(347 days)
The A-LYTE® Integrated Multisensor (IMT Na K Cl) is for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma (lithium heparin) and urine using the Atellica® Cl Analyzer. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of arge 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. Measurements of potassium 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. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The A-LYTE Na, K, and Cl assays use indirect Integrated Multisensor Technology (IMT). There are four electrodes used to measure electrolytes. Three of these electrodes are ionselective for sodium, potassium and chloride. A reference is also incorporated in the multisensor.
A diluted sample (1:10 with A-LYTE IMT Diluent)) is positioned in the sensor and Na+. K+ or Cl- ions establish equilibrium with the electrode surface. A potential is generated proportional to the logarithm of the analyte activity in the sample. The electrical potential generated on a sample is compared to the electrical potential generated on a standard solution, and the concentration of the desired ions is calculated by use of the Nernst equation.
This document describes the performance characteristics of the A-LYTE® Integrated Multisensor (IMT Na K Cl) device, which is used for the quantitative determination of sodium, potassium, and chloride in human serum, plasma, and urine. The information provided outlines the acceptance criteria for various performance metrics and the study results demonstrating that the device meets these criteria.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly list "acceptance criteria" in a separate table, but rather describes the design goals or target performance for each characteristic, followed by the obtained results. I will present these as acceptance criteria and reported performance.
Table 1: Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Analyte | Sample Type | Acceptance Criteria (Design Goal) | Reported Device Performance |
|---|---|---|---|---|
| Detection Capability | Na | Serum & Plasma | LoQ ≤ 50 mmol/L with ≤ 20% total error | LoQ = 43.4 mmol/L, with ≤ 20% total error (calculated using Westgard model) |
| Na | Urine | LoQ ≤ 10 mmol/L with ≤ 30% total error | LoQ = 6.12 mmol/L, with ≤ 30% total error | |
| K | Serum & Plasma | LoQ ≤ 1 mmol/L with ≤ 20% total error | LoQ = 0.606 mmol/L, with ≤ 20% total error | |
| K | Urine | LoQ ≤ 2 mmol/L with ≤ 30% total error | LoQ = 1.22 mmol/L, with ≤ 30% total error | |
| Cl | Serum & Plasma | LoQ ≤ 50 mmol/L with ≤ 20% total error | LoQ = 40.4 mmol/L, with ≤ 20% total error | |
| Cl | Urine | LoQ ≤ 20 mmol/L with ≤ 30% total error | LoQ = 8.70 mmol/L, with ≤ 30% total error | |
| Linearity | Na | Serum | Linear range 50–200 mmol/L (demonstrated linearity of claimed measuring range) | $y=0.9858x - 0.53$ (demonstrated linearity) |
| K | Serum | Linear range 1–10 mmol/L (demonstrated linearity of claimed measuring range) | $y=0.98229x - 0.0085$ (demonstrated linearity) | |
| Cl | Serum | Linear range 50–200 mmol/L (demonstrated linearity of claimed measuring range) | $y=1.00040x + 0.037$ (demonstrated linearity) | |
| Na | Urine | Linear range 10–300 mmol/L (demonstrated linearity of claimed measuring range) | $y=0.9505x - 5.556$ (demonstrated linearity) | |
| K | Urine | Linear range 2–300 mmol/L (demonstrated linearity of claimed measuring range) | $y=0.9668x - 0.020$ (demonstrated linearity) | |
| Cl | Urine | Linear range 20–330 mmol/L (demonstrated linearity of claimed measuring range) | $y=1.00429x - 2.135$ (demonstrated linearity) | |
| Precision | Na | Serum/Urine | Detailed precision criteria not explicitly defined as "acceptance criteria", but results are presented. | See detailed tables in the document (within-laboratory precision, repeatability). |
| K | Serum/Urine | See detailed tables in the document. | ||
| Cl | Serum/Urine | See detailed tables in the document. | ||
| Assay Comparison | Na | Serum/Urine | Correlation coefficient ≥ 0.980, slope for Na 1.00 ± 0.05 | Serum: r=0.998, y=1.00x-2.69; Urine: r=0.999, y=1.02x-4.47 |
| K | Serum | Correlation coefficient ≥ 0.980, slope for K 1.00 ± 0.07 | Serum: r=1.000, y=0.97x+0.0353 | |
| K | Urine | Correlation coefficient ≥ 0.980, slope for K 1.00 ± 0.05 | Urine: r=0.999, y=1.02x-0.209 | |
| Cl | Serum/Urine | Correlation coefficient ≥ 0.980, slope for Cl 1.00 ± 0.05 | Serum: r=0.999, y=0.99x+0.161; Urine: r=0.991, y=0.99x-0.582 | |
| Reproducibility | Na/K/Cl | Serum/Urine | Detailed reproducibility criteria not explicitly defined as "acceptance criteria", but results are presented. | See detailed tables in the document (repeatability, between-day/-lot/-instrument, total reproducibility). |
| Specimen Equivalency | Na/K/Cl | Plasma vs Serum | Not explicitly defined as acceptance criteria, but correlation coefficient and regression equations are provided. | Na: r=0.994; K: r=0.983; Cl: r=0.998 |
| Interferences | Na/K/Cl | Serum/Urine | Bias ≤ 10% (for specific interferents at specified concentrations), except for hemoglobin/Na (-6% bias) and hemoglobin/Cl (-7% to -9% bias) at 1000 mg/dL, and urine Na/heme (-9% bias) at 500 mg/dL. | See detailed tables in the document. No bias > 10% reported for HIL, except for a few instances that are specifically called out as not needing correction. |
| Non-Interfering Substances | Na/K/Cl | Serum/Urine | Bias ≤ 10% at specified concentrations (except Salicylate with bias ≤ 15% for Cl). | All substances tested shown to have bias ≤ 10% (except Salicylate for Cl, which is ≤ 15% and noted as such). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
-
Test Set Sample Sizes:
- Detection Capability (LoQ): 180 determinations for each analyte (Na, K, Cl) in both serum/plasma and urine.
- Linearity: 5 replicates per level for at least nine levels, implying a minimum of 45 measurements per analyte and sample type.
- Precision: N ≥ 80 for each sample type (serum and urine) for each analyte (Na, K, Cl).
- Assay Comparison:
- Na (Serum): 123 samples
- Na (Urine): 117 samples
- K (Serum): 119 samples
- K (Urine): 117 samples
- Cl (Serum): 123 samples
- Cl (Urine): 127 samples
- Reproducibility: N=225 results for each sample type (serum QC, human serum, human urine) per analyte (Na, K, Cl), with n=5 assays in 1 run for 5 days using 3 instruments and 3 sensor lots.
- Specimen Equivalency:
- Na (Lithium heparin plasma vs Serum): 138 samples
- K (Lithium heparin plasma vs Serum): 56 samples
- Cl (Lithium heparin plasma vs Serum): 136 samples
- Interferences: Not explicitly stated as a single "sample size," but implied from the number of test concentrations and conditions evaluated (e.g., specific concentrations of hemoglobin, bilirubin, lipemia).
- Non-Interfering Substances: Not explicitly stated as a single "sample size," but implied from the number of test concentrations and conditions evaluated.
-
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission for an in vitro diagnostic device, these studies are typically prospective validation studies conducted at the manufacturer's R&D facilities or contracted labs, adhering to CLSI guidelines.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is an in vitro diagnostic (IVD) for quantitative determination of electrolytes. The "ground truth" (or reference values) for these types of devices is established through:
- Reference Methods: Comparison against established, well-characterized reference methods or instruments (e.g., the predicate device in the assay comparison, or other highly accurate laboratory methods). In this case, "Atellica CH Na/K/Cl on Atellica CH Analyzer" served as the comparative assay, which itself would have been validated against reference standards.
- Certified Reference Materials: Use of calibrated standards and controls with known analyte concentrations derived from definitive methods.
Therefore, the concept of "experts" (like radiologists interpreting images) establishing ground truth does not directly apply here. Instead, ground truth is based on physical/chemical measurements and their traceability to metrological standards. There are no human experts involved in adjudicating the "truth" of an electrolyte concentration in a sample as there would be in image interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. As explained in point 3, the ground truth for this type of quantitative IVD assay is established through comparison to reference methods, not human adjudication of a qualitative or semi-quantitative outcome.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is an automated laboratory analyzer, specifically an Integrated Multisensor for electrolyte measurement. It is not an imaging AI device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the performance data presented (Detection Capability, Linearity, Precision, Reproducibility, Interferences) represent the standalone performance of the A-LYTE® Integrated Multisensor (IMT Na K Cl) on the Atellica® CI Analyzer. These are direct measurements of the device's analytical precision, accuracy, and interference profiles under controlled laboratory conditions, without human interpretation influencing the quantitative results. The Assay Comparison also represents the device's performance against another automated laboratory system (the predicate device).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for this device's performance studies is based on:
- Reference Standards/Methods: Calibrated reference materials and comparison to a legally marketed predicate device (TD-LYTE Integrated Multisensor on Trinidad CH System, now Atellica CH System). This ensures that the measured concentrations are accurately determined against established analytical benchmarks.
- Known Concentrations: For linearity, precision, and interference studies, samples are often spiked or diluted to known concentrations, or quality control materials with certified values are used.
8. The sample size for the training set:
Not applicable. This device is a measurement instrument based on established potentiometric technology (Ion-Selective Electrodes). It does not employ machine learning or AI models that require a separate "training set" in the conventional sense. The development and calibration of such devices rely on comprehensive analytical chemistry and engineering principles, using calibration standards, quality control materials, and extensive internal testing during the development phase. The data presented here are for the validation of the finalized device, not for its iterative training.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" for an AI model. For the development and calibration of the IMT, the ground truth would be established through a combination of:
- Primary Reference Materials: Use of highly pure chemical standards with accurately known concentrations.
- Secondary Reference Standards: Calibrated solutions traceable to primary standards.
- Reference Measurement Procedures: Highly accurate and precise analytical methods (e.g., flame photometry, coulometry, or isotope dilution mass spectrometry for elemental analysis) used to assign values to control materials and calibrators.
- Internal R&D and Optimization: Extensive testing and refinement of the sensor and instrument performance using these traceable standards during the development process.
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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" followed by the words "U.S. Food & Drug Administration".
July 25, 2023
Siemens Healthcare Diagnostics Inc. Anoop Joy Regulatory Clinical Affairs Specialist 511 Benedict Avenue Tarrytown, NY 10591
Re: K222438
Trade/Device Name: A-LYTE® Integrated Multisensor (IMT Na K Cl) Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium Test System Regulatory Class: Class II Product Code: JGS, CEM, CGZ Dated: January 31, 2023 Received: February 1, 2023
Dear Anoop Joy:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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 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) K222438
Device Name
A-LYTE® Integrated Multisensor (IMT Na K Cl)
Indications for Use (Describe)
The A-LYTE® Integrated Multisensor (IMT Na K Cl) is for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma (lithium heparin) and urine using the Atellica® Cl Analyzer. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of arge 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. Measurements of potassium 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. 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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510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: K222438
1. APPLICANT
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue, Tarrytown, NY 10591 USA
| Contact: | Anoop JoyRegulatory Clinical Affairs Specialist |
|---|---|
| Phone: | (516) 232-3307 |
| E-mail: | anoop.joy@siemens-healthineers.com |
Date Prepared: July 20, 2023
2. Requlatory Information
Assay: A-LYTE Integrated Multisensor (IMT Na K CI)
Trade Name: A-LYTE® Integrated Multisensor (IMT Na K CI)
Classification Name: Electrode, Ion Specific, Sodium Regulation: 21CFR862.1665 Classification: Class II Product Code: JGS Panel: Clinical Chemistry
Classification Name: Electrode, Ion Specific, Chloride Regulation: 21CFR862.1170 Classification: Class II Product Code: CGZ Panel: Clinical Chemistry
Classification Name: Electrode, Ion Specific, Potassium Requlation: 21CFR862.1600 Classification: Class II Product Code: CEM Panel: Clinical Chemistry
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3. PREDICATE DEVICE INFORMATION
| Predicate Device | 510(k) # | Class | Code |
|---|---|---|---|
| TD-LYTE Integrated Multisensor (Na, K, Cl)1 | K151767 | Class II | JGSCEMCGZ |
1Note: TD-LYTE Integrated Multisensor (Na, K, Cl) was renamed as A-LYTE Integrated Multisensor (Na, K, Cl) in K161954. The assay was commercialized as A-LYTE Integrated Multisensor (Na, K, C).
4. DEVICE DESCRIPTION
The A-LYTE Na, K, and Cl assays use indirect Integrated Multisensor Technology (IMT). There are four electrodes used to measure electrolytes. Three of these electrodes are ionselective for sodium, potassium and chloride. A reference is also incorporated in the multisensor.
A diluted sample (1:10 with A-LYTE IMT Diluent)) is positioned in the sensor and Na+. K+ or Cl- ions establish equilibrium with the electrode surface. A potential is generated proportional to the logarithm of the analyte activity in the sample. The electrical potential generated on a sample is compared to the electrical potential generated on a standard solution, and the concentration of the desired ions is calculated by use of the Nernst equation.
5. INTENDED USE
The A-LYTE® Integrated Multisensor (IMT Na K CI) is for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma (lithium heparin) and urine using the Atellica® CI Analyzer. Measurements of sodium 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. Measurements of potassium 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. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
6. INDICATIONS FOR USE
Same as Intended use
7. COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Below is a features comparison for the A-LYTE Integrated Multisensor (IMT Na K Cl) on the Atellica CI Analyzer and the predicate device Trinidad CH System.
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| Feature | Predicate Device:TD-LYTE on Trinidad CHSystem1 | New Device:IMT Na K CI on Atellica CIAnalyzer |
|---|---|---|
| Intended Use: | The TD-LYTE Integrated Multisensoris intended for the in vitro diagnosticuse in the quantitative determinationof sodium, potassium and chloride(Na, K, CI) in human serum, plasmaand urine using the Trinidad CHSystem | The A-LYTE IntegratedMultisensor (IMT Na K CI) is forin vitro diagnostic use in thequantitative determination ofsodium, potassium, andchloride (Na, K, CI) in humanserum, plasma (lithium heparin)and urine using the Atellica CIAnalyzer. |
| Indications for Use: | Measurements of sodium obtained bythis device are used in the diagnosisand treatment of aldosteronism(excessive secretion of the hormonealdosterone), diabetes insipidus(chronic excretion of large amounts ofdilute urine, accompanied by extremethirst), adrenal hypertension, Addison'sdisease (caused by destruction of theadrenal glands), dehydration,inappropriate antidiuretic hormonesecretion, or other diseases involvingelectrolyte imbalance.Measurements of potassium obtainedby this device are used to monitorelectrolyte balance in the diagnosis andtreatment of disease conditionscharacterized by low or high bloodpotassium levels.Chloride measurements are used in thediagnosis and treatment of electrolyteand metabolic disorders such as cysticfibrosis and diabetic acidosis. | Same |
| DeviceTechnology: | Indirect potentiometric measurementswith Integrated MultisensorTechnology (IMT) | Same |
| Sample Type: | Serum/plasma/urine | Same |
| Instrument: | Trinidad CH System1 | Atellica CI Analyzer |
| AnalyticalMeasuringInterval: | Serum/PlasmaNa: 50 – 200 mmol/LK: 1– 10 mmol/LCl: 50 – 200 mmol/LUrine | Same |
| Na: 10 – 300 mmol/LK: 2 – 300 mmol/LCl: 20 – 330 mmol/L | ||
| ReferenceInterval: | Serum / PlasmaNa: 136–145 mmol/LK (serum): 3.5–5.1 mmol/LK (plasma): 3.4–4.5 mmol/LCl: 98–107 mmol/LUrineNa: 40–220 mmol/LK: 25–125 mmol/LCl: 110–250 mmol/L | Same |
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1Note: Trinidad CH System was renamed as Atellica CH System in K161954. The system was commercialized as Atellica CH System.
8. PERFORMANCE CHARACTERISTICS DATA
Detection Capability
Detection capability was determined in accordance with CLSI Document EP17-A2. The Na assay is designed to have a limit of quantitation (LoQ) ≤ 50 mmol/L (50 mEq/L) with ≤ 20% total error for serum and plasma, and ≤ 10 mmol/L (10 mEq/L) with ≤ 30% total error for urine. The K assay is designed to have a LoQ ≤ 1 mmol/L (1 mEq/L) with ≤ 20% total error for serum and plasma, and ≤ 2 mmol/L (2 mEq/L) with ≤ 30% total error for urine. The Cl assay is designed to have a LoQ ≤ 50 mmol/L (50 mEg/L) with ≤ 20% total error for serum and plasma, and ≤ 20 mmol/L (20 mEq/L) with ≤ 30% total error for urine.
| Sample Type | Assay | Limit of Quantita-tion (LoQ)mmol/L (mEq/L) | Determinations | Total AnalyticalError Limit (%)ª |
|---|---|---|---|---|
| Serum and plasma | Na | 43.4 (43.4) | 180 | ≤ 20 |
| Urine | Na | 6.12 (6.12) | 180 | ≤ 30 |
| Serum and plasma | K | 0.606 (0.606) | 180 | ≤ 20 |
| Urine | K | 1.22 (1.22) | 180 | ≤ 30 |
| Serum and plasma | Cl | 40.4 (40.4) | 180 | ≤ 20 |
| Urine | Cl | 8.70 (8.70) | 180 | ≤ 30 |
a Calculated using the Westgard model.
Linearity
Linearity studies were performed following CLSI EP06-ED2. Dilution series composed of at least nine levels created by mixing the high and low pools of serum and urine. Measurements were made with N=5 replicates per level. The results of the linear regression analysis are summarized in the table below.
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| Specimen Type | Regression | Claimed Linear Range |
|---|---|---|
| Serum (Na) | $y=0.9858x - 0.53$ | 50–200 mmol/L (mEq/L) |
| Serum (K) | $y=0.98229x - 0.0085$ | 1–10 mmol/L (mEq/L) |
| Serum (CI) | $y=1.00040x + 0.037$ | 50–200 mmol/L (mEq/L) |
| Urine (Na) | $y=0.9505x - 5.556$ | 10–300 mmol/L (mEq/L) |
| Urine (K) | $y=0.9668x - 0.020$ | 2–300 mmol/L (mEq/L) |
| Urine (CI) | $y=1.00429x - 2.135$ | 20–330 mmol/L (mEq/L) |
The results demonstrated linearity of the claimed measuring range.
Precision
Precision was determined in accordance with CLSI Document EP05-A3. Samples were assayed on an Atellica Cl Analyzer in duplicate in 2 runs per day for 20 days (N ≥ 80 for each sample). The following results were obtained:
| Repeatability | Within-Laboratory Precision | |||||
|---|---|---|---|---|---|---|
| Sample Type | N | Mean mmol/L (mEq/L) | SDa mmol/L (mEq/L) | CVb (%) | SD mmol/L (mEq/L) | CV (%) |
| Serum 1 | 80 | 70.1 (70.1) | 0.20 (0.20) | 0.3 | 0.86 (0.86) | 1.2 |
| Serum QC 1 | 80 | 113 (113) | 0.39 (0.39) | 0.3 | 1.12 (1.12) | 1.0 |
| Serum QC 2 | 80 | 139 (139) | 0.58 (0.58) | 0.4 | 1.65 (1.65) | 1.2 |
| Serum QC 3 | 80 | 154 (154) | 0.55 (0.55) | 0.4 | 1.68 (1.68) | 1.1 |
| Urine 1 | 80 | 30.5 (30.5) | 0.40 (0.40) | 1.3 | 0.67 (0.67) | 2.2 |
| Urine QC 1 | 80 | 82.9 (82.9) | 0.31 (0.31) | 0.4 | 1.04 (1.04) | 1.2 |
| Urine 2 | 80 | 148 (148) | 0.52 (0.52) | 0.4 | 2.15 (2.15) | 1.5 |
| Urine 3 | 80 | 240 (240) | 0.82 (0.82) | 0.3 | 3.56 (3.56) | 1.5 |
Sodium (Na)
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| Repeatability | Within-Laboratory Precision | |||||
|---|---|---|---|---|---|---|
| Sample Type | N | Meanmmol/L (mEq/L) | SDammol/L (mEq/L) | CVb(%) | SDmmol/L (mEq/L) | CV(%) |
| Serum QC 1 | 80 | 2.44 (2.44) | 0.01 (0.01) | 0.5 | 0.03 (0.03) | 1.1 |
| Serum QC 2 | 80 | 4.04 (4.04) | 0.01 (0.01) | 0.4 | 0.04 (0.04) | 1.1 |
| Serum 1 | 80 | 6.03 (6.03) | 0.02 (0.02) | 0.4 | 0.07 (0.07) | 1.2 |
| Serum QC 3 | 80 | 7.16 (7.16) | 0.02 (0.02) | 0.3 | 0.08 (0.08) | 1.1 |
| Urine QC 1 | 80 | 30.8 (30.8) | 0.10 (0.10) | 0.3 | 0.28 (0.28) | 0.9 |
| Urine QC 2 | 80 | 75.4 (75.4) | 0.15 (0.15) | 0.2 | 0.79 (0.79) | 1.0 |
| Urine 1 | 80 | 248 (248) | 1.01 (1.01) | 0.4 | 3.21 (3.21) | 1.3 |
Potassium (K)
Chloride (Cl)
| Repeatability | Within-Laboratory Precision | |||||
|---|---|---|---|---|---|---|
| Sample Type | N | Mean mmol/L (mEq/L) | SDa mmol/L (mEq/L) | CVb (%) | SD mmol/L (mEq/L) | CV (%) |
| Serum QC 1 | 80 | 75.1 (75.1) | 0.35 (0.35) | 0.5 | 1.12 (1.12) | 1.5 |
| Serum QC 2 | 80 | 98.3 (98.3) | 0.33 (0.33) | 0.3 | 1.03 (1.03) | 1.0 |
| Serum QC 3 | 80 | 119 (119) | 0.40 (0.40) | 0.3 | 1.24 (1.24) | 1.0 |
| Serum 1 | 80 | 176 (176) | 0.61 (0.61) | 0.3 | 2.96 (2.96) | 1.7 |
| Urine 1 | 80 | 43.3 (43.3) | 0.25 (0.25) | 0.6 | 1.70 (1.70) | 3.9 |
| Urine QC 1 | 80 | 101 (101) | 0.35 (0.35) | 0.3 | 4.48 (4.48) | 4.5 |
| Urine QC 2 | 80 | 196 (196) | 0.52 (0.52) | 0.3 | 3.47 (3.47) | 1.8 |
| Urine 2 | 80 | 286 (286) | 0.83 (0.83) | 0.3 | 6.69 (6.69) | 2.3 |
Standard deviation. a
b Coefficient of variation.
Assay Comparison
The performance of the Atellica CH IMT Na K CI assay on the Atellica CI Analyzer (y) was compared with the performance of the comparative assay on the indicated system (x) and is designed to have a correlation coefficient of ≥ 0.980. The A-LYTE Na assay is designed to have a slope of 1.00 ± 0.05 for serum and urine specimens. The A-LYTE K assay is designed to have a slope of 1.00 ± 0.07 for serum specimens, and a slope of 1.00 ± 0.05 for urine specimens. The A-LYTE Classay is designed to have a slope of 1.00 ± 0.05 for serum and urine specimens. Assay comparison was determined using the Weighted Deming regression model in accordance with CLSI Document EP09c. The following results were obtained:
{9}------------------------------------------------
| Specimen | Comparative Assay (x) | Regression Equation | Sample Interval | Na | rb |
|---|---|---|---|---|---|
| Serum | Atellica CH Na onAtellica CH Analyzer | y = 1.00x - 2.69 mmol/L(y = 1.00x - 2.69 mEq/L) | 53.2–192 mmol/L(53.2–192 mEq/L) | 123 | 0.998 |
| Urine | Atellica CH Na onAtellica CH Analyzer | y = 1.02x - 4.47 mmol/L(y = 1.02x - 4.47 mEq/L) | 20.1–237 mmol/L(20.1–237 mEq/L) | 117 | 0.999 |
| Serum | Atellica CH K onAtellica CH Analyzer | y = 0.97x + 0.0353 mmol/L(y = 0.97x + 0.0353 mEq/L) | 1.40–9.85 mmol/L(1.40–9.85 mEq/L) | 119 | 1.000 |
| Urine | Atellica CH K onAtellica CH Analyzer | y = 1.02x -0.209 mmol/L(y = 1.02x -0.209 mEq/L) | 6.22–246 mmol/L(6.22–246 mEq/L) | 117 | 0.999 |
| Serum | Atellica CH Cl onAtellica CH Analyzer | y = 0.99x + 0.161 mmol/L(y = 0.99x + 0.161 mEq/L) | 52.7–196 mmol/L(52.7–196 mEq/L) | 123 | 0.999 |
| Urine | Atellica CH Cl onAtellica CH Analyzer | y = 0.99x - 0.582 mmol/L(y = 0.99x - 0.582 mEq/L) | 24.3–314 mmol/L(24.3–314 mEq/L) | 127 | 0.991 |
a Number of samples tested.
b Correlation coefficient.
Reproducibility
Reproducibility was determined in accordance with CLSI Document EP05-A3.13 Samples were assayed n=5 in 1 run for 5 days using 3 instruments and 3 sensor lots. The data were analyzed to calculate the following components of precision: repeatability, between-day, between-lot, between-instrument, and reproducibility (total). The following results were obtained:
{10}------------------------------------------------
Sodium (Na)
| Repeatability | Between-Day | Between-Lot | Between-Instrument | Total Reprodu-cibility | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample | Na | Meanmmol/L(mEq/L) | SDbmmol/L(mEq/L) | CVc(%) | SDmmol/L(mEq/L) | CV(%) | SDmmol/L(mEq/L) | CV(%) | SDmmol/L(mEq/L) | CV(%) | SDmmol/L(mEq/L) | CV(%) | ||
| Serum QC | 225 | 113(113) | 0.40(0.40) | 0.4 | 1.00(1.00) | 0.8 | 0.00(0.00) | 0.0 | 0.00(0.00) | 0.0 | 1.00(1.00) | 0.9 | ||
| Serum QC | 225 | 154(154) | 0.50(0.50) | 0.3 | 1.10(1.10) | 0.7 | 0.70(0.70) | 0.5 | 1.40(1.40) | 0.9 | 2.00(2.00) | 1.3 | ||
| NormalHumanSerum | 225 | 139(139) | 0.40(0.40) | 0.3 | 0.80(0.80) | 0.6 | 0.20(0.20) | 0.1 | 0.90(0.90) | 0.7 | 1.30(1.30) | 0.9 | ||
| NormalHumanSerum | 225 | 70.1(70.1) | 0.24(0.24) | 0.3 | 1.23(1.23) | 1.8 | 0.94(0.94) | 1.3 | 0.25(0.25) | 0.4 | 1.59(1.59) | 2.3 | ||
| NormalHumanUrine | 225 | 30.4(30.4) | 0.38(0.38) | 1.3 | 0.75(0.75) | 2.5 | 0.52(0.52) | 1.7 | 0.43(0.43) | 1.4 | 1.08(1.08) | 3.5 | ||
| NormalHumanUrine | 225 | 81.1(81.1) | 0.26(0.26) | 0.3 | 1.35(1.35) | 1.7 | 0.04(0.04) | 0.1 | 0.49(0.49) | 0.6 | 1.46(1.46) | 1.8 | ||
| NormalHumanUrine | 225 | 150(150) | 0.50(0.50) | 0.3 | 2.40(2.40) | 1.6 | 1.50(1.50) | 1.0 | 2.00(2.00) | 1.3 | 3.50(3.50) | 2.3 | ||
| NormalHumanUrine | 225 | 267(267) | 1.00(1.00) | 0.4 | 8.40(8.40) | 3.2 | 3.70(3.70) | 1.4 | 1.50(1.50) | 0.6 | 9.30(9.30) | 3.5 |
Potassium (K)
| Sample | Na | Meanmmol/L(mEq/L) | Repeatability | Between-Day | Between-Lot | Between-Instrument | Total Reprodu-cibility | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SDbmmol/L(mEq/L) | CVc(%) | SDmmol/L(mEq/L) | CV(%) | SDmmol/L(mEq/L) | CV(%) | SDmmol/L(mEq/L) | CV(%) | SDmmol/L(mEq/L) | CV(%) | |||
| Serum QC | 225 | 2.47(2.47) | 0.03(0.03) | 1.2 | 0.02(0.02) | 0.6 | 0.00(0.00) | 0.0 | 0.03(0.03) | 1.1 | 0.04(0.04) | 1.7 |
| Serum QC | 225 | 7.27(7.27) | 0.03(0.03) | 0.4 | 0.05(0.05) | 0.7 | 0.01(0.01) | 0.2 | 0.05(0.05) | 0.7 | 0.08(0.08) | 1.1 |
{11}------------------------------------------------
| NormalHumanSerum | 225 | 4.30(4.30) | 0.01(0.01) | 0.2 | 0.02(0.02) | 0.6 | 0.01(0.01) | 0.1 | 0.03(0.03) | 0.7 | 0.04(0.04) | 1.0 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NormalHumanSerum | 225 | 6.14(6.14) | 0.01(0.01) | 0.2 | 0.04(0.04) | 0.6 | 0.01(0.01) | 0.2 | 0.04(0.04) | 0.6 | 0.06(0.06) | 0.9 |
| NormalHumanUrine | 225 | 31.3(31.3) | 0.07(0.07) | 0.2 | 0.40(0.40) | 1.3 | 0.07(0.07) | 0.2 | 0.07(0.07) | 0.2 | 0.42(0.42) | 1.3 |
| NormalHumanUrine | 225 | 68.5(68.5) | 0.24(0.24) | 0.4 | 1.28(1.28) | 1.9 | 0.24(0.24) | 0.4 | 0.24(0.24) | 0.3 | 1.35(1.35) | 2.0 |
| NormalHumanUrine | 225 | 256(256) | 0.70(0.70) | 0.3 | 2.30(2.30) | 0.9 | 1.00(1.00) | 0.4 | 1.30(1.30) | 0.5 | 2.90(2.90) | 1.1 |
Chloride (Cl)
| Repeatability | Between-Day | Between-Lot | Between-Instrument | Total Reprodu-cibility | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample | Na | Meanmmol/L(mEq/L) | SDbmmol/L(mEq/L) | CVc(%) | SDmmol/L(mEq/L) | CV(%) | SDmmol/L(mEq/L) | CV(%) | SDmmol/L(mEq/L) | CV(%) | SDmmol/L(mEq/L) | CV(%) |
| Serum QC | 225 | 78.1(78.1) | 0.29(0.29) | 0.4 | 0.79(0.79) | 1.0 | 0.41(0.41) | 0.5 | 0.08(0.08) | 0.1 | 0.94(0.94) | 1.2 |
| Serum QC | 225 | 119(119) | 0.50(0.50) | 0.4 | 0.90(0.90) | 0.7 | 0.30(0.30) | 0.3 | 0.20(0.20) | 0.2 | 1.10(1.10) | 0.9 |
| NormalHumanSerum | 225 | 108(108) | 0.30(0.30) | 0.3 | 0.80(0.80) | 0.7 | 0.20(0.20) | 0.2 | 0.30(0.30) | 0.3 | 0.90(0.90) | 0.8 |
| NormalHumanSerum | 225 | 172(172) | 0.40(0.40) | 0.2 | 1.40(1.40) | 0.8 | 0.00(0.00) | 0.0 | 0.90(0.90) | 0.6 | 1.80(1.80) | 1.0 |
| NormalHumanUrine | 225 | 41.7(41.7) | 0.23(0.23) | 0.6 | 1.19(1.19) | 2.9 | 0.10(0.10) | 0.2 | 0.02(0.02) | 0.1 | 1.22(1.22) | 2.9 |
| NormalHumanUrine | 225 | 104(104) | 0.40(0.40) | 0.4 | 3.00(3.00) | 2.9 | 0.40(0.40) | 0.3 | 0.70(0.70) | 0.7 | 3.10(3.10) | 3.0 |
| NormalHumanUrine | 225 | 206(206) | 0.50(0.50) | 0.2 | 2.00(2.00) | 1.0 | 0.30(0.30) | 0.1 | 1.40(1.40) | 0.7 | 2.50(2.50) | 1.2 |
| NormalHumanUrine | 225 | 270(270) | 0.70(0.70) | 0.3 | 3.90(3.90) | 1.4 | 0.00(0.00) | 0.0 | 2.70(2.70) | 1.0 | 4.70(4.70) | 1.8 |
a Number of results.
b Standard deviation.
c Coefficient of variation.
Specimen Equivalency
{12}------------------------------------------------
Specimen equivalency was determined using linear regression model in accordance with CLSI Document EP09c. The following results were obtained:
| Assay | Specimen (y) | Reference Specimen (x) | Regression Equation | Sample Interval | Na | rb |
|---|---|---|---|---|---|---|
| Na | Lithium heparin plasma | Serum | $y = 1.02x - 1.87 \text{ mmol/L}$( $y = 1.02x - 1.87 \text{ mEq/L}$ ) | 53.4–190 mmol/L(53.4–190 mEq/L) | 138 | 0.994 |
| Kc | Lithium heparin plasma | Serum | $y = 0.99x - 0.207 \text{ mmol/L}$( $y = 0.99x - 0.207 \text{ mEq/L}$ ) | 1.41–9.33 mmol/L(1.41–9.33 mEq/L) | 56 | 0.983 |
| Cl | Lithium heparin plasma | Serum | $y = 1.00x - 0.201 \text{ mmol/L}$( $y = 1.00x - 0.201 \text{ mEq/L}$ ) | 53.7–197 mmol/L(53.7–197 mEq/L) | 136 | 0.998 |
Number of samples tested. a
b Correlation coefficient.
It is documented in the literature that potassium concentrations in plasma specimens can be lower than in serum specimens as a consequence of platelet rupture during coagulation. The extent of the potential difference is dependent on the platelet count in the specimen. The lower potassium reference intervals for plasma specimens compared to serum specimens reflect this known occurrence.
Interferences
Hemolysis, Icterus, and Lipemia (HIL)
The A-LYTE IMT Na K Cl multisensor was evaluated for interference from hemoglobin, bilirubin, and lipemia. Interfering substances at the levels indicated in the table below were tested in accordance with CLSI Document EP07 using the A-LYTE IMT Na K Cl multisensor. Bias is the difference in the results between the control sample (does not contain the interferent) and the test sample (contains the interferent) expressed in percent. Bias > 10% is considered interference. Analyte results should not be corrected based on this bias.
| Substance | Substance Test ConcentrationCommon Units (SI Units) | Analyte Concentrationmmol/L (mEq/L) | Percent Bias |
|---|---|---|---|
| Hemoglobin | 1000 mg/dL (10 g/L) | 136 (136) | -6 |
| 1000 mg/dL (10 g/L) | 159 (159) | -6 | |
| Bilirubin, conjugated | 60 mg/dL (1026 µmol/L) | 128 (128) | |
| 60 mg/dL (1026 µmol/L) | 146 (146) | 1 | |
| Bilirubin, unconjugated | 60 mg/dL (1026 µmol/L) | 132 (132) | |
| 60 mg/dL (1026 µmol/L) | 151 (151) | 0 | |
| Lipemia (Intralipid®) | 3000 mg/dL (30 g/L) | 122 (122) | |
| 3000 mg/dL (30 g/L) | 140 (140) | 1 | |
| Lipemia (Trig Fraction) | 1125 mg/dL (11.3 g/L) | 124 (124) | |
| 1125 mg/dL (11.3 g/L) | 145 (145) | 4 |
Serum/Plasma Interference - Sodium (Na)
{13}------------------------------------------------
| Substance | Substance Test ConcentrationCommon Units (SI Units) | Analyte Concentrationmmol/L (mEq/L) | Percent Bias |
|---|---|---|---|
| Bilirubin, conjugated | 60 mg/dL (1026 µmol/L) | 2.92 (2.92) | 0 |
| 60 mg/dL (1026 µmol/L) | 4.98 (4.98) | 0 | |
| Bilirubin, unconjugated | 60 mg/dL (1026 µmol/L) | 2.87 (2.87) | 0 |
| 60 mg/dL (1026 µmol/L) | 4.84 (4.84) | 0 | |
| Lipemia (Intralipid) | 3000 mg/dL (30 g/L) | 2.74 (2.74) | 6 |
| 3000 mg/dL (30 g/L) | 4.53 (4.53) | 1 | |
| Lipemia (Trig Fraction) | 2000 mg/dL (20.0 g/L) | 3.04 (3.04) | 2 |
| 2000 mg/dL (20.0 g/L) | 5.45 (5.45) | -1 |
Serum/Plasma Interference - Potassium (K)
Serum/Plasma Interference - Chloride (CI)
| Substance | Substance Test ConcentrationCommon Units (SI Units) | Analyte Concentrationmmol/L (mEq/L) | Percent Bias |
|---|---|---|---|
| Hemoglobin | 1000 mg/dL (10 g/L) | 93.6 (93.6) | -9 |
| 1000 mg/dL (10 g/L) | 119 (119) | -7 | |
| Bilirubin, conjugated | 60 mg/dL (1026 µmol/L) | 89.1 (89.1) | 0 |
| 60 mg/dL (1026 µmol/L) | 112 (112) | 0 | |
| Bilirubin, unconjugated | 60 mg/dL (1026 µmol/L) | 90.5 (90.5) | 0 |
| 60 mg/dL (1026 µmol/L) | 113 (113) | -1 | |
| Lipemia (Intralipid) | 3000 mg/dL (30 g/L) | 91.9 (91.9) | 2 |
| 3000 mg/dL (30 g/L) | 118 (118) | 1 | |
| Lipemia (Trig Fraction) | 1125 mg/dL (11.3 g/L) | 85.6 (85.6) | 6 |
| 1125 mg/dL (11.3 g/L) | 103 (103) | 5 |
Urine Interference - Sodium (Na)
| Substance | Substance Test ConcentrationCommon Units (SI Units) | Analyte Concentrationmmol/L (mEq/L) | Percent Bias |
|---|---|---|---|
| Hemoglobin | 500 mg/dL (5 g/L) | 58.2 (58.2) | -9 |
| 500 mg/dL (5 g/L) | 214 (214) | -2 | |
| Bilirubin, conjugated | 60 mg/dL (1026 µmol/L) | 47.0 (47.0) | 2 |
| 60 mg/dL (1026 µmol/L) | 197 (197) | 2 | |
| Bilirubin, unconjugated | 60 mg/dL (1026 µmol/L) | 51.8 (51.8) | -1 |
| 60 mg/dL (1026 µmol/L) | 205 (205) | 1 |
{14}------------------------------------------------
| Lipemia (Intralipid) | 2000 mg/dL (20 g/L) | 43.8 (43.8) | 2 |
|---|---|---|---|
| 2000 mg/dL (20 g/L) | 189 (189) | 1 | |
| Lipemia (Trig Fraction) | 250 mg/dL (2.5 g/L) | 47.7 (47.7) | 6 |
| 250 mg/dL (2.5 g/L) | 205 (205) | 2 |
Urine Interference - Potassium (K)
| Substance | Substance Test ConcentrationCommon Units (SI Units) | Analyte Concentrationmmol/L (mEq/L) | Percent Bias |
|---|---|---|---|
| Hemoglobin | 750 mg/dL (7.5 g/L) | 24.1 (24.1) | 9 |
| 750 mg/dL (7.5 g/L) | 184 (184) | 2 | |
| Bilirubin, conjugated | 60 mg/dL (1026 µmol/L) | 21.2 (21.2) | 0 |
| 60 mg/dL (1026 µmol/L) | 191 (191) | 1 | |
| Bilirubin, unconjugated | 60 mg/dL (1026 µmol/L) | 21.1 (21.1) | -1 |
| 60 mg/dL (1026 µmol/L) | 191 (191) | -1 | |
| Lipemia (Intralipid) | 2000 mg/dL (20 g/L) | 20.3 (20.3) | 1 |
| 2000 mg/dL (20 g/L) | 184 (184) | 1 | |
| Lipemia (Trig Fraction) | 2000 mg/dL (20 g/L) | 21.8 (21.8) | 3 |
| 2000 mg/dL (20 g/L) | 177 (177) | 2 |
Urine Interference - Chloride (CI)
| Substance | Substance Test ConcentrationCommon Units (SI Units) | Analyte Concentrationmmol/L (mEq/L) | Percent Bias |
|---|---|---|---|
| Hemoglobin | 500 mg/dL (5 g/L) | 56.9 (56.9) | -7 |
| 500 mg/dL (5 g/L) | 210 (210) | -2 | |
| Bilirubin, conjugated | 60 mg/dL (1026 µmol/L) | 52.7 (52.7) | -1 |
| 60 mg/dL (1026 µmol/L) | 212 (212) | -1 | |
| Bilirubin, unconjugated | 60 mg/dL (1026 µmol/L) | 54.9 (54.9) | 0 |
| 60 mg/dL (1026 µmol/L) | 210 (210) | -1 | |
| Lipemia (Intralipid) | 2000 mg/dL (20 g/L) | 54.7 (54.7) | 1 |
| 2000 mg/dL (20 g/L) | 200 (200) | 1 | |
| Lipemia (Trig Fraction) | 500 mg/dL (5.0 g/L) | 53.9 (53.9) | 8 |
| 500 mg/dL (5.0 g/L) | 202 (202) | 2 |
{15}------------------------------------------------
Non-Interfering Substances
The following substances do not interfere with the A-LYTE IMT Na K Cl multisensor at the concentrations indicated in the table below. Bias due to these substances is ≤ 10%. The Na and Cl assay interferences were tested with urine pools at approximately 50 mmol/L and 200 mmol/L of Na and Cl. The K assay interference was tested with urine pools at approximately 25 mmol/L and 200 mmol/L of K. The Na assay interferences were tested with serum pools at approximately 130 mmol/L and 150 mmol/L of Na. The K assay interference was tested with serum pools at approximately 3 mmol/L and 5 mmol/L of K. The Cl assay interference was tested with serum pools at approximately 90 mmol/L and 110 mmol/L of Cl.
| Substance | Specimen Type | Substance Test ConcentrationCommon Units (SI Units) |
|---|---|---|
| Acetaminophen | Urine | 200 mg/dL (13,231 µmol/L) |
| N-Acetyl cysteine | Urine | 2 mg/dL (123 µmol/L) |
| Ascorbic acid | Urine | 60 mg/dL (3409 µmol/L) |
| Bromide (CI) | Serum | 35 mg/dL (4375 µmol/L) |
| Citrate (Na, K) | Serum | 1 g/dL (52,051 µmol/L) |
| Citrate (CI) | Serum | 0.5 g/dL (26,025 µmol/L) |
| Fluoride (CI) | Serum | 0.25 g/dL (132 µmol/L) |
| Gentamycin sulfate | Urine | 10 mg/dL (194 µmol/L) |
| Ibuprofen (Na, K) | Urine | 500 mg/dL (24,272 µmol/L) |
| Ibuprofen (CI) | Urine | 400 mg/dL (19,418 µmol/L) |
| Iodine (CI) | Serum | 25 mg/dL (1975 µmol/L) |
| Iron (K) | Serum | 0.25 g/dL (44,767 µmol/L) |
| Levodopa | Urine | 15 mg/dL (761 µmol/L) |
| Ofloxacin (Na, K) | Urine | 90 mg/dL (2491 µmol/L) |
| Ofloxacin (CI) | Urine | 80 mg/dL (2214 µmol/L) |
| Phenazopyridine | Urine | 30 mg/dL (1407 µmol/L) |
| Salicylate (CI)a | Serum | 50 mg/dL (3623 µmol/L) |
| Sodium cefoxitin | Urine | 660 mg/dL (14,686 µmol/L) |
| Tetracycline | Urine | 15 mg/dL (338 µmol/L) |
| Low pH | Urine | pH 4 |
| High pH | Urine | pH 8 |
a Bias due to salicylate is ≤ 15%.
9. CONCLUSION
The candidate devices are substantially equivalent to the Predicate devices and yields substantially equivalent Performance Characteristics.
§ 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.