A-LYTE® Integrated Multisensor (IMT Na K Cl)
Device Facts
| Record ID | K222438 |
|---|---|
| Device Name | A-LYTE® Integrated Multisensor (IMT Na K Cl) |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Product Code | JGS · Clinical Chemistry |
| Decision Date | Jul 25, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1665 |
| Device Class | Class 2 |
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® 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.
Device Story
A-LYTE Integrated Multisensor (IMT) uses indirect potentiometric technology to measure sodium, potassium, and chloride concentrations in human serum, lithium heparin plasma, and urine. The device utilizes four ion-selective electrodes (three for analytes, one reference) integrated into the Atellica CI Analyzer. Operation involves diluting samples 1:10 with IMT diluent; ions establish equilibrium with electrode surfaces, generating electrical potentials proportional to the logarithm of analyte activity. The system compares sample potential against a standard solution potential, calculating concentrations via the Nernst equation. Used in clinical laboratory settings by trained technicians. Output is quantitative electrolyte concentration, which clinicians use to diagnose and monitor metabolic and electrolyte disorders. Benefits include rapid, accurate electrolyte assessment for patient management.
Clinical Evidence
Bench testing only. Performance validated per CLSI guidelines (EP17-A2, EP06-ED2, EP05-A3, EP09c, EP07). Precision studies (N≥80) showed repeatability CVs ≤1.3% and within-lab CVs ≤4.5%. Linearity confirmed across claimed ranges. Assay comparison against Atellica CH system showed correlation coefficients (r) ≥0.991. Interference testing evaluated HIL (hemoglobin, icterus, lipemia) and various drugs; bias was generally ≤10%.
Technological Characteristics
Indirect potentiometric measurement using ion-selective electrodes (Na+, K+, Cl-) and a reference electrode. System performs automatic two-point calibration every 4 hours and one-point calibration checks per sample. Operates on Atellica CI analyzer. Reagents include Standard A, Standard B + Salt-Bridge, Diluent, and Diluent Check. Sensor stability: 14 days or 5000 samples.
Indications for Use
Indicated for quantitative determination of sodium, potassium, and chloride in human serum, lithium heparin plasma, and urine to aid in diagnosis and treatment of electrolyte imbalances, aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, cystic fibrosis, and diabetic acidosis.
Regulatory Classification
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.
Predicate Devices
- TD-LYTE Integrated Multisensor (Na, K, Cl) (K151767)
Related Devices
- K170320 — Alinity c ICT Sample Diluent · Abbott Laboratories · Oct 24, 2017
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K222438
B Applicant
Siemens Healthcare Diagnostics Inc.
C Proprietary and Established Names
A-LYTE® Integrated Multisensor (IMT Na K Cl)
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JGS | Class II | 21 CFR 862.1665 - Sodium Test System | CH - Clinical Chemistry |
| CGZ | Class II | 21 CFR 862.1170 - Chloride test system | CH - Clinical Chemistry |
| CEM | Class II | 21 CFR 862.1600 - Potassium test system | CH - Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
Addition of previously cleared assays to a new instrument
B Measurand:
Sodium $(\mathrm{Na}^{+})$, Potassium $(\mathrm{K}^{+})$ and Chloride $(\mathrm{Cl}^{-})$
C Type of Test:
Quantitative, ion specific electrodes
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) 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 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.
C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
D Special Instrument Requirements:
Atellica® CI Analyzer
IV Device/System Characteristics:
A Device Description:
The A-LYTE® Integrated Multisensor (IMT Na, K, and Cl) is comprised of four electrodes (one ion selective electrode Na⁺, K⁺, Cl⁻ respectively) and one reference electrode.
Materials needed for the A-LYTE ® Integrated Multisensor (IMT, Na, K, and Cl) system but distributed separately include the A-LYTE IMT Standard A & Standard B + Salt-Bridge, A-LYTE IMT Diluent and A-LYTE IMT Diluent Check.
B Principle of Operation:
The A-LYTE® Integrated Multisensor (Na, K, Cl) uses indirect Integrated Multisensor Technology (IMT). There are four electrodes used to measure electrolytes. Three of these electrodes are ion selective for sodium, potassium and chloride. A reference electrode is also incorporated in the multisensory.
K222438 - Page 2 of 15
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During the testing, a diluted sample is delivered to the sensor and $\mathrm{Na}^{+}$, $\mathrm{K}^{+}$, $\mathrm{Cl}^{-}$ 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.
The Atellica CI IMT system performs a two points automatic calibration in duplicate every 4 hours. In addition, the system will routinely perform a one point calibration check with each sample measurement. Auto-calibration occurs after power on, with the changing of standards A, B, or a sensor and when the system software is reset.
## V Substantial Equivalence Information:
### A Predicate Device Name(s):
TD-LYTE Integrated Multisensor (IMT, Na, K, Cl)
### B Predicate 510(k) Number(s):
K151767
### C Comparison with Predicate(s):
| Device & Predicate Device(s): | K222438 | K151767 |
| --- | --- | --- |
| Device Trade Name | A-LYTE® Integrated Multisensor (IMT Na K Cl) | TD-LYTE Integrated Multisensor (IMT, Na, K, Cl) * |
| | | |
| Intended Use/Indications For Use | 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. | Same |
| Test Principle | Indirect potentiometric measurements with Integrated Multisensor Technology (IMT) | Same |
| Sample Type | Serum, plasma (lithium heparin) and urine | Same |
| Measuring Range | Serum/Plasma Na: 50-200 mmol/L K: 1-10 mmol/L | Same |
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| | Cl: 50-200 mmol/L
Urine
Na: 10-300 mmol/L
K: 2-300 mmol/L
Cl: 20-330 mmol/L | |
| --- | --- | --- |
| | | |
| Special Instrument Requirement | Atellica CI ® Analyzer | Trinidad CH Analyzer* |
*The TD-LYTE Integrated Multisensor (Na, K, Cl) was renamed A-LYTE® Integrated Multisensor (Na, K, Cl) and the Trinidad Clinical Chemistry (CC) system was renamed Atellica CH analyzer in K161954.
VI Standards/Guidance Documents Referenced:
CLSI EP05-A3, Evaluation of Precision of Quantitative Measurement Procedures - Third Edition.
CLSI EP06, Evaluation of the Linearity of Quantitative Measurement Procedures - Second Edition.
CLSI EP09c, Measurement Procedure Comparison and Bias Estimation Using Patient Samples-Third Edition.
CLSI EP28-A3c, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory -Third Edition.
CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures– Second Edition.
CLSI EP07, Interference Testing in Clinical Chemistry –Third Edition.
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VII Performance Characteristics (if/when applicable):
# A Analytical Performance:
# 1. Precision/Reproducibility:
# Precision
The precision study was performed in accordance with CLSI EP05-A3. Repeatability (within run) and within-laboratory precision for $\mathrm{Na}^+$ , $\mathrm{K}^+$ and $\mathrm{Cl}^-$ were evaluated using quality control samples and native samples. Each sample was assayed in duplicate per run, two (2) runs per day for twenty (20) days using one (1) lot of reagent and one (1) instrument ( $N = 80$ for each sample). Repeatability and within-lab precision were calculated and summarized below. The within-lab precision includes the within-run (repeatability), between-run, and between-day variance components.
Sodium (Na)
| Specimen | N | Mean (mmol/L) | Repeatability | | Within Lab | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD (mmol/L) | CV (%) | SD (mmol/L) | CV (%) |
| Serum 1 | 80 | 70.1 | 0.20 | 0.3 | 0.86 | 1.2 |
| Serum QC 1 | 80 | 113 | 0.39 | 0.3 | 1.12 | 1.0 |
| Serum QC 2 | 80 | 139 | 0.58 | 0.4 | 1.65 | 1.2 |
| Serum QC 3 | 80 | 154 | 0.55 | 0.4 | 1.68 | 1.1 |
| Urine 1 | 80 | 30.5 | 0.40 | 1.3 | 0.67 | 2.2 |
| Urine QC 1 | 80 | 82.9 | 0.31 | 0.4 | 1.04 | 1.2 |
| Urine 2 | 80 | 148 | 0.52 | 0.4 | 2.15 | 1.5 |
| Urine 3 | 80 | 240 | 0.82 | 0.3 | 3.56 | 1.5 |
Potassium (K)
| Specimen | N | Mean (mmol/L) | Repeatability | | Within Lab | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD (mmol/L) | CV (%) | SD (mmol/L) | CV (%) |
| Serum QC 1 | 80 | 2.44 | 0.01 | 0.5 | 0.03 | 1.1 |
| Serum QC 2 | 80 | 4.04 | 0.01 | 0.4 | 0.04 | 1.1 |
| Serum 1 | 80 | 6.03 | 0.02 | 0.4 | 0.07 | 1.2 |
| Serum QC 3 | 80 | 7.16 | 0.02 | 0.3 | 0.08 | 1.1 |
| Urine QC1 | 80 | 30.8 | 0.10 | 0.3 | 0.28 | 0.9 |
| Urine QC2 | 80 | 75.4 | 0.15 | 0.2 | 0.79 | 1.0 |
| Urine 1 | 80 | 248 | 1.01 | 0.4 | 3.21 | 1.3 |
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Chloride (Cl)
| Specimen | N | Mean (mmol/L) | Repeatability | | Within Lab | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD (mmol/L) | CV (%) | SD (mmol/L) | CV (%) |
| Serum QC 1 | 80 | 75.1 | 0.35 | 0.5 | 1.12 | 1.5 |
| Serum QC 2 | 80 | 98.3 | 0.33 | 0.3 | 1.03 | 1.0 |
| Serum QC 3 | 80 | 119 | 0.40 | 0.3 | 1.24 | 1.0 |
| Serum 1 | 80 | 176 | 0.61 | 0.3 | 2.96 | 1.7 |
| Urine 1 | 80 | 43.3 | 0.25 | 0.6 | 1.70 | 3.9 |
| Urine QC 1 | 80 | 101 | 0.35 | 0.3 | 4.48 | 4.5 |
| Urine QC 2 | 80 | 196 | 0.52 | 0.3 | 3.47 | 1.8 |
| Urine 2 | 80 | 286 | 0.83 | 0.3 | 6.69 | 2.3 |
## Reproducibility
A reproducibility study was performed in accordance with CLSI EP05-A3. Each sample was assayed five (5) times in one (1) run for five (5) days using three (3) instruments and three (3) sensor lots. Within-run (repeatability), between-day, between-sensor lot, between-instrument, and total reproducibility results were calculated. The results for the reproducibility studies are summarized below.
Sodium (Na)
| | | | Repeatability | | Between-Day | | Between-Lot | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample | N | Mean mmol/L | SD mmol/L | CV% | SD mmol/L | CV% | SD mmol/L | CV% |
| Serum4 | 225 | 70.1 | 0.24 | 0.3 | 1.23 | 1.8 | 0.94 | 1.3 |
| Serum QC 1 | 225 | 113 | 0.40 | 0.4 | 1.00 | 0.8 | 0.00 | 0.0 |
| Serum3 | 225 | 139 | 0.40 | 0.3 | 0.80 | 0.6 | 0.20 | 0.1 |
| Serum QC 2 | 225 | 154 | 0.50 | 0.3 | 1.10 | 0.7 | 0.70 | 0.5 |
| Urine 1 | 225 | 30.4 | 0.38 | 1.3 | 0.75 | 2.5 | 0.52 | 1.7 |
| Urine 3 | 225 | 81.1 | 0.26 | 0.3 | 1.35 | 1.7 | 0.04 | 0.1 |
| Urine 4 | 225 | 150 | 0.50 | 0.3 | 2.40 | 1.6 | 1.50 | 1.0 |
| Urine 6 | 225 | 267 | 1.00 | 0.4 | 8.40 | 3.2 | 3.70 | 1.4 |
| | | | Between-Instrument | | Reproducibility | |
| --- | --- | --- | --- | --- | --- | --- |
| Sample | N | Mean mmol/L | SD mmol/L | CV% | SD mmol/L | CV% |
| Serum4 | 225 | 70.1 | 0.25 | 0.4 | 1.59 | 2.3 |
| Serum QC 1 | 225 | 113 | 0.00 | 0.0 | 1.00 | 0.9 |
| Serum3 | 225 | 139 | 0.90 | 0.7 | 1.30 | 0.9 |
| Serum QC 2 | 225 | 154 | 1.40 | 0.9 | 2.00 | 1.3 |
| Urine 1 | 225 | 30.4 | 0.43 | 1.4 | 1.08 | 3.5 |
| Urine 3 | 225 | 81.1 | 0.49 | 0.6 | 1.46 | 1.8 |
| Urine 4 | 225 | 150 | 2.00 | 1.3 | 3.50 | 2.3 |
| Urine 6 | 225 | 267 | 1.50 | 0.6 | 9.30 | 3.5 |
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Potassium (K)
| | | | Repeatability | | Between-Day | | Between-Lot | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample | N | Mean mmol/L | SD mmol/L | CV % | SD mmol/L | CV % | SD mmol/L | CV% |
| Serum QC 1 | 225 | 2.47 | 0.03 | 1.2 | 0.02 | 0.6 | 0.00 | 0.0 |
| Serum QC 2 | 225 | 7.27 | 0.03 | 0.4 | 0.05 | 0.7 | 0.01 | 0.2 |
| Serum3 | 225 | 4.30 | 0.01 | 0.2 | 0.02 | 0.6 | 0.01 | 0.1 |
| Serum5 | 225 | 6.14 | 0.01 | 0.2 | 0.04 | 0.6 | 0.01 | 0.2 |
| Urine 2 | 225 | 31.3 | 0.07 | 0.2 | 0.40 | 1.3 | 0.07 | 0.2 |
| Urine 3 | 225 | 68.5 | 0.24 | 0.4 | 1.28 | 1.9 | 0.24 | 0.4 |
| Urine 5 | 225 | 256 | 0.70 | 0.3 | 2.30 | 0.9 | 1.00 | 0.4 |
| | | | Between-Instrument | | Reproducibility | |
| --- | --- | --- | --- | --- | --- | --- |
| Sample | N | Mean mmol/L | SD mmol/L | CV% | SD mmol/L | CV% |
| Serum QC 1 | 225 | 2.47 | 0.03 | 1.1 | 0.04 | 1.7 |
| Serum QC 2 | 225 | 7.27 | 0.05 | 0.7 | 0.08 | 1.1 |
| Serum3 | 225 | 4.30 | 0.03 | 0.7 | 0.04 | 1.0 |
| Serum5 | 225 | 6.14 | 0.04 | 0.6 | 0.06 | 0.9 |
| Urine 2 | 225 | 31.3 | 0.07 | 0.2 | 0.42 | 1.3 |
| Urine 3 | 225 | 68.5 | 0.24 | 0.3 | 1.35 | 2.0 |
| Urine 5 | 225 | 256 | 1.30 | 0.5 | 2.90 | 1.1 |
Chloride (Cl)
| | | | Repeatability | | Between-Day | | Between-Lot | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample | N | Mean mmol/L | SD mmol/L | CV% | SD mmol/L | CV% | SD mmol/L | CV% |
| Serum QC 1 | 225 | 78.1 | 0.29 | 0.4 | 0.79 | 1.0 | 0.41 | 0.5 |
| Serum QC 2 | 225 | 119 | 0.50 | 0.4 | 0.90 | 0.7 | 0.30 | 0.3 |
| Serum3 | 225 | 108 | 0.30 | 0.3 | 0.80 | 0.7 | 0.20 | 0.2 |
| Serum6 | 225 | 172 | 0.40 | 0.2 | 1.40 | 0.8 | 0.00 | 0.0 |
| Urine 1 | 225 | 41.7 | 0.23 | 0.6 | 1.19 | 2.9 | 0.10 | 0.2 |
| Urine 3 | 225 | 104 | 0.40 | 0.4 | 3.00 | 2.9 | 0.40 | 0.3 |
| Urine 4 | 225 | 206 | 0.50 | 0.2 | 2.00 | 1.0 | 0.30 | 0.1 |
| Urine 5 | 225 | 270 | 0.70 | 0.3 | 3.90 | 1.4 | 0.00 | 0.0 |
| | | | Between-Instrument | | Reproducibility | |
| --- | --- | --- | --- | --- | --- | --- |
| Sample | N | Mean mmol/L | SD mmol/L | CV% | SD mmol/L | CV% |
| Serum QC 1 | 225 | 78.1 | 0.08 | 0.1 | 0.94 | 1.2 |
| Serum QC 2 | 225 | 119 | 0.20 | 0.2 | 1.10 | 0.9 |
| Serum3 | 225 | 108 | 0.30 | 0.3 | 0.90 | 0.8 |
| Serum6 | 225 | 172 | 0.90 | 0.6 | 1.80 | 1.0 |
| Urine 1 | 225 | 41.7 | 0.02 | 0.1 | 1.22 | 2.9 |
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| | | | Between-Instrument | | Reproducibility | |
| --- | --- | --- | --- | --- | --- | --- |
| Sample | N | Mean mmol/L | SD mmol/L | CV% | SD mmol/L | CV% |
| Urine 3 | 225 | 104 | 0.70 | 0.7 | 3.10 | 3.0 |
| Urine 4 | 225 | 206 | 1.40 | 0.7 | 2.50 | 1.2 |
| Urine 5 | 225 | 270 | 2.70 | 1.0 | 4.70 | 1.8 |
2. Linearity:
The linearity studies were performed following the recommendations in the CLSI guideline EP06 2nd Edition. For each analyte, nine (9) equally spaced samples were prepared by mixing high and low concentration samples to cover the claimed measurement range. Five (5) replicates were measured for each sample using one (1) instrument and one (1) reagent lot. The mean of these replicates was compared to the expected values and the results of weighted linear (for Na, K serum and urine) or ordinary (for Cl serum and urine) linear regressions are summarized in the table below:
| Analyte in Serum | Claimed Measuring Range (mmol/L) | Sample Range Tested (mmol/L) | Slope | Intercept | R² |
| --- | --- | --- | --- | --- | --- |
| Sodium (Na) | 50 to 200 | 46.0 to 217 | 0.986 | -0.53 | 0.999 |
| Potassium (K) | 1 to 10 | 0.827 to 11.2 | 0.982 | -0.0085 | 0.999 |
| Chloride (Cl) | 50 to 200 | 44.6 to 215 | 1.000 | 0.037 | 0.999 |
| Analyte in Urine | Claimed Measuring Range (mmol/L) | Sample Range Tested (mmol/L) | Slope | Intercept | R² |
| --- | --- | --- | --- | --- | --- |
| Sodium (Na) | 10 to 300 | 8.41 to 313 | 0.951 | -5.556 | 0.991 |
| Potassium (K) | 2 to 300 | 1.82 to 332 | 0.967 | -0.020 | 0.999 |
| Chloride (Cl) | 20 to 330 | 19 to 355 | 1.004 | -2.135 | 0.999 |
3. Analytical Specificity/Interference:
Interference studies were performed following the recommendations in the CLSI guideline EP07 3rd edition to determine the effects from potential endogenous and exogenous substances on the sensor performance using urine and serum samples. In this study, samples with high and low analyte levels were divided into two groups: i.e., test sample (with added interferent) and control sample (with no added interferent). Each test sample and control sample was assayed in five (5) replicates with one (1) reagent lot on one (1) instrument.
The sponsor defines that interference is considered non-significant if the bias between the test and control sample are within $\pm 10\%$ for all tested interferences. The highest concentration tested that showed non-significant interference are summarized below:
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Sodium (serum)
| Substances | Maximum concentration tested that demonstrated no significant interference |
| --- | --- |
| Hemoglobin | 1000 mg/dL |
| Conjugated Bilirubin | 60 mg/dL |
| Unconjugated Bilirubin | 60 mg/dL |
| Lipemia (Intralipid) | 3000 mg/dL |
| Lipemia (Trig Fraction) | 1125 mg/dL |
| Potassium | 10 mM |
| Magnesium | 20 mg/dL |
| Calcium | 20 mg/dL |
| Lithium | 3.5 mg/dL |
| Borate | 2.5 mg/dL |
| Acetate | 20 mg/dL |
| Benzoate | 10 mg/dL |
| Citrate | 1 g/dL |
| Ammonium | 0.5 mmol/L |
| Thiopental | 14 mg/dL |
Sodium (urine)
| Substances | Maximum concentration tested that demonstrated no significant interference |
| --- | --- |
| Hemoglobin | 500 mg/dL |
| Conjugated Bilirubin | 60 mg/dL |
| Unconjugated Bilirubin | 60 mg/dL |
| Lipemia (Intralipid) | 2000 mg/dL |
| Lipemia (Trig) | 250 mg/dL |
| Acetaminophen | 200 mg/dL |
| N-Acetyl cysteine | 2 mg/dL |
| Ascorbic Acid | 60 mg/dL |
| Sodium Cefoxitin | 660 mg/dL |
| Gentamycin Sulfate | 10 mg/dL |
| Ibuprofen | 500 mg/dL |
| Levodopa | 15 mg/dL |
| Ofloxacin | 90 mg/dL |
| Phenazopyridine | 30 mg/dL |
| Tetracycline | 15 mg/dL |
| pH | 4 and 8 |
Potassium (serum)
| Substances | Maximum concentration tested that demonstrated no significant interference |
| --- | --- |
| Conjugated Bilirubin | 60 mg/dL |
| Unconjugated Bilirubin | 60 mg/dL |
| Lipemia (Intralipid) | 3000 mg/dL |
| Lipemia (Trig Fraction) | 2000 mg/dL |
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| Substances | Maximum concentration tested that demonstrated no significant interference |
| --- | --- |
| Magnesium | 20 mg/dL |
| Calcium | 20 mg/dL |
| Lithium | 3.5 mg/dL |
| Borate | 2.5 mg/dL |
| Acetate | 20 mg/dL |
| Benzoate | 10 mg/dL |
| Citrate | 1 g/dL |
| Ammonium | 0.5 mmol/L |
| Iron | 0.25 g/dL |
Potassium (urine)
| Substances | Maximum concentration tested that demonstrated no significant interference |
| --- | --- |
| Hemoglobin | 750 mg/dL |
| Conjugated Bilirubin | 60 mg/dL |
| Unconjugated Bilirubin | 60 mg/dL |
| Lipemia (Intralipid) | 2000 mg/dL |
| Lipemia (Trig) | 2000 mg/dL |
| Acetaminophen | 200 mg/dL |
| N-Acetyl cysteine | 2 mg/dL |
| Ascorbic Acid | 60 mg/dL |
| Sodium Cefoxitin | 660 mg/dL |
| Gentamycin Sulfate | 10 mg/dL |
| Ibuprofen | 500 mg/dL |
| Levodopa | 15 mg/dL |
| Ofloxacin | 90 mg/dL |
| Phenazopyridine | 30 mg/dL |
| Tetracycline | 15 mg/dL |
| pH | 4 and 8 |
Chloride (serum)
| Substances | Maximum concentration tested that demonstrated no significant interference |
| --- | --- |
| Hemoglobin | 1000 mg/dL |
| Conjugated Bilirubin | 60 mg/dL |
| Unconjugated Bilirubin | 60 mg/dL |
| Lipemia (Intralipid) | 3000 mg/dL |
| Lipemia (Trig Fraction) | 1125 mg/dL |
| Borate | 2.5 mg/dL |
| Acetate | 20 mg/dL |
| Benzoate | 150 mg/dL |
| Citrate | 0.5 g/dL |
| Sulfate | 2 mmol/L |
| Salicylate | 50 mg/dL |
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| Substances | Maximum concentration tested that demonstrated no significant interference |
| --- | --- |
| Oxalate | 0.5 mmol/L |
| Fluoride | 0.25g/dL |
| Iodine | 25 mg/dL |
| Bromide | 35 mg/dL |
Chloride (urine)
| Substances | Maximum Concentration tested that demonstrated no significant interference |
| --- | --- |
| Hemoglobin | 500 mg/dL |
| Conjugated Bilirubin | 60 mg/dL |
| Unconjugated Bilirubin | 60 mg/dL |
| Lipemia (Intralipid) | 2000 mg/dL |
| Lipemia (Trig) | 500 mg/dL |
| Acetaminophen | 200 mg/dL |
| N-Acetyl cysteine | 2 mg/dL |
| Ascorbic Acid | 60 mg/dL |
| Sodium Cefoxitin | 660 mg/dL |
| Gentamycin Sulfate | 10 mg/dL |
| Ibuprofen | 400 mg/dL |
| Levodopa | 15 mg/dL |
| Ofloxacin | 80 mg/dL |
| Phenazopyridine | 30 mg/dL |
| Tetracycline | 15 mg/dL |
| pH | 4 and 8 |
The sponsor added the following limitations in the package insert:
- Avoid hemolyzed samples for potassium. Hemolyzed samples may give incorrect elevated potassium. Intracellular potassium concentration is 30-50-fold greater than that of extracellular serum or plasma.
- Samples exposed to benzalkonium salts present in certain blood catheter devices will cause falsely elevated sodium and potassium measurements.*
*Koch TR, Cook JD. Benzalkonium interference with test methods for potassium and sodium. Clin. Chem. 1990; 36:807-8.
4. Assay Reportable Range:
Based on the limit of quantification (LoQ), precision, linearity, and dilution recovery the ranges over which results can be reported are provided below:
| Analyte | Analytical Measuring Interval (AMI) (mmol/L) | Extended Measuring Interval (EMI) (mmol/L) |
| --- | --- | --- |
| Na⁺ (serum) | 50 – 200 | NA |
| K⁺ (serum) | 1 – 10 | NA |
| Cl⁻ (serum) | 50 – 200 | NA |
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| Analyte | Analytical Measuring Interval (AMI) (mmol/L) | Extended Measuring Interval (EMI) (mmol/L) |
| --- | --- | --- |
| Na+(urine) | 10 – 300 | 300 – 600 |
| K+(urine) | 2 – 300 | 300 – 600 |
| Cl-(urine) | 20 – 330 | 330 – 660 |
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Traceability
The A-LYTE Na assay is traceable to a flame emission spectrophotometry reference method, which uses reference materials from the National Institute of Standards and Technology (NIST), via patient sample correlation and is verified using NIST Reference Serum.
The A-LYTE K assay is traceable to a flame emission spectrophotometry reference method, which uses reference materials from the National Institute of Standards and Technology (NIST), via patient sample correlation and is verified using NIST Reference Serum.
The A-LYTE Cl assay is traceable to a colorimetric reference method, which uses reference materials from the National Institute of Standards and Technology (NIST), via patient sample correlation and is verified using NIST Reference Serum.
Stability
The A-LYTE® Integrated Multisensor (Na, K, Cl) is stable for 14 days on board or for testing up to 5000 samples per sensor, whichever comes first.
6. Detection Limit:
Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) were evaluated in accordance with CLSI EP17-A2.
LoB was determined non-parametrically by running four (4) blank samples in five (5) replicates per sample for three (3) days on three (3) instruments. The LoD was determined parametrically by running four (4) low samples of each sample type in five (5) replicates per sample for three (3) days on three (3) instruments. LoQ was determined by testing four (4) low samples of each sample type in five (5) replicates per sample for three (3) days on three (3) instruments. The results are summarized in the table below:
| Sodium | LoB (mmol/L) | LoD (mmol/L) | LoQ (mmol/L) | Observed Total Error at LoQ |
| --- | --- | --- | --- | --- |
| Serum | 9.69 | 11.1 | 43.4 | 6% |
| Urine | 2.74 | 3.18 | 6.12 | 15% |
| Potassium | LoB (mmol/L) | LoD (mmol/L) | LoQ (mmol/L) | Observed Total Error at LoQ |
| --- | --- | --- | --- | --- |
| Serum | 0.0848 | 0.0969 | 0.606 | 10% |
| Urine | 0.0403 | 0.0545 | 1.22 | 4% |
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| Chloride | LoB (mmol/L) | LoD (mmol/L) | LoQ (mmol/L) | Observed Total Error at LoQ |
| --- | --- | --- | --- | --- |
| Serum | 3.23 | 3.54 | 40.4 | 3% |
| Urine | 6.5 | 6.94 | 8.7 | 15% |
# 7. Assay Cut-Off:
Not applicable.
# B Comparison Studies:
# 1. Method Comparison with Predicate Device:
Method comparison studies were performed following the CLSI guideline EP09c $3^{\mathrm{rd}}$ edition. Patient samples for each sample type, i.e., serum and urine, were each tested on the predicate test system (x) and on the candidate test system. Two replicates were processed for each sample on both systems. The first replicate results were used in statistical analyses. Weighted-Deming regression analyses for the three measurands are summarized below:
| Analyte | Specimen Type | N | Slope | Intercept | Correlation Coefficient (r) | Concentration Range Tested (mmol/L) | Claimed Measuring range (mmol/L) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Na | Serum | 123 | 1.00 | -2.69 | 0.998 | 53.2-192 | 50-200 |
| Na | Urine | 117 | 1.02 | -4.47 | 0.999 | 20.1-237 | 10-300 |
| K | Serum | 119 | 0.97 | 0.0353 | 1.000 | 1.40-9.85 | 1-10 |
| K | Urine | 117 | 1.02 | -0.209 | 0.999 | 6.22-246 | 2-300 |
| Cl | Serum | 123 | 0.99 | 0.161 | 0.999 | 52.7-196 | 50-200 |
| Cl | Urine | 127 | 0.99 | -0.582 | 0.991 | 24.3-314 | 20-330 |
# 2. Matrix Comparison:
Serum and lithium heparin plasma equivalency was demonstrated for the sodium, potassium, and chloride assays on the Atellica® CI analyzer by testing matched samples. Two replicates of each sample were tested and only the first replicate was used for the analyses. The table below summarizes Deming linear regression result statistics when comparing lithium heparin plasma sample results (Y) to serum sample results (X):
| Analyte | Specimen Type (Y) | Reference Specimen (x) | N | Slope | Intercept | Correlation Coefficient (r) | Tested Concentration Range (mmol/L) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Na | Lithium Heparin Plasma | Serum | 138 | 1.02 | -1.87 | 0.994 | 53.4-190 |
| K* | | | 56 | 0.99 | -0.207 | 0.914 | 1.41-9.33 |
| Cl | | | 136 | 1.00 | -0.201 | 0.998 | 53.7-197 |
* The sponsor included the following statement in the labeling:
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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.
## C Clinical Studies:
1. Clinical Sensitivity:
Not applicable
2. Clinical Specificity:
Not applicable
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable
## D Clinical Cut-Off:
Not applicable
## E Expected Values/Reference Range:
The sponsor provided information to support the following reference intervals that are cited from literature$^{1,2}$.
| Specimen Type | Analyte | Reference Interval |
| --- | --- | --- |
| Serum | Na | 136-145 mmol/L |
| | K | 3.5-5.1 mmol/L |
| | Cl | 98-107 mmol/L |
| Plasma | Na | 136-145 mmol/L |
| | K | 3.4-4.5 mmol/L |
| | Cl | 98-107 mmol/L |
| Urine | Na | 40-220 mmol/24 hr |
| | K | 25-125 mmol/24 hr |
| | Cl | 110-250 mmol/24 hr |
## References:
1. Fischbach, F., Dunning, M. (2015) A manual of laboratory and diagnostic tests (9th ed), Philadelphia, PA: Wolters Kluwer Health/Lippincott Williams & Wilkins. (P245 Na Urine 40-220 mmol/24 hrs and P246 K Urine 25-125 mmol/24 hrs)
2. Bruns et al. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 5th ed. Philadelphia, PA (P813 Cl Urine- 110-250 mmol/24 hrs)
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VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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