EasyStat 300
Device Facts
| Record ID | K211559 |
|---|---|
| Device Name | EasyStat 300 |
| Applicant | Medica Corporation |
| Product Code | CHL · Clinical Chemistry |
| Decision Date | Jan 27, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1120 |
| Device Class | Class 2 |
Intended Use
The EasyStat 300 is designed for clinical laboratory use, making quantitative measurements of pO2 (partial pressure of oxygen), pCO2 (partial pressure of carbon dioxide), and pH (hydrogen ion activity) in whole blood (arterial/venous) samples from Li-Heparinized Syringes or Capillary Tubes. This Analyzer should only be used by trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with blood gas and/or acid-base disturbances. Blood gases (pO2, pCO2) and pH measurements in blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Device Story
EasyStat 300 is a microprocessor-controlled blood gas analyzer for clinical laboratories. It accepts Li-heparinized whole blood samples (175μL syringe or 100μL capillary). The device uses potentiometric sensors for pH and pCO2, and an amperometric sensor for pO2. It incorporates a reagent module with calibrating and conditioning solutions. The system features a touch-sensitive screen for operator guidance, a thermal printer for results, and a USB port for data download and software updates. It provides quantitative measurements of pH, pCO2, and pO2, plus calculated parameters (e.g., HCO3-, base excess, oxygen saturation). Operators (trained technicians) use the device to diagnose and treat life-threatening acid-base disturbances. The system requires daily quality control using EasyQC materials and periodic sensor replacement/cleaning. The device benefits patients by providing rapid, accurate blood gas analysis to guide clinical decision-making.
Clinical Evidence
Method comparison study performed in a clinical laboratory using >200 donor whole blood samples and modified (spiked/diluted) samples. Compared EasyStat 300 against predicate EasyStat. Results showed favorable correlation for pH, pCO2, and pO2. Linear regression slopes, coefficients of variation, and predicted bias at decision levels were within specifications. Additional non-clinical bench testing included 20-day precision studies (aqueous controls), 5-day reproducibility studies (whole blood), linearity studies (CLSI EP06-A), and selectivity/interference studies (CLSI EP07-A).
Technological Characteristics
Potentiometric (pH, pCO2) and amperometric (pO2) sensor technology. Reagent module with aqueous calibrants. Dimensions: 14.5"W x 13"H x 7"D. Connectivity: USB, Ethernet, RS232, SD card. Power: 110/115VAC or 220VAC. Compliance: EN61010, EN55011, UL3101, C22.2. Microprocessor-controlled with TFT LCD touch screen and thermal printer.
Indications for Use
Indicated for trained technicians in clinical laboratories to perform quantitative measurements of pH, pCO2, and pO2 in arterial/venous whole blood samples to aid in the diagnosis and treatment of patients with blood gas and/or acid-base disturbances.
Regulatory Classification
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.
Predicate Devices
- EasyStat pH, PCO2, PO2, Hct, Na+, K+, Ca++ Analyzer (K021515)
Related Devices
- K142220 — Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) · Nova Biomedical Corporation · Oct 17, 2014
- K173797 — Stat Profile Prime Plus Analyzer System · Nova Biomedical Corporation · Jul 17, 2018
- K193246 — Stat Profile Prime Plus Analyzer System · Nova Biomedical Corporation · Jan 24, 2020
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION".
January 27, 2023
Medica Corporation Photios Makris VP Regulatory Affairs 5 Oak Park Drive Bedford, MA 01730
Re: K211559
Trade/Device Name: EasyStat 300 Regulation Number: 21 CFR 862.1120 Regulation Name: Blood Gases (PCO2, PO2) and Blood pH Test System Regulatory Class: Class II Product Code: CHL Dated: September 30, 2022 Received: October 3, 2022
Dear Photios Makris:
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
{1}------------------------------------------------
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 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,
Digitally signed by Paula Paula Caposino -S Caposino -S Date: 2023.01.27
12:07:22 -05'00' Paula V. Caposino, Ph.D. Acting Deputy 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) k211559
Device Name EasyStat 300
#### Indications for Use (Describe)
The EasyStat 300 is designed for clinical laboratory use, making quantitative measurements of pO2 (partial pressure of oxygen), pCO2 (partial pressure of carbon dioxide), and pH (hydrogen ion activity) in whole blood (arterial/venous) samples from Li-Heparinized Syringes or Capillary Tubes. This Analyzer should only be used by trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with blood gas and/or acid-base disturbances.
Blood gases (p02, pCO2) and pH measurements in blood are used in the diagnosis and treatment of life-threatening acidbase disturbances.
Type of Use (Select one or both, as applicable)
| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
# 510(k) Summary
## Submitted By:
Medica Corporation 5 Oak Park Drive Bedford, MA 01730
# Contact Person:
Photios Makris, VP. Regulatory Affairs Phone: 781-541-7443 Fax: 781-275-2731 pmakris@medicacorp.com E-mail:
# Summary Prepared:
January 25th, 2023
| Trade Name: | EasyStat 300 |
|----------------------|--------------------------------------|
| Common Name: | Blood Gas Analyzer |
| Classification Name: | Blood Gases and Blood pH Test System |
#### Regulatory Information:
#### EasyStat 300 Analyzer
| Description | Regulation No. | Device Class | Product Code |
|------------------------|----------------|--------------|--------------|
| Blood Gas and blood pH | 862.1120 | II | CHL |
#### EasyQC BGEM Material for EasyStat
| Description | Regulation No. | Device Class | Product Code |
|--------------------------|----------------|--------------|--------------|
| Quality control Material | 862.1660 | Class I | JJY |
#### Predicate devices:
| Description | 510(k) | Regulation No. | Device Class | Product Code |
|-----------------------------|---------|----------------|--------------|--------------|
| EasyStat Blood Gas Analyzer | K021515 | 862.1120 | II | CHL |
| | | | | |
{4}------------------------------------------------
### Device Description and Indications for Use:
The EasyStat 300 is a system for use by health care professionals to rapidly analyze whole blood samples. Good Laboratory Practices (GLPs) are strongly advised when using the EasyStat 300. The analyzer incorporates a Reagent Module containing the "calibrating" solutions A2, B2, and a "conditioning" solution C2, which is also use a calibrant for the Oxygen sensor. Calibrations are performed automatically or on-demand by the user to establish the "slope" of each sensor used in the calculation of the patient sample.
The EasyStat 300 uses 175μL of whole blood in the "Syringe" mode and 100μL of whole blood in the "Capillary" mode to analyze patient samples. Medica provides a capillary tube kit (REF 8303) used for the capillary data collection in this submission. The EasyStat 300 reports results for blood Gases (PCO2, PO2), and pH. Additionally, it provides a number of calculated parameters based on the reported results and a number of input parameters as described in the Operator's Manual.
The EasyStat 300 is a microprocessor-controlled device with a touch sensitive screen that guides the operator through the different menu options and proper operation. It also incorporates a thermal printer to record all reported results and patient information as described in the Operator's Manual. The device software has incorporated routines to assist the end-user with maintenance, cleaning, and troubleshooting activities also outlined in the manual. The incorporated USB port may be used to download data and also to update the software version based on detailed instructions by Medica Corporation.
The blood gas and pH sensors require calibration and cleaning after a predefined number of samples are analyzed as described in the Operator's Manual. The pH and PCO2 sensors are based on potentiometric sensor design, generating a small voltage that is dependent on the concentrations of these analytes in the patient sample. The PO2 sensor is based on amperometric sensor design that generates a small current that is dependent on the concentration of oxygen in the patient sample. The theory and mathematical formulas on which the sensor functionality is based are described in the Operator's Manual.
Medica's EasyQC materials (REF 8315/8316/8317 and 8309) are specifically formulated for the EasyStat 300. Medica requires the use of quality controls everyday patient samples are analyzed and after any troubleshooting is performed, as instructed in the Operator's Manual, to validate the performance of the analyzer. The analyzer stores QC results and provides a statistical analysis of its performance using Levey-Jennings plots for the last 30 consecutive days. The EasyQC materials for the EasyStat 300 have a minimum of three years shelf-life when stored refrigerated (20-80C).
The Reagent Module (REF 8101) has a twelve-month shelf-life when stored at 4º-25ºC. Use-life depends on the number of samples analyzed and the overall performance of the sensors. The analyzer monitors the consumption of calibrant solution A2 and warns the operator when the reagent module is about to expire. A typical Use-life for an average user is expected to be 15
{5}------------------------------------------------
days and/or 350 samples whichever comes first. This feature is the one provided with the predicate EasyStat analyzer.
The sensors have one-year shelf-life when stored at 4º 25ºC for blood gases (PCO2, PO2), pH. Use-Life of the sensors is determined from their calibration profiles and from the reported results during the EasyQC analysis. Sensors are replaced by the operator as described in the Operator's Manual. An automatic calibration is performed after installation to qualify the new sensor(s) and the operator is instructed to use the EasyQC multi-level QC materials to validate the EasyStat 300 performance.
The EasyStat 300 may be equipped with a Medica provided barcode scanner (REF 8420) via a USB port to automatically enter patient sample and EasyQC material info. Details are provided in the operator's Manual.
To maintain the performance of the analyzer Medica provides a cleaning solution (REF 8305) and a troubleshooting kit (REF 8250). Their proper uses are described also in the operator's Manual.
Intended use and Indications for use of the analytes measured by the EasyStat 300 are:
The EasyStat 300 provides quantitative measurements of pH (hydrogen ion activity), pCO2 (partial pressure of carbon dioxide), and pO2 (partial pressure of oxygen) in Li-heparinized whole blood (arterial/venous) samples from Syringes or Capillary Tubes. This Analyzer should only be used by trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with blood gas and/or acid-base disturbances.
pCO2, PO2 (blood gases) and pH measurements in blood are used in the diagnosis and treatment of lifethreatening acid-base disturbances.
The EasyStat 300 has the same technical characteristics with the predicate device. Sensor technology, Reagent module calibrating solutions, principles of operation, and parameters measured are practically the same. User device display may differ due to the new touch sensitive screen, user menu preferences, and more friendly user interface. None of these differences affect the performance when compared to the predicate EasyStat analyzer. The following sections provide a brief discussion of the performance characteristics of the EasyStat 300 based on the studies submitted to determine substantial equivalency.
All tests on the following sections are non-clinical bench tests except for Method Comparison, which was performed on a clinical laboratory using actual venous and arterial blood. The non-clinical tests also used contrived venous blood of aqueous QC materials that are part of the EasyStat 300 system.
{6}------------------------------------------------
| | EasyStat 300 | EasyStat Ca++ |
|-----------------------|---------------------------------------------|---------------------------------------------|
| 510(k) Number | New IVD Device | K021515 |
| Manufacturer | Medica Corp. | Medica Corp. |
| Address | 5 Oak Park Dr. Bedford, MA 01730 | 5 Oak Park Dr. Bedford, MA 01730 |
| Intended Use | Clinical Laboratories | Clinical Laboratories |
| Indications for Use | Same with predicate devices | Same with submitted device |
| Operating Principle | Potentiometric | Potentiometric |
| pH | Potentiometric | Potentiometric |
| PCO2 | Potentiometric | Potentiometric |
| PO2 | Amperometric | Amperometric |
| Calibrant Base | Aqueous | Aqueous |
| Measured Parameters | pH, pCO2, pO2 | pH, PCO2, PO2 |
| Sample Type | Whole Blood | Whole Blood |
| Sample Volume | 175µL Syringe, 100 µL Capillary | 120µL Syringe, 95 µL Capillary |
| Analysis Time | 110 seconds | 120 seconds |
| Measured Range | | |
| pH | 6.800 to 8.000 units | 6.500 to 8.000 units |
| pCO2 | 5.0 – 150.0 mmHg | 5.0 – 150.0 mmHg |
| pO2 | 5-700 mHg | 5-700 mmHg |
| Display | TFT LCD, Touch screen | LCD |
| Printer | Thermal | Thermal |
| Communication Ports | USB (5), 1 for Barcode reader | None |
| | Ethernet (1) | None |
| | RS232 Serial (1) | RS232 Serial (1) |
| | SD card port (1) | None |
| | N/A | Barcode Reader |
| Calculated Parameters | Patient Temp. Correction, pH, PCO2, PO2 | Patient Temp. Correction, pH, PCO2, O2 |
| | Total Hemoglobin | Total Hemoglobin |
| | Hematocrit, measured | Hematocrit, measured |
| | Total CO2 (TCO2) | Total CO2 (TCO2) |
| | Bicarbonate (HCO3-) | Bicarbonate (HCO3-) |
| | Base excess of blood (BEb) | Base excess of blood (BEb) |
| | Base excess of Extracellular fluid (BEecf) | Base excess of Extracellular fluid (BEecf) |
| | Standard Bicarbonate (SBC) | Standard Bicarbonate (SBC) |
| | Oxygen Saturation calculated at P50 (%SO2c) | Oxygen Saturation calculated at P50 (%SO2c) |
| | Total Oxygen Content (ctO2) | Total Oxygen Content (ctO2) |
| | Alveolar-Arterial O2 Gradient (A-aDO2) | Alveolar-Arterial O2 Gradient (A-aDO2) |
| | Respiratory Index (RI) | Respiratory Index (RI) |
| Safety Compliance | EN61010 | EN61010 |
| EMC Compliance | EN55011 | EN55011 |
| UL Tested | UL3101 | UL3101 |
| CSA Tested | C22.2 | C22.2 |
| Dimensions | 14.5"WX13"HX7"D | 14.25"W X 12.5"H X 7"D |
| Voltage Requirements | 110/115VAC, 50-60Hz, 220VAC, 50-60Hz | 110/115VAC, 50-60Hz, 220VAC, 50-60Hz |
# Substantial Equivalency Between EasyStat 300 and predicate EasyStat
{7}------------------------------------------------
All tests on the following sections are non-clinical bench tests except for Method Comparison, which was performed on a clinical laboratory using actual venous and arterial blood. The non-clinical tests also used contrived venous blood of aqueous QC materials that are part of the EasyStat 300 system.
{8}------------------------------------------------
# Performance Summaries:
# Precision Studies:
#### Repeatability 20-Day Precision Study (Syringe & Capillary Modes) – Aqueous Controls
Medica used the EasyStat 300 tri-level aqueous EasyQC material to establish the Total and Within-Run precision of all analytes reported by the EasyStat 300. Each of the quality control levels were analyzed in three EasyStat 300 analyzers for twenty days taking duplicate readings in the morning (AM) and afternoon (PM). All results were within specification.
| | Precision<br>Estimate | Level | Target | Performance<br>Specs | | System 1_P21 | | | System 2_P22 | | | System 3_P23 | | |
|------|------------------------------|-------|--------|----------------------|------|--------------|-------|-----|--------------|-------|-----|--------------|-------|-----|
| | | | | SD | CV | Mean | SD | CV | Mean | SD | CV | Mean | SD | CV |
| PO2 | Within-<br>Device<br>(Total) | 1 | 36 | 2.5 | | 36 | 1.39 | | 35 | 1.33 | | 37 | 1.18 | |
| | | 2 | 98 | 2.5 | | 99 | 1.61 | | 98 | 2.23 | | 99 | 1.56 | |
| | | 3 | 136 | | 2.5% | 137 | | 1.4 | 137 | | 1.4 | 138 | | 1.5 |
| PCO2 | Within-<br>Device<br>(Total) | 1 | 69.0 | | 5.0% | 68.9 | | 0.9 | 68.1 | | 0.9 | 68.3 | | 0.8 |
| | | 2 | 45.0 | | 4.0% | 45.4 | | 1.2 | 45.2 | | 1.0 | 45.2 | | 0.9 |
| | | 3 | 21.0 | 2.0 | | 21.2 | 0.28 | | 21.4 | 1.13 | | 21.1 | 0.23 | |
| pH | Within-<br>Device<br>(Total) | 1 | 7.186 | 0.020 | | 7.183 | 0.002 | | 7.182 | 0.002 | | 7.185 | 0.001 | |
| | | 2 | 7.411 | 0.015 | | 7.410 | 0.002 | | 7.410 | 0.003 | | 7.408 | 0.002 | |
| | | 3 | 7.621 | 0.020 | | 7.622 | 0.004 | | 7.623 | 0.002 | | 7.618 | 0.002 | |
#### Typical Repeatability Precision Study (Syringe Mode) – Aqueous Controls
#### Typical Repeatability Precision Study (Capillary Mode) – Aqueous Controls
| 20 Day QC Precision (Capillary Mode) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|--------------------------------------|-------------------------------|-------------------------------|--------|----------------------|-------|--------|-------|-------|--------|-------|-------|--------|-------|-------|------|---|-------|-------|------|-------|-------|------|-------|-------|------|-------|-------|------|-----|------|--------------------------|-------|------|-------|-------|------|-------|-------|------|-------|-------|------|------|-------------------------------|-----|-------|-------|------|-------|-------|------|-------|-------|------|-------|-------|------|------|-----|-------|-------|------|-------|-------|------|-------|-------|------|-------|-------|------|------|-----|-------|-------------------------------|---|-------|-------|------|-------|-------|------|-------|-------|------|----|-------------------------------|-------|-------|-------|---|-------|-------|------|-------|-------|------|-------|-------|------|-------|-------|-------|-------|---|-------|-------|------|-------|-------|------|-------|-------|------|-------|-------|-------|-------|--------------------------|-------|-------|-------|-------|-------|-------|-------|-------|-------|----|--------------------------|-------|-------|-------|--|-------|-------|-------|-------|-------|-------|-------|-------|-------|------|-------|-------|-------|--|-------|-------|-------|-------|-------|-------|-------|-------|-------|------|-------|-------|-------|--|-------|-------|------|-------|-------|------|-------|-------|------|
| Analyte | Precision<br>Estimate | Level | Target | Performance<br>Specs | | Unit 1 | | | Unit 2 | | | Unit 3 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | SD | CV | Mean | SD | CV | Mean | SD | CV | Mean | SD | CV | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PO2 | Repeatability<br>(Within-Run) | 1 | 36 | 3 | | 53 | 2.70 | 5.1 | 53 | 1.70 | 3.2 | 52 | 2.41 | 4.6 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | 2 | 98 | 3 | | 107 | 1.51 | 1.4 | 108 | 1.84 | 1.7 | 108 | 1.99 | 1.8 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | 3 | 136 | | 3.0% | 140 | 1.85 | 1.3 | 140 | 1.52 | 1.1 | 141 | 2.50 | 1.8 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PO2 | Within-Device<br>(Total) | 1 | 36 | 4 | | 53 | 3.67 | 7.0 | 53 | 2.81 | 5.3 | 52 | 4.00 | 7.7 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | 2 | 98 | 4 | | 107 | 2.49 | 2.3 | 108 | 2.37 | 2.2 | 108 | 2.25 | 2.1 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | 3 | 136 | | 4.0% | 140 | 2.30 | 1.6 | 140 | 3.17 | 2.3 | 141 | 2.72 | 1.9 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PCO2 | Repeatability<br>(Within-Run) | 1 | 69.0 | | 5.0% | 63.4 | 0.96 | 1.5 | 63.0 | 0.93 | 1.5 | 63.2 | 0.68 | 1.1 | | 2 | 45.0 | | 4.0% | 41.4 | 0.45 | 1.1 | 41.1 | 0.50 | 1.2 | 41.2 | 0.42 | 1.0 | | 3 | 21.0 | 1.5 | | 21.2 | 0.19 | 0.9 | 21.4 | 0.21 | 1.0 | 21.2 | 0.23 | 1.1 | PCO2 | Within-Device<br>(Total) | 1 | 69.0 | | 5.0% | 63.4 | 1.14 | 1.8 | 63.0 | 1.15 | 1.8 | 63.2 | 1.00 | 1.6 | | 2 | 45.0 | | 4.0% | 41.4 | 0.52 | 1.3 | 41.1 | 0.55 | 1.3 | 41.2 | 0.46 | 1.1 | | 3 | 21.0 | 2.0 | | 21.2 | 0.23 | 1.1 | 21.4 | 0.27 | 1.3 | 21.2 | 0.25 | 1.2 | pH | Repeatability<br>(Within-Run) | 1 | 7.186 | 0.020 | | 7.209 | 0.004 | 0.06 | 7.192 | 0.006 | 0.08 | 7.197 | 0.007 | 0.09 | | 2 | 7.411 | 0.015 | | 7.433 | 0.003 | 0.04 | 7.421 | 0.003 | 0.04 | 7.423 | 0.002 | 0.03 | | 3 | 7.621 | 0.020 | | 7.619 | 0.004 | 0.05 | 7.612 | 0.003 | 0.03 | 7.609 | 0.003 | 0.04 | pH | Within-Device<br>(Total) | 1 | 7.186 | 0.020 | | 7.209 | 0.011 | 0.16 | 7.192 | 0.008 | 0.10 | 7.197 | 0.011 | 0.16 | | 2 | 7.411 | 0.015 | | 7.433 | 0.009 | 0.12 | 7.421 | 0.003 | 0.04 | 7.423 | 0.005 | 0.06 | | 3 | 7.621 | 0.020 | | 7.619 | 0.007 | 0.10 | 7.612 | 0.004 | 0.05 | 7.609 | 0.004 | 0.06 |
| | PCO2 | Repeatability<br>(Within-Run) | 1 | 69.0 | | 5.0% | 63.4 | 0.96 | 1.5 | 63.0 | 0.93 | 1.5 | 63.2 | 0.68 | 1.1 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | 2 | 45.0 | | 4.0% | 41.4 | 0.45 | 1.1 | 41.1 | 0.50 | 1.2 | 41.2 | 0.42 | 1.0 | | 3 | 21.0 | 1.5 | | 21.2 | 0.19 | 0.9 | 21.4 | 0.21 | 1.0 | 21.2 | 0.23 | 1.1 | PCO2 | Within-Device<br>(Total) | 1 | 69.0 | | 5.0% | 63.4 | 1.14 | 1.8 | 63.0 | 1.15 | 1.8 | 63.2 | | 1.00 | 1.6 | | 2 | 45.0 | | 4.0% | 41.4 | 0.52 | 1.3 | 41.1 | 0.55 | 1.3 | 41.2 | 0.46 | 1.1 | | 3 | 21.0 | 2.0 | | 21.2 | 0.23 | 1.1 | 21.4 | 0.27 | 1.3 | 21.2 | 0.25 | 1.2 | pH | Repeatability<br>(Within-Run) | 1 | 7.186 | 0.020 | | 7.209 | 0.004 | 0.06 | 7.192 | 0.006 | 0.08 | | 7.197 | 0.007 | 0.09 | | 2 | 7.411 | 0.015 | | 7.433 | 0.003 | 0.04 | 7.421 | 0.003 | 0.04 | 7.423 | 0.002 | 0.03 | | 3 | 7.621 | 0.020 | | 7.619 | 0.004 | 0.05 | 7.612 | 0.003 | 0.03 | 7.609 | 0.003 | 0.04 | pH | Within-Device<br>(Total) | 1 | 7.186 | 0.020 | | 7.209 | 0.011 | 0.16 | 7.192 | 0.008 | | 0.10 | 7.197 | 0.011 | 0.16 | | 2 | 7.411 | 0.015 | | 7.433 | 0.009 | 0.12 | 7.421 | 0.003 | 0.04 | 7.423 | 0.005 | 0.06 | | 3 | 7.621 | 0.020 | | 7.619 | 0.007 | 0.10 | 7.612 | 0.004 | 0.05 | 7.609 | 0.004 | 0.06 | | | | | | | | | | |
| | | 2 | 45.0 | | 4.0% | 41.4 | 0.45 | 1.1 | 41.1 | 0.50 | 1.2 | 41.2 | 0.42 | 1.0 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | 3 | 21.0 | 1.5 | | 21.2 | 0.19 | 0.9 | 21.4 | 0.21 | 1.0 | 21.2 | 0.23 | 1.1 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| PCO2 | Within-Device<br>(Total) | 1 | 69.0 | | 5.0% | 63.4 | 1.14 | 1.8 | 63.0 | 1.15 | 1.8 | 63.2 | 1.00 | 1.6 | | 2 | 45.0 | | 4.0% | 41.4 | 0.52 | 1.3 | 41.1 | 0.55 | 1.3 | 41.2 | 0.46 | 1.1 | | 3 | 21.0 | 2.0 | | 21.2 | 0.23 | 1.1 | 21.4 | 0.27 | 1.3 | 21.2 | 0.25 | 1.2 | pH | Repeatability<br>(Within-Run) | 1 | 7.186 | 0.020 | | 7.209 | 0.004 | 0.06 | 7.192 | 0.006 | 0.08 | 7.197 | 0.007 | 0.09 | | 2 | 7.411 | 0.015 | | 7.433 | 0.003 | 0.04 | 7.421 | 0.003 | 0.04 | 7.423 | 0.002 | 0.03 | | 3 | 7.621 | 0.020 | | 7.619 | 0.004 | 0.05 | 7.612 | 0.003 | 0.03 | 7.609 | 0.003 | 0.04 | pH | Within-Device<br>(Total) | 1 | 7.186 | 0.020 | | 7.209 | 0.011 | 0.16 | 7.192 | 0.008 | 0.10 | 7.197 | 0.011 | 0.16 | | 2 | 7.411 | 0.015 | | 7.433 | 0.009 | 0.12 | 7.421 | 0.003 | 0.04 | 7.423 | 0.005 | 0.06 | | 3 | 7.621 | 0.020 | | 7.619 | 0.007 | 0.10 | 7.612 | 0.004 | 0.05 | 7.609 | 0.004 | 0.06 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | PCO2 | Within-Device<br>(Total) | 1 | 69.0 | | 5.0% | 63.4 | 1.14 | 1.8 | 63.0 | 1.15 | 1.8 | 63.2 | 1.00 | 1.6 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | 2 | 45.0 | | 4.0% | 41.4 | 0.52 | 1.3 | 41.1 | 0.55 | 1.3 | 41.2 | 0.46 | 1.1 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | 3 | 21.0 | 2.0 | | 21.2 | 0.23 | 1.1 | 21.4 | 0.27 | 1.3 | 21.2 | 0.25 | 1.2 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| pH | Repeatability<br>(Within-Run) | 1 | 7.186 | 0.020 | | 7.209 | 0.004 | 0.06 | 7.192 | 0.006 | 0.08 | 7.197 | 0.007 | 0.09 | | 2 | 7.411 | 0.015 | | 7.433 | 0.003 | 0.04 | 7.421 | 0.003 | 0.04 | 7.423 | 0.002 | 0.03 | | 3 | 7.621 | 0.020 | | 7.619 | 0.004 | 0.05 | 7.612 | 0.003 | 0.03 | 7.609 | 0.003 | 0.04 | pH | Within-Device<br>(Total) | 1 | 7.186 | 0.020 | | 7.209 | 0.011 | 0.16 | 7.192 | 0.008 | 0.10 | 7.197 | 0.011 | 0.16 | | 2 | 7.411 | 0.015 | | 7.433 | 0.009 | 0.12 | 7.421 | 0.003 | 0.04 | 7.423 | 0.005 | 0.06 | | 3 | 7.621 | 0.020 | | 7.619 | 0.007 | 0.10 | 7.612 | 0.004 | 0.05 | 7.609 | 0.004 | 0.06 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | pH | Repeatability<br>(Within-Run) | 1 | 7.186 | 0.020 | | 7.209 | 0.004 | 0.06 | 7.192 | 0.006 | 0.08 | 7.197 | 0.007 | 0.09 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | 2 | 7.411 | 0.015 | | 7.433 | 0.003 | 0.04 | 7.421 | 0.003 | 0.04 | 7.423 | 0.002 | 0.03 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | 3 | 7.621 | 0.020 | | 7.619 | 0.004 | 0.05 | 7.612 | 0.003 | 0.03 | 7.609 | 0.003 | 0.04 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| pH | Within-Device<br>(Total) | 1 | 7.186 | 0.020 | | 7.209 | 0.011 | 0.16 | 7.192 | 0.008 | 0.10 | 7.197 | 0.011 | 0.16 | | 2 | 7.411 | 0.015 | | 7.433 | 0.009 | 0.12 | 7.421 | 0.003 | 0.04 | 7.423 | 0.005 | 0.06 | | 3 | 7.621 | 0.020 | | 7.619 | 0.007 | 0.10 | 7.612 | 0.004 | 0.05 | 7.609 | 0.004 | 0.06 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | pH | Within-Device<br>(Total) | 1 | 7.186 | 0.020 | | 7.209 | 0.011 | 0.16 | 7.192 | 0.008 | 0.10 | 7.197 | 0.011 | 0.16 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | 2 | 7.411 | 0.015 | | 7.433 | 0.009 | 0.12 | 7.421 | 0.003 | 0.04 | 7.423 | 0.005 | 0.06 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | 3 | 7.621 | 0.020 | | 7.619 | 0.007 | 0.10 | 7.612 | 0.004 | 0.05 | 7.609 | 0.004 | 0.06 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
{9}------------------------------------------------
### Reproducibility (5-Day) Precision Study - Syringe & Capillary Modes
This study was performed as a substitute to the typical single run with twenty whole blood replicates. We chose to use the option allowed in the CLSI EP05-A3 protocol to run five replicates of whole blood for five days. All results were within specification.
| | Within-Run, 5-day w. Blood Study | | | | |
|---------|----------------------------------|-----|-------------|-------------|-------------|
| Analyte | Metric | | Level 1 | Level 2 | Level 3 |
| | Avg (mmHg) | | 39 | 78 | 223 |
| PO2 | SD (mmHg) | | 0.6 | 1.7 | 3.3 |
| | CV(%) | | 1.5 | 2.1 | 1.5 |
| | specification | | 2.5mmHg | 2.5mmHg | 3.0% |
| | Avg (mmHg) | | 36.9 | 67.4 | 132.6 |
| PCO2 | SD (mmHg) | | 0.5 | 1.3 | 2.7 |
| | CV(%) | | 1.3 | 1.9 | 2.1 |
| | specification | | 2.0% | 3.0% | 3.0% |
| | Avg (pH units) | | 7.410 | 7.216 | 7.588 |
| pH | SD (pH units) | | 0.007 | 0.010 | 0.007 |
| CV(%) | | 0.1 | 0.1 | 0.1 | |
| | specification | | 0.015 units | 0.015 units | 0.015 units |
Typical Repeatability Performance of the EasyStat 300 operating in "Syringe" mode
### Typical Reproducibility Performance of the EasyStat 300 operating in "Capillary" mode
| | Within-Run, 5-day w. Blood Study | | | |
|---------|----------------------------------|-------------|-------------|-------------|
| Analyte | Metric | Level 1 | Level 2 | Level 3 |
| PO2 | Avg (mmHg) | 39.7 | 80.8 | 225.2 |
| | SD (mmHg) | 0.9 | 1.1 | 2.2 |
| | CV(%) | 2.3 | 1.4 | 1 |
| | specification | 2.4mmHg | 3.0% | 3.0% |
| PCO2 | Avg (mmHg) | 36.0 | 65.9 | 131.1 |
| | SD (mmHg) | 0.91 | 1.91 | 2.62 |
| | CV(%) | 2.5 | 2.9 | 2 |
| | specification | 4.0% | 5.0% | 5.0% |
| pH | Avg (pH units) | 7.409 | 7.218 | 7.561 |
| | SD (pH units) | 0.008 | 0.011 | 0.006 |
| | CV(%) | 0.1 | 0.1 | 0.1 |
| | specification | 0.015 units | 0.015 units | 0.015 units |
#### Conclusion of Precision Studies
Medica's Total precision and Within-Run precision studies, demonstrate that the EasyStat 300 Blood-Gas/Electrolyte/metabolite analyzer is precise and true to Medica's performance specifications and comparable to the predicate device in this submission.
{10}------------------------------------------------
#### Linearity Study
This study followed the CLSI EP06-A protocol officially recognized by the FDA. The linearity performance on the EasyStat 300 was evaluated using nine (9) to eleven (11) spiked and diluted whole blood specimens to cover the reportable range for each analyte. The pre-assayed whole blood samples were finally tested in triplicate on three EasyStat 300 analyzers to establish the linearity performance for each analyte. The table below shows a summary of the obtained results that met all device specifications.
| Linearity Summary for one of the three EasyStat 300 analyzers operating in the "Syringe" mode | | | | | | | | | | |
|-----------------------------------------------------------------------------------------------|----------|-----------|-------|-----------|-------|-------|--|-----------|-------|-------|
| Analyte | Date | Predicate | ES300 | Syringe | | | | | | |
| | | | | Sensor 1 | | | | Sensor 2 | | |
| | | | | Linearity | Slope | R2 | | Linearity | Slope | R2 |
| PO2 | 12/26/19 | ES_4 | P7 | PASS | 1.016 | 0.999 | | | | |
| | | | P8 | PASS | 1.027 | 0.998 | | | | |
| | | | P17 | PASS | 1.013 | 0.999 | | | | |
| PCO2 | 12/26/19 | ES_3 | P7 | PASS | 1.066 | 0.999 | | | | |
| | | | P8 | PASS | 0.984 | 0.998 | | | | |
| | | | P17 | PASS | 0.983 | 0.996 | | | | |
| pH | 01/22/20 | ES_4 | P7 | PASS | 1.008 | 0.996 | | PASS | 1.011 | 0.996 |
| | | | P8 | PASS | 1.022 | 0.997 | | PASS | 0.981 | 0.997 |
| | | | P17 | PASS | 1.027 | 0.997 | | PASS | 1.061 | 0.997 |
#### Conclusion of Linearity Study
Data from the linearity study on three EasyStat 300 analyzers performed according to CLSI EP6-A demonstrate that all analytes (pH, pCO2, pO2) reported by the EasyStat 300 are linear within the advertised reportable range.
{11}------------------------------------------------
#### Method Comparison Study
This study followed the CLSI EP9-A2 protocol. For this study we used whole blood from more than 200 donors plus six modified whole blood samples (spiked and diluted). All blood samples were tested on the predicate devices twice and on three EasyStat 300 analyzers. Some samples were modified to achieve analyte levels covering the reportable range using tonometry.
In addition, the "Capillary" mode on The EasyStat 300 was evaluated against the "Capillary" mode on the predicate EasyStat analyzer using the same whole blood samples collected with the same capillary tubes.
#### Conclusion of the Method Comparison Study
Data from the Method Comparison study on three EasyStat 300 analyzers demonstrate that all analytes (pH, pCO2, pO2) reported by the EasyStat 300 are favorably correlated to the predicate/reference device selected for this study. For all analytes (pH, pCO2, pO2), the linear regression slope, the coefficient of variation, and the calculated predicted bias at the decision levels for each analyte were within specifications.
Typical correlation results for all analytes (pO2, pCO2, pH) are shown below:
{12}------------------------------------------------
Image /page/12/Figure/1 description: This image contains four scatter plots comparing PO2 measurements using different methods (Syringe vs. Capillary) and their corresponding absolute differences. The top two plots show linear regressions, while the bottom two display absolute differences between ES300 PO2 and EasyStat PO2. Each method includes a table summarizing statistical parameters such as 'n', slope, intercept, R-squared, standard error, predicted bias, 95% confidence interval, 100% total allowable error, and status for MDL values of 30, 45, and 60. The Syringe method has a sample size of 272, while the Capillary method has a sample size of 224.
## pO2 Method Comparison Analysis (Syringe & Capillary Modes)
{13}------------------------------------------------
Image /page/13/Figure/1 description: The image shows two scatter plots and a table comparing PCO2 measurement methods using a syringe. The first scatter plot, titled "PCO2 Method Comparison (Syringe), Linear Regression", plots ES300 PCO2 (Rep 1) against EasyStat PCO2 (Avg), with a linear regression line. The second scatter plot, titled "PCO2 Method Comparison (Syringe), Absolute Difference", plots the difference between ES300 PCO2 (Rep 1) and EasyStat PCO2 (Avg) against EasyStat PCO2 (Avg). The table provides statistical data, including n=265, Slope=1.040, Intercept=-1.159, R^2=0.992, and Std Error=1.326, as well as predicted bias, confidence intervals, allowable errors, and status for MDL values of 5.0, 62.5, and 150.0, all of which PASS.
### pCO2 Method Comparison Analysis (Syringe & Capillary Modes)
Image /page/13/Figure/3 description: The image contains two scatter plots comparing PCO2 measurement methods using capillary samples. The first plot, titled "PCO2 Method Comparison (Capillary), Linear Regression," shows a linear regression analysis with EasyStat PCO2 (Avg) on the x-axis and ES300 PCO2 (Rep 1) on the y-axis. The second plot, titled "PCO2 Method Comparison (Capillary), Absolute Difference," displays the absolute difference between the two methods against EasyStat PCO2 (Avg). The image also includes a table with statistical parameters such as n=219, Slope=0.943, Intercept=2.624, R^2=0.911, and Std Error=1.946.
Min
7.0
61.3
143.3
2.34
-0.94
-5.93
5.0
62.5
150.0
Max
7.6
61.8
144.8
Min
0.0
57.5
138.0
Max
10.0
67.5
162.0
PASS
PASS
PASS
510(k) Summary, k211559/S001
{14}------------------------------------------------
Image /page/14/Figure/1 description: The image shows a pH method comparison between a syringe and a capillary. There are four scatter plots in the image. The top two plots show a linear regression between the two methods, while the bottom two plots show the absolute difference between the two methods. There are also tables that show the slope, intercept, R^2, and standard error for each method, as well as the predicted bias, 95% confidence interval, and 100% total allowable error.
### pH Method Comparison Analysis (Syringe & Capillary Modes)
{15}------------------------------------------------
#### Sensitivity
The sensitivity study is used to validate the low end of the Reportable Range for a particular assay on the EasyStat 300. The study first establishes the Limit of Blank (LoB) that is the starting point for determining the Limit of Detection (LoD) and subsequently the Limit of Quantitation (LoQ).
The sensitivity study in this submission followed the guidelines from CLSI EP17-A. It was performed on three ES 300 analyzers covering the pH and blood gas sensors.
The following table lists the measured LoB, LoD, and LoQ for all analytes reported by the EasyStat 300 analyzer.
| Analyte | Type of sample used | LoB | LoD | LoQ | Lowest Detection Limit (LDL) | LoQ < LDL? |
|---------|----------------------|----------------|----------------|----------------|------------------------------|------------|
| pO2 | Tonometered w. Blood | 3 mmHg | 4 mmHg | 4 mmHg | 5 mmHg | Yes |
| pCO2 | Tonometered w. Blood | 2.8 mmHg | 4.6 mmHg | 4.6 mmHg | 5.0 mmHg | Yes |
| pH | Buffered Saline | 6.140 pH units | 6.498 pH units | 6.498 pH units | 6.800 pH units | Yes |
# Conclusion of the Sensitivity Study
The lower reportable limit for each assay on the EasyStat 300 was based on the LoQ result calculated or experimentally determined in this sensitivity studies indicate that the following values may be used as the lowest limit of the reportable range of each assay available on the EasyStat 300.
p02: 5 mmHg pCO2: 5.0 mmHg 6.800 units pH
{16}------------------------------------------------
### Selectivity
The selectivity (interference) study has followed in principle the guidelines from CLSI EP07-A. The level chosen is the typical normal value for a particular analyte in whole blood. All collected data are from spiked whole blood samples collected from healthy donors.
| | Interference | Test Level | Gas/pH<br>Level | pO2 | | pCO2 | | pH | |
|----|--------------------------|----------------|-----------------|--------------|---------|--------------|---------|------------------|-----------------|
| | | | | Change, mmHg | %Change | Change, mmHg | %Change | Change, pH Units | Conclusion |
| 1 | Acetaminophen | 15.6 mg/dL | A | 1.7 | 6.7 | 0.6 | 1.6 | 0.009 | No Interference |
| | | | B | 5.3 | 3.1 | 2.1 | 2.3 | 0.001 | No Interference |
| 2 | Albumin<br>(Protein) | 60 g/L | A | -0.3 | -0.55 | 0.4 | 1.2 | 0.029 | No Interference |
| | | | B | 3.3 | 2.1 | 1.0 | 1.1 | 0.027 | No Interference |
| 3 | Amoxicillin | 0.206 mM | A | -0.3 | -1.3 | 0.3 | 0.9 | -0.005 | No Interference |
| | | | B | -1.7 | -1.1 | 1.2 | 1.4 | 0.006 | No Interference |
| 4 | Aprotinin | 50 mg/L | A | -1.00 | -1.91 | -0.3 | -0.7 | 0.007 | No Interference |
| | | | B | 1.3 | 0.8 | 0.2 | 0.3 | 0.003 | No Interference |
| 5 | Atracurium | 50 mg/L | A | 0.0 | 0.0 | -0.2 | -0.7 | 0.016 | No Interference |
| | | | B | 1.3 | 0.8 | 0.4 | 0.4 | 0.001 | No Interference |
| 6 | Benzalkonium<br>chloride | 5 mg/L | A | -0.3 | -1.4 | -0.3 | -0.8 | 0.006 | No Interference |
| |…
