Plus Analyzer System .
- Primary Sensor Cartridge .
- Auxiliary Sensor Cartridge
- Stat Profile Prime Plus Auto-Cartridge Quality Control Pack
- Stat Profile Prime Plus Calibrator Cartridge
- Stat Profile Prime Plus External Ampuled Control .
- . IFU/Labeling
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Healthcare professionals in clinical laboratory settings and for point-of-care usage.
POC sites including a Cardiothoracic Intensive Care Unit (CTICU), an Emergency Department (ED) and a Respiratory Therapy Lab (RT).
Description of the training set, sample size, data source, and annotation protocol
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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.
Data Source: Quality control materials or discarded blood gas specimens.
Annotation Protocol: The testing compared results obtained by trained Healthcare Professionals to results obtained by POC personnel on the same specimens using the same analyzer.
Total Imprecision Performance:
Sample Size: 3 levels of Stat Profile Prime Plus Quality Control/Linearity Materials run in duplicate each day for 20 runs on 3 Stat Profile Prime Plus analyzers.
Protocol: CLSI EP5-A2T.
Within-Run Whole Blood Precision:
Sample Size: Minimum of two (2) point-of-care operators at each of the three (3) POC sites for a total of nine (9) operators. Each 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.
Protocol: Not specified, but involved POC operator performing sample analysis steps.
Within-Run Control and Linearity Material:
Sample Size: Three (3) Stat Profile Prime Plus analyzers and four (4) different lots of calibrator cartridges. Each run consisted of 20 replicate measurements.
Protocol: CLSI EP5-A2 as guidance.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision/Reproducibility - Within Run and Run to Run Study (Lactate)
Study Type: Replication studies
Sample Size: Not explicitly stated as a single number but involves multiple runs and replicates across three analyzers.
Within Run Precision: 20 replicates for each sample type and level.
Run to Run Precision: Auto QC Cartridge - 2 runs per day for forty runs (240 samples in total for pooled mean), Whole Blood - triplicate analyses on five samples in ten runs (30 samples in total for pooled mean for each of 5 blood levels).
Key Results:
Auto QC Cartridge (Levels 4 and 5) Within Run Precision: SD 0.00-0.05, CV% 0.00-0.68.
Quality Control Ampules (Levels 4 and 5) Within Run Precision: SD 0.00-0.1, CV% 0.00-1.6.
Whole Bloods (5 levels) Within Run Precision: SD 0.1-0.3, CV% 1.3-8.0.
Auto QC Cartridge (Levels 4 and 5) Run to Run Imprecision: Pooled Mean 2.0-7.0, Within run SD 0.0-0.1, %CV 1.0-1.5, Total imprecision SD 0.1, Total %CV 1.4-3.5.
Whole Blood (5 levels) Run to Run Precision: Pooled Mean 1.4-17.3, SD 0.2-0.7, CV% 1.8-13.9.
Linearity Testing Study (Lactate)
Study Type: Linearity study
Sample Size: 9 levels of whole blood samples, analyzed in triplicate.
Key Results:
Slope: 0.9936 to 1.0011
Intercept: -0.0950 to 0.1751
r: 0.9982 to 0.9988
The results support the claimed measurement range of 0.3 - 20.0 mmol/L.
Specificity / Interference Testing Study (Lactate)
Study Type: Interference testing study
Key Results: Identified substances and their highest concentrations that showed no significant interference. Glycolic acid and hydroxyurea interfere with lactate at all concentrations.
Detection Limit Testing Study (Lactate)
Study Type: Assessment of low level test performance
Sample Size:
LoB: Blank samples run five times on two analyzers with different lots of reagent calibrator pack.
LoD: Low level samples run four times on two analyzers with different lots of reagent calibrator pack; five different low level samples run over three days (60 replicates per reagent lot).
LoQ: Low level samples run three times on two analyzers with different lots of reagent calibrator pack; four different low level samples run over three days (36 replicates per reagent lot).
Key Results: LoB 0.0 mmol/L, LoD 0.1 mmol/L, LoQ 0.1 mmol/L. All were below the lower limit of the claimed lactate measurement range of 0.3 mmol/L.
Summary of Point-of-Care Testing
Study Type: Point-of-Care (POC) study to show substantial equivalence.
Sample Size: A total of 61 Respiratory Care, 12 Nursing, and 1 Exercise Physiology POC personnel participated. Tested using quality control materials or discarded blood gas specimens.
Method Comparison Studies (Point of Care vs Lab)
Study Type: Method Comparison studies
Sample Size:
Glu: N=419, 8 altered samples
Lac: N=413, 0 altered samples
BUN: N=413, 0 altered samples
Creat: N=429, 16 altered samples
Key Results:
Glu: Slope 1.0102, Intercept -0.9232, r 0.9988
Lac: Slope 1.0181, Intercept -0.0796, r 0.9975
BUN: Slope 0.9969, Intercept 0.0674, r 0.9990
Creat: Slope 0.9984, Intercept -0.0025, r 0.9987
Total Imprecision Performance (POC)
Study Type: Total imprecision estimates
Sample Size: 3 levels of Stat Profile Prime Plus Quality Control/Linearity Materials run in duplicate each day for 20 runs on 3 Stat Profile Prime Plus analyzers.
Key Results:
Glu (mg/dL): Within Run CV% 1.4-2.2, Total CV% 1.3-2.4
Lac (mmol/L): Within Run CV% 1.0-3.1, Total CV% 2.2-3.4
BUN (mg/dL): Within Run CV% 0.7-4.4, Total CV% 2.4-5.1
Creat (mg/dL): Within Run CV% 1.1-3.6, Total CV% 5.2-6.4
Within-Run Whole Blood Precision (POC)
Study Type: Within-run precision
Sample Size: A minimum of two (2) point-of-care operators at each of the three (3) POC sites for a total of nine (9) operators. Each run consisted of ten (10) replicate measurements using both fresh, native and altered whole blood samples (5 native, 2 altered).
Key Results (representative ED site):
Glu (mg/dL): SD 0.47-8.57, %CV 0.79-5.24
Lac (mmol/L): SD 0.05-0.45, %CV 4.08-6.68
BUN (mg/dL): SD 0.00-1.23, %CV 0.00-7.03
Creat (mg/dL): SD 0.00-0.46, %CV 0.00-4.61
Within-Run Control and Linearity Material (POC)
Study Type: Within-run precision
Sample Size: 3 Stat Profile Prime Plus analyzers and 4 different lots of calibrator cartridges used across 3 testing sites. Each run consisted of 20 replicate measurements.
Key Results (representative ED site):
Glu (mg/dL): SD 0.5-5.5, %CV 1.2-1.7
Lac (mmol/L): SD 0.04-0.1, %CV 0.8-9.5
BUN (mg/dL): SD 0.5-0.9, %CV 1.8-3.1
Creat (mg/dL): SD 0.04-0.08, %CV 1.0-3.1
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 13, 2020
Nova Biomedical Corporation Rachel Gilbert Regulatory Affairs Specialist II 200 Prospect Street Waltham, Massachusetts 02454
Re: K200349
Trade/Device Name: Stat Profile Prime Plus Analyzer System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, CDS, CGL, KHP Dated: February 5, 2020 Received: February 12, 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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, M.T., Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200349
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 Glucose, Lactate, Creatinine, and Blood Urea Nitrogen in heparinized arterial and venous whole blood.
| 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 |
| Creatinine (Creat) | Creatinine measurement is used in the diagnosis and treatment of certain renal
conditions and for monitoring adequacy of dialysis. |
| Blood Urea
Nitrogen (BUN) | Blood Urea Nitrogen measurement is used in the diagnosis and treatment of certain
renal and metabolic diseases |
| 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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510(k) Summary K200349
| 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 5, 2020 |
Proprietary Name: Stat Profile Prime Plus Analyzer System
Common or Usual Name: Blood Analyzer
Classification Name: Multiple
| Requlation section | Classification | Product
code |
|---------------------------------------------|----------------|-----------------|
| 21 CFR § 864.1345 Glucose Test System | Class II | CGA |
| 21 CFR § 862.1225 Creatinine Test System | Class II | CGL |
| 21 CFR § 862.1770 Urea Nitrogen Test System | Class II | CDS |
| 21 CFR § 862.1450 Lactic Acid Test System * | Class I | KHP |
- Meets Limitations to Exemptions 21 CFR § 862.9(c)(9)
Predicate Device:
K180340 – Stat Profile Prime Plus Analyzer System
Purpose:
.
Modification of a previously cleared device (K180340) - modify the intended use of the device to include Point-of-Care (POC) use.
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 Glu. Lactate
- Primary Sensor Card 2 shall enable and report the following listed analytes:
- o Glu, Lactate
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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 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 insures the analyzer is working properly at all times.
The Stat Profile Prime Plus Analyzer accepts samples from syringes and open tubes. The minimum sample size for analysis is 135 µL.
Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.
Stat Profile Prime Plus Analyzer System Components:
The Stat Profile Prime Plus Analyzer System is comprised of the following components.
- Stat Profile Prime Plus Analyzer System .
- Primary Sensor Cartridge .
- Auxiliary Sensor Cartridge
- Stat Profile Prime Plus Auto-Cartridge Quality Control Pack ●
- Stat Profile Prime Plus Calibrator Cartridge ●
- Stat Profile Prime Plus External Ampuled Control .
- . IFU/Labeling
Sample Types:
The Stat Profile Prime Plus Analyzer System accepts lithium heparinized arterial and venous whole blood.
Measured Parameters:
The Stat Profile Prime Plus Analyzer System measures:
- Glucose (Glu) ●
- Lactate (Lac) ●
- Creatinine (Creat)
- Blood Urea Nitrogen (BUN). ●
Calculated Parameters:
The Stat Profile Prime Plus Analyzer System also provides the following parameter results calculated based on results of the directly measured parameters:
- BUN/Creat Ratio (BUN/Creat) ●
- Blood Osmolality (OSM) ●
- . Estimated Glomerular Filtration Rate (eGFR)
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 Glucose, Lactate, Creatinine, and Blood Urea Nitrogen in heparinized arterial and venous whole blood.
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Indications for Use:
| 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 |
| Creatinine (Creat) | Creatinine measurement is used in the diagnosis and treatment of certain renal
conditions and for monitoring adequacy of dialysis. |
| Blood Urea
Nitrogen (BUN) | Blood Urea Nitrogen measurement is used in the diagnosis and treatment of
certain renal and metabolic diseases |
Summary of the Technological Characteristics:
The Stat Profile Prime Plus Analyzer System is substantially equivalent to the previously cleared for market Stat Profile Prime Plus Analyzer System in intended use. It uses the same sensor technology and measurement algorithms, and the formulations of the internal controls and the calibration cartridge are the same for the tested parameters.
Principles of Measurement:
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 HzO2 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 HzO2 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.
Creatinine:
The Prime Plus Creatinine sensor uses 3 enzymes. These 3 enzymes catalyze the conversion of Creatinine, ultimately forming formaldehyde, glycine, and hydrogen peroxide. At a constant potential of 0.70, 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 Creatinine concentration of the sample.
BUN:
The Prime Plus Analyzer uses urease, which has been chemically bonded to a membrane, to catalyze the conversion of urea present in the sample to ammonia and CO2. At the pH of the sample, ammonia converts predominantly to the ammonium ion. An ammonium ion selective electrode is used to detect the ammonium formed by the above reactions. This measurement is the concentration of urea present in the original sample via the Nernst equation.
Traceability (Lactate):
The reagents and standards containing lactate are derived from reagent grade lithium lactate. In the absence of a standard reference material from NIST, the traceability is established by comparing standards made from lithium lactate to lithium reference standards made from NIST SRM 924a, lithium carbonate. The validation is accomplished by using a Nova analyzer using a membrane covered amperometric electrode.
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Reference Values1,2,3,4,5:
Reference values for glucose, creatinine. BUN, and lactate on the Stat Profile Prime Plus Analyzer System are cited from literature.
| Analyte | Default (US) Units of Measure | International (SI) Units of Measure |
|---|---|---|
| Glucose | 65-95 mg/dL | 3.61-5.27 mmol/L |
| Lactate | 0.7 – 2.5 mmol/L 6.3 – 22.5 mg/dL | 0.7 – 2.5 mmol/L 6.3 – 22.5 mg/dL |
| Creatinine | Male: 0.7 - 1.3 mg/dL | Male: 61.9 – 114.9 mmol/L; 61,900 – 114,900 μmol/L |
| Female: 0.6 - 1.1 mg/dL | Female: 53.0 – 97.2 mmol/L; 53,000 – 97,200 μmol/L | |
| BUN | 7 – 14 mg/dL | 5.0 – 10.0 mmol/L |
Summary of Performance Testing (Lactate):
Testing was completed to show that the Stat Profile Prime Plus Analyzer System demonstrates substantial equivalence to the Stat Profile pHOx Ultra Analyzer System (K110648). In this submission, only Lactate data for detection limit, linearity, and interference/specificity was reviewed. Performance data for all other analytes was presented and reviewed in the predicate device submission (K180340 - Stat Profile Prime Plus Analyzer System).
Precision/Reproducibility - Within Run and Run to Run Study:
Within Run and Run to Run precision for lactate was evaluated by replication studies performed on three Stat Profile Prime Plus Analyzers.
Within Run Precision testing consisting of one run of each of the following sample types and levels was performed, 20 replicates per run:
- Stat Profile Prime Plus Auto QC Cartridge: Levels 4 and 5 ●
- Stat Profile Prime Plus Quality Control Ampules: Levels 4 and 5 ●
- Five whole bloods, sampled from syringes ●
- o One normal un-manipulated whole blood sample was run.
- The other four whole blood lactate concentration were varied by spiking with a O concentrated lactate solution made with saline.
Run to Run Precision was evaluated on each of the following sample types:
- Stat Profile Prime Plus Auto QC Cartridge: Levels 4 and 5 samples were evaluated in QC ● mode in duplicate, two runs per day for a total of forty runs
- Whole Blood - triplicate analyses was performed on five whole blood samples in ten separate runs during a single day. The systems were recalibrated before each triplicate run.
- One normal un-manipulated whole blood sample was run. o
- The other four whole blood lactate concentration were varied by spiking with a O concentrated lactate solution made with saline.
The results are summarized below:
| Parameter | n = 20 | PP1 | PP2 | PP3 | Pooled |
|---|---|---|---|---|---|
| Lac, mmol/L (Level 4) | Mean | 2.0 | 2.0 | 2.0 | 2.0 |
| SD | 0.00 | 0.00 | 0.00 | 0.00 | |
| CV% | 0.00 | 0.00 | 0.00 | 0.00 | |
| Lac, mmol/L (Level 5) | Mean | 6.9 | 6.9 | 6.9 | 6.9 |
| SD | 0.00 | 0.00 | 0.05 | 0.03 | |
| CV% | 0.00 | 0.00 | 0.68 | 0.44 |
Table 1: Auto QC Cartridge: Levels 4 and 5 - Precision Testing Results
1Statland, Bernard, Clinical Decision Levels for Lab Tests, Medical Economics Books, 1987.
2 Burtis, Carl A. and Ashwood, Edward R., ed. 1994. Tietz Textbook of Clinical Chemistry, W. B. Saunders Co. Philadelphia, PA.
3 Tofaletti, J., Hammes, M.E., Gray, R., Lineberry, B., and Abrams, B. 1992. "Lactate Measured in Diluted Whole Blood and Plasmas: Comparison of Methods and Effects of Hematocrit," Clinical Chemistry, Vol. 38, No. 12.
4 Bemstein, W.K., Auden, J., Bhatiani, A., Kerzner, R., Davison, L., Miller, C., and Chernow, B. 1994. "Simultaneous Artate Determinations in Critically III Patients," Critical Care Medicine, Vol. 22.
5 Tietz, Norbert W., ed. 1983. Clinical Guide to Laboratory Tests, W. B. Saunders Co., Philadelphia, PA.
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| Parameter | n = 20 | PP1 | PP2 | PP3 | Pooled |
|---|---|---|---|---|---|
| Lac, | |||||
| mmol/L | |||||
| (Level 4) | Mean | 1.9 | 1.9 | 1.9 | 1.9 |
| SD | 0.00 | 0.00 | 0.00 | 0.00 | |
| CV% | 0.00 | 0.00 | 0.00 | 0.00 | |
| Lac, | |||||
| mmol/L | |||||
| (Level 5) | Mean | 6.6 | 6.4 | 6.5 | 6.5 |
| SD | 0.1 | 0.1 | 0.1 | 0.1 | |
| CV% | 1.2 | 1.3 | 1.2 | 1.6 |
Table 2: Quality Control Ampules: Levels 4 and 5 – Precision Testing Results
Table 3: Whole Bloods, Sampled from Syringes – Precision Testing Results
| Parameter | n = 20 | PP1 | PP2 | PP3 | Pooled |
|---|---|---|---|---|---|
| Lac, mmol/L (Blood #1) | Mean | 2.0 | 2.1 | 2.3 | 2.2 |
| SD | 0.1 | 0.1 | 0.1 | 0.2 | |
| CV% | 6.8 | 6.8 | 5.1 | 8.0 | |
| Lac, mmol/L (Blood #2) | Mean | 4.8 | 4.7 | 4.7 | 4.7 |
| SD | 0.2 | 0.1 | 0.1 | 0.1 | |
| CV% | 3.2 | 2.6 | 3.0 | 3.1 | |
| Lac, mmol/L (Blood #3) | Mean | 7.4 | 7.7 | 7.5 | 7.5 |
| SD | 0.2 | 0.2 | 0.2 | 0.2 | |
| CV% | 3.2 | 2.9 | 2.9 | 3.2 | |
| Lac, mmol/L (Blood #4) | Mean | 11.0 | 11.1 | 10.8 | 11.0 |
| SD | 0.3 | 0.2 | 0.2 | 0.3 | |
| CV% | 2.7 | 1.9 | 1.8 | 2.4 | |
| Lac, mmol/L (Blood #5) | Mean | 16.7 | 16.7 | 16.5 | 16.6 |
| SD | 0.2 | 0.3 | 0.3 | 0.3 | |
| CV% | 1.3 | 1.5 | 1.9 | 1.7 |
Table 4: Auto QC Cartridge: Levels 4 and 5 – Run to Run Imprecision
| Sample | Pooled
Mean | N | Within run
SD (Sr) | Within run
% CV | Total imprecision
SD (St) | Total
Imprecision
%CV |
|------------|----------------|-----|-----------------------|--------------------|------------------------------|-----------------------------|
| QC Level 4 | 2.0 | 240 | 0.0 | 1.5 | 0.1 | 3.5 |
| QC Level 5 | 7.0 | 240 | 0.1 | 1.0 | 0.1 | 1.4 |
Table 5: Whole Blood – Run to Run Precision
| Parameter | n = 30 | PP1 | PP2 | PP3 | pooled |
|---|---|---|---|---|---|
| Lac, mmol/L (Blood #1) | Mean | 1.4 | 1.4 | 1.4 | 1.4 |
| SD | 0.2 | 0.2 | 0.2 | 0.2 | |
| CV% | 13.3 | 14.0 | 14.7 | 13.9 | |
| Lac, mmol/L (Blood #2) | Mean | 4.9 | 4.8 | 4.8 | 4.8 |
| SD | 0.2 | 0.2 | 0.2 | 0.2 | |
| CV% | 4.7 | 4.1 | 4.1 | 4.5 | |
| Lac, mmol/L (Blood #3) | Mean | 7.1 | 6.9 | 7.4 | 7.1 |
| SD | 0.3 | 0.5 | 0.2 | 0.4 | |
| CV% | 4.5 | 7.4 | 3.1 | 6.0 |
8
| Parameter | n = 30 | PP1 | PP2 | PP3 | pooled |
|---|---|---|---|---|---|
| Lac, | |||||
| mmol/L | |||||
| (Blood #4) | Mean | 12.1 | 11.2 | 12.2 | 11.8 |
| SD | 0.6 | 0.5 | 0.4 | 0.7 | |
| CV% | 4.6 | 4.8 | 3.1 | 5.7 | |
| Lac, | |||||
| mmol/L | |||||
| (Blood #5) | Mean | 17.4 | 17.2 | 17.2 | 17.3 |
| SD | 0.3 | 0.3 | 0.3 | 0.3 | |
| CV% | 2.0 | 1.7 | 1.5 | 1.8 |
Linearity Testing Study:
A Linearity study was performed to assess the linearity of lactate to verify the Analytical Measurement Range (AMR) for the Stat Profile Prime Plus Analyzer System. The evaluation of the linear range included lower and upper limits of the AMR and medical decision limits using whole blood samples analyzed in triplicate. All Stat Profile Prime Plus results were compared to the reference analyzer and/or the product specifications defined in the Stat Profile Prime Marketing Requirements document. The results are summarized below:
| | claimed
measurement range | analyzer | total # of
levels | specimen
range | slope | intercept | r |
|--|------------------------------|----------|----------------------|-------------------|--------|-----------|--------|
| | 0.3 - 20.0 | PP1 | 9 | 0.2 - 23.5 | 0.9936 | -0.0950 | 0.9983 |
| | | PP2 | 9 | 0.2 - 23.4 | 0.9965 | 0.1751 | 0.9982 |
| | | PP3 | 9 | 0.2 - 23.0 | 1.0011 | 0.0012 | 0.9988 |
Table 6: Prime Plus Lactate Linearity
The results support the claimed measurement range of 0.3 - 20.0 mmol/L.
Specificity / Interference Testing Study:
An interference testing study was performed to identify substances that may interfere with Stat Profile Prime Plus lactate sensor. A dose response study was done for glycolic acid and hydroxyurea because the difference between the test and control sample was greater than the allowed bias of ±10%. From the dose response study, it was found that glycolic acid and hydroxyurea interferes with lactate at all concentrations. The results are summarized below:
Table 7: Prime Plus Lactate Interference
| Substance Tested | Highest concentration tested
that showed no significant
interference |
|------------------------|----------------------------------------------------------------------------|
| Acetaminophen | 20 mg/dL |
| Acetoacetate | 2 mmol/L (20 mg/dL) |
| Acetylsalicylic Acid | 3.62 mmol/L (65 mg/dL) |
| Ammonium Chloride | 107 µmol/L (0.6 mg/dL) |
| Ascorbic Acid | 50 mg/dL |
| Benzalkonium Chloride | 10 mg/L |
| Bilirubin | 342 µmole/L (20 mg/dL) |
| B-hydroxybutyrate | 2 mmol/L (20 mg/dL) |
| Dobutamine | 2 mg/dL |
| Dopamine Hydrochloride | 5.87 µmol/L (0.1 mg/dL) |
| EDTA | 3 mmol/L (88 mg/dL) |
| Ethanol | 86.8 mmol/L (400 mg/dL) |
| Sodium Fluoride | 105 µmol/L (441 mg/dL) |
9
| Substance Tested | Highest concentration tested
that showed no significant
interference |
|--------------------|----------------------------------------------------------------------------|
| D-Galactose | 1 mmol/L (18 mg/dL) |
| Glucosamine | 30 µmol/L (0.5 mg/dL) |
| Glucose | 1000 mg/dL |
| Hemoglobin | 2 g/dL |
| Heparin | 100 IU/mL |
| Ibuprofen | 2.4 mmol/L (50 mg/dL) |
| Intralipid | 1000 mg/dL |
| Maltose | 13 mmol/L (445 mg/dL) |
| Mannose | 1 mmol/L (18 mg/dL) |
| Sodium Bromide | 37.5 mmol/L (386 mg/dL) |
| Sodium Pyruvate | 309 µmol/L (3.4 mg/dL) |
| Salicylic Acid | 4.34 mmol/L (60 mg/dL) |
| Sodium Citrate | 12 mmol/L (310 mg/dL) |
| Sodium Oxalate | 500 mg/dL |
| Sodium Thiocyanate | 6.8 mmol/L (55 mg/dL) |
| Urea | 40 mg/dL |
| Uric Acid | 1.4 mmol/L (24 mg/dL) |
| Xylose | 25 mg/dL |
Detection Limit Testing Study:
A study was performed to assess the low level test performance for lactate using altered blood samples for determining Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ). The studies were performed following the recommendations in Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition, CLSI EP17-A2.
LoB: Blank samples were run five times on two analyzers with different lots of reagent calibrator pack. The LoB was estimated non-parametrically by sorting the samples from low to high and averaging the 57th and 58th sample using the typical Type I error risk of a=0.05. The two reagent lot is reported as the LoB.
LoD: The low level samples were run four times on two analyzers with different lots of reagent calibrator pack. Five different low level samples were run over three day, giving a total of 60 replicates per reagent lot. The LoD was calculated following the recommendations in CLSI quidance. The greater LoD of the two reagent lot is reported as the LoD.
LoQ: The low level samples were run three times on two analyzers with different lots of reagent calibrator pack. Four different low level samples were run over three days, giving a total of 36 replicates per reagent lot. The calculated TE (total error) for all samples by each reagent lot met the accuracy goal of TE ≤ 0.3.
The LoB, LoD and LoQ were all below the lower limit of the claimed lactate measurement range of 0.3 mmol/L for the Stat Profile Prime Plus Analyzer. The results are summarized in Table 8:
10
| LoB | LoD | LoQ |
|---|---|---|
| 0.0 mmol/L | 0.1 mmol/L | 0.1 mmol/L |
Summary of Point-of-Care Testing:
A Point-of-Care (POC) study was conducted to show that the Stat Profile Prime Plus Analyzer System for glucose, creatinine, BUN, and lactate demonstrates substantial equivalence to the predicate submission. The testing compared results obtained by trained Healthcare Professionals to results obtained by POC personnel on the same specimens using the same analyzer. The Stat Profile Prime Plus Analyzer was evaluated by point-of-care (POC) personnel in 3 POC sites including a Cardiothoracic Intensive Care Unit (CTICU), an Emergency Department (ED) and a Respiratory Therapy Lab (RT). A total of 61 Respiratory Care, 12 Nursing, and 1 Exercise Physiology POC personnel participated from the 3 POC settings over the course of the study. The personnel represent trained, qualified staff found in typical POC sites where blood gas analyzers are utilized. All testing was performed using quality control materials or discarded blood gas specimens.
Method Comparison Studies:
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 below.
| | | | | | | | 95% Confidence
Interval of Bias | | |
|---------|-----|----------------------|-------------|--------|-----------|--------|------------------------------------|----------------|----------------|
| analyte | N | # altered
samples | range | Slope | Intercept | r | MDL | Lower
Limit | Upper
Limit |
| Glu | 419 | 8 | 16 - 493 | 1.0102 | -0.9232 | 0.9988 | 40
120 | 39
120 | 40
121 |
| Lac | 413 | 0 | 0.5 - 16.5 | 1.0181 | -0.0796 | 0.9975 | 2
6 | 1.9
6.0 | 2.0
6.1 |
| BUN | 413 | 0 | 4.0 - 100.0 | 0.9969 | 0.0674 | 0.9990 | 12
50 | 11.9
49.8 | 12.1
50.1 |
| Creat | 429 | 16 | 0.2 - 11.3 | 0.9984 | -0.0025 | 0.9987 | 1.6
6.0 | 1.6
6.0 | 1.6
6.0 |
Table 9: Venous and Arterial 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 10 and 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.
11
| Total Imprecision Data-Level 4 | |||||
|---|---|---|---|---|---|
| Mean | Within Run SD | Within Run %CV | Total SD | Total %CV | |
| Glu (mg/dL) | 81 | 1.1 | 1.4 | 1.1 | 1.3 |
| Lac (mmol/L) | 1.8 | 0.1 | 2.8 | 0.1 | 3.2 |
| BUN (mg/dL) | 15.7 | 0.6 | 3.6 | 0.8 | 4.8 |
| Creat (mg/dL) | 1.1 | 0.04 | 3.5 | 0.1 | 5.5 |
| Total Imprecision Data-Level 5 | |||||
| Glu (mg/dL) | 298 | 4.4 | 1.5 | 5.2 | 1.7 |
| Lac (mmol/L) | 6.7 | 0.2 | 3.1 | 0.2 | 3.4 |
| BUN (mg/dL) | 49.8 | 2.2 | 4.4 | 2.5 | 5.1 |
| Creat (mg/dL) | 7.4 | 0.1 | 1.8 | 0.4 | 5.2 |
| Total Imprecision Data-Linearity Level 4 | |||||
| Glu (mg/dL) | 32 | 0.7 | 2.2 | 0.8 | 2.4 |
| Lac (mmol/L) | 16.5 | 0.2 | 1.0 | 0.4 | 2.2 |
| Total Imprecision Data-Linearity Level 3 | |||||
| BUN (mg/dL) | 24.3 | 0.2 | 0.7 | 0.6 | 2.4 |
| Creat (mg/dL) | 4.9 | 0.1 | 1.1 | 0.3 | 6.4 |
Table 10: Total Imprecision from ED Site
Within-Run Whole Blood Precision:
Whole blood with-run precision of the Stat Profile Prime Plus Analyzer System in the hands of point-of- care operators was assessed by a minimum of two (2) point-of-care operators at each of the three (3) POC sites for a total of nine (9) operators across the 3 testing locations. Each precision run consisted of ten (10) replicate measurements using both fresh, native and altered whole blood samples. A total of five (5) different native samples and two (2) altered samples were evaluated at each site. Each whole blood specimen was maintained in a syringe. The POC operator performed all sample analysis steps including sample analysis, removal of resultant air bubble(s) from the syringe, recapping of the syringe and mixing prior to the next sample analysis. The whole blood within-run precision data from one representative POC site is shown below 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 11: Within Run Precision with Whole Blood Samples (n=10) – ED Site
| Mean | SD | %CV | 95% CI | ||
|---|---|---|---|---|---|
| Sample 1 | |||||
| Glu (mg/dL) | 140.8 | 2.97 | 2.11 | 135 - 147 | |
| Lac (mmol/L) | 3.30 | 0.22 | 6.55 | 2.9 - 3.7 | |
| BUN (mg/dL) | 13.9 | 0.32 | 2.28 | 13 - 15 | |
| Creat (mg/dL) | 1.42 | 0.06 | 4.45 | 1.3-1.5 | |
| Sample 2 | |||||
| Glu (mg/dL) | 60.0 | 0.47 | 0.79 | 59-61 | |
| Lac (mmol/L) | 1.43 | 0.07 | 4.72 | 1.3-1.6 | |
| BUN (mg/dL) | 7.5 | 0.53 | 7.03 | 6.0-9 | |
| Creat (mg/dL) | 0.60 | 0.00 | 0.00 | 0.6-0.6 | |
| Sample 3 | |||||
| Glu (mg/dL) | 86.5 | 2.17 | 2.51 | 82-91 | |
| Lac (mmol/L) | 2.47 | 0.13 | 5.41 | 2.2 - 2.7 | |
| BUN (mg/dL) | 21.0 | 0.00 | 0.00 | 21-21 | |
| Creat (mg/dL) | 1.68 | 0.04 | 2.51 | 1.6-1.8 |
12
| Mean | SD | %CV | 95% CI | |
|---|---|---|---|---|
| Sample 4 | ||||
| Glu (mg/dL) | 83.3 | 2.26 | 2.72 | 79 - 88 |
| Lac (mmol/L) | 2.49 | 0.17 | 6.68 | 2.2 - 2.8 |
| BUN (mg/dL) | 21.3 | 0.48 | 2.27 | 20 - 22 |
| Creat (mg/dL) | 1.56 | 0.05 | 3.31 | 1.5 - 1.7 |
| Sample 5 | ||||
| Glu (mg/dL) | 71.3 | 0.82 | 1.15 | 70 - 73 |
| Lac (mmol/L) | 1.24 | 0.05 | 4.16 | 1.1 - 1.3 |
| BUN (mg/dL) | 19.0 | 0.00 | 0.00 | 19 - 19 |
| Creat (mg/dL) | 3.30 | 0.05 | 1.43 | 3.2 - 3.4 |
| Sample 6 (Altered) | ||||
| Glu (mg/dL) | 349.4 | 8.57 | 2.45 | 332 - 367 |
| Lac (mmol/L) | 4.69 | 0.19 | 4.08 | 4.3 - 5.1 |
| BUN (mg/dL) | 57.8 | 1.23 | 2.13 | 55 - 60 |
| Creat (mg/dL) | 5.94 | 0.22 | 3.65 | 5.5 - 6.4 |
| Sample 7 (Altered) | ||||
| Glu (mg/dL) | 109.0 | 5.72 | 5.24 | 98 - 120 |
| Lac (mmol/L) | 11.4 | 0.45 | 3.98 | 10.5 - 12.3 |
| BUN (mg/dL) | 82.7 | 1.16 | 1.40 | 80 - 85 |
| Creat (mg/dL) | 10.03 | 0.46 | 4.61 | 9.1 - 11.0 |
Within-Run Control and Linearity Material:
Typical within-run precision of the Stat Profile Prime Plus Analyzer System in the hands of point-of-care operators was assessed using methods described in CLSI "Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guidelines - Second Edition", CLSI EP5-A2 as guidance. A total of three (3) Stat Profile Prime Plus analyzers and four (4) different lots of calibrator cartridges were used in the study. One analyzer was used at each testing site and calibrator cartridges from 3 of the 4 calibrator cartridge lots were used at the ED site, 2 at the CTICU site, and 2 at the RT site.
Using test materials consisting of a combination of available quality Control and Linearity materials to cover the analytes measurement ranges (Low, Normal and High) precision runs were performed by POC Staff members within each of the testing locations. Each run consisted of 20 replicate measurements. Representative within-run precision results from one site are summarized in the table below:
Table 12: Within Run Precision with Controls and Linearity Material (n=20) - ED
| Within Run Precision with Controls and Linearity Material (n=20) = ED | ||||
|---|---|---|---|---|
| Within Run Precision-Level 4 | ||||
| Mean | SD | %CV | 95% CI | |
| Glu (mg/dL) | 81 | 1.4 | 1.7 | 78.1-83.5 |
| Lac (mmol/L) | 1.7 | 0.05 | 2.9 | 1.6-1.8 |
| BUN (mg/dL) | 16.5 | 0.5 | 3.1 | 15.4-17.5 |
| Creat (mg/dL) | 1.2 | 0.04 | 3.1 | 1.1-1.3 |
| Within Run Precision-Linearity Level 1 | ||||
| Glu (mg/dL) | 446 | 5.5 | 1.2 | 434.6-456.8 |
| Lac (mmol/L) | 0.4 | 0.04 | 9.5 | 0.3-0.5 |
| Within Run Precision-Linearity Level 4 | ||||
| Glu (mg/dL) | 34 | 0.5 | 1.5 | 32.8-34.8 |
| Lac (mmol/L) | 16.9 | 0.1 | 0.8 | 16.6-17.2 |
| Within Run Precision- Linearity Level 2 | ||||
| BUN (mg/dL) | 49.2 | 0.9 | 1.8 | 47.4-51 |
| Creat (mg/dL) | 7.5 | 0.08 | 1.1 | 7.4-7.7 |
13
| Within Run Precision- Linearity Level 3 | ||||
|---|---|---|---|---|
| BUN (mg/dL) | 24.5 | 0.5 | 2.1 | 23.4-25.5 |
| Creat (mg/dL) | 4.8 | 0.05 | 1.0 | 4.7-4.9 |
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 System (K180340).
14
| Characteristic | Predicate (K180340): | 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 Glucose, | ||
| Creatinine, and Blood Urea Nitrogen, 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 Glucose, Creatinine, and | ||
| Blood Urea Nitrogen 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 | ||
| Glu | 15-500 mg/dL | Same |
| Creat | 0.2-12.0 mg/dL | Same |
| BUN | 3-100 mg/dL | Same |
| Principles of | ||
| Measurement | ||
| Glu | Enzymatic sensor | Same |
| Creat | Enzymatic sensor | Same |
| BUN | Enzymatic sensor | 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 13: Comparison of Predicate and Proposed Devices (Glucose, Creatinine, BUN)
Table 14: Comparison of Predicate and Proposed Device (Lactate)
| Characteristic | Predicate (K110648): | Proposed: |
|---|---|---|
| Indication For Use | The Nova Stat Profile pHOx Ultra Analyzer is | |
| intended for in vitro diagnostic use by health | ||
| care professionals and for point-of-care | ||
| usage in the quantitative determination of | ||
| Lactate in heparinized whole blood, serum, or | ||
| plasma. | 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 Lactate in heparinized | ||
| arterial and venous whole blood. | ||
| Sample Types | Syringe, capillary tube | Lithium heparin whole blood from syringes |
| and open collection tubes | ||
| Sample Volume | 150µL / 60µL (micro) | 135µL |
| Measurement Range | 0.3-20 mmol/L | Same |
| Principles of | ||
| Measurement | Enzymatic sensor | Same |