Who is the manufacturer of A-LYTE® Integrated Multisensor (IMT Na K Cl)?

Siemens Healthcare Diagnostics, Inc. filed the 510(k) submission for A-LYTE® Integrated Multisensor (IMT Na K Cl) (K222438).

What is the FDA product code for A-LYTE® Integrated Multisensor (IMT Na K Cl)?

JGS. It is classified under 21 CFR 862.1665 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for A-LYTE® Integrated Multisensor (IMT Na K Cl)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for A-LYTE® Integrated Multisensor (IMT Na K Cl)?

TD-LYTE Integrated Multisensor (Na, K, Cl) (K151767).

Who can help prepare an FDA 510(k) submission like A-LYTE® Integrated Multisensor (IMT Na K Cl)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

A-LYTE® Integrated Multisensor (IMT Na K Cl)

K222438 · Siemens Healthcare Diagnostics, Inc. · JGS · Jul 25, 2023 · Clinical Chemistry

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

Intended 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)

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Submission Summary (Full Text)

{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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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 {4}------------------------------------------------ # 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. {7}------------------------------------------------ | 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) {8}------------------------------------------------ | | | | 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: {9}------------------------------------------------ | 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.