Who is the manufacturer of Alinity c ICT Sample Diluent?

Abbott Laboratories filed the 510(k) submission for Alinity c ICT Sample Diluent (K170320).

What is the FDA product code for Alinity c ICT Sample Diluent?

CGZ. It is classified under 21 CFR 862.1170 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for Alinity c ICT Sample Diluent?

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

Who can help prepare an FDA 510(k) submission like Alinity c ICT Sample Diluent?

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.

Alinity c ICT Sample Diluent

Q: What are the predicate devices for Alinity c ICT Sample Diluent?

ICT (Na+, K+, Cl-) Sample Diluent (k980367).

K170320 · Abbott Laboratories · CGZ · Oct 24, 2017 · Clinical Chemistry

Device Facts

Record ID	K170320
Device Name	Alinity c ICT Sample Diluent
Applicant	Abbott Laboratories
Product Code	CGZ · Clinical Chemistry
Decision Date	Oct 24, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1170
Device Class	Class 2

Intended Use

The Alinity c ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine on the Alinity c analyzer. Sodium measurements 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. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases 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

Alinity c ICT Sample Diluent is a reagent used on the Alinity c analyzer for indirect potentiometric measurement of sodium, potassium, and chloride ions in human serum, plasma, or urine. The device utilizes ion-selective electrodes (ISE) with ion-specific membranes; an electrical potential develops across the membranes relative to a reference electrode, following the Nernst equation. The analyzer compares this voltage against stored calibrator values to calculate ion concentration. Used in clinical laboratory settings by trained technicians. Output is a quantitative electrolyte concentration value, which clinicians use to diagnose and monitor metabolic and electrolyte disorders. The device benefits patients by providing accurate electrolyte status for clinical decision-making.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP05-A2; linearity per EP06-A; interference per EP07-A2; method comparison per EP09-A3. Method comparison against ARCHITECT analyzer showed high correlation (r=1.00) for all analytes across serum and urine. No clinical data presented.

Technological Characteristics

Indirect ion-selective electrode (ISE) potentiometric sensing. Reagent 1 contains buffer. Container: Polypropylene with black colorant; closure: HDPE. Connectivity: Integrated with Alinity c analyzer. Software: Embedded firmware for signal processing and Nernst equation calculation.

Indications for Use

Indicated for quantitation of sodium, potassium, and chloride in human serum, plasma, or urine for diagnosis/treatment of electrolyte/metabolic disorders including aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate ADH secretion, cystic fibrosis, and diabetic acidosis.

Regulatory Classification

Identification

A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Predicate Devices

ICT (Na+, K+, Cl-) Sample Diluent (k980367)

Related Devices

K222438 — A-LYTE® Integrated Multisensor (IMT Na K Cl) · Siemens Healthcare Diagnostics, Inc. · Jul 25, 2023
K990036 — CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 · Careside, Inc. · Mar 18, 1999
K051646 — ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH · Pointe Scientific, Inc., · Oct 7, 2005
K070531 — ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER · Thermo Fisher Scientific · Sep 4, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 24, 2017 ABBOTT LABORATORIES ZAMAN KHAN ASSOCIATE DIRECTOR, REGULATORY AFFAIRS DEPT. 09AA. BLDG. CP01-3 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064 Re: K170320 Trade/Device Name: Alinity c ICT Sample Diluent Regulation Number: 21 CFR 862.1170 Regulation Name: Chloride test system Regulatory Class: II Product Code: CGZ, CEM, JGS Dated: September 12, 2017 Received: September 13, 2017 Dear Zaman Khan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Kellie B. Kelm -S for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) k170320 Device Name Alinity c ICT Sample Diluent #### Indications for Use (Describe) The Alinity c ICT (Integrated Chip Technology) is used for the quantitation of sodium, and chloride in human serum, plasma, or urine on the Alinity c analyzer. Sodium measurements 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. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases 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) | | |----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | ☑ 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}------------------------------------------------ ## k170320 510(k) Summary (Summary of Safety and Effectiveness) This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. # I. Applicant Name Abbott Laboratories Dept. 09AA, Bldg CP1 100 Abbott Park Road Abbott Park, IL 60064 Primary contact person for all communications: Zaman Khan ADD, Associate Director, Regulatory Affairs Phone: (224) 668-2002 Fax: (224) 667-4836 Email: Zaman.Khan@abbott.com Secondary contact person for all communications: Amy Ghering, Ph.D. ADD, Associate Director, Regulatory Affairs Phone: (224) 668-6934 Fax: (224) 667-4836 Email: Amy.Ghering@abbott.com Date Summary Prepared: January 31, 2017 Date Summary Revised: October 19, 2017 {4}------------------------------------------------ # II. Device Name # Alinity c ICT Sample Diluent Device Classification: Class II Classification Name: Electrode, ion-specific, chloride/potassium/sodium Governing Regulation: 862.1170/862.1600/862.1665 Product Code: CGZ/CEM/JGS # III. Predicate Device Reagent ICT (Na*, K†, Cl´) Sample Diluent (k980367), List No. (LN) 2P32 for use on Abbott ARCHITECT c8000 and Abbott AEROSET # IV. Description of Device # A. Alinity c ICT Sample Diluent #### Kit Contents Volumes (mL) listed in the table below indicate the volume per cartridge. | Component | 07P5320 | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Tests per cartridge | તે તે જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ | | Number of cartridges per kit | 10 | | Test per kit | 9350 | | Reagent 1 (R1) | 68.2 mL | | Reagent | Active Ingredient | Concentration | |-----------|-------------------|---------------| | Reagent 1 | Buffer | NA | {5}------------------------------------------------ # B. Calibrators ### 1. The Alinity c ICT Serum Calibrator contains: 5 Bottles (2.9 mL each) of Alinity c ICT Serum Calibrators. Calibrators L and H contain Bovine Serum Albumin, Sodium chloride, Potassium chloride, and Sodium nitrate. | | Concentration | | | |------------|---------------|------------|------------| | Calibrator | Sodium | Potassium | Chloride | | L | 120 mmol/L | 3.4 mmol/L | 80 mmol/L | | H | 160 mmol/L | 8.0 mmol/L | 120 mmol/L | Calibrators L and H are manufactured gravimetrically using ACS grade sodium chloride, potassium chloride, and sodium nitrate. The concentrations of sodium and potassium are determined using flame photometry calibrated against NIST Standard Reference Material. The concentration of chloride is determined using titration with silver calibrated against NIST Standard Reference Material (NIST - National Institute of Standards and Technology). # 2. Alinity c ICT Urine Calibrator 5 Bottles (2.9 mL each) of Alinity c ICT Urine Calibrators. Calibrators L and H contain sodium chloride, potassium chloride, and sodium nitrate. | | Concentration | | | |-------------|---------------|-------------|------------| | Calibrator | Sodium | Potassium | Chloride | | Urine Cal L | 50 mmol/L | 9.0 mmol/L | 50 mmol/L | | Urine Cal H | 180 mmol/L | 90.0 mmol/L | 180 mmol/L | Calibrators L and H are manufactured gravimetrically using ACS grade sodium chloride, potassium chloride, and sodium nitrate. The concentrations of sodium, potassium, and chloride are determined using reference method (flame photometry, titration using silver) calibrated against NIST SRM 918 and NIST SRM 919 (NIST - National Institute of Standards and Technology). {6}------------------------------------------------ #### C. Principles of the Procedure Ion-selective electrodes (ISE) for sodium, potassium, and chloride utilize membranes selective to each of these ions. An electrical potential (voltage) is developed across the membranes between the reference and measuring electrodes in accordance with the Nernst equation. The voltage is compared to previously determined calibrator voltages and converted into ion concentration. Methodology: Ion-selective electrode diluted (Indirect) #### V. Intended Use of the Device The Alinity c ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine on the Alinity c analyzer. Sodium measurements 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. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases 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. #### VI. Comparison of Technological Characteristics The Alinity c ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine on the Alinity c System. A comparison of the candidate assay (Alinity c ICT Sample Diluent, List No. 07P53) and the predicate assay (ICT (Na+, K+, Cl ) Sample Diluent, List No. 2P32 on the ARCHITECT System) is presented in Table 1 and Table 2 starting on page 5. {7}------------------------------------------------ | Table 1: Assay Similarities | | | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------| | Characteristics | Candidate Assay Alinity c ICT Sample Diluent (LN 07P53) | Predicate Assay (k980367) ICT (Na+, K+, Cl-) Sample Diluent Assay on the AEROSET/ARCHITECT c8000 System (LN 2P32) | | | | Technical Characteristics | | Reagent Formulation | Active Ingredient: Buffer | Same bulk as Alinity c. | | Analyte Measured | Sodium, potassium, and chloride. | Same | | Intended Use/Indications for Use | The Alinity c ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine. | Same | | Assay Principle | Ion-selective electrode diluted (Indirect). | Same | | Detection of Analyte | Potentiometric. | Same | | Specimen Type | Human serum, plasma or urine. | Same | | Performance Characteristics | | | | Assay Range | Serum/Plasma Sodium: 100 to 200 mmol/L. Potassium 1.0 to 10.0 mmol/L. Chloride: 50 to 150 mmol/L. Urine Sodium: 20 to 400 mmol/L. Potassium: 1.0 to 300.0 mmol/L. Chloride: 20 to 300 mmol/L. | Same | | Measuring Interval | Serum/Plasma The measuring interval for the sodium assay is 100 to 200 mmol/L. The measuring interval for the potassium assay is 1.0 to 10.0 mmol/L. The measuring interval for the chloride assay is 50 to 150 mmol/L. Urine The measuring interval for the sodium assay is 20 to 400 mmol/L. The measuring interval for the potassium assay is 1.0 to 300.0 mmol/L. The measuring interval for the chloride assay is 20 to 300 mmol/L. | Same | | Characteristics | Candidate Assay Alinity c ICT Sample Diluent (LN 07P53) | Predicate Assay (k980367) ICT (Na+, K+, Cl-) Sample Diluent Assay on the AEROSET/ARCHITECT c8000 System (LN 2P32) | | Tube Type Equivalency | Serum Serum tubes (with or without gel barrier). | Same | | | Plasma Collection tubes Acceptable anticoagulants are: Lithium heparin (with or without gel barrier) Sodium heparin (full draw) | | | Use of Calibrators | Yes | Same | | | Use of Controls | Yes, commercially available controls | # Table 1: Assay Similarities {8}------------------------------------------------ # Table 2: Assay Differences | Assay Characteristics | Candidate Assay Alinity c ICT Sample Diluent (LN 07P53) | Predicate Assay (k980367) ICT (Na $+$ , K $+$ , Cl $-$ ) Sample Diluent Assay on the AEROSET/ARCHITECT c8000 System (LN 2P32) | |---------------------------------------|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | Technical Characteristics | | | | Reagent Container | Polypropylene Black colorant | High Density Polyethylene Natural color (Contains no colorant) | | Closure Material (contact only) | High Density Polyethylene Black color | F217 cap liner Polyethylene Foam between Low-Density Polyethylene liners Green color. | {9}------------------------------------------------ # VII. Summary of Nonclinical Performance Within-Laboratory Precision (20-Day) Alinity c ICT Sample Diluent Sodium assay – Serum Samples Precision was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP05-A2. A summary of results is presented below: | Sample | Control Lot | n | Mean (mmol/L) | Within-Run (Repeatability) | | Within-Laboratory (Total)a | | |--------------------|----------------|-----|------------------|-------------------------------|-----|----------------------------|--------------------| | | | | | SD | %CV | SD (Rangeb) | %CV (Rangeb) | | Control Level 1 | 1 | 249 | 125 | 0.5 | 0.4 | 0.9 (0.8 - 1.0) | 0.7 (0.6-0.8) | | | 2 | 249 | 125 | 0.5 | 0.4 | 0.9 (0.8 - 0.9) | 0.7 (0.6 - 0.8) | | Control Level 2 | 1 | 252 | 144 | 0.5 | 0.4 | 0.9 (0.8-1.0) | 0.6 (0.6-0.7) | | | 2 | 249 | 144 | 0.5 | 0.4 | 0.9 (0.8-1.0) | 0.6 (0.5-0.7) | | Control Level 3 | 1 | 249 | 161 | 0.5 | 0.3 | 1.0 (0.9-1.1) | 0.6 (0.6-0.7) | | | 2 | 249 | 161 | 0.6 | 0.4 | 1.1 (0.9-1.2) | 0.7 (0.6-0.7) | | Panel A | N/A | 496 | 112 | 0.4 | 0.4 | 0.8 (0.6-0.9) | 0.7 (0.6-0.8) | | Panel B | N/A | 498 | 190 | 0.8 | 0.4 | 1.4 (1.2-1.6) | 0.7 (0.6-0.9) | 4 Includes within-run, between-run, and between-day variability. b Maximum and minimum SD or %CV for each reagent lot and instrument combination. The precision of the Alinity c ICT Sample Diluent Sodium assay was considered acceptable if the within-laboratory (total) imprecision (within-run, between-run, and between-day) was ≤ 1.5 % CV for serum samples targeted between 131.0 to 153.0 mmol/L. {10}------------------------------------------------ The Alinity c ICT Sample Diluent Sodium assay demonstrated acceptable precision. Alinity c ICT Sample Diluent Potassium assay – Serum Samples Precision was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP05-A2. A summary of results is presented below: | | | | | | Within-Run (Repeatability) | | Within-Laboratory (Total)a | | |--------------------|----------------|-----|------------------|------|-------------------------------|---------------------|----------------------------|--| | Sample | Control Lot | n | Mean (mmol/L) | SD | %CV | SD (Rangeb) | %CV (Rangeb) | | | Control Level 1 | 1 | 246 | 2.8 | 0.03 | 0.9 | 0.04 (0.04-0.04) | 1.4 (1.3-1.5) | | | | 2 | 246 | 2.8 | 0.01 | 0.3 | 0.01 (0.00-0.02) | 0.4 (0.0-0.6) | | | Control Level 2 | 1 | 246 | 4.0 | 0.02 | 0.6 | 0.03 (0.03-0.03) | 0.8 (0.8-0.9) | | | | 2 | 246 | 4.0 | 0.01 | 0.3 | 0.02 (0.02-0.02) | 0.5 (0.5-0.5) | | | Control Level 3 | 1 | 246 | 6.8 | 0.03 | 0.4 | 0.05 (0.04-0.05) | 0.7 (0.6-0.7) | | | | 2 | 246 | 6.8 | 0.03 | 0.5 | 0.05 (0.04-0.05) | 0.7 (0.6-0.7) | | | Panel A | N/A | 491 | 1.6 | 0.02 | 1.1 | 0.03 (0.00-0.04) | 1.7 (0.0-2.7) | | | Panel B | N/A | 492 | 9.4 | 0.04 | 0.4 | 0.06 (0.05-0.07) | 0.7 (0.5-0.8) | | 4 Includes within-run, between-run, and between-day variability. b Maximum and minimum SD or %CV for each reagent lot and instrument combination. The precision Alinity c ICT Sample Diluent Potassium assay was considered acceptable if the within-laboratory (total) imprecision (within-run, between-run, and between-day) was ≤ 2.7 % CV for serum samples targeted between 4.0 to 6.0 mmol/L. The Alinity c ICT Sample Diluent Potassium assay demonstrated acceptable precision. {11}------------------------------------------------ # Alinity c ICT Sample Diluent Chloride assay – Serum Samples Precision was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP05-A2. | Sample | Control Lot | n | Mean (mmol/L) | Within-Run (Repeatability) | | Within-Laboratory (Total)a | | |--------------------|----------------|-----|------------------|-------------------------------|-----|----------------------------|------------------| | | | | | SD | %CV | SD (Rangeb) | %CV (Rangeb) | | Control Level 1 | 1 | 243 | 85 | 0.5 | 0.6 | 0.7 (0.6-0.8) | 0.8 (0.7-0.9) | | | 2 | 243 | 84 | 0.4 | 0.5 | 0.6 (0.5-0.7) | 0.7 (0.5-0.9) | | Control Level 2 | 1 | 243 | 95 | 0.4 | 0.4 | 0.6 (0.6-0.7) | 0.7 (0.6-0.8) | | | 2 | 243 | 94 | 0.4 | 0.5 | 0.6 (0.5-0.7) | 0.6 (0.5-0.7) | | Control Level 3 | 1 | 243 | 110 | 0.5 | 0.5 | 0.8 (0.6-0.9) | 0.7 (0.5-0.9) | | | 2 | 243 | 109 | 0.5 | 0.5 | 0.7 (0.5-0.9) | 0.7 (0.5-0.8) | | Panel A | N/A | 486 | 55 | 0.3 | 0.6 | 0.6 (0.4-0.6) | 1.0 (0.8-1.2) | | Panel B | N/A | 485 | 132 | 0.6 | 0.4 | 1.0 (0.7-1.3) | 0.8 (0.5-0.9) | A summary of results is presented below: 4 Includes within-run, between-run, and between-day variability. b Maximum and minimum SD or %CV for each reagent lot and instrument combination. The precision Alinity c ICT Sample Diluent Chloride assay was considered acceptable if the within-laboratory (total) imprecision (within-run, between-run, and between-day) was ≤ 2.0 % CV for serum samples targeted between 89.0 to 99.0 mmol/L. The Alinity c ICT Sample Diluent Chloride assay demonstrated acceptable precision. {12}------------------------------------------------ # Alinity c ICT Sample Diluent Sodium assay – Urine Samples Precision was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP05-A2. | Sample | Control Lot | n | Mean (mmol/L) | Within-Run (Repeatability) | | Within-Laboratory (Total)a | | |--------------------|----------------|-----|------------------|-------------------------------|-----|----------------------------|------------------| | | | | | SD | %CV | SD (Rangeb) | %CV (Rangeb) | | Control Level 1 | 1 | 240 | 92 | 0.6 | 0.7 | 1.0 (0.9-1.1) | 1.1 (1.0-1.2) | | | 2 | 240 | 92 | 0.5 | 0.5 | 0.7 (0.7-0.8) | 0.8 (0.7-0.9) | | Control Level 2 | 1 | 240 | 161 | 0.7 | 0.4 | 1.0 (0.9-1.1) | 0.6 (0.6-0.7) | | | 2 | 240 | 161 | 0.6 | 0.4 | 1.5 (1.0-1.8) | 0.9 (0.7-1.1) | | Panel A | N/A | 480 | 21 | 0.5 | 2.3 | 0.6 (0.5-0.8) | 2.9 (2.3-3.7) | | Panel B | N/A | 480 | 383 | 1.5 | 0.4 | 3.9 (2.5-4.7) | 1.0 (0.7-1.2) | A summary of results is presented below: 4 Includes within-run, between-run, and between-day variability. b Maximum and minimum SD or %CV for each reagent lot and instrument combination. The precision Alinity c ICT Sample Diluent Sodium assay was considered acceptable if the within-laboratory (total) imprecision (within-run, between-run, and between-day) was ≤ 3.0 % CV for urine samples targeted between 79.0 to 181.0 mmol/L. The Alinity c ICT Sample Diluent Sodium assay demonstrated acceptable precision. {13}------------------------------------------------ # Alinity c ICT Sample Diluent Potassium assay – Urine Samples Precision was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP05-A2. | | | | | Within-Run (Repeatability) | | Within-Laboratory (Total)a | | |--------------------|----------------|-----|------------------|-------------------------------|------|----------------------------|---------------------| | Sample | Control Lot | n | Mean (mmol/L) | SD | %CV | SD (Rangeb) | %CV (Rangeb) | | Control Level 1 | 1 | 240 | 16.6 | 0.06 | 0.3 | 0.13 (0.13-0.14) | 0.8 (0.8-0.9) | | | 2 | 240 | 16.6 | 0.05 | 0.3 | 0.12 (0.11-0.12) | 0.7 (0.7-0.7) | | Control Level 2 | 1 | 240 | 58.1 | 0.17 | 0.3 | 0.34 (0.29-0.39) | 0.6 (0.5-0.7) | | | 2 | 240 | 58.2 | 0.17 | 0.3 | 0.49 (0.29-0.62) | 0.8 (0.5-1.1) | | Panel A | N/A | 480 | 1.7 | 0.02 | 1.4 | 0.04 (0.04-0.04) | 2.4 (2.3-2.6) | | | Panel B | N/A | 480 | 127.7 | 0.35 | 0.3 | 0.68 (0.50-0.83) | | Panel C | | N/A | 479 | 284.5 | 0.82 | 0.3 | 1.91 (1.65-2.12) | A summary of results is presented below: 4 Includes within-run, between-run, and between-day variability. b Maximum and minimum SD or %CV for each reagent lot and instrument combination. The precision Alinity c ICT Sample Diluent Potassium assay was considered acceptable if the within-laboratory (total) imprecision (within-run, between-run, and between-day) was ≤ 3 % CV for urine samples targeted between 31.0 to 84.0 mmol/L. The Alinity c ICT Sample Diluent Potassium assay demonstrated acceptable precision. {14}------------------------------------------------ # Alinity c ICT Sample Diluent Chloride assay – Urine Samples Precision was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP05-A2. | Sample | Control Lot | n | Mean (mmol/L) | Within-Run (Repeatability) | | Within-Laboratory (Total)a | | |--------------------|----------------|-----|------------------|-------------------------------|-----|----------------------------|------------------| | | | | | SD | %CV | SD (Rangeb) | %CV (Rangeb) | | Control Level 1 | 1 | 240 | 103 | 0.5 | 0.4 | 0.9 (0.8-1.0) | 0.9 (0.8-0.9) | | | 2 | 240 | 103 | 0.5 | 0.5 | 0.8 (0.8-0.8) | 0.8 (0.8-0.8) | | Control Level 2 | 1 | 240 | 193 | 0.7 | 0.4 | 1.2 (1.1-1.3) | 0.6 (0.6-0.7) | | | 2 | 240 | 193 | 0.7 | 0.4 | 1.9 (1.3-2.4) | 1.0 (0.7-1.2) | | Panel A | N/A | 479 | 24 | 0.3 | 1.1 | 0.4 (0.1-0.5) | 1.6 (0.4-2.2) | | Panel B | N/A | 480 | 273 | 0.9 | 0.3 | 2.2 (1.9-2.3) | 0.8 (0.7-0.8) | A summary of results is presented below: 4 Includes within-run, between-run, and between-day variability. b Maximum and minimum SD or %CV for each reagent lot and instrument combination. The precision Alinity c ICT Sample Diluent Chloride assay was considered acceptable if the within-laboratory (total) imprecision (within-run, between-run, and between-day) was ≤ 1.8 % CV for urine samples targeted between 79.0 to 218.0 mmol/L. The Alinity c ICT Sample Diluent Chloride assay demonstrated acceptable precision {15}------------------------------------------------ # Linearity Alinity c ICT Sample Diluent Sodium, Potassium, Chloride assays – Serum Samples Linearity was evaluated based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP06-A. The mean observed linear range concentrations ranged from 27 to 259 mmol/L for the sodium sample set. The mean observed linear range concentrations ranged from 0.5 to 14.3 mmol/L for the potassium sample set. The mean observed linear range concentrations ranged from 22 to 172 mmol/L for the chloride sample set. Alinity c ICT Sample Diluent Sodium, Potassium, Chloride assays – Urine Samples Linearity was evaluated based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP06-A. The mean observed linear range concentrations ranged from 1 to 474 mmol/L for the sodium sample set. The mean observed linear range concentrations ranged from 0.1 to 366.0 mmol/L for the potassium sample set. The mean observed linear range concentrations ranged from 5 to 346 mmol/L for the chloride sample set. {16}------------------------------------------------ # Measuring Interval # Serum - The measuring interval of the Alinity c ICT Sodium assay is 100 to . 200 mmol/L. - The measuring interval of the Alinity c ICT Potassium assay is 1.0 to . 10.0 mmol/L. - The measuring interval of the Alinity c ICT Chloride assay is 50 to 150 mmol/L. . # Urine - . The measuring interval of the Alinity c ICT Sodium assay is 20 to 400 mmol/L. - The measuring interval of the Alinity c ICT Potassium assay is 1.0 to 300.0 mmol/L. - . The measuring interval of the Alinity c ICT Chloride assay is 20 to 300 mmol/L. The measuring interval is defined as the range of values in mmol/L which meets the limits of acceptable performance for linearity, imprecision, and bias. The inputs to the measuring interval include imprecision and linearity. {17}------------------------------------------------ # Interference Alinity c ICT Sample Diluent Sodium assay Serum Samples Potential interference was evaluated based on guidance from the Clinical Laboratory and Standards Institute (CLSI) document EP07-A2. For sodium serum a bias of > 2% was considered significant interference. The Alinity c ICT Sample Diluent Sodium assay using the serum application is not susceptible to interference effects from the following interferents at the interferent levels listed in the table below: | Interferent | Interferent Level | |------------------------|-------------------| | Unconjugated Bilirubin | ≤ 60 mg/dL | | Conjugated Bilirubin | ≤ 30 mg/dL | | Hemoglobin | ≤ 500 mg/dL | | Triglycerides | ≤ 2000 mg/dL | | Ascorbic Acid | ≤ 6 mg/dL | | Acetaminophen | ≤ 20 mg/dL | | Ibuprofen | ≤ 50 mg/dL | | Acetylcysteine | ≤ 167 mg/dL | | Acetylsalicylic Acid | ≤ 66 mg/dL | | Benzalkonium Chloride | ≤ 1 mg/dL | {18}------------------------------------------------ # Alinity c ICT Sample Diluent Potassium assay – Serum Samples Potential interference was evaluated based on guidance from the Clinical Laboratory and Standards Institute (CLSI) document EP07-A2. For potassium serum a bias of > 10% was considered significant interference. The Alinity c ICT Sample Diluent Potassium assay using the serum application is not susceptible to interference effects from the following interferents at the interferent levels listed in the table below: | Interferent | Interferent Level | |------------------------|-------------------| | Unconjugated Bilirubin | ≤ 60 mg/dL | | Conjugated Bilirubin | ≤ 60 mg/dL | | Hemoglobin | ≤ 100 mg/dL | | Triglycerides | ≤ 2000 mg/dL | | Ascorbic Acid | ≤ 6 mg/dL | | Acetaminophen | ≤ 20 mg/dL | | Ibuprofen | ≤ 50 mg/dL | | Acetylcysteine | ≤ 167 mg/dL | | Acetylsalicylic Acid | ≤ 66 mg/dL | | Sodium Salicylate | ≤ 70 mg/dL | | Benzalkonium Chloride | ≤ 5 mg/dL | {19}------------------------------------------------ # Alinity c ICT Sample Diluent Chloride assay – Serum Samples Potential interference was evaluated based on guidance from the Clinical Laboratory and Standards Institute (CLSI) document EP07-A2. For chloride serum a bias of > 10% was considered significant interference. The Alinity c ICT Sample Diluent Chloride assay using the serum application is not susceptible to interference effects from the following interferents at the interferent levels listed in the table below: | Interferent | Interferent Level | |------------------------|-------------------| | Unconjugated Bilirubin | ≤ 60 mg/dL | | Conjugated Bilirubin | ≤ 20 mg/dL | | Hemoglobin | ≤ 1000 mg/dL | | Triglycerides | ≤ 2000 mg/dL | | Ascorbic Acid | ≤ 6 mg/dL | | Acetaminophen | ≤ 20 mg/dL | | Ibuprofen | ≤ 50 mg/dL | | Acetylcysteine | ≤ 16.7 mg/dL | | Acetylsalicylic Acid | ≤ 66 mg/dL | | Sodium Salicylate | ≤ 70 mg/dL | | Benzalkonium Chloride | ≤ 10 mg/dL | | Lithium Bromide | ≤ 20 mg/dL | | Lithium Iodide | ≤ 25.4 mg/dL | | Sodium Azide | ≤ 325 mg/dL | {20}------------------------------------------------ Potential interference was evaluated based on guidance from the Clinical Laboratory and Standards Institute (CLSI) document EP07-A2. For sodium urine a bias of > 10% was considered significant interference. The Alinity c ICT Sample Diluent Sodium assay using the urine application is not susceptible to interference effects from the following interferents at the interferent levels listed in the table below: | Interferent | Interferent Level | | | |--------------------------|-------------------|--|--| | Protein | < 50 mg/dL | | | | Glucose | < 1000 mg/dL | | | | Ascorbate | < 200 mg/dL | | | | 8.5 N Acetic Acid | < 6.25 mL/dL | | | | Boric Acid | < 250 mg/dL | | | | 6 N Hydrochloric Acid | < 2.5 mL/dL | | | | 6 N Nitric Acid | < 5.0 mL/dL | | | | Acetaminophen | < 20 mg/dL | | | | Ibuprofen | < 50 mg/dL | | | | Acetylcysteine | < 167 mg/dL | | | | Conjugated Bilirubin | < 60 mg/dL | | | | Hemoglobin | < 1000 mg/dL | | | | pH (range) | 3.52 to 8.58 | | | | Specific Gravity (range) | 1.004 to 1.027 | | | {21}------------------------------------------------ Potential interference was evaluated based on guidance from the Clinical Laboratory and Standards Institute (CLSI) document EP07-A2. For potassium urine a bias of > 10% was considered significant interference. The Alinity c ICT Sample Diluent Potassium assay using the urine application is not susceptible to interference effects from the following interferents at the interferent levels listed in the table below: | Interferent | Interferent Level | |--------------------------|-------------------| | Protein | ≤ 50 mg/dL | | Glucose | ≤ 1000 mg/dL | | Ascorbate | ≤ 200 mg/dL | | 8.5 N Acetic Acid | ≤ 6.25 mL/dL | | Boric Acid | ≤ 250 mg/dL | | 6 N Hydrochloric Acid | ≤ 2.5 mL/dL | | 6 N Nitric Acid | ≤ 5.0 mL/dL | | Sodium Oxalate | ≤ 60 mg/dL | | Sodium Carbonate | ≤ 1.25 g/dL | | Sodium Fluoride | ≤ 400 mg/dL | | Acetaminophen | ≤ 20 mg/dL | | Ibuprofen | ≤ 50 mg/dL | | Acetylcysteine | ≤ 167 mg/dL | | Conjugated Bilirubin | ≤ 60 mg/dL | | Hemoglobin | ≤ 500 mg/dL | | pH (range) | 3.58 to 8.03 | | Specific Gravity (range) | 1.010 to 1.025 | {22}------------------------------------------------ # Alinity c ICT Sample Diluent Chloride assay – Urine Samples Potential interference was evaluated based on guidance from the Clinical Laboratory and Standards Institute (CLSI) document EP07-A2. For potassium urine a bias of > 10% was considered significant interference. The Alinity c ICT Sample Diluent Chloride assay using the urine application is not susceptible to interference effects from the following interferents at the interferent levels listed in the table below: | Interferent | Interferent Level | |--------------------------|-------------------| | Protein | ≤ 50 mg/dL | | Glucose | ≤ 1000 mg/dL | | Ascorbate | ≤ 200 mg/dL | | 8.5 N Acetic Acid | ≤ 6.25 mL/dL | | Boric Acid | ≤ 250 mg/dL | | 6 N Nitric Acid | ≤ 5.0 mL/dL | | Sodium Carbonate | ≤ 1.25 g/dL | | Sodium Fluoride | ≤ 400 mg/dL | | Sodium Oxalate | ≤ 60 mg/dL | | Acetaminophen | ≤ 20 mg/dL | | Ibuprofen | ≤ 50 mg/dL | | Acetylcysteine | ≤ 16.7 mg/dL | | Conjugated Bilirubin | ≤ 60 mg/dL | | Hemoglobin | ≤ 1000 mg/dL | | pH (range) | 3.52 to 7.97 | | Specific Gravity (range) | 1.006 to 1.033 | {23}------------------------------------------------ # Method Comparison Alinity c ICT Sample Diluent Sodium, Potassium and Chloride assay – Serum and Urine Samples The method comparison study was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP09-A3. Human serum and urine specimens that spanned the measuring interval of the assay were evaluated for serum and urine testing respectively. The results analyzed using Passing-Bablok regression method are summarized in the tables below: # Sodium | | Units | n | Correlation Coefficient | Intercept | Slope | Concentration Range | |--------------------------------------------|--------------|-----|----------------------------|-----------|-------|------------------------| | Alinity c Sodium vs ARCHITECT Sodium | Serum mmol/L | 141 | 1.00 | -0.50 | 1.00 | 101-197 | | | Urine mmol/L | 101 | 1.00 | 0.88 | 0.99 | 22-386 | # Potassium | | Units | n | Correlation Coefficient | Intercept | Slope | Concentration Range | |-----------------------------------------------------|--------------|-----|----------------------------|-----------|-------|------------------------| | Alinity c Potassium vs ARCHITECT Potassium | Serum mmol/L | 122 | 1.00 | 0.00 | 1.00 | 1.3-9.4 | | | Urine mmol/L | 107 | 1.00 | -1.23 | 1.05 | 4.3-266.1 | # Chloride | | Units | n | Correlation Coefficient | Intercept | Slope | Concentration Range | |------------------------------------------------|--------------|-----|----------------------------|-----------|-------|------------------------| | Alinity c Chloride vs ARCHITECT Chloride | Serum mmol/L | 120 | 1.00 | 0.00 | 1.00 | 52-148 | | | Urine mmol/L | 112 | 1.00 | -0.30 | 1.00 | 25-299 | {24}------------------------------------------------ The method comparison study results for the investigational method, Alinity c ICT Sample Diluent Sodium, Potassium, and Chloride, versus the comparator method, ARCHITECT ICT Sample Diluent Sodium, Potassium, and Chloride, are acceptable. # Tube Type Equivalency Alinity c ICT Sample Diluent Sodium, Potassium, and Chloride assay Tube type equivalency was performed based on guidance from the Clinical Laboratory Standards Institute (CLSI) document EP07-A2 to evaluate whether specific blood collection tube types are suitable for use with the Alinity c ICT Sample Diluent for the Sodium, Potassium, and Chloride assays. Samples were collected from a minimum of 40 donors and evaluated across tube types. The following blood collection tube types are acceptable for use with the Alinity c ICT Sample Diluent Sodium, Potassium, and Chloride assays: - . Serum - Serum separator ● - Lithium heparin ● - Sodium heparin ● - . Lithium heparin plasma separator {25}------------------------------------------------ #### VIII. Summary of Clinical Performance This section does not apply. # IX. Conclusion Drawn from Nonclinical Laboratory Studies The similarities and differences between the candidate assay (Alinity c ICT Sample Diluent, List No. 07P53) and the predicate assay (ICT (Na+, K+, Cl ) Sample Diluent, List No. 2P32) are presented in the table on page 5. The minor differences between the candidate ICT sodium, potassium and chloride assays and the predicate ICT sodium, potassium and chloride assays raise no new issues of safety and effectiveness. The performance results presented in this 510(k) demonstrate that the Alinity c ICT Sample Diluent is safe and effective for the stated intended use. The results presented in this 510(k) premarket notification demonstrate that the Alinity c ICT Sample Diluent is substantially equivalent to the respective predicate device (ICT (Na+, K+, C1 ) Sample Diluent (k980367)).