(284 days)
Not Found
No
The device description and performance studies focus on standard analytical techniques (ISE) and statistical analysis, with no mention of AI or ML.
No
This device is an in vitro diagnostic (IVD) device used for measuring electrolytes, which aids in the diagnosis and treatment of conditions, but it does not directly treat or prevent diseases. The "For in vitro diagnostic use only" clearly states its purpose.
Yes
The device is intended for "in vitro diagnostic use only" and its measurements are used in the "diagnosis and treatment" of various diseases involving electrolyte imbalances.
No
The device description explicitly states it is an "automated, microprocessor-controlled electrolyte analyzer" that "utilizes ion selective electrodes (ISE) to measure test samples" and has an "interactive LCD touch screen." These are hardware components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "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." It also concludes with "For in vitro diagnostic use only."
- Purpose: The device is intended to measure analytes (Na+, K+, Cl-) in biological samples (serum, whole blood) to provide information for the diagnosis and treatment of various medical conditions involving electrolyte imbalance. This is the core function of an in vitro diagnostic device.
- Clinical Laboratory Use: The intended use specifies that the measurements are to be conducted by a trained professional in a clinical laboratory, which is a typical setting for IVD use.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JGS, CEM, CGZ, JJE
Device 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.
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 professional in a clinical laboratory. The instrument should be used in laboratories that routinely conform to government regulations or accreditation requirements for quality.
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)
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.
- Sodium (Pooled Human Serum): Level 1 (N=80, Mean 95.2 mmol/L), Level 2 (N=80, Mean 134.7 mmol/L), Level 3 (N=80, Mean 178.8 mmol/L).
- Potassium (Pooled Human Serum): Level 1 (N=80, Mean 2.77 mmol/L), Level 2 (N=80, Mean 4.01 mmol/L), Level 3 (N=80, Mean 6.59 mmol/L).
- Chloride (Pooled Human Serum): Level 1 (N=80, Mean 63.2 mmol/L), Level 2 (N=80, Mean 90.1 mmol/L), Level 3 (N=80, Mean 114.4 mmol/L).
- Sodium (Human Whole Blood): Level 1 (N=40, Mean 98.9 mmol/L), Level 2 (N=40, Mean 136.8 mmol/L), Level 3 (N=40, Mean 161.0 mmol/L).
- Potassium (Pooled Human Serum): Level 1 (N=40, Mean 2.14 mmol/L), Level 2 (N=40, Mean 3.29 mmol/L), Level 3 (N=40, Mean 7.78 mmol/L). Note: Table heading says "Pooled Human Serum" but context is under "Precision values for whole blood".
- Chloride (Human Whole Blood): Level 1 (N=40, Mean 69.5 mmol/L), Level 2 (N=40, Mean 104.4 mmol/L), Level 3 (N=40, Mean 129.9 mmol/L).
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.
- Serum Matrix:
- Sodium: 10 levels, Tested Range 35.9-203.5 mmol/L, Reportable Range 40-205 mmol/L.
- Potassium: 11 levels, Tested Range 1.26-19.62 mmol/L, Reportable Range 1.5-15.0 mmol/L.
- Chloride: 11 levels, Tested Range 30.1-202.3 mmol/L, Reportable Range 50-200 mmol/L.
- Whole Blood Matrix:
- Sodium: 11 levels, Tested Range 33-217.5 mmol/L, Reportable Range 40-205 mmol/L.
- Potassium: 11 levels, Tested Range 1.45-18.49 mmol/L, Reportable Range 1.5-15.0 mmol/L.
- Chloride: 10 levels, Tested Range 33.4-214.6 mmol/L, Reportable Range 50-200 mmol/L.
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.
- Serum Matrix (N=100 for each analyte):
- Sodium: Slope 0.971, Intercept 2.794, R^2 0.9869, Syx 2.37. Tested Range 43.3-194.2 mmol/L.
- Potassium: Slope 1.014, Intercept -0.165, R^2 0.9959, Syx 2.37. Tested Range 1.51-14.72 mmol/L.
- Chloride: Slope 0.950, Intercept 6.143, R^2 0.9854, Syx 2.36. Tested Range 55-192.6 mmol/L.
- Whole Blood Matrix (N=100 for each analyte):
- Sodium: Slope 1.002, Intercept -1.600, R^2 0.9865, Syx 1.91. Tested Range 43.3-204.6 mmol/L.
- Potassium: Slope 1.028, Intercept -0.205, R^2 0.9946, Syx 1.91. Tested Range 1.58-14.84 mmol/L.
- Chloride: Slope 0.953, Intercept 4.923, R^2 0.9806, Syx 1.88. Tested Range 53-192.2 mmol/L.
Interference Study:
In accordance with CLSI EP07-A2, an evaluation of the effects of potentially interfering substances was conducted. Interferent substances were chosen that have the potential to interfere with analytes (sodium, potassium, chloride). Each interferent was tested higher than the therapeutic concentration. The highest concentration of each interferent that did not show significant interference was determined for serum and whole blood samples.
- Serum Interference Observations: Cholesterol showed interference with Chloride assay (bias > 3.4mmol/L). Potassium Thiocyanate showed interference with Chloride assay (bias > 4.3mmol/L). Sodium Bromide showed interference with Chloride assay (bias > 4.5mmol/L). Sodium Fluoride showed interference with Chloride (bias 12.4mmol/L) and Potassium (bias 0.64mmol/L). Sodium Iodide showed interference with Chloride (bias 3.3mmol/L) and continued interference for Potassium (bias > 0.24mmol/L).
- Whole Blood Interference Observations: Bilirubin, Total showed interference with Potassium assay (bias > 0.22mmol/L). Cholesterol showed interference with Chloride assay (bias > 3.6mmol/L). Hemoglobin showed interference with Potassium assay (bias > 0.27mmol/L). Potassium Thiocyanate showed interference with Chloride assay (bias > 4.7mmol/L). Salicylic Acid showed interference with Chloride (bias > 8.5) and Potassium (bias > 0.24mmol/L). Sodium Bromide showed interference with Chloride (bias > 22.1mmol/L) and Potassium (bias > 0.32mmol/L). Sodium Iodide showed interference with Chloride assay (bias 8.2mmol/L).
- Key result: Avoid Hemolyzed samples for potassium as they may give incorrect elevated potassium.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Precision data provided in SD and CV; Linearity data provided in Slope, Intercept, R2; Method correlation data provided in Slope, Intercept, R2, Syx.)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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) |
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3
5 510(k)171476 Summary
| Applicant: | Awareness Technology
1935 SW Martin Highway
Palm City, FL 34990 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Steve Andrus
Quality Assurance Manager
Phone: 772.283.6540 ext. 220
Fax: 772.283.8020
Email: 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 clinical | ||
| laboratory use by laboratory | ||
| professionals to assess the levels of | ||
| Sodium, Potassium, and Chloride | ||
| found in serum and lithium heparin | ||
| venous whole blood. The analysis is | ||
| performed in-vitro, and neither the | ||
| analyzer nor any of its components | ||
| come in contact with the patient. The | ||
| instrument should be used in | ||
| laboratories that routinely conform to | ||
| government regulations or | ||
| accreditation requirements for quality. | ||
| On each day of use, analyze the | ||
| SelectaLyte™ Quality Control Kit Tri | ||
| Level at least once. | The AVL 9180 Electrolyte | |
| Analyzer is intended to be used | ||
| for the measurement of sodium, | ||
| potassium, chloride, ionized | ||
| calcium and lithium in whole | ||
| blood, serum or plasma, urine, | ||
| dialysate solutions, or QC | ||
| materials as appropriate by | ||
| minimally trained personnel | ||
| qualified to preform and to | ||
| report these values in a clinical | ||
| laboratory setting. These | ||
| analytes are commonly used in | ||
| the diagnosis and management | ||
| of patients with a broad range of | ||
| renal, metabolic and | ||
| cardiovascular disorders and, as | ||
| such, have come to be among | ||
| those which are considered by | ||
| the American Association of | ||
| Clinical Chemistry to have a | ||
| potential of being life | ||
| Electrolytes Measured | Sodium (Na+), Potassium (K+), and | |
| Chloride (Cl-) | threatening if left uncontrolled. | |
| Sodium (Na+), Potassium (K+), | ||
| Chloride (Cl-), Lithium(Li+), | ||
| Calcium(Ca2+) | ||
| Samples Type Measured | Serum and lithium heparin venous | |
| whole blood | Whole blood, serum or plasma, | |
| urine, dialysate solutions, or QC | ||
| materials | ||
| Sample Volume | 85 µL | 95 µL |
| Sample Detection Sensor | Yes | No |
| SE Sample Measurement | ||
| Range for all Types | Na+: 40 - 205 mmol/L | |
| K+: 1.5 – 15.0 mmol/L | ||
| Cl-: 50 - 200 mmol/L | Na+: 40 - 205 mmol/L | |
| K+: 1.5 – 15.0 mmol/L | ||
| Cl-: 50 - 200 mmol/L | ||
| Model | SelectaLyte | AVL |
| Reagent Pack | Cal Standard: 650mL | |
| SLOPE Standard: 125mL | ||
| Reference Solution: 125 mL | ||
| Waste bag | Standard A 350 mL | |
| Standard B 85 mL | ||
| Reference Solution 85 mL | ||
| Waste bag | ||
| Results Storage | Sample Results: 200 | |
| QC Results: 270 | Sample Results: 200 | |
| QC Results: 35 | ||
| Display | Interactive touch screen 8.9cm | |
| (3.5") LCD, color graphic display | 32 character, 2 line display | |
| Output | Thermal printer with graphic | |
| capability, 29-character width. | ||
| USB Memory Stick | Thermal paper | |
| 32 character, 2-line | ||
| alphanumeric display | ||
| Power Requirements: | 100-240VAC, 50/60Hz 55W | |
| maximum | 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 |
|---|
| Pooled
Human
Serum | 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
| Pooled
Human
Serum | 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
| Pooled
Human
Serum | 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.
| Human
Whole
Blood | 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
| Pooled
Human
Serum | 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
| Human
Whole
Blood | 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 | # of | |||||
| Levels | Slope | Intercept | Correlation | |||
| Coefficient | 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 | # of
Levels | Slope | Intercept | Correlation
Coefficient | 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 did
not 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 did
not 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 did
not 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.