Who is the manufacturer of EasyStat 300?

Medica Corporation filed the 510(k) submission for EasyStat 300 (K220396).

What is the FDA product code for EasyStat 300?

CEM. It is classified under 21 CFR 862.1600 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for EasyStat 300?

510(k) clearance (submission type: Traditional).

What are the predicate devices for EasyStat 300?

EasyLyte Calcium/Chloride Analyzer (K963694).

Who can help prepare an FDA 510(k) submission like EasyStat 300?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EasyStat 300

K220396 · Medica Corporation · CEM · Sep 26, 2023 · Clinical Chemistry

Device Facts

Record ID	K220396
Device Name	EasyStat 300
Applicant	Medica Corporation
Product Code	CEM · Clinical Chemistry
Decision Date	Sep 26, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1600
Device Class	Class 2

Intended Use

The EasyStat 300 is designed for clinical laboratory use, making quantitative measurements of potassium (K+), ionized calcium (Ca++), and chloride (Cl-) in whole blood (arterial/venous) samples from Li-Heparinized Syringes. This Analyzer should only be used by trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with electrolyte and/or acid-base disturbances. Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Calcium (Ca++) (ionized) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Device Story

EasyStat 300 is a clinical laboratory analyzer for rapid measurement of K+, Ca++, and Cl- in whole blood (175µL sample). It utilizes Ion Selective Electrode (ISE) sensors; automated calibration via Reagent Module (solutions A2, B2, C2) establishes sensor slopes. Operators use the device in clinical labs; results are used to monitor electrolyte balance and diagnose metabolic disorders. The system stores QC data (Levey-Jennings plots) and supports optional barcode scanning for sample entry. It provides calculated parameters based on measured electrolytes. Clinical benefit includes rapid, accurate electrolyte assessment to guide treatment of critical conditions like tetany or acidosis.

Clinical Evidence

Bench testing only. Studies included 5-day repeatability and 20-day reproducibility precision, linearity (CLSI EP06-A), method comparison (CLSI EP9-A2) against EasyStat (k063376) using 198 samples, sensitivity (CLSI EP17-A), and selectivity/interference testing. Results showed high correlation (R2 > 0.98) and precision within specifications for all analytes. No adverse effects reported.

Technological Characteristics

Ion Selective Electrode (ISE) sensing principle for potentiometric measurement of K+, Ca++, and Cl-. Aqueous calibrant base. Dimensions/form factor: clinical benchtop analyzer. Connectivity: USB (5 ports), Ethernet, RS232, SD card. Software: embedded system for automated calibration, QC tracking, and result calculation. Sensors have one-year shelf life.

Indications for Use

Indicated for patients requiring electrolyte monitoring for acid-base disturbances, parathyroid disease, bone disease, chronic renal disease, tetany, cystic fibrosis, or diabetic acidosis. For use with whole blood (arterial/venous) samples from Li-Heparinized Syringes. Contraindicated for patients taking perchlorate.

Regulatory Classification

Identification

A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Predicate Devices

EasyLyte Calcium/Chloride Analyzer (K963694)

Reference Devices

EasyStat 300 Analyzer (K211559)
K063376

Related Devices

K152327 — EasyLyte Na/K/Cl/Ca Analyzer · Medica Corporation · Dec 1, 2016
K102959 — PROLYTE ELECTROLYTE ANALYZER · Diamond Diagnostics, Inc. · Jan 14, 2011
K961458 — AVL 9180 ELECTROLYTE ANALYZER · Avl Scientific Corp. · Jun 12, 1996
K121040 — SMARTLYTE ELECTROLYTE ANALYZER · Diamond Diagnostics, Inc. · Aug 30, 2012

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 26, 2023 Medica Corporation Photios Makris VP Regulatory Affairs 5 Oak Park Drive Bedford, MA 01730 Re: K220396 Trade/Device Name: EasyStat 300 Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium Test System Regulatory Class: Class II Product Code: JFP, CGZ, CEM Dated: December 1, 2022 Received: December 2, 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 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, # Paula V. Caposino -S Paula Caposino, Ph.D. Acting Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) k220396 Device Name EasyStat 300 #### Indications for Use (Describe) The EasyStat 300 is designed for clinical laboratory use, making quantitative measurements of potassium (K+), ionized calcium (Ca++), and chloride (Cl-) in whole blood (arterial/venous) samples from Li-Heparinized Syringes. This Analyzer should only be used by trained technical laboratories to aid in the dagnosis and treatment of patients with electrolyte and/or acid-base disturbances. Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Calcium (Ca++) (ionized) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. | 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) | CONTINUE ON A SEPARATE PAGE IF NEEDEDThis 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 for k220396 ### 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 E-mail: pmakris@medicacorp.com #### Summary Prepared: September 24th, 2023 #### Trade Name: EasyStat 300 Common Name: Blood Gas Analyzer Classification Name: Potassium, chloride, Calcium Test Systems #### Regulatory Information: #### EasyStat 300 | Description | Regulation No. | Device Class | Product Code | |-----------------------|----------------|--------------|--------------| | Potassium Test system | 862.1600 | II | CEM | | Calcium Test System | 862.1145 | II | JFP | | Chloride Test System | 862.1170 | II | CGZ | #### Predicate devices: EasyLyte Calcium/Chloride (k963694) | Description | 510(k) | Device Class | Product Code | |----------------------|----------|--------------|--------------| | Calcium Test System | 862.1145 | II | JFP | | Chloride Test System | 862.1170 | II | CGZ | {4}------------------------------------------------ # Device Description: The EasyStat 300 is a system for use by health care professionalsto rapidly analyze venous and arterial whole blood samples in a clinical laboratory setting. The analyzer incorporates a Reagent Module containing the "calibrating" solutions A2, B2, and a "conditioning" solution C2. 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 analyzer employs "Ion Selective Electrode" (ISE) sensors for K*, Ca**, Cl¯. The EasyStat 300 uses 175µL of whole blood in the "Syringe" mode to analyze patient samples. The EasyStat 300 reports results for Potassium (K+), Calcium (Ca++), Chloride (Cl-). 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. Medica's EasyQC materials (REF 8315/8316/8317) are specifically formulated for the EasyStat 300. Medica requires the use of quality controls every day 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 Reagent Module (REF 8101) has a twelve-month shelf-life when stored at 4º-25ºC. The electrolyte sensors (K, Ca, Cl) have one-year shelf-life when stored at 4º-25ºC. 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 information. 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. {5}------------------------------------------------ # Similarities and Differences to Predicate: | | EasyStat 300 | EasyLyte calcium/Chloride | |----------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------| | 510(k) Number | New IVD Device | K963694 | | 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 | Ion Specific Electrodes | Ion Specific Electrodes | | Ca++ | Potentiometric | Potentiometric | | Cl- | Potentiometric | Potentiometric | | Calibrant Base | Aqueous | Aqueous | | Measured Parameters on Predicate Utilized for Submission | K+, Ca++, Cl- | Ca++, Cl- | | Sample Type | Whole Blood | Whole Blood | | Sample Volume | 175µL Syringe | 100µL Syringe | | Analysis Time | 110 seconds | 55 seconds | | Measured Range | | | | Ca++ | 0.25-5.00 mmol/L | 0.10-6.00 mmol/L | | Cl- | 50.0 150.0 mM/L | 25.0 200.0 mM/L | | Communication Ports | USB (5), 1 for Barcode reader Ethernet (1) RS232 Serial (1) SD card port (1) N/A | None RS232 Serial(1) None Barcode Reader | #### Similarities and Differences Between Devices Used in this Notification {6}------------------------------------------------ #### Indications for Use: The EasyStat 300 is designed for clinical laboratory use, making quantitative measurements of potassium (K+), ionized calcium (Ca++), and chloride (Cl-) in whole blood (arterial/venous) samples from Li-Heparinized Syringes. This analyzer should only be used by trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with electrolyte and/or acid-base disturbances. Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Calcium (Ca++) (ionized) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms), Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. # Performance Summary: The following studies were performed in a laboratory setting (Bench test) using venous whole blood from adult volunteers. There were no adverse effects or safety concerns during any of the studies. Summaries of the studies are presented here. Repeatability (5-day) and Reproducibility (20-day) Precision: Linearity Method Comparison Sensitivity Selectivity: # Performance Conclusions: Clinical and Non-clinical (bench) test data included in this submission, indicate that the new device (EasyStat 300) performs equivalently to the predicate device (EasyStat-Cl). {7}------------------------------------------------ # 20-Day Precision Study – 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. | | | | | Performance Specs | | Actual Performance | | | | | | System 2 - P22 | | | | | | System 3 - P23 | | | | | | |---------|-------------------------------|---|-------|----------------------|--------|--------------------|------|------|-------|------|------|----------------|------|------|-------|------|------|----------------|------|------|-------|------|-----| | Analyte | Precision Estimate | | | Level | Target | SD | CV | Mean | SD | CV | Mean | SD | CV | Mean | SD | CV | Mean | SD | CV | Mean | SD | CV | | | Cl- | Repeatability (Within-Run) | 1 | 79.0 | 2.0 | | 79.2 | 0.04 | | 79.2 | 0.05 | | 79.2 | 0.04 | | 79.3 | 0.04 | | 79.0 | 0.05 | | 79.1 | 0.04 | | | | | 2 | 102.0 | | 1.5% | 101.3 | | 0.0 | 101.4 | | 0.0 | 101.3 | | 0.1 | 101.5 | | 0.0 | 101.5 | | 0.0 | 101.5 | | 0.1 | | | | 3 | 130.0 | | 1.7% | 129.7 | | 0.1 | 129.8 | | 0.0 | 129.7 | | 0.1 | 129.8 | | 0.1 | 130.3 | | 0.1 | 130.4 | | 0.1 | | | Within- Device (Total) | 1 | 79.0 | 2.5 | | 79.2 | 0.13 | | 79.2 | 0.13 | | 79.2 | 0.16 | | 79.3 | 0.16 | | 79.0 | 0.24 | | 79.1 | 0.24 | | | | | 2 | 102.0 | | 1.8% | 101.3 | | 0.1 | 101.4 | | 0.1 | 101.3 | | 0.1 | 101.5 | | 0.1 | 101.5 | | 0.1 | 101.5 | | 0.1 | | | | 3 | 130.0 | | 2.0% | 129.7 | | 0.1 | 129.8 | | 0.1 | 129.7 | | 0.1 | 129.8 | | 0.1 | 130.3 | | 0.1 | 130.4 | | 0.1 | | Ca++ | Repeatability (Within-Run) | 1 | 1.72 | | 2.0% | 1.72 | | 0.1 | 1.72 | | 0.2 | 1.72 | | 0.2 | 1.72 | | 0.2 | 1.73 | | 0.2 | 1.73 | | 0.2 | | | | 2 | 1.10 | | 2.0% | 1.10 | | 0.0 | 1.10 | | 0.0 | 1.10 | | 0.0 | 1.10 | | 0.0 | 1.12 | | 0.3 | 1.12 | | 0.4 | | | | 3 | 0.52 | 0.02 | | 0.52 | 0.00 | | 0.52 | 0.00 | | 0.52 | 0.00 | | 0.52 | 0.00 | | 0.53 | 0.00 | | 0.53 | 0.00 | | | | | 1 | 1.72 | | 2.5% | 1.72 | | 0.1 | 1.72 | | 0.2 | 1.72 | | 0.2 | 1.72 | | 0.3 | 1.73 | | 0.3 | 1.73 | | 0.3 | | | Within- Device (Total) | 2 | 1.10 | | 2.5% | 1.10 | | 0.0 | 1.10 | | 0.0 | 1.10 | | 0.0 | 1.10 | | 0.0 | 1.12 | | 0.4 | 1.12 | | 0.5 | | | | 3 | 0.52 | 0.03 | | 0.52 | 0.00 | | 0.52 | 0.00 | | 0.52 | 0.00 | | 0.52 | 0.00 | | 0.53 | 0.00 | | 0.53 | 0.00 | | | K+ | | 1 | 2.66 | 0.07 | | 2.67 | 0.00 | | 2.66 | 0.00 | | 2.64 | 0.00 | | 2.65 | 0.00 | | 2.70 | 0.00 | | 2.70 | 0.00 | | | | Repeatability (Within-Run) | 2 | 4.25 | | 1.5% | 4.28 | | 0.1 | 4.26 | | 0.1 | 4.24 | | 0.2 | 4.24 | | 0.2 | 4.31 | | 0.1 | 4.31 | | 0.1 | | | | 3 | 6.00 | | 2.0% | 6.03 | | 0.1 | 6.00 | | 0.1 | 5.99 | | 0.2 | 5.97 | | 0.3 | 6.07 | | 0.1 | 6.07 | | 0.2 | | K+ | | 1 | 2.66 | 0.10 | | 2.67 | 0.00 | | 2.66 | 0.01 | | 2.64 | 0.01 | | 2.65 | 0.01 | | 2.70 | 0.01 | | 2.70 | 0.01 | | | | Within- | 2 | 4.25 | | 2.0% | 4.28 | | 0.1 | 4.26 | | 0.2 | 4.24 | | 0.2 | 4.24 | | 0.3 | 4.31 | | 0.2 | 4.31 | | 0.3 | | | Device (Total) | 3 | 6.00 | | 2.5% | 6.03 | | 0.1 | 6.00 | | 0.2 | 5.99 | | 0.2 | 5.97 | | 0.3 | 6.07 | | 0.4 | 6.07 | | 0.4 | {8}------------------------------------------------ # Repeatability (5-Day) Study – Whole blood samples This study was performed as a substitute to the typical single run with twenty whole blood replicated by the instability of potassium within the time required to complete the study (about 90 minutes). Instead, 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 Precision from 5-Day Study - Syringe Mode - Table A | | | | | | | | | | | | | | | | | | | | | | | |---------|----------------------------------------------------------------|----------|-------|----------|---------|----------|-----------------------------------------------------|------|-------|-------------------|-------|----------|-------|---------------------------------------|------|----------|--------|----------|-------|----------|----------------------------|------|--| | | Stat | | | | Level 1 | | | | | | | Level 2 | | | | Level 3 | | | | | | | | | Analyte | | System 1 | | System 2 | | System 3 | | Spec | | System 1 | | System 2 | | System 3 | | System 1 | | System 2 | | System 3 | | | | | | | | | | | | Sensor 1 Sensor 2 Sensor 1 Sensor 2 Sensor 1 Sensor | | | Sensor 1 Sensor 2 | | | | 2 Sensor 1 Sensor 2 Sensor 1 Sensor 2 | Spec | Sensor 1 | Sensor | Sensor 1 | | | Sensor 2 Sensor 1 Sensor 2 | Spec | | | | Avg | 73.8 | 73.8 | 73.9 | 74.0 | 73.7 | 73.7 | | 100.8 | 100.6 | 101.6 | 101.4 | 101.3 | 101.1 | | 121.7 | 121.5 | 123.0 | 122.7 | 123.0 | 122.7 | | | | CI- | SD | 0.24 | 0.28 | 0.35 | 0.37 | 0.22 | 0.25 | 2.0 | 0.25 | 0.23 | 0.27 | 0.26 | 0.17 | 0.15 | | 0.17 | 0.21 | 0.24 | 0.21 | 0.19 | 0.22 | | | | | CV | 0.3 | 0.4 | 0.5 | 0.5 | 0.3 | 0.3 | | 0.2 | 0.2 | 0.3 | 0.3 | 0.2 | 0.1 | 1.5 | 0.1 | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 | 1.7 | | | | Avg | 0.44 | 0.44 | 0.45 | 0.44 | 0.45 | 0.44 | | 1.28 | 1.28 | 1.29 | 1.28 | 1.29 | 1.29 | | 2.43 | 2.43 | 2.42 | 2.40 | 2.45 | 2.45 | | | | Ca++ | SD | 0.001 | 0.001 | 0.000 | 0.001 | 0.000 | 0.001 | 0.02 | 0.003 | 0.002 | 0.005 | 0.006 | 0.005 | 0.006 | | 0.0009 | 0.012 | 0.013 | 0.024 | 0.009 | 0.018 | | | | | CV | 0.2 | 0.2 | 0.0 | 0.2 | 0.0 | 0.2 | | 0.2 | 0.2 | 0.4 | 0.5 | 0.4 | 0.5 | 2.0 | 0.4 | 0.5 | 0.5 | 1.0 | 0.4 | 0.7 | 2.0 | | | | Avg | 2.15 | 2.15 | 2.18 | 2.18 | 2.18 | 2.18 | | 4.60 | 4.60 | 4.62 | 4.58 | 4.62 | 4.57 | | 7.79 | 7.81 | 7.81 | 7.68 | 7.81 | 7.71 | | | | K+ | SD | 0.007 | 0.008 | 0.007 | 0.008 | 0.008 | 0.006 | 0.07 | 0.025 | 0.020 | 0.022 | 0.021 | 0.025 | 0.026 | | 0.061 | 0.061 | 0.057 | 0.062 | 0.068 | 0.093 | | | | | CV | 0.3 | 0.4 | 0.3 | 0.4 | 0.4 | 0.3 | | 0.5 | 0.4 | 0.5 | 0.5 | 0.6 | 0.6 | 1.5 | 0.7 | 0.8 | 0.7 | 0.8 | 0.9 | 1.2 | 2.0 | | Typical Precision Performance of the EasyStat 300 operating in "Syringe" mode # Conclusion of Precision Studies Medica's Total precision and Within-Run precision studies, demonstrate that the EasyStat 300 analyzer is precise and true to Medica's performance specifications and comparable to the predicate devices in this submission. {9}------------------------------------------------ # 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 operating in the "Syringe" mode | | | | | | | | | | |-------------------------------------------------------------------------------------|----------|-----------|-------|-----------|-------|-------|-----------|-------|-------| | Analyte | Date | Predicate | ES300 | Sensor 1 | | | Sensor 2 | | | | | | | | Linearity | Slope | R2 | Linearity | Slope | R2 | | Cl- | 12/27/19 | ES_3 | P1 | PASS | 0.948 | 1.000 | PASS | 0.947 | 0.999 | | Cl- | 12/27/19 | ES_3 | P2 | PASS | 0.968 | 1.000 | PASS | 0.960 | 1.000 | | Cl- | 12/27/19 | ES_3 | P4 | PASS | 0.971 | 1.000 | PASS | 0.964 | 1.000 | | Ca++ | 12/12/19 | ES_2 | P1 | PASS | 0.970 | 1.000 | PASS | 0.989 | 0.999 | | Ca++ | 12/12/19 | ES_2 | P2 | PASS | 0.984 | 1.000 | PASS | 0.982 | 1.000 | | Ca++ | 12/12/19 | ES_2 | P4 | PASS | 0.962 | 1.000 | PASS | 0.981 | 1.000 | | K+ | 12/12/19 | ES_2 | P1 | PASS | 0.976 | 0.999 | PASS | 0.981 | 0.999 | | K+ | 12/12/19 | ES_2 | P2 | PASS | 0.983 | 1.000 | PASS | 0.962 | 1.000 | | K+ | 12/12/19 | ES_2 | P4 | PASS | 0.978 | 0.999 | PASS | 0.977 | 1.000 | # Conclusion of Linearity Study Data from the linearity study on three EasyStat 300 analyzers performed according to CLSI EP6-A demonstrate that all analytes (K, Ca, Cl) reported by the EasyStat 300 are linear within the advertised reportable range. # Method Comparison Study This study followed the CLSI EP9-A2 protocol. For this study we used whole blood from 192 donors plus six modified whole blood samples (spiked and diluted). All blood samples were tested on the reference device twice and on three EasyStat 300 analyzers in duplicate. Some samples were modified to achieve analyte levels covering the reportable range. The samples were spiked with salts or diluted using plasma diluted with saline from the same donor. For electrolytes the reference analyzer was the EasyStat, k063376. {10}------------------------------------------------ # Conclusion of the Method Comparison Study Data from the Method Comparison study on three EasyStat 300 demonstrates that all analytes (K, Ca, Cl) reported by the EasyStat 300 are favorably correlated to the reference device selected for this study. For all analytes, 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 are shown below: Image /page/10/Figure/3 description: The image is a scatter plot titled "K+ Method Comparison (Syringe), Linear Regression". The x-axis is labeled "EasyStat K+ (Avg), mmol/L" and ranges from 0.00 to 20.00. The y-axis is labeled "ES300 K+ (Rep 1), mmol/L" and ranges from 0.00 to 20.00. A black line of best fit is plotted through the data points. | n | Slope | Intercept | R2 | Std Error | |-----|-------|-----------|-------|-----------| | 198 | 0.962 | 0.130 | 0.997 | 0.081 | | MDL | Predicted Bias | 95% Confidence Interval | | 100% Total Allowable Error | | Status | |------|-------------------|-------------------------|------|-------------------------------|------|--------| | | | Min | Max | Min | Max | | | 3.00 | 0.016 | 3.01 | 3.02 | 2.50 | 3.50 | PASS | | 5.80 | -0.090 | 5.70 | 5.72 | 5.30 | 6.30 | PASS | | 7.50 | -0.155 | 7.33 | 7.36 | 7.00 | 8.00 | PASS | {11}------------------------------------------------ Image /page/11/Figure/0 description: The image is a scatter plot titled "Cl- Method Comparison (Syringe), Linear Regression". The x-axis is labeled "EasyStat Cl- (Avg), mmol/L" and ranges from 50.0 to 150.0. The y-axis is labeled "ES300 Cl- (Rep 1), mmol/L" and ranges from 50.0 to 150.0. There is a black line of best fit going through the data points. | n | Slope | Intercept | R2 | Std Error | |-----|-------|-----------|-------|-----------| | 198 | 1.007 | -0.378 | 0.981 | 0.995 | | MDL | Predicted Bias | 95% Confidence Interval | | 100% Total Allowable Error | | Status | |-------|-------------------|-------------------------|-------|-------------------------------|-------|--------| | | | Min | Max | Min | Max | | | 90.0 | 0.25 | 90.1 | 90.4 | 85.5 | 94.5 | PASS | | 112.0 | 0.41 | 112.3 | 112.5 | 106.4 | 117.6 | PASS | Image /page/11/Figure/3 description: The image is a scatter plot titled "Ca++ Method Comparison (Syringe), Linear Regression". The x-axis is labeled "EasyStat Ca++ (Avg), mmol/L" and ranges from 0.00 to 5.00. The y-axis is labeled "ES300 Ca++ (Rep 1), mmol/L" and ranges from 0.00 to 5.00. There is a black line of best fit going through the data points. | n | Slope | Intercept | R 2 | Std Error | |-----|-------|-----------|---------|-----------| | 198 | 0.987 | -0.017 | 0.994 | 0.025 | | MDL | Predicted Bias | 95% Confidence Interval | | 100% Total Allowable Error | | Status | |------|-------------------|-------------------------|------|-------------------------------|------|--------| | | | Min | Max | Min | Max | | | 0.37 | -0.022 | 0.34 | 0.35 | 0.27 | 0.47 | PASS | | 0.82 | -0.028 | 0.79 | 0.79 | 0.72 | 0.92 | PASS | | 1.58 | -0.038 | 1.54 | 1.54 | 1.42 | 1.74 | PASS | {12}------------------------------------------------ # 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 covering the electrolyte (K*, Cl¯, Ca**) sensors. The following table lists the measured LoB, LoD, and LoQ for all analytes reported by the EasyStat 300. | Analyte | LoB | LoD | LoQ | Lowest Detection Limit (LDL) | LoQ < LDL? | |---------|-------------|-------------|-------------|---------------------------------|------------| | K | 0.17 mmol/L | 0.20 mmol/L | 0.20 mmol/L | 1.00 mmol/L | Yes | | Ca | 0.25 mmol/L | 0.25 mmol/L | 0.25 mmol/L | 0.25 mmol/L | Yes | | Cl | 2.4 mmol/L | 3.1 mmol/L | 42.4 mmol/L | 50.0 mmol/L | 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. K+: 1.00 mmol/L Cl-: 50.0 mmol/L Ca++: 0.25 mmol/L {13}------------------------------------------------ # Selectivity The selectivity (interference) study has followed in principle the guidelines from CLSI EPO7-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. Analyte changes less than the Total Allowable error (TAE) of nominal value are marked as "No Interference". | Substance | Concentration | K+ (mmol/L) No Interference when change <0.30 mmol/Lor < ±7% | Cl- (mmol/L No Interference when change < ±5.0 mmol/L | Ca++ (mmol/L No Interference when change <0.10 mmol/Lor < ±10% | No Interference on the listed sensors | |---------------|---------------|-----------------------------------------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------| | | | 3.90 | 104.6 | 1.14 | K, Cl, Ca | | Acetaminophen | 16 mg/dL | 1.50 | 78.0 | 0.57 | K, Cl, Ca | | Ammonium | | 4.79 | n/a* | 1.20 | K, Ca | | (Chloride) | 0.151 mmol/L | 2.33 | n/a* | 0.65 | K, Ca | | Benzalkonium | | 3.75 | n/a* | 1.24 | K, Ca | | (Chloride) | 5 mg/L | 1.52 | n/a* | 0.59 | K, Ca | | Bromide | | 4.15 | n/a** | 1.16 | K, Ca | | (Sodium) | 37.5 mmol/L | 2.44 | n/a** | 0.72 | K, Ca | | | | 4.30 | 101.9 | 1.10 | K, Cl, Ca | | Bilirubin | 20 mg/dL | 1.73 | 83.4 | 0.62 | K, Cl, Ca | | Calcium | | 3.91 | n/a* | n/a* | K | | (Chloride) | 5.0 mmol/L | 1.78 | n/a* | n/a* | K | | Citrate *** | | 4.25 | n/a** | n/a*** | K | | (Sodium) | 12 mmol/L | 1.90 | n/a** | n/a*** | K | | | | 4.72 | 99.9 | 1.23 | K, Cl, Ca | | Ethanol | 130 mmol/L | 1.74 | 79.2 | 0.56 | K, Cl, Ca | | Fluoride | | n/a** | 102.8 | 1.22 | Cl, Ca | | (Sodium) | 63.2 umol/L | n/a** | 79.9 | 0.57 | Cl, Ca | | | | 4.19 | 103.5 | 1.32 | K, Cl, Ca | | Heparin-Na | 300 U/dL | 1.45 | 76.2 | 0.57 | K, Cl, Ca | | Hydroxy Urea | | 3.80 | 101.9 | 1.20 | K, Cl, Ca | | | 3.08 mg/dL | 1.54 | 78.2 | 0.59 | K, Cl, Ca | | | | n/a** | 104.5 | 1.17 | Cl, Ca | | Ibuprofen | 1.06 mmol/L | n/a** | 82.6 | 0.56 | Cl, Ca | | | | n/a** | 89.2 | 1.00 | K, Cl, Ca | | Intralipid | 2% | n/a** | 68.7 | 0.35 | K, Cl, Ca | | Iodide | | n/a | n/a** | 1.23 | Ca | | (Potassium) | 3.0 mmol/L | n/a | n/a** | 0.58 | Ca | | Ipratropium | 0.08 mg/L | 3.94 | 104.0 | 1.18 | K, Cl, Ca | | (Bromide) | | 1.54 | 81.5 | 0.54 | K, Cl, Ca | | Lithium | 3.2 mmol/L | 4.04 | n/a | 1.18 | K, Ca | | (Chloride) | | 1.63 | n/a* | 0.49 | K, Ca | | Magnesium | | 4.08 | n/a* | 1.20 | K, Ca | | (Chloride) | 4.1 mmol/L | 1.59 | n/a* | 0.56 | K, Ca | | Oxalate | 90 umol/L | n/a* | 104.9 | 1.18 | Cl, Ca | | (Potassium) | | n/a* | 80.9 | 0.57 | Cl, Ca | | | | | | | | | | | 4.23 | 106.9 | n/a** | K, Cl | | pH | 8.0 units | 1.87 | 85.8 | n/a** | K, Cl | | (Sodium) | | 4.14 | 105.6 | 1.21 | K, Cl, Ca | | Perchlorate | 6 mg/dL | 1.62 | 77.5 | 0.58 | K, Cl, Ca | | (Sodium) | | 4.30 | 105.4 | 1.20 | K, Cl, Ca | | Salicylate | 0.207 mmol/L | 1.71 | 79.2 | 0.57 | K, Cl, Ca | | Na | | 3.70 | n/a | ો : 15 | K, Ca | | (Chloride) | 170 mmol/L | 1.67 | n/a | 0.59 | K, Ca | | Thiocyanate | | n/a* | n/a* | 1.12 | Ca | | (Potassium) | 898 umol/L | n/a* | n/a* | 0.52 | Ca | | Thiocyanate | 600 umol/L | 3.75 | n/a** | n/a* | K | | (Sodium) | 600 umol/L | 2.07 | n/a** | n/a* | K | Table I below lists substances that were tested with no interference on the listed analytes. {14}------------------------------------------------ (*) Not tested for this analyte. (**) See Table II (***) Citrate is a strong binding substance to ionized calcium. Table II below lists substances the demonstrated interference with the listed analyte results. The table also provides the concentrations of the interferant level, the bias observed, and the direction (Positive/Negative). | Interfering Substance | Affected Analyte | Analyte concentration | Interferant Concentration Tested | Bias observed | Comments | | |--------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | Bromide | Chloride Interference when change > ±5mmol/L or±5%) | 105 mmol/L 82 mmol/L 121 mmol/L | 1.5 1.5 37.5 | + 4.2mmol/L + 4.2mmol/L + 49 mmol/L | No significant interference (<±5mmol/L or±5%) Significant positive interference from Bromide above 1.5 mmol/L | | | | Citrate (see note) | Chloride Interference when change > ±5mmol/L or±5%) | 103 mmol/L 80 mmol/L 103 mmol/L 103 mmol/L | 3.0 mmol/L 3.0 mmol/L 6.0 mmol/L 9.0 mmol/L | - 3.0 mmol/L - 3.0 mmol/L -7.0 mmol/L -10.5 mmol/L | No significant interference (<±5mmol/L or ± 5%) Significant negative interference from citrate above 3.0 mmol/L | | | | Fluoride | Potassium Interference when change >0.3 mmol/L or > ± 7% | 1.42 mmol/L 1.93 mmol/L 4.3 mmol/L | 55.0 µmol/L 63.2 µmol/L 63.2 µmol/L | -0.014 mmol/L -0.3 mmol/L -0.4 mmol/L | | Ibuprofen | | | Potassium Interference when change >0.3 mmol/L or > ± 7% | 3.85 mmol/L 2.13 mmol/L 4.75 mmol/L 1.83 mmol/L | 1.0 mmol/L 1.0 mmol/L 1.06 mmol/L 1.06 mmol/L | +0.11 mmol/L +0.15 mmol/L +0.5 mmol/L +0.08 mmol/L | | | Intralipid | | Potassium Interference when change >0.3 mmol/L or > ± 7% | 1.45 mmol/L 3.67 mmol/L 4.6 mmol/L 1.24 mmol/L 6.6 mmol/L | 1gr/dL (1%) 1gr/dL (1%) 1.5gr/dL (1.5%) 2gr/dL (2%) 2gr/dL (2%) | -0.07 mmol/L -0.02 mmol/L -0.75 mmol/L -0.18 mmol/L -2.4 mmol/L | | Iodide | | Chloride Interference when change > ± 5mmol/L or ± 5%) | 84 mmol/L 103 mmol/L 103.0 mmol/L | 0.55 mmol/L 0.65 mmol/L 3.0 mmol/L | +3.6 mmol/L +4.7 mmol/L +10 mmol/L | No significant interference (<±5mmol/L or±5%) | {15}------------------------------------------------ | | > ± 5mmol/L or ± 5%) | 78.9 mmol/L | 3.0 mmol/L | +18.8 mmol/L | Significant positive interference from iodide above 0.55 mmol/L | |-------------|--------------------------------------------------------------------------------|-------------|------------|--------------|---------------------------------------------------------------------------------| | | Chloride Interference | 82.8 mmol/L | 600 µmol/L | +4.4 mmol/L | No significant interference (<± 5mmol/L or ± 5%) | | Thiocyanate | when change > ± 5mmol/L or ± 5%) | 82.0 mmol/L | 898 µmol/L | +11.8 mmol/L | Significant positive interference from thiocyanate above 60 µmol/L | | | Chloride Interference | 84 mmol/L | 5 mmol/L | -2.1 mmol/L | No significant interference (<± 5mmol/L or ± 5%) | | Thiosulfate | when change > ± 5mmol/L or ± 5%) | 80.1 mmol/L | 20 mmol/L | -8.1 mmol/L | | | | Potassium Interference when change >0.3 mmol/L or > ± 7% | 3.9 mmol/L | 5 mmol/L | -0.12 mmol/L | No significant interference (<±0.3 mmol/L or ± 7%) | | Thiosulfate | | 4.64 mmol/L | 10 mmol/L | -0.23 mmol/L | | | | Ionized Calcium Interference when change >0.1 mmol/L or > ± 10% | 1.22 mmol/L | 5 mmol/L | -0.07 mmol/L | No significant interference (<±0.1 mmol/L or ± 10%) | | Thiosulfate | | 0.53 mmol/L | 5 mmol/L | -0.01 mmol/L | | | pH | Ionized Calcium Interference when change >0.1 mmol/L or > ± 10% | 1.15 mmol/L | 7.75 Units | -0.12 mmol/L | Significant negative interference from high pH at and above 7.75 pH units | Note: Citrate is a strong binding substance to ionized calcium similar to EDTA # Performance Conclusions: The technological and functional characteristics of the new EasyStat 300 described in the 510(k) summary are substantially equivalent to that of the reference device EasyStat-Cl (k063376) for K*, Cl¯, and Ca**. The analytical study results demonstrate the EasyStat 300 is safe and effective for its intended purpose and equivalent in performance to the reference device.