(347 days)
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No
The device description and performance studies focus on electrochemical measurement using ion-selective electrodes and the Nernst equation, which are traditional analytical chemistry methods, not AI/ML. There is no mention of AI, ML, or related concepts in the summary.
No.
The device is an in vitro diagnostic device used to measure levels of sodium, potassium, and chloride in human samples, which can aid in diagnosis and treatment monitoring, but it does not directly provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "for in vitro diagnostic use" and that measurements obtained by this device are "used in the diagnosis and treatment" of various conditions.
No
The device description explicitly states the use of "four electrodes" and describes the physical process of ion-selective measurement, indicating it is a hardware-based device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states, "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..." This directly identifies the device's purpose as being used outside of the body for diagnostic purposes.
- Device Description: The description details how the device measures analytes (Na, K, Cl) in biological samples (serum, plasma, urine) using ion-selective electrodes. This is a typical method for in vitro diagnostic testing.
- Performance Studies: The document describes various performance studies (Detection Capability, Linearity, Precision, Assay Comparison, etc.) conducted on the device using biological samples. These types of studies are standard for demonstrating the analytical performance of an IVD.
- Predicate Device: The mention of a predicate device (K151767; TD-LYTE Integrated Multisensor (Na, K, Cl)) which is also an IVD, further supports the classification of this device as an IVD.
The information provided clearly indicates that the A-LYTE® Integrated Multisensor is intended to be used in a laboratory setting to analyze human biological samples for the purpose of aiding in the diagnosis and treatment of various medical conditions. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JGS, CEM, CGZ
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Detection Capability: 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 size: 180 determinations for each analyte in serum/plasma and urine.
Linearity: 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. Results demonstrated linearity of the claimed measuring range.
Precision: 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). Data provided as Mean, SD, and CV for Repeatability and Within-Laboratory Precision for Sodium, Potassium, and Chloride in Serum and Urine.
Assay Comparison: Performance of the Atellica CH IMT Na K CI assay on the Atellica CI Analyzer (y) was compared with the comparative assay on the indicated system (x). 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 Cl assay is designed to have a slope of 1.00 ± 0.05 for serum and urine specimens. Determined using Weighted Deming regression model in accordance with CLSI Document EP09c. Sample sizes: Serum Na (123), Urine Na (117), Serum K (119), Urine K (117), Serum Cl (123), Urine Cl (127). Correlation coefficients ranged from 0.991 to 1.000.
Reproducibility: 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 (N=225 for each sample condition). Data analyzed to calculate repeatability, between-day, between-lot, between-instrument, and reproducibility (total) for Sodium, Potassium, and Chloride in Serum and Urine.
Specimen Equivalency: Determined using linear regression model in accordance with CLSI Document EP09c for Lithium heparin plasma vs. Serum. Sample sizes: Na (138), K (56), Cl (136). Correlation coefficients ranged from 0.983 to 0.998.
Interferences (Hemolysis, Icterus, Lipemia (HIL)): Evaluated in accordance with CLSI Document EP07. Bias > 10% is considered interference. Data provided for Hemoglobin, Bilirubin (conjugated and unconjugated), Intralipid, and Trig Fraction for Sodium, Potassium, and Chloride in Serum/Plasma and Urine. Sodium in serum/plasma showed a bias of -6% with 1000 mg/dL Hemoglobin. Potassium in serum/plasma showed no bias > 10%. Chloride in serum/plasma showed -9% at 1000 mg/dL Hemoglobin. Urine Sodium showed -9% at 500 mg/dL Hemoglobin. Urine Potassium showed 9% at 750 mg/dL Hemoglobin. Urine Chloride showed -7% at 500 mg/dL Hemoglobin.
Non-Interfering Substances: Tested at specified concentrations. Bias due to these substances is ≤ 10%, except for Salicylate (Cl) in serum which had a bias ≤ 15%.
Key results:
- Detection capability met the design specifications with LoQ values for Na, K, and Cl in serum/plasma and urine.
- Linearity demonstrated across the claimed measuring ranges for all analytes and specimen types.
- Precision showed low SD and CV values for repeatability and within-laboratory precision across various sample types and concentrations.
- Assay comparison demonstrated high correlation coefficients (≥ 0.991) and slopes close to 1 across all analytes and specimen types when compared to the predicate.
- Reproducibility data showed acceptable variability across different days, lots, and instruments.
- Specimen equivalency indicated strong correlation between Lithium heparin plasma and serum samples.
- Identified interference levels for HIL substances were within acceptable limits or noted when exceeding 10%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Bias, SD, CV, Correlation Coefficient (r) and slopes were provided.
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" 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
1
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
2
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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3
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 Joy
Regulatory 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 | JGS |
| CEM | |||
| CGZ |
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.
5
| Feature | Predicate Device:
TD-LYTE on Trinidad CH
System1 | New Device:
IMT Na K CI on Atellica CI
Analyzer |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The TD-LYTE Integrated Multisensor
is intended for the in vitro diagnostic
use in the quantitative determination
of sodium, potassium and chloride
(Na, K, CI) in human serum, plasma
and urine using the Trinidad CH
System | 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, CI) in human
serum, plasma (lithium heparin)
and urine using the Atellica CI
Analyzer. |
| Indications for Use: | 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. | Same |
| Device
Technology: | Indirect potentiometric measurements
with Integrated Multisensor
Technology (IMT) | Same |
| Sample Type: | Serum/plasma/urine | Same |
| Instrument: | Trinidad CH System1 | Atellica CI Analyzer |
| Analytical
Measuring
Interval: | Serum/Plasma
Na: 50 – 200 mmol/L
K: 1– 10 mmol/L
Cl: 50 – 200 mmol/L
Urine | Same |
| | Na: 10 – 300 mmol/L
K: 2 – 300 mmol/L
Cl: 20 – 330 mmol/L | |
| Reference
Interval: | Serum / Plasma
Na: 136–145 mmol/L
K (serum): 3.5–5.1 mmol/L
K (plasma): 3.4–4.5 mmol/L
Cl: 98–107 mmol/L
Urine
Na: 40–220 mmol/L
K: 25–125 mmol/L
Cl: 110–250 mmol/L | Same |
6
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 Analytical
Error 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 | Mean | ||||
| mmol/L (mEq/L) | SDa | |||||
| mmol/L (mEq/L) | CVb | |||||
| (%) | SD | |||||
| mmol/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:
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| Specimen | Comparative Assay (x) | Regression Equation | Sample Interval | Na | rb |
|---|---|---|---|---|---|
| Serum | Atellica CH Na on | ||||
| Atellica 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 on | ||||
| Atellica 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 on | ||||
| Atellica 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 on | ||||
| Atellica 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 on | ||||
| Atellica 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 on | ||||
| Atellica 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 | Mean
mmol/L
(mEq/L) | SDb
mmol/L
(mEq/L) | CVc
(%) | | SD
mmol/L
(mEq/L) | CV
(%) | SD
mmol/L
(mEq/L) | CV
(%) | SD
mmol/L
(mEq/L) | CV
(%) | SD
mmol/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 | |
| Normal
Human
Serum | 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 | |
| Normal
Human
Serum | 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 | |
| Normal
Human
Urine | 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 | |
| Normal
Human
Urine | 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 | |
| Normal
Human
Urine | 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 | |
| Normal
Human
Urine | 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 | Mean
mmol/L
(mEq/L) | Repeatability | | Between-Day | | Between-Lot | | Between-
Instrument | | Total Reprodu-
cibility | |
|----------|-----|---------------------------|--------------------------|------------|-------------------------|-----------|-------------------------|-----------|-------------------------|-----------|----------------------------|-----------|
| | | | SDb
mmol/L
(mEq/L) | CVc
(%) | SD
mmol/L
(mEq/L) | CV
(%) | SD
mmol/L
(mEq/L) | CV
(%) | SD
mmol/L
(mEq/L) | CV
(%) | SD
mmol/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
| Normal
Human
Serum | 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 |
|--------------------------|-----|----------------|----------------|-----|----------------|-----|----------------|-----|----------------|-----|----------------|-----|
| Normal
Human
Serum | 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 |
| Normal
Human
Urine | 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 |
| Normal
Human
Urine | 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 |
| Normal
Human
Urine | 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 | Mean
mmol/L
(mEq/L) | SDb
mmol/L
(mEq/L) | CVc
(%) | SD
mmol/L
(mEq/L) | CV
(%) | SD
mmol/L
(mEq/L) | CV
(%) | SD
mmol/L
(mEq/L) | CV
(%) | SD
mmol/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 |
| Normal
Human
Serum | 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 |
| Normal
Human
Serum | 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 |
| Normal
Human
Urine | 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 |
| Normal
Human
Urine | 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 |
| Normal
Human
Urine | 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 |
| Normal
Human
Urine | 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 Concentration
Common Units (SI Units) | Analyte Concentration
mmol/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 Concentration
Common Units (SI Units) | Analyte Concentration
mmol/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 Concentration
Common Units (SI Units) | Analyte Concentration
mmol/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 Concentration
Common Units (SI Units) | Analyte Concentration
mmol/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 Concentration
Common Units (SI Units) | Analyte Concentration
mmol/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 Concentration
Common Units (SI Units) | Analyte Concentration
mmol/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 Concentration
Common 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.