(284 days)
The SelectaLyte™ Electrolyte Analyzer (Na+, K+, Cl-) is an in vitro device intended to be used for the measurement of ionized Sodium (Na+), Potassium (K+), and Chloride (Cl-) in serum and lithium heparin venous whole blood samples. The measurements are to be conducted by a trained professional in a clinical laboratory. For in vitro diagnostic use only.
The SelectaLyte Sodium (Na+) assay is intended to measure sodium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
The SelectaLyte Potassium (K+) assay is intended to measure potassium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
The SelectaLyte Chloride (Cl-) assays is intended to measure chloride. Measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The SelectaLyte™ Electrolyte Analyzer (Na*, K*, Cl) is an automated, microprocessor-controlled electrolyte analyzer for measurement of Sodium (Na*), and Chloride (Cl`) in serum, whole blood and QC aqueous solutions. The SelectaLyte™ Electrolyte Analyzer (Na*, K*, Cl') utilizes ion selective electrodes (ISE) to measure test samples, and display the results automatically. The instrument features automatic and on-demand calibration, patient data storage, and interactive LCD touch screen.
Acceptance Criteria and Device Performance for SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
The provided text details the performance evaluation of the SelectaLyte Electrolyte Analyzer as part of its 510(k) premarket notification. The acceptance criteria and the device's performance are primarily demonstrated through studies on precision, linearity, method correlation, and interference.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria values in table format (e.g., "CV must be < X%"). However, the acceptance for each study is implicitly demonstrated by the successful completion of the CLSI (Clinical and Laboratory Standards Institute) guidelines and the reported results falling within acceptable laboratory practice (e.g., correlation coefficients close to 1, small biases relative to the predicate device, acceptable precision metrics). The "Reportable Range" serves as a key acceptance criterion for linearity and method correlation.
Here's a summary of the reported device performance, which implies that these values met the internal acceptance criteria for substantial equivalence:
Table 1: Reported Device Performance
| Study Type | Analyte | Matrix | Key Performance Metric (Accepted Value / Reported Value) |
|---|---|---|---|
| Precision | Sodium | Human Serum | Within-Lab CV: (0.82% @ 95.2), (0.54% @ 134.7), (0.84% @ 178.8) mmol/L |
| Within-Lab SD: (0.78), (0.72), (1.51) mmol/L | |||
| Sodium | Whole Blood | Within-Lab CV: (0.43% @ 98.9), (0.24% @ 136.8), (0.14% @ 161.0) mmol/L | |
| Within-Lab SD: (0.42), (0.32), (0.23) mmol/L | |||
| Potassium | Human Serum | Within-Lab CV: (0.79% @ 2.77), (0.78% @ 4.01), (0.97% @ 6.59) mmol/L | |
| Within-Lab SD: (0.02), (0.03), (0.06) mmol/L | |||
| Potassium | Whole Blood | Within-Lab CV: (1.27% @ 2.14), (2.07% @ 3.29), (1.07% @ 7.78) mmol/L | |
| Within-Lab SD: (0.03), (0.07), (0.08) mmol/L | |||
| Chloride | Human Serum | Within-Lab CV: (0.91% @ 63.2), (0.82% @ 90.1), (0.93% @ 114.4) mmol/L | |
| Within-Lab SD: (0.58), (0.74), (1.06) mmol/L | |||
| Chloride | Whole Blood | Within-Lab CV: (0.81% @ 69.5), (0.50% @ 104.4), (0.40% @ 129.9) mmol/L | |
| Within-Lab SD: (0.57), (0.52), (0.53) mmol/L | |||
| Linearity | Sodium | Serum | Correlation Coefficient: 0.9988; Tested Range: 35.9-203.5 mmol/L; Reportable Range: 40-205 mmol/L |
| Potassium | Serum | Correlation Coefficient: 0.9999; Tested Range: 1.26-19.62 mmol/L; Reportable Range: 1.5-15.0 mmol/L | |
| Chloride | Serum | Correlation Coefficient: 0.9999; Tested Range: 30.1-202.3 mmol/L; Reportable Range: 50-200 mmol/L | |
| Sodium | Whole Blood | Correlation Coefficient: 0.9995; Tested Range: 33-217.5 mmol/L; Reportable Range: 40-205 mmol/L | |
| Potassium | Whole Blood | Correlation Coefficient: 0.9993; Tested Range: 1.45-18.49 mmol/L; Reportable Range: 1.5-15.0 mmol/L | |
| Chloride | Whole Blood | Correlation Coefficient: 1.0000; Tested Range: 33.4-214.6 mmol/L; Reportable Range: 50-200 mmol/L | |
| Method Correlation | Sodium | Serum | R^2: 0.9869; Syx: 2.37; Tested Range: 43.3-194.2 mmol/L; Reportable Range: 40-205 mmol/L |
| Potassium | Serum | R^2: 0.9959; Syx: 2.37; Tested Range: 1.51-14.72 mmol/L; Reportable Range: 1.5-15.0 mmol/L | |
| Chloride | Serum | R^2: 0.9854; Syx: 2.36; Tested Range: 55.0-192.6 mmol/L; Reportable Range: 50-200 mmol/L | |
| Sodium | Whole Blood | R^2: 0.9865; Syx: 1.91; Tested Range: 43.3-204.6 mmol/L; Reportable Range: 40-205 mmol/L | |
| Potassium | Whole Blood | R^2: 0.9946; Syx: 1.91; Tested Range: 1.58-14.84 mmol/L; Reportable Range: 1.5-15.0 mmol/L | |
| Chloride | Whole Blood | R^2: 0.9806; Syx: 1.88; Tested Range: 53.0-192.2 mmol/L; Reportable Range: 50-200 mmol/L | |
| Interference | All | Serum | Highest concentrations of listed interferents tested did not show significant interference (unless explicitly stated otherwise in "Observations" section) |
| All | Whole Blood | Highest concentrations of listed interferents tested did not show significant interference (unless explicitly stated otherwise in "Observations" section) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision Study:
- Serum: N=80 for each of three levels of pooled human serum, for each analyte (Sodium, Potassium, Chloride). (2 machines, multiple users, 2 runs/day over 20 days = 80 measurements).
- Whole Blood: N=40 for each of three levels of pooled human whole blood, for each analyte (Sodium, Potassium, Chloride). (40 replicates per sample after calibrations every 10 consecutive replicates).
- Linearity Study:
- Serum: 4 replicates at each level, over 10 or 11 levels of concentration for each analyte. (e.g., Sodium: 10 levels * 4 replicates = 40 samples).
- Whole Blood: 4 replicates at each level, over 10 or 11 levels of concentration for each analyte. (e.g., Sodium: 11 levels * 4 replicates = 44 samples).
- Method Correlation Study:
- N=100 samples (serum and whole blood, respectively) for each analyte compared to the predicate device (AVL 9180 Electrolyte Analyzer). 10% of samples were spiked or diluted to span the claimed measuring ranges.
- Interference Study:
- The number of samples for the interference study is not explicitly stated as a single "N". Multiple interferent substances were tested at various concentrations. The methodology follows CLSI EP07-A2. The highest concentration that did not show significant interference is reported.
Data Provenance: The document does not explicitly state the country of origin of the human serum or whole blood samples. It mentions "Pooled Human Serum" or "Human Whole Blood." The studies are retrospective as they were conducted as part of the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This device is an in vitro diagnostic (IVD) electrolyte analyzer. The "ground truth" for the test set is established by the analytical reference methods or predicate device measurements, not by human expert interpretation (e.g., radiologists reading images). Therefore, there were no "experts" in the sense of medical professionals adjudicating diagnostic test results for the test set.
4. Adjudication Method for the Test Set
Not applicable for this type of in vitro diagnostic device test. The "truth" is determined by the analytical performance of the device against reference methods or the legally marketed predicate device, as per CLSI guidelines, rather than human consensus or adjudication of clinical interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging devices where human readers interpret medical images, and the AI's impact on their performance is being evaluated. For an IVD device like the SelectaLyte Electrolyte Analyzer, performance is assessed through analytical studies (precision, linearity, correlation) comparing the device's measurements to established standards or a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented (Precision, Linearity, Method Correlation, Interference) are all "standalone" in nature for an IVD device. They evaluate the analytical performance of the SelectaLyte Electrolyte Analyzer itself, independent of immediate human interpretation of results, beyond the standard operation by a trained professional in a clinical laboratory. The device outputs numerical values for Na+, K+, and Cl-, and these values are compared to known concentrations or predicate device results.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation varied by study:
- Precision: The ground truth is the inherent concentration of the analyte within the stable, homogeneous pooled human serum or whole blood samples, and the consistency of repeated measurements.
- Linearity: The ground truth is established by accurately prepared intermediate concentration samples through proportional mixing of high and low concentration pools, aiming for known, linearly distributed concentrations.
- Method Correlation: The ground truth is the measurements obtained from the legally marketed predicate device (AVL 9180 Electrolyte Analyzer). This demonstrates substantial equivalence.
- Interference: The ground truth is the expected analyte concentration in the presence of various potentially interfering substances, assessed against a baseline without the interferent, looking for significant bias.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" or "validation set" in the context of machine learning. This is a traditional IVD device, not an AI/ML-driven device. The studies described are validation studies performed on the final device to demonstrate its performance characteristics.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this document describes the validation of a traditional IVD device, not the development or training of an AI/ML model. Therefore, there is no "training set" in the machine learning sense, nor is there ground truth established for such a set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
February 27, 2018
Awareness Technology, Inc. Steve Andrus Quality Assurance Manager 1935 SW Martin Hwy Palm City, FL 34990
Re: K171476
Trade/Device Name: SelectaLvte Electrolyte Analyzer (Na+, K+, Cl-) Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Code: JGS, CEM, CGZ, JJE Dated: December 29, 2017 Received: January 18, 2018
Dear Steve Andrus:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
{1}------------------------------------------------
Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K171476
Device Name
SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
Indications for Use (Describe)
The SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) is an in vitro device intended to be used for the measurement of ionized Sodium (Na+), Potassium (K+), and Chloride (Cl-) in serum and lithium heparin venous whole blood samples. The measurements are to be conducted by a trained professional in a clinical laboratory. For in-vitro diagnostic use only.
The SelectaLyte Sodium (Na+) assay is intended to measure sodium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
The SelectaLyte Potassium (K+) assay is intended to measure potassium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
The SelectaLyte Chloride (Cl-) assays is intended to measure chloride. 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
5 510(k)171476 Summary
| Applicant: | Awareness Technology1935 SW Martin HighwayPalm City, FL 34990 |
|---|---|
| Contact Person: | Steve AndrusQuality Assurance ManagerPhone: 772.283.6540 ext. 220Fax: 772.283.8020Email: sandrus@awaretech.com |
| Date of Preparation: | 02/22/2018 |
| Trade Name:Common Name: | SelectaLyte™ Electrolyte Analyzer (Na+, K+, Cl-)Ion-specific electrolyte analyzer for sodium, potassium and chloride |
| Product Nomenclature | Class | Product Code | Regulation Number | Review Panel |
|---|---|---|---|---|
| Electrode, Ion-Specific,Sodium | II | JGS | 862.1665 | Clinical Chemistry |
| Electrode, Ion-Specific,Potassium | II | CEM | 862.1600 | Clinical Chemistry |
| Electrode, Ion-Specific,Chloride | II | CGZ | 862.1170 | Clinical Chemistry |
| Analyzer, Chemistry(Photometric, Discrete),For Clinical Use | I | JJE | 862.2160 | Clinical Chemistry |
Substantial Equivalence
Awareness Technology is claiming substantial equivalence to the predicate device, AVL 9180 Electrolyte Analyzer, 510(k) number K961458.
Description
The SelectaLyte™ Electrolyte Analyzer (Na*, K*, Cl) is an automated, microprocessor-controlled electrolyte analyzer for measurement of Sodium (Na*), and Chloride (Cl`) in serum, whole blood and QC aqueous solutions. The SelectaLyte™ Electrolyte Analyzer (Na*, K*, Cl') utilizes ion selective electrodes (ISE) to measure test samples, and display the results automatically. The instrument features automatic and on-demand calibration, patient data storage, and interactive LCD touch screen.
{4}------------------------------------------------
Indications of Use
The Selectalyte™ Electrolyte Analyzer (Na+, K+, Cl-) is an in vitro device intended to be used for the measurement of ionized Sodium (Na+), Potassium (K+), and Chloride (Cl-) in serum and lithium heparin venous whole blood samples. The measurements are to be conducted by a trained professional in a clinical laboratory.
For in vitro diagnostic use only.
The SelectaLyte Sodium (Na+) assay is intended to measure sodium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
The SelectaLyte Potassium (K+) assay is intended to measure potassium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
The SelectaLyte Chloride (Cl-) assays is intended to measure chloride. Measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Principles of Measurement
The principles of measurement used in the SelectaLyte™ Electrolyte Analyzer (Na*, K*, Cl'), Model 3910 are identical to the principles existing in the electrolyte analyzer to which substantial equivalence is claimed.
The SelectaLyte™ Electrolyte Analyzer (Na*, K*, Cl`) measures sodium, potassium, and chloride in dialysate using ion selective electrode technology. The sodium electrode contains a glass tube, specially formulated to be sensitive to sodium ions. The potassium electrode incorporates neutral carrier ionophore membranes which are highly selective for their respective ions. The chloride electrode contains an ionophore covalently bound to a substrate which is sensitively charged ins. The potential of each electrode is measured relative to a fixed, stable reference established by a silver/silver chloride electrode in concentrated salt solution. The measured potential varies with the concentration of the ion sensed by the electrode.
Calibration
The SelectaLyte™ Electrolyte Analyzer (Na*, K, Cl), Model 3910 preforms a 2-point calibration every 4 hours and by request with a known fluid from the SelectaLyte™ Reagent Pack. A 1-point calibration is preformed automatically during each measurement.
{5}------------------------------------------------
| Model | SelectaLyte | AVL |
|---|---|---|
| Manufacturer | Awareness Technology Inc. | Roche Diagnostic AVL 9180 |
| Technology | Ion Selective Electrode | Ion Selective Electrode |
| Intended Use | The SelectaLyte Electrolyte Analyzer(Na+, K+, Cl-) is designed for clinicallaboratory use by laboratoryprofessionals to assess the levels ofSodium, Potassium, and Chloridefound in serum and lithium heparinvenous whole blood. The analysis isperformed in-vitro, and neither theanalyzer nor any of its componentscome in contact with the patient. Theinstrument should be used inlaboratories that routinely conform togovernment regulations oraccreditation requirements for quality.On each day of use, analyze theSelectaLyte™ Quality Control Kit TriLevel at least once. | The AVL 9180 ElectrolyteAnalyzer is intended to be usedfor the measurement of sodium,potassium, chloride, ionizedcalcium and lithium in wholeblood, serum or plasma, urine,dialysate solutions, or QCmaterials as appropriate byminimally trained personnelqualified to preform and toreport these values in a clinicallaboratory setting. Theseanalytes are commonly used inthe diagnosis and managementof patients with a broad range ofrenal, metabolic andcardiovascular disorders and, assuch, have come to be amongthose which are considered bythe American Association ofClinical Chemistry to have apotential of being life |
| Electrolytes Measured | Sodium (Na+), Potassium (K+), andChloride (Cl-) | threatening if left uncontrolled.Sodium (Na+), Potassium (K+),Chloride (Cl-), Lithium(Li+),Calcium(Ca2+) |
| Samples Type Measured | Serum and lithium heparin venouswhole blood | Whole blood, serum or plasma,urine, dialysate solutions, or QCmaterials |
| Sample Volume | 85 µL | 95 µL |
| Sample Detection Sensor | Yes | No |
| SE Sample MeasurementRange for all Types | Na+: 40 - 205 mmol/LK+: 1.5 – 15.0 mmol/LCl-: 50 - 200 mmol/L | Na+: 40 - 205 mmol/LK+: 1.5 – 15.0 mmol/LCl-: 50 - 200 mmol/L |
| Model | SelectaLyte | AVL |
| Reagent Pack | Cal Standard: 650mLSLOPE Standard: 125mLReference Solution: 125 mLWaste bag | Standard A 350 mLStandard B 85 mLReference Solution 85 mLWaste bag |
| Results Storage | Sample Results: 200QC Results: 270 | Sample Results: 200QC Results: 35 |
| Display | Interactive touch screen 8.9cm(3.5") LCD, color graphic display | 32 character, 2 line display |
| Output | Thermal printer with graphiccapability, 29-character width.USB Memory Stick | Thermal paper32 character, 2-linealphanumeric display |
| Power Requirements: | 100-240VAC, 50/60Hz 55Wmaximum | 100-115 - VAC 50-60 Hz, 0.8 A |
Predicate Comparison
{6}------------------------------------------------
Predicate Comparison Continued
{7}------------------------------------------------
Precision Study
In accordance with CLSI EP05-A2 precision evaluation of within-run (Sr), between-run (Srr), and within-lab (ST) precision was determined using two machines and multiple users for 2 runs per day over the duration of 20 days for each matrix.
| The procision recults for Sodium |
|---|
| PooledHumanSerum | N | Mean(mmol/L) | Within Run | Run to Run | Within Lab | |||
|---|---|---|---|---|---|---|---|---|
| SD(mmol/L) | CV(%) | SD(mmol/L) | CV(%) | SD(mmol/L) | CV(%) | |||
| (Level 1) | 80 | 95.2 | 0.27 | 0.29% | 0.53 | 0.55% | 0.78 | 0.82% |
| (Level 2) | 80 | 134.7 | 0.33 | 0.25% | 0.59 | 0.44% | 0.72 | 0.54% |
| (Level 3) | 80 | 178.8 | 0.28 | 0.16% | 1.38 | 0.77% | 1.51 | 0.84% |
The precision results for Potassium
| PooledHumanSerum | N | Mean(mmol/L) | Within Run | Run to Run | Within Lab | |||
|---|---|---|---|---|---|---|---|---|
| SD(mmol/L) | CV(%) | SD(mmol/L) | CV(%) | SD(mmol/L) | CV(%) | |||
| (Level 1) | 80 | 2.77 | 0.02 | 0.64% | 0.01 | 0.43% | 0.02 | 0.79% |
| (Level 2) | 80 | 4.01 | 0.02 | 0.52% | 0.02 | 0.51% | 0.03 | 0.78% |
| (Level 3) | 80 | 6.59 | 0.02 | 0.24% | 0.06 | 0.90% | 0.06 | 0.97% |
The precision results for Chloride
| PooledHumanSerum | N | Mean(mmol/L) | Within Run | Run to Run | Within Lab | |||
|---|---|---|---|---|---|---|---|---|
| SD(mmol/L) | CV(%) | SD(mmol/L) | CV(%) | SD(mmol/L) | CV(%) | |||
| (Level 1) | 80 | 63.2 | 0.29 | 0.46% | 0.30 | 0.48% | 0.58 | 0.91% |
| (Level 2) | 80 | 90.1 | 0.31 | 0.34% | 0.62 | 0.69% | 0.74 | 0.82% |
| (Level 3) | 80 | 114.4 | 0.30 | 0.26% | 0.98 | 0.86% | 1.06 | 0.93% |
Precision values for whole blood reported from testing with calibrations every consecutive replicates of 10 to total 40 replicates for each sample.
| HumanWholeBlood | N | Mean(mmol/L) | Within Run | Within Lab | ||
|---|---|---|---|---|---|---|
| (Level 1) | 40 | 98.9 | 0.69(mmol/L) | 0.70% | 0.42(mmol/L) | 0.43% |
| (Level 2) | 40 | 136.8 | 0.58(mmol/L) | 0.42% | 0.32(mmol/L) | 0.24% |
| (Level 3) | 40 | 161.0 | 0.35(mmol/L) | 0.22% | 0.23(mmol/L) | 0.14% |
The precision results for Sodium
The precision results for Potassium
| PooledHumanSerum | N | Mean(mmol/L) | Within Run | Within Lab | ||
|---|---|---|---|---|---|---|
| SD(mmol/L) | CV(%) | SD(mmol/L) | CV(%) | |||
| (Level 1) | 40 | 2.14 | 0.03 | 1.33% | 0.03 | 1.27% |
| (Level 2) | 40 | 3.29 | 0.07 | 2.03% | 0.07 | 2.07% |
| (Level 3) | 40 | 7.78 | 0.06 | 0.79% | 0.08 | 1.07% |
The precision results for Chloride
| HumanWholeBlood | N | Mean(mmol/L) | Within Run | Within Lab | ||
|---|---|---|---|---|---|---|
| SD(mmol/L) | CV(%) | SD(mmol/L) | CV(%) | |||
| (Level 1) | 40 | 69.5 | 0.88 | 1.26% | 0.57 | 0.81% |
| (Level 2) | 40 | 104.4 | 0.95 | 0.91% | 0.52 | 0.50% |
| (Level 3) | 40 | 129.9 | 0.70 | 0.54% | 0.53 | 0.40% |
{8}------------------------------------------------
Linearity Study
In accordance with CLSI EP06-A equally spaced intermediate concentration samples were prepared accurately by proportionately mixing high and low concentration pools. 4 replicates were read at each level. The testing duration for each analyte was processed on the same day. Acceptable performance criteria by CLIA 88 in 42 CFR 493-931 Routine Chemistry.
| Linearity Summary Matrix: Serum | ||||||
|---|---|---|---|---|---|---|
| Analyte | # ofLevels | Slope | Intercept | CorrelationCoefficient | Tested Range(mmol/L) | Reportable Range(mmol/L) |
| Sodium | 10 | 0.9878 | -3.8077 | 0.9988 | 35.9-203.5 | 40-205 |
| Potassium | 11 | 1.0103 | -0.1360 | 0.9999 | 1.26-19.62 | 1.5-15.0 |
| Chloride | 11 | 0.9990 | -1.3194 | 0.9999 | 30.1-202.3 | 50-200 |
Linearity Summary | Matrix: Serum
Linearity Summary | Matrix: Whole Blood
| Analyte | # ofLevels | Slope | Intercept | CorrelationCoefficient | Tested Range(mmol/L) | Reportable Range(mmol/L) |
|---|---|---|---|---|---|---|
| Sodium | 11 | 1.0064 | -4.2822 | 0.9995 | 33-217.5 | 40-205 |
| Potassium | 11 | 1.0083 | -0.4117 | 0.9993 | 1.45-18.49 | 1.5-15.0 |
| Chloride | 10 | 1.0003 | 0.3451 | 1.0000 | 33.4-214.6 | 50-200 |
Method Correlation Study
In accordance with CLSI EPO9-A2 Method comparison to the predicate device was performed with each matrix for each analyte. 10% of the samples were spiked or diluted to fully span the claimed measuring ranges.
Method Correlation Summary Data
| Method Correlation Summary Data | Matix: Serum | ||||||
|---|---|---|---|---|---|---|---|
| Analyte | N | Slope | Intercept | R^2 | Syx | Tested Range(mmol/L) | Reportable Range(mmol/L) |
| Sodium | 100 | 0.971 | 2.794 | 0.9869 | 2.37 | 43.3-194.2 | 40-205 |
| Potassium | 100 | 1.014 | -0.165 | 0.9959 | 2.37 | 1.51-14.72 | 1.5-15.0 |
| Chloride | 100 | 0.950 | 6.143 | 0.9854 | 2.36 | 55-192.6 | 50-200 |
Matix: Whole Blood
| Analyte | N | Slope | Intercept | R^2 | Syx | Tested Range(mmol/L) | Reportable Range(mmol/L) |
|---|---|---|---|---|---|---|---|
| Sodium | 100 | 1.002 | -1.600 | 0.9865 | 1.91 | 43.3-204.6 | 40-205 |
| Potassium | 100 | 1.028 | -0.205 | 0.9946 | 1.91 | 1.58-14.84 | 1.5-15.0 |
| Chloride | 100 | 0.953 | 4.923 | 0.9806 | 1.88 | 53-192.2 | 50-200 |
{9}------------------------------------------------
Interference Study
In accordance with CLSI EP07-A2 The interference study is an evaluation of the effects of potentially interfering substances to decrease medically significant error within the laboratory and identify potential hazards. Interferent substances were chosen that have the potential to interfere with analytes (sodium, potassium, chloride) as reference and Drug Interference and Drug Effects in Clinical Chemistry E5 by Tryding. Each interferent was tested higher than the therapeutic concentration of the relevant drug; then evaluated to show the degree of interference.
The highest concentration of each interferent that did not show interference for the serum sodium, potassium, and chloride assays is shown in the table below.
| Analyte | Interferent | Highest concentration tested that didnot show significant interference |
|---|---|---|
| Serum Sodium | Bilirubin Conjugate | 1000.0 mg/dL |
| Cholesterol | 503.1 mg/dL | |
| Hemoglobin | 200.0 mg/dL | |
| Isoniazid | 4.0 mg/dL | |
| Lithium Acetate | 21.1 mg/dL | |
| Magnesium Acetate | 213.6 mg/dL | |
| Metronidazole | 12.0 mg/dL | |
| Serum Potassium | Bilirubin Conjugate | 1000.0 mg/dL |
| Cholesterol | 503.1 mg/dL | |
| Hemoglobin | 200.0 mg/dL | |
| Isoniazid | 4.0 mg/dL | |
| Lithium Acetate | 21.1 mg/dL | |
| Magnesium Acetate | 213.6 mg/dL | |
| Metronidazole | 12.0 mg/dL | |
| Sodium Fluoride | 0.33 mg/dL | |
| Sodium Heparin | 3000.0 U/L | |
| Sodium Iodide* | 5.6 mg/dL | |
| Triglycerides | 2364.3 mg/dL | |
| Vancomycin | 10.3 mg/dL | |
| Serum Chloride | Acetylcysteine | 166.5 mg/dL |
| Acetylsalicylic Acid | 65.2 mg/dL | |
| Ampicillin | 5.3 mg/dL | |
| Bilirubin Conjugate | 1000.0 mg/dL | |
| Cefoxitin | 69.5 mg/dL | |
| Cholesterol | 200.0 mg/dL | |
| Doxycycline | 3.2 mg/dL | |
| EDTA | 0.13 mg/dL | |
| Hemoglobin | 200.0 mg/dL | |
| Ibuprofen | 55.4 mg/dL | |
| Isoniazid | 4.0 mg/dL | |
| Lithium Acetate | 21.1 mg/dL | |
| Magnesium Acetate | 213.6 mg/dL | |
| Metronidazole | 12.0 mg/dL | |
| Paracetamol | 20.0 mg/dL |
Interference Effect Summary Data
*Continued Interference
{10}------------------------------------------------
| Analyte | Interferent | Highest concentration tested that didnot show significant interference |
|---|---|---|
| Serum Chloride | pH (High) | ~8.0 |
| Potassium Thiocyanate | 25.1 mg/dL | |
| Rifampicin | 6.4 mg/dL | |
| Sodium Bicarbonate | 294.0 mg/dL | |
| Sodium Bromide* | 24.1 mg/dL | |
| Sodium Fluoride | 0.33 mg/dL | |
| Sodium Heparin | 3000.0 U/L | |
| Sodium Iodide | 5.6 mg/dL | |
| Triglycerides | 2364.3 mg/dL | |
| Vancomycin | 10.3 mg/dL |
Interference Effect Summary Data
*Continued Interference
Serum Interference Observations
Cholesterol showed interference with Chloride assay at concentrations 503 mg/dL, 251 mg/dL with a bias greater than 3.4mmol/L.
Potassium Thiocyanate showed interference with Chloride assay at concentrations 66.9 mg/dL, 33.4 mg/dL, with a bias greater than 4.3mmol/L.
Sodium Bromide showed interference with Chloride assay at all concentrations tested with a bias greater than 4.5mmol/L.
Sodium Fluoride showed interference with Chloride and Potassium assays at concentration 0.44mg/dL with a bias of 12.4mmol/L for chloride and 0.64mmol/L for potassium.
Sodium Iodide showed interference with Chloride and Potassium assays at concentration 44.8mg/dL, 22.5 mg/dL, 11.2mg/dL, with a bias of 3.3mmol/L for chloride and continued interference for potassium with a bias greater than 0.24mmol/L.
{11}------------------------------------------------
The highest concentration of each interferent that did not show interference for the whole blood sodium, potassium, and chloride assays is shown in the table below.
| Analyte | Interferent | Highest concentration tested that didnot show significant interference |
|---|---|---|
| Whole Blood Sodium | Acetone | 69.7 mg/dL |
| Acetylsalicylic Acid | 59.1 mg/dL | |
| Benzalkonium Chloride | 0.67 mg/dL | |
| Bilirubin Conjugate | 1000.0 mg/dL | |
| Bilirubin, Total | 20.0 mg/dL | |
| Cholesterol | 503.1 mg/dL | |
| Creatinine | 5.0 mg/dL | |
| Ethanol | 399.9 mg/dL | |
| Hemoglobin | 200.0 mg/dL | |
| Potassium Thiocyanate | 66.9 mg/dL | |
| Salicylic Acid | 59.9 mg/dL | |
| Whole Blood Potassium | Acetone | 69.7 mg/dL |
| Acetylsalicylic Acid | 59.1 mg/dL | |
| Bilirubin Conjugate | 1000.0 mg/dL | |
| Bilirubin, Total | 10.0 mg/dL | |
| Cholesterol | 503.1 mg/dL | |
| Creatinine | 5.0 mg/dL | |
| Ethanol | 399.9 mg/dL | |
| Hemoglobin | 150.0 mg/dL | |
| Salicylic Acid | 15.0 mg/dL | |
| Sodium Bromide | 48.2 mg/dL | |
| Whole Blood Chloride | Acetone | 69.7 mg/dL |
| Acetylsalicylic Acid | 59.1 mg/dL | |
| Bilirubin Conjugate | 1000.0 mg/dL | |
| Bilirubin, Total | 20.0 mg/dL | |
| Cholesterol | 251.6 mg/dL | |
| Creatinine | 5.0 mg/dL | |
| Ethanol | 399.9 mg/dL | |
| Hemoglobin | 200.0 mg/dL | |
| Potassium Thiocyanate *8.4 mg/dL | ||
| Salicylic Acid | 45.0 mg/dL | |
| Sodium Bromide *24.1 mg/dL | ||
| Sodium Iodide | 11.3 mg/dL |
Interference Effect Summary Data
*Continued Interference
Whole Blood Interference Observations
Bilirubin, Total showed interference with Potassium assay at concentrations 20 mg/dL, 15 mg/dL, with a bias greater than 0.22mmol/L.
Cholesterol showed interference with Chloride assay at concentrations 503 mg/dL, with a bias greater than 3.6mmol/L.
Hemoglobin showed interference with Potassium assay at concentrations 200 mg/dL, 377 mg/dL, 251 mg/dL with a bias greater than 0.27mmol/L.
{12}------------------------------------------------
Whole Blood Interference Observations Continued
Potassium Thiocyanate showed interference with Chloride assay at all concentrations tested with a bias greater than 4.7mmol/L.
Salicylic Acid showed interference with Chloride assay at concentration 60 mg/dL with a bias greater than 8.5 and Potassium assay at concentrations 60 mg/dL, 29mg/dL, 22.5 mg/dL with a bias greater than 0.24mmol/L.
Sodium Bromide showed interference with Chloride assay at all concentrations tested with a bias greater than 22.1mmol/L and Potassium assay at concentrations 386 mg/dL, 93.5 mg/dL, 22.5 mg/dL with a bias greater than 0.32mmol/L.
Sodium lodide showed interference with Chloride assay at concentration 44.8mg/dL with a bias of 8.2mmol/L.
Avoid Hemolyzed samples for potassium. Hemolyzed samples may give incorrect elevated potassium.
Reference Ranges
Concentration levels for each analyte represent medical decision levels as stated by Mosby's Diagnostic and Laboratory Test Reference 8ed. 2017 (See pages 260, 750, and 874 for additional information)
| Analyte | Reference Range (mmol/L) | |
|---|---|---|
| Clinical Range | ||
| Sodium | 136 - 145 | |
| Potassium | 3.5 - 5.0 | |
| Chloride | 98 - 106 |
Conclusions
Analysis of the comparative measurement presented in the 510(k) for this device, data collected for precision, linearity, and correlation demonstrates that the Selectalyte Analyzer (with Na *, K *, Cl ) is safe, effective and substantially equivalent to the predicate device to which it is compared.
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.