Predicate Devices

Reference Devices

EasyStat (K063376)

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard clinical chemistry analyzer using Ion Selective Electrodes (ISE) and basic statistical analysis (Levey-Jennings plots). There is no mention of AI, ML, or any advanced algorithms beyond standard analytical calculations.

Therapeutic

No
The device is an in vitro diagnostic (IVD) device used for quantitative measurements of electrolytes in blood samples to aid in diagnosis and treatment, rather than directly treating a disease condition.

Diagnostic

Yes
The "Intended Use" section explicitly states that the analyzer is designed "to aid in the diagnosis and treatment of patients with electrolyte and/or acid-base disturbances." This indicates its role in providing information for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical analyzer that uses Ion Selective Electrode (ISE) sensors and processes whole blood samples. It also mentions hardware components like a Reagent Module and the possibility of a barcode scanner.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The device is designed for "clinical laboratory use, making quantitative measurements of potassium (K+), ionized calcium (Ca++), and chloride (Cl-) in whole blood (arterial/venous) samples". It is intended "to aid in the diagnosis and treatment of patients with electrolyte and/or acid-base disturbances." This clearly indicates it is used to test samples taken from the human body to provide information for diagnostic purposes.
Device Description: It analyzes "venous and arterial whole blood samples" using "Ion Selective Electrode (ISE) sensors" to measure specific analytes. This is a typical method for in vitro diagnostic testing.
Performance Studies: The document describes various performance studies (Repeatability, Reproducibility, Linearity, Method Comparison, Sensitivity, Selectivity) conducted on whole blood samples and quality control materials. These studies are standard requirements for demonstrating the performance of an IVD device.
Quality Control: The document mentions the use of "Medica's EasyQC materials" and the requirement for "quality controls every day patient samples are analyzed" to "validate the performance of the analyzer." This is a crucial aspect of quality assurance for IVD devices.
Predicate Device: The mention of predicate devices (K963694; EasyLyte Calcium/Chloride) and a reference device (K063376; EasyStat) which are also IVD devices further supports that the EasyStat 300 falls under the IVD category.

All these points align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes

JFP, CGZ, CEM

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained technical laboratories / clinical laboratory setting

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Repeatability (5-day) and Reproducibility (20-day) Precision:

Study Type: Laboratory setting (Bench test) precision studies.
Sample Size: Not explicitly stated for whole blood, but "three EasyStat 300 analyzers" and "three EasyStat 300 analyzers for twenty days taking duplicate readings" were used for aqueous controls. For whole blood, "five replicates of whole blood for five days" were used.
Key Results:
- Aqueous Controls (20-Day Precision): All results were within specification. Tables provide detailed CV and SD for Cl-, Ca++, and K+ across three systems and multiple levels.
- Whole Blood Samples (5-Day Repeatability): All results were within specification. Tables provide detailed Avg, SD, and CV for Cl-, Ca++, and K+ across three systems and multiple levels ("Sensor 1 Sensor 2").
Conclusion: The EasyStat 300 analyzer is precise and true to Medica's performance specifications and comparable to the predicate devices.

Linearity Study:

Study Type: Linearity study following CLSI EP06-A protocol.
Sample Size: Nine (9) to eleven (11) spiked and diluted whole blood specimens, tested in triplicate on three EasyStat 300 analyzers.
Key Results: All analytes (Cl-, Ca++, K+) passed linearity tests within the advertised reportable range across all three EasyStat 300 analyzers and both sensors. Slope and R2 values were provided.
Conclusion: Data demonstrate that all analytes (K, Ca, Cl) reported by the EasyStat 300 are linear within the advertised reportable range.

Method Comparison Study:

Study Type: Method comparison study following CLSI EP9-A2 protocol.
Sample Size: 192 donors plus six modified whole blood samples (spiked and diluted).
Key Results:
- For K+, Cl-, and Ca++, linear regression analysis showed high R2 values (0.997 for K+, 0.981 for Cl-, 0.994 for Ca++).
- Predicted bias at decision levels for all analytes were within specifications, indicated as "PASS" for all listed MDLs.
Conclusion: All analytes (K, Ca, Cl) reported by the EasyStat 300 are favorably correlated to the reference device. Linear regression slope, coefficient of variation, and calculated predicted bias were within specifications.

Sensitivity Study:

Study Type: Sensitivity study following CLSI EP17-A guidelines.
Sample Size: Not explicitly stated, but performed on three ES 300.
Key Results: Established Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) for K+, Ca++, and Cl-. Lowest Detection Limits (LDL) were also provided, with LoQ being less than LDL for all.
- K+: LoB 0.17 mmol/L, LoD 0.20 mmol/L, LoQ 0.20 mmol/L, LDL 1.00 mmol/L.
- Ca++: LoB 0.25 mmol/L, LoD 0.25 mmol/L, LoQ 0.25 mmol/L, LDL 0.25 mmol/L.
- Cl-: LoB 2.4 mmol/L, LoD 3.1 mmol/L, LoQ 42.4 mmol/L, LDL 50.0 mmol/L.
Conclusion: The lowest reportable limits for each assay on the EasyStat 300 are 1.00 mmol/L for K+, 50.0 mmol/L for Cl-, and 0.25 mmol/L for Ca++.

Selectivity Study:

Study Type: Selectivity (interference) study following CLSI EPO7-A guidelines.
Sample Size: Not explicitly stated, but involves spiked whole blood samples from healthy donors.
Key Results:
- Table I lists numerous substances (e.g., Acetaminophen, Bilirubin, Ethanol) that showed "No Interference" on K, Cl, Ca sensors at specific concentrations.
- Table II lists substances that demonstrated interference:
  - Bromide: Significant positive interference on Chloride above 1.5 mmol/L.
  - Citrate: Significant negative interference on Chloride above 3.0 mmol/L.
  - Fluoride: Negative interference on Potassium above 63.2 µmol/L demonstrated.
  - Ibuprofen: Positive interference on Potassium observed.
  - Intralipid: Negative interference on Potassium observed.
  - Iodide: Significant positive Interference on Chloride above 0.55 mmol/L.
  - Thiocyanate: Significant positive interference on Chloride above 60 µmol/L.
  - Thiosulfate: Negative interference on Chloride observed.
  - pH: Significant negative interference on Ionized Calcium from high pH at and above 7.75 pH units.
Conclusion: Identified substances with and without interference on the listed analytes.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Sensitivity defined as LoB, LoD, LoQ.
LoB
K: 0.17 mmol/L
Ca: 0.25 mmol/L
Cl: 2.4 mmol/L

LoD
K: 0.20 mmol/L
Ca: 0.25 mmol/L
Cl: 3.1 mmol/L

LoQ
K: 0.20 mmol/L
Ca: 0.25 mmol/L
Cl: 42.4 mmol/L

Lowest Detection Limit (LDL)
K: 1.00 mmol/L
Ca: 0.25 mmol/L
Cl: 50.0 mmol/L

Method Comparison (Linear Regression Metrics)
K+
n: 198
Slope: 0.962
Intercept: 0.130
R2: 0.997
Std Error: 0.081
Predicted Bias at 3.00 MDL: 0.016 (PASS)
Predicted Bias at 5.80 MDL: -0.090 (PASS)
Predicted Bias at 7.50 MDL: -0.155 (PASS)

Cl-
n: 198
Slope: 1.007
Intercept: -0.378
R2: 0.981
Std Error: 0.995
Predicted Bias at 90.0 MDL: 0.25 (PASS)
Predicted Bias at 112.0 MDL: 0.41 (PASS)

Ca++
n: 198
Slope: 0.987
Intercept: -0.017
R2: 0.994
Std Error: 0.025
Predicted Bias at 0.37 MDL: -0.022 (PASS)
Predicted Bias at 0.82 MDL: -0.028 (PASS)
Predicted Bias at 1.58 MDL: -0.038 (PASS)

Predicate Device(s):

EasyLyte Calcium/Chloride (K963694)

Reference Device(s):

EasyStat (K063376)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.1600 Potassium test system.

(a)
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.(b)
Classification. Class II.

Summary

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: