Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on ion-selective electrode technology and standard analytical methods, with no mention of AI or ML.

Therapeutic

No

Explanation: This device is an in vitro diagnostic (IVD) tool used to measure electrolytes (sodium, potassium, and chloride) in human samples. It provides quantitative information for diagnosis and treatment monitoring, but it does not directly apply or deliver a therapy.

Diagnostic

Yes

The device is explicitly stated to be "used in the diagnosis and treatment of" various conditions involving electrolyte imbalance, and its measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases. This clearly indicates a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "reagent kit containing Reagent 1 (Buffer)" and is used with calibrators on an analyzer that utilizes "ion-selective electrodes (ISE)". These are physical components, not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that the device is used for the "quantitation of sodium, potassium, and chloride in human serum, plasma, or urine". These are biological specimens taken from the human body.
Purpose: The measurements obtained are used in the "diagnosis and treatment of diseases involving electrolyte imbalance," "monitoring electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels," and "diagnosis and treatment of electrolyte and metabolic disorders". This clearly indicates a medical purpose for diagnosing or treating conditions.
Device Description: The device is a "reagent kit" used with calibrators on an "analyzer". This describes components and a system used to perform tests on biological samples.
Methodology: The methodology is "Ion-selective electrode diluted (Indirect)" and the detection is "Potentiometric". These are standard laboratory techniques used for in vitro testing.
Performance Studies: The performance studies are conducted using "human serum and urine specimens" and evaluate metrics relevant to the accuracy and reliability of in vitro tests (precision, linearity, interference, method comparison).
Predicate Device: The presence of a predicate device (K980367; ICT (Na+, K+, Cl-) Sample Diluent (LN) 2P32 for use on Abbott ARCHITECT c8000 and Abbott AEROSET) which is also an IVD, further supports the classification of this device as an IVD.

All of these factors align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

CGZ, CEM, JGS

Device Description

The Alinity c ICT Sample Diluent kit contains Reagent 1 (Buffer). The Alinity c ICT Serum Calibrator contains 5 bottles (2.9 mL each) of Calibrators L and H, which contain Bovine Serum Albumin, Sodium chloride, Potassium chloride, and Sodium nitrate. The Alinity c ICT Urine Calibrator contains 5 bottles (2.9 mL each) of Calibrators L and H, which contain sodium chloride, potassium chloride, and sodium nitrate. The device utilizes ion-selective electrodes (ISE) for sodium, potassium, and chloride, which develop an electrical potential across selective membranes to determine ion concentration based on the Nernst equation. The methodology used is Ion-selective electrode diluted (Indirect).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Within-Laboratory Precision (20-Day)
The study was performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP05-A2.

Alinity c ICT Sample Diluent Sodium assay – Serum Samples: n ranged from 249 to 498. The precision was considered acceptable if the within-laboratory (total) imprecision was ≤ 1.5 % CV for serum samples targeted between 131.0 to 153.0 mmol/L. The assay demonstrated acceptable precision.
Alinity c ICT Sample Diluent Potassium assay – Serum Samples: n ranged from 246 to 492. The precision was considered acceptable if the within-laboratory (total) imprecision was ≤ 2.7 % CV for serum samples targeted between 4.0 to 6.0 mmol/L. The assay demonstrated acceptable precision.
Alinity c ICT Sample Diluent Chloride assay – Serum Samples: n ranged from 243 to 485. The precision was considered acceptable if the within-laboratory (total) imprecision was ≤ 2.0 % CV for serum samples targeted between 89.0 to 99.0 mmol/L. The assay demonstrated acceptable precision.
Alinity c ICT Sample Diluent Sodium assay – Urine Samples: n ranged from 240 to 480. The precision was considered acceptable if the within-laboratory (total) imprecision was ≤ 3.0 % CV for urine samples targeted between 79.0 to 181.0 mmol/L. The assay demonstrated acceptable precision.
Alinity c ICT Sample Diluent Potassium assay – Urine Samples: n ranged from 240 to 480. The precision was considered acceptable if the within-laboratory (total) imprecision was ≤ 3 % CV for urine samples targeted between 31.0 to 84.0 mmol/L. The assay demonstrated acceptable precision.
Alinity c ICT Sample Diluent Chloride assay – Urine Samples: n ranged from 240 to 480. The precision was considered acceptable if the within-laboratory (total) imprecision was ≤ 1.8 % CV for urine samples targeted between 79.0 to 218.0 mmol/L. The assay demonstrated acceptable precision.

Linearity
Evaluated based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP06-A.

Serum Samples:
- Sodium: Linear range concentrations from 27 to 259 mmol/L.
- Potassium: Linear range concentrations from 0.5 to 14.3 mmol/L.
- Chloride: Linear range concentrations from 22 to 172 mmol/L.
Urine Samples:
- Sodium: Linear range concentrations from 1 to 474 mmol/L.
- Potassium: Linear range concentrations from 0.1 to 366.0 mmol/L.
- Chloride: Linear range concentrations from 5 to 346 mmol/L.

Interference
Evaluated based on guidance from the Clinical Laboratory and Standards Institute (CLSI) document EP07-A2.

Sodium Serum: Bias > 2% considered significant. Not susceptible to interference from listed interferents at specified levels.
Potassium Serum: Bias > 10% considered significant. Not susceptible to interference from listed interferents at specified levels.
Chloride Serum: Bias > 10% considered significant. Not susceptible to interference from listed interferents at specified levels.
Sodium Urine: Bias > 10% considered significant. Not susceptible to interference from listed interferents at specified levels.
Potassium Urine: Bias > 10% considered significant. Not susceptible to interference from listed interferents at specified levels.
Chloride Urine: Bias > 10% considered significant. Not susceptible to interference from listed interferents at specified levels.

Method Comparison
Performed based on guidance from the Clinical and Laboratory Standards Institute (CLSI) document EP09-A3. Human serum and urine specimens spanning the measuring interval were evaluated. Results analyzed using Passing-Bablok regression method.

Sodium:
- Serum: n=141, Correlation Coefficient=1.00, Intercept=-0.50, Slope=1.00, Concentration Range=101-197 mmol/L
- Urine: n=101, Correlation Coefficient=1.00, Intercept=0.88, Slope=0.99, Concentration Range=22-386 mmol/L
Potassium:
- Serum: n=122, Correlation Coefficient=1.00, Intercept=0.00, Slope=1.00, Concentration Range=1.3-9.4 mmol/L
- Urine: n=107, Correlation Coefficient=1.00, Intercept=-1.23, Slope=1.05, Concentration Range=4.3-266.1 mmol/L
Chloride:
- Serum: n=120, Correlation Coefficient=1.00, Intercept=0.00, Slope=1.00, Concentration Range=52-148 mmol/L
- Urine: n=112, Correlation Coefficient=1.00, Intercept=-0.30, Slope=1.00, Concentration Range=25-299 mmol/L
  The results were acceptable.

Tube Type Equivalency
Performed based on guidance from the Clinical Laboratory Standards Institute (CLSI) document EP07-A2. Samples collected from a minimum of 40 donors.

Acceptable tube types: Serum, Serum separator, Lithium heparin, Sodium heparin, Lithium heparin plasma separator.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K980367

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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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)

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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

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).

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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.

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.

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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. |

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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 | 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.

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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 | 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.

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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 | 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	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)).