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 Description

The Alinity c ICT Sample Diluent is a reagent kit containing Reagent 1 (Buffer). It is used with the Alinity c ICT Serum Calibrator and Alinity c ICT Urine Calibrator on the Alinity c analyzer. The system utilizes ion-selective electrodes (ISE) for sodium, potassium, and chloride, which develop an electrical potential across membranes selective to each ion. This voltage is compared to calibrator voltages and converted into ion concentration. The methodology is Ion-selective electrode diluted (Indirect) and the detection is Potentiometric.

AI/ML Overview

The provided document describes the Alinity c ICT Sample Diluent, a device used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine. The document mainly focuses on non-clinical performance studies to demonstrate substantial equivalence to a predicate device, rather than a clinical study with acceptance criteria in the traditional sense of diagnostic accuracy or reader performance.

Here's an analysis of the provided information based on your requested criteria:

The studies presented are primarily analytical performance studies (precision, linearity, interference, method comparison, and tube type equivalency) to demonstrate the device's accuracy and reliability compared to a predicate device. The acceptance criteria are internal, predefined thresholds for these analytical performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Analyte & Matrix	Acceptance Criteria	Reported Device Performance
Precision	Sodium (Serum)	Within-laboratory (total) imprecision ≤ 1.5% CV (for 131-153 mmol/L)	Max 0.7% CV (125 mmol/L), Max 0.7% CV (190 mmol/L)
	Potassium (Serum)	Within-laboratory (total) imprecision ≤ 2.7% CV (for 4.0-6.0 mmol/L)	Max 1.7% CV (1.6 mmol/L), Max 0.7% CV (9.4 mmol/L)
	Chloride (Serum)	Within-laboratory (total) imprecision ≤ 2.0% CV (for 89.0-99.0 mmol/L)	Max 1.0% CV (55 mmol/L), Max 0.8% CV (132 mmol/L)
	Sodium (Urine)	Within-laboratory (total) imprecision ≤ 3.0% CV (for 79.0-181.0 mmol/L)	Max 2.9% CV (21 mmol/L), Max 1.1% CV (92 mmol/L)
	Potassium (Urine)	Within-laboratory (total) imprecision ≤ 3.0% CV (for 31.0-84.0 mmol/L)	Max 2.4% CV (1.7 mmol/L), Max 0.8% CV (58.2 mmol/L)
	Chloride (Urine)	Within-laboratory (total) imprecision ≤ 1.8% CV (for 79.0-218.0 mmol/L)	Max 1.6% CV (24 mmol/L), Max 1.0% CV (193 mmol/L)
Interference	Sodium (Serum)	Bias > 2% considered significant interference	Not susceptible within specified interferent levels
	Potassium (Serum)	Bias > 10% considered significant interference	Not susceptible within specified interferent levels
	Chloride (Serum)	Bias > 10% considered significant interference	Not susceptible within specified interferent levels
	Sodium (Urine)	Bias > 10% considered significant interference	Not susceptible within specified interferent levels
	Potassium (Urine)	Bias > 10% considered significant interference	Not susceptible within specified interferent levels
	Chloride (Urine)	Bias > 10% considered significant interference	Not susceptible within specified interferent levels
Method Comparison	Na, K, Cl (Serum)	Acceptable correlation, slope, and intercept (relative to predicate)	Correlation 1.00, Slope ~1.00, Intercept ~0.00 (all)
	Na, K, Cl (Urine)	Acceptable correlation, slope, and intercept (relative to predicate)	Correlation 1.00, Slope ~1.00, Intercept ~0.00 (all, minor variations)
Linearity	All analytes/matrices	Meets limits of acceptable performance	Demonstrated linearity across specified ranges
Measuring Interval	All analytes/matrices	Meets limits of acceptable performance for linearity, imprecision, and bias	Measuring intervals are defined and stated
Tube Type Equivalency	All analytes/matrices	Demonstrate suitability across acceptable tube types	Deemed acceptable for listed tube types

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, for patient samples. The studies are described as "Within-Laboratory Precision" and "Method Comparison," implying they were conducted in a controlled laboratory setting.

Precision Studies (Test Set):
- Serum Samples: For Sodium, Potassium, and Chloride assays, each control level (3 levels) typically had n=243 to n=252 measurements per control lot. For patient panels, n=485 to n=498 measurements were performed.
- Urine Samples: For Sodium, Potassium, and Chloride assays, each control level (2 levels) typically had n=240 measurements per control lot. For patient panels, n=479 to n=480 measurements were performed.
Method Comparison (Test Set):
- Sodium (Serum): n=141
- Sodium (Urine): n=101
- Potassium (Serum): n=122
- Potassium (Urine): n=107
- Chloride (Serum): n=120
- Chloride (Urine): n=112
- Data Provenance: "Human serum and urine specimens that spanned the measuring interval of the assay were evaluated." The specific origin (e.g., country) is not mentioned. These are likely prospective samples collected for testing.
Interference Studies (Test Set): Not explicitly stated, but typically these studies use spiked samples or samples with naturally elevated interferents.
Tube Type Equivalency (Test Set): Samples were collected from a minimum of 40 donors.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This type of device (in-vitro diagnostic for electrolyte measurement) does not typically involve human experts establishing ground truth in the way medical imaging or pathology devices do. The "ground truth" for these analytical studies is established by:

Reference Methods: For calibrator concentrations, "flame photometry calibrated against NIST Standard Reference Material" and "titration with silver calibrated against NIST Standard Reference Material" were used.
Predicate Device: For method comparison, the "ARCHITECT ICT Sample Diluent Sodium, Potassium, and Chloride" is used as the comparator method, implying its results are considered the established values for comparison.
Known Concentrations: For precision, linearity, and interference studies, samples are often prepared with known concentrations or spiked with specific substances.

Therefore, the concept of "experts establishing ground truth" as in qualitative diagnostic interpretation is not applicable here.

4. Adjudication Method for the Test Set

Not applicable for this type of analytical performance study. Adjudication methods like 2+1 or 3+1 are used for qualitative assessments, typically when human interpretations are being compared, or when there's disagreement among experts on a ground truth.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. This is an analytical performance study for an in-vitro diagnostic instrument component, not a diagnostic imaging or AI-driven interpretive device. Therefore, a MRMC comparative effectiveness study involving human readers with and without AI assistance is not relevant.

6. Standalone (Algorithm Only) Performance Study

Yes, implicitly. The entirety of the reported Nonclinical Performance (precision, linearity, interference, method comparison, and tube type equivalency) represents the standalone performance of the Alinity c ICT Sample Diluent device on the Alinity c analyzer. There is no "human-in-the-loop" aspect to the measurement of electrolyte concentrations by this automated system.

7. Type of Ground Truth Used

Reference Methods: NIST Standard Reference Materials, flame photometry, and titration with silver were used to establish the ground truth for calibrator concentrations.
Comparator (Predicate) Device: The ARCHITECT ICT Sample Diluent was used as the comparator for method comparison studies.
Known Concentrations/Spiked Samples: For precision, linearity, and interference studies, samples with known or precisely prepared concentrations were used.

8. Sample Size for the Training Set

This document does not describe the development of an algorithm that would require a separate "training set" in the context of machine learning. The device is an in-vitro diagnostic reagent and system based on established ion-selective electrode technology. Its performance is evaluated through analytical studies, not by training a model on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As explained in point 8, there is no "training set" in the machine learning sense for this device.

Summary

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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.

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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

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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.

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.

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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

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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

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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).

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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.

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.

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Table 1: Assay Similarities
Characteristics	Candidate AssayAlinity c ICT Sample Diluent (LN 07P53)	Predicate Assay (K980367)ICT (Na+, K+, Cl-) Sample Diluent Assay onthe AEROSET/ARCHITECT c8000 System(LN 2P32)
		Technical Characteristics
ReagentFormulation	Active Ingredient: Buffer	Same bulk as Alinity c.
AnalyteMeasured	Sodium, potassium, and chloride.	Same
IntendedUse/Indicationsfor Use	The Alinity c ICT (Integrated Chip Technology) is used for the quantitation ofsodium, potassium, and chloride in human serum, plasma, or urine.	Same
Assay Principle	Ion-selective electrode diluted (Indirect).	Same
Detection ofAnalyte	Potentiometric.	Same
Specimen Type	Human serum, plasma or urine.	Same
Performance Characteristics
Assay Range	Serum/PlasmaSodium: 100 to 200 mmol/L.Potassium 1.0 to 10.0 mmol/L.Chloride: 50 to 150 mmol/L.UrineSodium: 20 to 400 mmol/L.Potassium: 1.0 to 300.0 mmol/L.Chloride: 20 to 300 mmol/L.	Same
MeasuringInterval	Serum/PlasmaThe 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.UrineThe 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 AssayAlinity c ICT Sample Diluent (LN 07P53)	Predicate Assay (K980367)ICT (Na+, K+, Cl-) Sample Diluent Assay onthe AEROSET/ARCHITECT c8000 System(LN 2P32)
Tube TypeEquivalency	SerumSerum tubes (with or without gel barrier).	Same
	PlasmaCollection tubesAcceptable anticoagulants are:Lithium heparin (with or without gel barrier)Sodium heparin (full draw)
Use ofCalibrators	Yes	Same
	Use of Controls	Yes, commercially available controls

Table 1: Assay Similarities

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Table 2: Assay Differences

AssayCharacteristics	Candidate AssayAlinity c ICT Sample Diluent (LN 07P53)	Predicate Assay (K980367)ICT (Na $+$ , K $+$ , Cl $-$ ) Sample Diluent Assay onthe AEROSET/ARCHITECT c8000 System(LN 2P32)
Technical Characteristics
ReagentContainer	PolypropyleneBlack colorant	High Density PolyethyleneNatural color (Contains no colorant)
ClosureMaterial(contact only)	High Density PolyethyleneBlack color	F217 cap linerPolyethylene Foam between Low-DensityPolyethylene linersGreen color.

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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	ControlLot	n	Mean(mmol/L)	Within-Run(Repeatability)		Within-Laboratory (Total)a
				SD	%CV	SD(Rangeb)	%CV(Rangeb)
ControlLevel 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)
ControlLevel 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)
ControlLevel 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.

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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	ControlLot	n	Mean(mmol/L)	SD	%CV	SD(Rangeb)	%CV(Rangeb)
ControlLevel 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)
ControlLevel 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)
ControlLevel 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.

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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	ControlLot	n	Mean(mmol/L)	Within-Run(Repeatability)		Within-Laboratory (Total)a
				SD	%CV	SD(Rangeb)	%CV(Rangeb)
ControlLevel 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)
ControlLevel 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)
ControlLevel 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.

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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	ControlLot	n	Mean(mmol/L)	Within-Run(Repeatability)		Within-Laboratory (Total)a
				SD	%CV	SD(Rangeb)	%CV(Rangeb)
ControlLevel 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)
ControlLevel 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.

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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	ControlLot	n	Mean(mmol/L)	SD	%CV	SD(Rangeb)	%CV(Rangeb)
ControlLevel 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)
ControlLevel 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.

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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	ControlLot	n	Mean(mmol/L)	Within-Run(Repeatability)		Within-Laboratory (Total)a
				SD	%CV	SD(Rangeb)	%CV(Rangeb)
ControlLevel 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)
ControlLevel 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

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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.

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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.

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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

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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

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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

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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

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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

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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

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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	CorrelationCoefficient	Intercept	Slope	ConcentrationRange
Alinity c Sodiumvs ARCHITECTSodium	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	CorrelationCoefficient	Intercept	Slope	ConcentrationRange
Alinity cPotassiumvs ARCHITECTPotassium	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	CorrelationCoefficient	Intercept	Slope	ConcentrationRange
Alinity c Chloridevs ARCHITECTChloride	Serum mmol/L	120	1.00	0.00	1.00	52-148
	Urine mmol/L	112	1.00	-0.30	1.00	25-299

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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

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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)).

Regulation Number and Section

§ 862.1170 Chloride test system.

(a)
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.(b)
Classification. Class II.