(592 days)
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.
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.
Here's an analysis of the provided text to extract the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance studies (Precision, Linearity, Method Comparison, Sensitivity, Selectivity) and lists specifications or desired outcomes that serve as acceptance criteria. The actual performance is described within each study's results.
Note: The document does not explicitly present a "table of acceptance criteria and reported device performance" as a single, consolidated table. I will construct it based on the details provided in different sections.
| Study Type | Analyte | Acceptance Criteria / Performance Specification | Reported Device Performance (Summary from text) |
|---|---|---|---|
| 20-Day Precision (Aqueous Controls) | Cl- (Repeatability) | Level 1: SD 2.0 | Level 1: SD ~0.04-0.05 |
| Cl- (Repeatability) | Level 2: 1.5% CV | Level 2: CV ~0.0% | |
| Cl- (Repeatability) | Level 3: 1.7% CV | Level 3: CV ~0.1% | |
| Cl- (Within-Device Total) | Level 1: SD 2.5 | Level 1: SD ~0.13-0.24 | |
| Cl- (Within-Device Total) | Level 2: 1.8% CV | Level 2: CV ~0.1% | |
| Cl- (Within-Device Total) | Level 3: 2.0% CV | Level 3: CV ~0.1% | |
| Ca++ (Repeatability) | Level 1: 2.0% CV | Level 1: CV ~0.1-0.2% | |
| Ca++ (Repeatability) | Level 2: 2.0% CV | Level 2: CV ~0.0-0.4% | |
| Ca++ (Repeatability) | Level 3: SD 0.02 | Level 3: SD ~0.00 | |
| Ca++ (Within-Device Total) | Level 1: 2.5% CV | Level 1: CV ~0.1-0.3% | |
| Ca++ (Within-Device Total) | Level 2: 2.5% CV | Level 2: CV ~0.0-0.5% | |
| Ca++ (Within-Device Total) | Level 3: SD 0.03 | Level 3: SD ~0.00 | |
| K+ (Repeatability) | Level 1: SD 0.07 | Level 1: SD ~0.00 | |
| K+ (Repeatability) | Level 2: 1.5% CV | Level 2: CV ~0.1-0.2% | |
| K+ (Repeatability) | Level 3: 2.0% CV | Level 3: CV ~0.1-0.3% | |
| K+ (Within-Device Total) | Level 1: SD 0.10 | Level 1: SD ~0.00-0.01 | |
| K+ (Within-Device Total) | Level 2: 2.0% CV | Level 2: CV ~0.1-0.3% | |
| K+ (Within-Device Total) | Level 3: 2.5% CV | Level 3: CV ~0.1-0.4% | |
| 5-Day Repeatability (Whole Blood) | Cl- | All results within specification (implied from 20-day aqueous specs, though not explicitly restated for whole blood) | CVs generally 0.1-0.5% |
| Ca++ | All results within specification | CVs generally 0.2-1.0% (SDs 0.000-0.024) | |
| K+ | All results within specification | CVs generally 0.3-1.2% (SDs 0.006-0.093) | |
| Linearity Study | Cl-, Ca++, K+ | All analytes linear within the advertised reportable range (PASS in table) | All analytes demonstrated linearity with R2 values close to 1.000 (e.g., K+ 0.999-1.000, Ca++ 0.999-1.000, Cl- 0.999-1.000) |
| Method Comparison Study | K+ (e.g. at 3.00 MDL) | Predicted Bias within 95% Confidence Interval and within 100% Total Allowable Error | Bias 0.016 (CI 3.01-3.02), Total Allowable Error 2.50-3.50. Status: PASS |
| Cl- (e.g. at 90.0 MDL) | Predicted Bias within 95% Confidence Interval and within 100% Total Allowable Error | Bias 0.25 (CI 90.1-90.4), Total Allowable Error 85.5-94.5. Status: PASS | |
| Ca++ (e.g. at 0.37 MDL) | Predicted Bias within 95% Confidence Interval and within 100% Total Allowable Error | Bias -0.022 (CI 0.34-0.35), Total Allowable Error 0.27-0.47. Status: PASS | |
| Sensitivity Study | K+ | LoQ < Lowest Detection Limit (LDL) | LoQ = 0.20 mmol/L, LDL = 1.00 mmol/L (LoQ < LDL - Yes) |
| Ca++ | LoQ < Lowest Detection Limit (LDL) | LoQ = 0.25 mmol/L, LDL = 0.25 mmol/L (LoQ < LDL - Yes) | |
| Cl- | LoQ < Lowest Detection Limit (LDL) | LoQ = 42.4 mmol/L, LDL = 50.0 mmol/L (LoQ < LDL - Yes) | |
| Selectivity Study | K+, Cl-, Ca++ | No Interference when change < Total Allowable Error (TAE) of nominal value (e.g., K+ <0.30 mmol/L or < ±7%) | Many substances showed "No Interference" (Table I). Some interferents identified with specific biases and concentrations (Table II). The document implies acceptance if interferences are within defined limits or characterized. |
The "Performance Conclusions" section on page 6 and 15 state that the device "performs equivalently to the predicate device" and is "safe and effective for its intended purpose and equivalent in performance to the reference device," implying all acceptance criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
- Precision Studies (Aqueous Controls):
- Each of the three quality control levels (tri-level aqueous EasyQC material) was analyzed.
- Tested in three EasyStat 300 analyzers.
- Tested for twenty days.
- Duplicate readings in the morning (AM) and afternoon (PM).
- Total samples: 3 (levels) * 3 (analyzers) * 20 (days) * 2 (readings/day) = 360 data points per analyte for aqueous controls.
- Provenance: "in a laboratory setting (Bench test)" using "aqueous controls."
- Repeatability (5-Day) Study – Whole Blood Samples:
- Five replicates of whole blood samples.
- Tested over five days.
- Number of distinct whole blood samples is not explicitly stated, but it was "whole blood from adult volunteers."
- Provenance: "venous whole blood from adult volunteers," "in a laboratory setting (Bench test)."
- Linearity Study:
- Nine (9) to eleven (11) spiked and diluted whole blood specimens per analyte.
- Tested on three EasyStat 300 analyzers.
- Tested in triplicate.
- Total samples: (9 to 11) * 3 (analytes) * 3 (analyzers) * 3 (replicates) = approximately 243 to 297 data points.
- Provenance: "spiked and diluted whole blood specimens."
- Method Comparison Study:
- 192 donors.
- Six modified whole blood samples (spiked and diluted).
- Total of 198 samples.
- Tested on the reference device twice.
- Tested on three EasyStat 300 analyzers in duplicate.
- Total samples: 198 (unique samples).
- Provenance: "whole blood from 192 donors plus six modified whole blood samples (spiked and diluted)." The donors' country of origin is not specified, but the study was conducted "in a laboratory setting (Bench test)." This is a prospective collection for the study.
- Sensitivity Study:
- Performed on three ES 300 analyzers.
- Specific number of blanks/low-concentration samples not explicitly stated but implies sufficient measurements as per CLSI EP17-A.
- Provenance: Not specified, but likely laboratory-prepared samples.
- Selectivity Study:
- Provenance: "spiked whole blood samples collected from healthy donors." Country/origin not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document describes performance studies for an in-vitro diagnostic device that measures potassium, calcium, and chloride levels. The "ground truth" for such devices is typically established by:
- Reference methods/predicate devices.
- Certified reference materials.
- Laboratory-prepared controls with known concentrations.
The document states:
- For the Method Comparison Study, the "reference analyzer was the EasyStat, K063376."
- For Precision Studies, "EasyStat 300 tri-level aqueous EasyQC material" was used, implying certified or well-characterized control materials.
- For Linearity, "pre-assayed whole blood samples" were used.
Therefore, the ground truth was established by:
- A predicate device/reference analyzer (EasyStat, K063376).
- Certified/characterized quality control materials (EasyQC material).
- Pre-assayed/spiked laboratory samples.
There is no mention of "experts" in the context of clinical interpretation or subjective assessment to establish ground truth because this is a quantitative measurement device, not an image-based or qualitative diagnostic. The "experts" in this context would be the technicians operating the reference methods and preparing the samples, ensuring accurate measurement. Their specific qualifications are not detailed beyond "trained technicians in clinical laboratories" mentioned in the Indications for Use.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used for studies where subjective interpretation is involved, such as reading medical images, to establish a consensus ground truth.
For the EasyStat 300, which is a quantitative measurement device, the "ground truth" is established through:
- Reference instrument measurements.
- Known concentrations of control materials.
- Statistical comparison to established methods (e.g., linear regression, bias analysis).
Therefore, no multi-reader adjudication method (like 2+1 or 3+1) was used or is relevant for these types of analytical performance studies. The comparison is between the new device's readings and the established/known values.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools that involve human interpretation (e.g., radiologists reading images with or without AI assistance).
The EasyStat 300 is an in-vitro diagnostic instrument that performs automated quantitative measurements; it does not involve human interpretation of complex data that could be augmented by AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies performed for the EasyStat 300 represent standalone performance of the device. The device itself (the "algorithm" or instrumentation in this context) performs the measurements and generates results. While it requires a trained technician to operate it and load samples, the performance metrics (precision, linearity, method comparison, sensitivity) evaluate the inherent analytical capabilities of the analyzer without a human "in-the-loop" making diagnostic interpretations based on the device's output. The device provides quantitative results; it doesn't provide interpretations that a human would then refine.
7. The Type of Ground Truth Used
The ground truth used for the studies includes:
- Reference method/predicate device measurements: For the Method Comparison study, the "EasyStat, K063376" was the reference analyzer.
- Reference materials/known concentrations: "Tri-level aqueous EasyQC material" and "spiked and diluted whole blood specimens" with known or established values were used for precision, linearity, and sensitivity studies.
- Venous whole blood from adult volunteers and healthy donors: Used for precision and selectivity studies, where the measurements were compared against expected ranges or changes from a baseline.
8. The Sample Size for the Training Set
The provided document describes analytical validation studies for regulatory submission (510(k)) of an in-vitro diagnostic device. These types of submissions typically focus on analytical performance testing rather than machine learning model validation with distinct "training" and "test" sets. The EasyStat 300 is an instrument using "Ion Selective Electrode" (ISE) sensors and doesn't explicitly describe a machine learning algorithm that undergoes a training phase in the context of this document.
Therefore, the concept of a "training set" in the context of artificial intelligence/machine learning is not applicable to this device as described. The document does not mention any training data or set used for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" identified for an AI/ML algorithm in the provided document, the question of how its ground truth was established is not applicable. The device's performance relies on its hardware (ISE sensors) and predefined algorithms for calculation and calibration, not on a machine learning model trained on a data set.
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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
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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
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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) |
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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 |
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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.
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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 onPredicate Utilized forSubmission | 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 readerEthernet (1)RS232 Serial (1)SD card port (1)N/A | NoneRS232 Serial(1)NoneBarcode Reader |
Similarities and Differences Between Devices Used in this Notification
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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).
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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.
| PerformanceSpecs | Actual Performance | System 2 - P22 | System 3 - P23 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Analyte | PrecisionEstimate | 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 | PredictedBias | 95% Confidence Interval | 100% TotalAllowable 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 | PredictedBias | 95% Confidence Interval | 100% TotalAllowable 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 | PredictedBias | 95% Confidence Interval | 100% TotalAllowable 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 DetectionLimit (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 Interferencewhen change <0.30mmol/Lor < ±7% | Cl- (mmol/LNo Interferencewhen change< ±5.0 mmol/L | Ca++ (mmol/LNo Interferencewhen change <0.10mmol/Lor < ±10% | NoInterferenceon the listedsensors |
|---|---|---|---|---|---|
| 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).
| InterferingSubstance | AffectedAnalyte | Analyteconcentration | InterferantConcentrationTested | Bias observed | Comments | |
|---|---|---|---|---|---|---|
| Bromide | ChlorideInterferencewhen change> ±5mmol/Lor±5%) | 105 mmol/L82 mmol/L121 mmol/L | 1.51.537.5 | + 4.2mmol/L+ 4.2mmol/L+ 49 mmol/L | No significant interference(<±5mmol/L or±5%)Significant positiveinterference from Bromideabove 1.5 mmol/L | |
| Citrate(see note) | ChlorideInterferencewhen change> ±5mmol/Lor±5%) | 103 mmol/L80 mmol/L103 mmol/L103 mmol/L | 3.0 mmol/L3.0 mmol/L6.0 mmol/L9.0 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 negativeinterference from citrateabove 3.0 mmol/L | |
| Fluoride | PotassiumInterferencewhen change>0.3 mmol/Lor > ± 7% | 1.42 mmol/L1.93 mmol/L4.3 mmol/L | 55.0 µmol/L63.2 µmol/L63.2 µmol/L | -0.014 mmol/L-0.3 mmol/L-0.4 mmol/L | ||
| Ibuprofen | PotassiumInterferencewhen change>0.3 mmol/Lor > ± 7% | 3.85 mmol/L2.13 mmol/L4.75 mmol/L1.83 mmol/L | 1.0 mmol/L1.0 mmol/L1.06 mmol/L1.06 mmol/L | +0.11 mmol/L+0.15 mmol/L+0.5 mmol/L+0.08 mmol/L | ||
| Intralipid | PotassiumInterferencewhen change>0.3 mmol/Lor > ± 7% | 1.45 mmol/L3.67 mmol/L4.6 mmol/L1.24 mmol/L6.6 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 | ChlorideInterferencewhen change> ± 5mmol/Lor ± 5%) | 84 mmol/L103 mmol/L103.0 mmol/L | 0.55 mmol/L0.65 mmol/L3.0 mmol/L | +3.6 mmol/L+4.7 mmol/L+10 mmol/L | No significant interference(<±5mmol/L or±5%) |
{15}------------------------------------------------
| > ± 5mmol/Lor ± 5%) | 78.9 mmol/L | 3.0 mmol/L | +18.8 mmol/L | Significant positiveinterference from iodideabove 0.55 mmol/L | |
|---|---|---|---|---|---|
| ChlorideInterference | 82.8 mmol/L | 600 µmol/L | +4.4 mmol/L | No significant interference(<± 5mmol/L or ± 5%) | |
| Thiocyanate | when change> ± 5mmol/Lor ± 5%) | 82.0 mmol/L | 898 µmol/L | +11.8 mmol/L | Significant positiveinterference from thiocyanateabove 60 µmol/L |
| ChlorideInterference | 84 mmol/L | 5 mmol/L | -2.1 mmol/L | No significant interference(<± 5mmol/L or ± 5%) | |
| Thiosulfate | when change> ± 5mmol/Lor ± 5%) | 80.1 mmol/L | 20 mmol/L | -8.1 mmol/L | |
| PotassiumInterferencewhen change>0.3 mmol/Lor > ± 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 | ||
| IonizedCalciumInterferencewhen change>0.1 mmol/Lor > ± 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 | IonizedCalciumInterferencewhen change>0.1 mmol/Lor > ± 10% | 1.15 mmol/L | 7.75 Units | -0.12 mmol/L | Significant negativeinterference from high pH atand 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.
§ 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.