The Alinity ci-series is a System comprised of inity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations including up to four Alinity i processing modules, up to four Alinity c processing modules, or a combination of up to four of Alinity i and Alinity c processing modules with a shared system control module to form a single workstation.

The Alinity c System is a fully automated, random/continuous access, clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids.

The Alinity i System is a fully automated analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology is used to determine the presence of antigens, antibodies, and analytes in samples.

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.

The Alinity c Glucose Reagent Kit is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the Alinity c analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Alinity i Total B-hCG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative and qualitative determination of beta-human chorionic gonadotropin (B-hCG) in human serum and plasma for the early detection of pregnancy on the Alinity i analyzer.

Device Description

The Alinity ci-series is comprised of individual Alinity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations which include either multiple Alinity i processing modules, multiple Alinity c processing modules, or a combination of up to four of both Alinity i and Alinity c processing modules with a shared system control module (SCM). The SCM includes the reagent and sample manager (RSM). The multimodule configurations do not have a separate device label or list number. In a multimodule configuration, each processing module retains its original unique identification label.

AI/ML Overview

The document describes the non-clinical performance evaluation of the Alinity ci-series system, Alinity i Total ß-hCG Reagent Kit, Alinity c Glucose Reagent Kit, and Alinity c ICT Sample Diluent. The study focuses on demonstrating equivalent performance between the original single-module configurations and the new multi-module configurations.

Here's an breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating "equivalent performance" between the investigational multimodule system and the previously cleared single-module predicate devices. The reported performance metrics are precision (%CV) and method comparison parameters (slope and correlation coefficient). The document doesn't explicitly state numerical acceptance criteria thresholds, but rather implies that the observed results were within an acceptable range for "equivalent performance."

Test Category	Analyte/Assay	Unit	Acceptance Criteria (Implicit: Equivalent Performance to Predicate)	Reported Device Performance (Investigational Method)
Within-Laboratory Precision (5-Day)	Alinity i Total ß-hCG	%CV	Expected to be comparable to, or within acceptable limits of, predicate device's precision.	1.2% to 5.0% for samples from 5.25 to 12,850 mIU/mL
	Alinity c Glucose (Serum)	%CV	Expected to be comparable to, or within acceptable limits of, predicate device's precision.	0.4% to 1.8% for samples from 7 to 688 mg/dL
	Alinity c Glucose (Urine)	%CV	Expected to be comparable to, or within acceptable limits of, predicate device's precision.	0.6% to 1.3% for samples from 36 to 737 mg/dL
	Alinity c ICT Sodium	%CV	Expected to be comparable to, or within acceptable limits of, predicate device's precision.	0.3% to 0.5% for samples from 110 to 193 mmol/L
	Alinity c ICT Potassium	%CV	Expected to be comparable to, or within acceptable limits of, predicate device's precision.	0.5% to 2.7% for samples from 1.9 to 9.0 mmol/L
	Alinity c ICT Chloride	%CV	Expected to be comparable to, or within acceptable limits of, predicate device's precision.	0.4% to 1.2% for samples from 55 to 140 mmol/L
Method Comparison	Alinity i Total ß-hCG	Slope	Expected to be close to 1.00 (indicating good agreement).	0.98
	Alinity i Total ß-hCG	Correlation Coeff.	Expected to be close to 1.00 (indicating strong correlation).	1.00 (for samples ranging from 2.74 to 14,998.60 mIU/mL)
	Alinity c Glucose (Serum)	Slope	Expected to be close to 1.00 (indicating good agreement).	1.00
	Alinity c Glucose (Serum)	Correlation Coeff.	Expected to be close to 1.00 (indicating strong correlation).	1.00 (for samples ranging from 14 to 659 mg/dL)
	Alinity c Glucose (Urine)	Slope	Expected to be close to 1.00 (indicating good agreement).	0.99
	Alinity c Glucose (Urine)	Correlation Coeff.	Expected to be close to 1.00 (indicating strong correlation).	1.00 (for samples ranging from 1 to 705 mg/dL)
	Alinity c ICT Sodium	Slope	Expected to be close to 1.00 (indicating good agreement).	1.00
	Alinity c ICT Sodium	Correlation Coeff.	Expected to be close to 1.00 (indicating strong correlation).	1.00 (for samples ranging from 120 to 198 mmol/L)
	Alinity c ICT Potassium	Slope	Expected to be close to 1.00 (indicating good agreement).	1.00
	Alinity c ICT Potassium	Correlation Coeff.	Expected to be close to 1.00 (indicating strong correlation).	1.00 (for samples ranging from 2.3 to 9.6 mmol/L)
	Alinity c ICT Chloride	Slope	Expected to be close to 1.00 (indicating good agreement).	1.00
	Alinity c ICT Chloride	Correlation Coeff.	Expected to be close to 1.00 (indicating strong correlation).	1.00 (for samples ranging from 89 to 144 mmol/L)

2. Sample size used for the test set and the data provenance

The document does not explicitly state the exact sample sizes (number of patient samples) for the precision and method comparison studies. It provides ranges of analyte concentrations, implying that multiple samples spanning these ranges were tested.

Precision Studies: Samples across various concentration ranges (e.g., 5.25 to 12,850 mIU/mL for ß-hCG, 7 to 688 mg/dL for glucose serum, etc.) were used. The term "5-day precision" suggests a study design where samples are run over 5 days to assess within-laboratory variability.
Method Comparison Studies: Samples across various concentration ranges were used (e.g., 2.74 to 14,998.60 mIU/mL for ß-hCG, 14 to 659 mg/dL for glucose serum, etc.).

Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that it's a pre-market submission to the FDA, the studies are typically prospective and conducted by the manufacturer, often at their own facilities or clinical study sites.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this type of device. The ground truth for quantitative laboratory assays is typically established by reference methods or the performance of a cleared predicate device, not by expert consensus or physician review in the way it would be for imaging diagnostics. The "ground truth" here is the measurement obtained from the previously cleared single-module systems.

4. Adjudication method for the test set

Not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation (e.g., radiology reads) to resolve discrepancies among multiple expert reviewers. Here, the comparison is against quantitative measurements from a reference or predicate system.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission is for an in vitro diagnostic (IVD) system that performs automated quantitative measurements, not an AI-assisted diagnostic imaging device that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the performance of the automated Alinity ci-series system. The studies described (precision and method comparison) are essentially standalone performance evaluations comparing the new multimodule system to the existing single-module systems. There is no "human-in-the-loop" component in the sense of an operator making diagnostic interpretations based on the output. Operators load samples and reagents and manage the system, but the analytical measurement itself is automated.

7. The type of ground truth used

The ground truth used for comparison in these non-clinical studies is the performance of the predicate devices (Alinity i System for Alinity i Total ß-hCG, and Alinity c System for Alinity c Glucose and ICT assays) in their single-module configurations. The goal was to demonstrate "equivalent performance" of the new multimodule configurations to these already cleared systems. This is a form of comparative effectiveness against a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This document describes the validation of a laboratory instrument system and reagent kits through non-clinical performance studies (precision, method comparison), not an AI/machine learning model that requires a distinct "training set." The methodology involves biochemical reactions and optical/potentiometric detection, which are established principles, not learned from a dataset.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of an AI/ML model for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 19, 2023

Abbott Laboratories Melissa Vaughan Director, Regulatory Affairs 1915 Hurd Drive Irving, Texas 75038

Re: K230790

Trade/Device Name: Alinity i Total ß-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: DHA, CFR, JGS, CEM, CGZ, JJE Dated: March 21, 2023 Received: March 22, 2023

Dear Melissa Vaughan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Marianela Perez-torres -S

Marianela Perez-Torres, Ph.D. Acting Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230790

Device Name

Alinity ci-series, Alinity c ICT Sample Diluent, Alinity c Glucose Reagent Kit, Alinity i Total 8-hCG Reagent Kit

Indications for Use (Describe)

The Alinity ci-series is intended for in vitro diagnostic use only.

The Alinity c System is a fully automated, random/continuous access, clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids.

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

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. 510(k) Number

K230790

II. Applicant Name

Abbott Laboratories 1915 Hurd Drive Irving, TX 75038

Primary contact person for all communications:

Melissa Vaughan, Director, Regulatory Affairs Core Diagnostics Phone: (972) 518-6895 Cell: (469) 203-2772 Email: melissa.vaughan@abbott.com

Secondary contact person for all communications:

Amna Shamim, Sr. Regulatory Affairs Specialist Core Diagnostics Phone: (972) 518-6924 Email: amna.shamim(@abbott.com

Date Summary Prepared: May 19, 2023

III. Device Name

. Alinity ci-series
Device Classification: Class I Classification Name: Discrete photometric chemistry analyzer for clinical use Governing Regulation: 21 CFR § 862.2160 Code: JJE

Alinity i Total ß-hCG Reagent Kit Device Classification: Class II

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Classification Name: Human chorionic gonadotropin (HCG) test system Governing Regulation: 862.1155 Code: DHA

Alinity c Glucose Reagent Kit

Device Classification: Class II Classification Name: Hexokinase, glucose Governing Regulation: CFR 862.1345 Code: CFR

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 Code: CGZ/CEM/JGS

IV. Predicate Device

Alinity i System (K170317)

Alinity i Total β-hCG (K170317)

Alinity c System (K170316)

Alinity c Glucose (K170316)

Alinity c ICT Sample Diluent (K170320)

V. Description of Device

A. Introduction

The Alinity i System (K170317) and the Alinity c System (K170316) were designed to be combined into multimodule configurations. The Alinity ci-series is comprised of individual processing modules that may be arranged into individual or multimodule configurations which include either multiple Alinity i processing modules, multiple Alinity c processing modules, or a combination of up to four of both Alinity i and Alinity c processing modules with a shared system control module (SCM). The SCM includes the reagent and sample manager (RSM). The multimodule configurations do not have a separate device label or list number. In a multimodule configuration, each processing module retains its original unique identification label.

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B. Multimodule System (Device Design and Components)

1. Multimodule Overview

The Alinity ci-series multimodule configuration includes a combination of up to 4 Alinity i and Alinity c processing modules which perform all sample processing activities independently and can be physically joined to form a single multimodule configuration with the multimodule integration kit. The selection of processing module(s) determines the configuration of the system. Each multimodule configuration includes a single shared SCM with a single shared RSM.

a. Svstem Control Module

The SCM contains the following items:

. A user interface computer provides the software interface to the Alinity ci-series and provides an interface to a host or middleware computer.
. The power supply operates the user interface computer and the RSM.

b. Reagent and Sample Manager

The RSM is a transport system used to load calibrators, controls, specimens, reagents, and onboard solutions. The design of the RSM provides random and continuous access to load and unload sample racks, calibration and control racks, and reagent cartridges.

One primary RSM transports samples and reagents through an Alinity ci-series regardless of the type and number of processing modules.

The RSM performs the following functions:

. Lifts racks and cartridges from the loading area and moves them past the barcode reader
. Positions racks and cartridges for the barcode reader to identify samples, reagents, and solutions
Moves racks and cartridges to the appropriate processing module or returns • them to the loading area

c. Alinity i Processing Module

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The Alinity i processing module uses chemiluminescent microparticle immunoassay (CMIA) detection technology to measure the concentration of analytes in samples. The Alinity i processing module is an immunoassay analyzer that performs sample processing. The processing module processes a maximum of 200 CMIA tests per hour and has 47 positions in the reagent carousel to hold assay reagent cartridges and calibrator/control racks at a controlled temperature.

Assay processing occurs within a single processing module, and there is no difference in the execution of an assay when run on a single module or a multimodule configuration.

d. Alinity c Processing Module

The Alinity c processing module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. An integrated chip technology (ICT) module is used to measure potentiometric assays (electrolytes). The ICT module contains Na+, K+, C1-, and reference electrodes to potentiometrically measure the concentration of analytes in samples.

The Alinity c System is a chemistry analyzer that performs sample processing. The Alinity c processing module is capable of processing a maximum of 1350 photometric and potentiometric tests per hour and has a reagent carousel with 70 positions to hold assay reagent cartridges and calibrator/control racks at a controlled temperature.

Assay processing occurs within a single processing module, and there is no difference in the execution of an assay when run on a single module or a multimodule configuration.

e. Multimodule Integration Kit

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The multimodule integration kit provides the components necessary to physically connect different processing modules, which extends the RSM, to create a shared load platform for multimodule configurations.

C. Alinity i Total β-hCG Reagent Kit

The Alinity i Total β-hCG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative and qualitative determination of beta-human chorionic gonadotropin (B-hCG) in human serum and plasma for the early detection of pregnancy on the Alinity i analyzer.

D. Alinity c Glucose Reagent Kit

The Alinity c Glucose Reagent Kit is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the Alinity c analyzer.

E. Alinity c ICT Sample Diluent

Alinity c ICT (Integrated Chip Technology) (Na+, K+, and Cl is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine on the Alinity c analyzer.

VI. Intended Use of the Device

The Alinity ci-series is intended for in vitro diagnostic use only.

The Alinity ci-series is a System comprised of individual Alinity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations including up to four Alinity i processing modules, up to four Alinity c processing modules, or a combination of up to four of Alinity i and Alinity c processing modules with a shared system control module to form a single workstation.

The Alinity c System is a fully automated, random/continuous access, clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids.

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The Alinity i System is a fully automated analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.

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.

VII. Comparison of Technological Characteristics

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The similarities and differences between the subject device Alinity ci-series and the predicate device(s) Alinity i System (K170317) and Alinity c System (K170316) are presented in the comparison table below. There is no difference between the subject and predicate devices' indications for use. The minor technological differences between the subject device and the predicate device do not affect the safety and effectiveness of the subject device. The results presented in this 510(k) demonstrate that the Alinity ci-series multimodule system is safe and effective for the stated intended use.

Comparison of Subject & Predicate Device
	Subject Device:Alinity ci-series (MultimoduleSystem)	Predicate Device:Alinity i System(K170317)	Predicate Device:Alinity c System(K170316)	Comparison
	General Device Characteristics Similarities
Methodology	- Alinity i processing module:chemiluminescent microparticleimmunoassay(CMIA)- Alinity c processing module:Spectrophotometry(monochromatic andbichromatic modes ofmeasurement)	CMIA	Spectrophotometry(monochromaticand bichromaticmodes ofmeasurement)	Same
Intended Useand Indicationsfor Use	The Alinity ci-series is intendedfor in vitro diagnostic use only.The Alinity ci-series is aSystem comprised of individualAlinity i or Alinity canalyzers/processing modulesthat may be arranged intoindividual or multimoduleconfigurations including up tofour Alinity i processingmodules, up to four Alinity cprocessing modules, or acombination of up to four ofAlinity i and Alinity cprocessing modules with ashared system control moduleto form a single workstation.The Alinity c System is a fullyautomated, random/continuousaccess, clinical chemistryanalyzer intended for the invitro determination of analytesin body fluids.	The Alinity iSystem is a fullyautomatedanalyzer allowingrandom andcontinuous access,as well as priorityand automatedretest processingusingchemiluminescentmicroparticleimmunoassay(CMIA)technology.CMIA technologyis used todetermine thepresence ofantigens,antibodies, andanalytes insamples.	The Alinity cSystem is a fullyautomated,random/continuousaccess, clinicalchemistry analyzerintended for the invitro determinationof analytes in bodyfluids.	Same
Comparison of Subject & Predicate Device
	Subject Device:Alinity ci-series (MultimoduleSystem)	Predicate Device:Alinity i System(K170317)	Predicate Device:Alinity c System(K170316)	Comparison
	General Device Characteristics Similarities
	The Alinity i System is a fullyautomated analyzer allowingrandom and continuous access,as well as priority andautomated retest processingusing chemiluminescentmicroparticle immunoassay(CMIA) technology. CMIAtechnology is used to determinethe presence of antigens,antibodies, and analytes insamples.
Principle ofAnalyteDetection	- Alinity i processing module:utilize chemiluminescent labelswith magnetic microparticlesolid phase for analytedetection.- Alinity c processing module:utilize photometric andpotentiometric technology foranalyte detection.	Alinity i systemsutilizechemiluminescentlabels withmagneticmicroparticlesolid phase foranalyte detection.	Alinity c systemsutilize photometricand potentiometrictechnology foranalyte detection.	Same
SampleAspiration	Directly from sample tubes,control bottles within eachindependent Alinity i and/orAlinity c processing modules	Directly fromsample tubes,control bottles	Directly fromsample tubes,control bottles	Same
PhysicalLaboratoryAutomationSystem (LAS)	Pipettor probe samples from theback of the individualprocessing module	Pipettor probesamples from theback of theindividualprocessingmodule	Pipettor probesamples from theback of theindividualprocessing module	Same
SampleTransport	- Shared robotic sample handlercustomized to systemconfiguration. Shared transportsystem provides random andcontinuous access to samplesfor each Alinity i or Alinity cprocessing module from ashared load platform.- Moves samples requiringmultiple tests to multipleindependent processingmodules as ordered.- Autoretest capability- Priority and batch sampleloading	- Robotic samplehandler. Transportsystem that hasrandom andcontinuous accessto samples.- Autoretestcapability- Priority andbatch sampleloading	- Robotic samplehandler. Transportsystem that hasrandom andcontinuous accessto samples.- Autoretestcapability- Priority and batchsample loading	Same
Comparison of Subject & Predicate Device
	Subject Device:Alinity ci-series (MultimoduleSystem)	Predicate Device:Alinity i System(K170317)	Predicate Device:Alinity c System(K170316)	Comparison
General Device Characteristics Similarities
SampleIdentification	The RSM performs thefollowing functions:- Lifts racks and cartridgesfrom the loading area andmoves them past the barcodereader.- Positions racks and cartridgesfor the barcode reader toidentify samples, reagents, andsolutions.	The RSMperforms thefollowingfunctions:- Lifts racks andcartridges fromthe loading areaand moves thempast the barcodereader.- Positions racksand cartridges forthe barcode readerto identifysamples, reagents,and solutions.	The RSM performsthe followingfunctions:- Lifts racks andcartridges from theloading area andmoves them pastthe barcode reader.- Positions racksand cartridges forthe barcode readerto identify samples,reagents, andsolutions.	Same

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Comparison of Subject & Predicate Device
	Subject Device:Alinity ci-series (Multimodule System)Alinity i Total β-hCG	Predicate Device:Alinity i Total β-hCG(K170317)
General Device Characteristics Similarities
Assay Protocol	2-step	Same
Methodology	Chemiluminescent MicroparticleImmunoassay (CMIA)	Same
Calibration Curve Type	6-point4 Parameter Logistic Curve fit datareduction method(4PLC, Y-weighted)	Same
Intended Use/Indications forUse	The Alinity i Total β-hCG assay is achemiluminescent microparticleimmunoassay (CMIA) used for thequantitative and qualitativedetermination of beta-human chorionicgonadotropin (β-hCG) in human serumand plasma for the early detection ofpregnancy on the Alinity i analyzer.	Same
Specimen Type	Serum and plasma	Same
Specific Analyte Detected	Total β-hCG	Same
Formulation	Microparticles – Anti-β-hCG (mouse,monoclonal) coated microparticles inTRIS buffer with protein (bovine)stabilizers. Minimum concentration:0.06% solids. Preservatives:antimicrobial agents. Conjugate - Anti-β-hCG (mouse, monoclonal) acridinium-labeled conjugate in MES buffer withprotein (bovine) stabilizers. Minimumconcentration: 2.9 µg/mL. Preservative:antimicrobial agent.	Same

A comparison of the representative immunoassay is presented below.

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A comparison of the representative clinical chemistry assays are presented in the following tables below.

Comparison of Subject & Predicate Device
	Subject Device:Alinity ci-series (Multimodule System)Alinity c Glucose	Predicate Device:Alinity c Glucose(K170316)
General Device Characteristics Similarities
Assay Protocol	1-step	Same
Assay Principle	Glucose is phosphorylated by hexokinase (HK)in the presence of adenosine triphosphate(ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosinediphosphate (ADP). Glucose-6-phosphatedehydrogenase (G-6-PDH) specificallyoxidizes G-6-P to 6-phosphogluconate with theconcurrent reduction of nicotinamide adeninedinucleotide (NAD) to nicotinamide adeninedinucleotide reduced (NADH). One micromoleof NADH is produced for each micromole ofglucose consumed. The NADH producedabsorbs light at 340 nm and can be detectedspectrophotometrically as an increasedabsorbance	Same
Methodology	Spectrophotometry (monochromatic andbichromatic modes of measurement)	Same
Calibration Curve Type	Linear (End up)	Same
Intended Use	The Alinity c Glucose Reagent Kit is used forthe quantitation of glucose in human serum,plasma, urine, or cerebrospinal fluid (CSF) onthe Alinity c analyzer. Glucose measurementsare used in the diagnosis and treatment ofcarbohydrate metabolism disorders includingdiabetes mellitus, neonatal hypoglycemia andidiopathic hypoglycemia, and of pancreaticislet cell carcinoma.	Same
Indications for Use	A glucose test system is a device intended tomeasure glucose quantitatively in blood andother body fluids. Glucose measurements areused in the diagnosis and treatment ofcarbohydrate metabolism disorders includingdiabetes mellitus, neonatal hypoglycemia, andidiopathic hypoglycemia, and of pancreaticislet cell carcinoma.	Same
Specimen Type	Human serum, plasma, urine, or CSF	Same
Specific Analyte Detected	Glucose	Same
Formulation	R1: Active ingredients: ATP •2Na (9.0mg/mL), NAD (5.0 mg/mL), G-6-PDH (3000U/L), Hexokinase (15 000 U/L), Preservative:sodium azide (0.05%).	Same

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	Subject Device:Alinity ci-series (MultimoduleSystem)Alinity c ICT Sample Diluent	Predicate Device:Alinity c ICT Sample Diluent(K170320)
General Device Characteristics Similarities
Assay Protocol	1-step	Same
Assay Principle	Ion-selective electrode diluted(Indirect)	Same
Methodology	Potentiometric	Same
Calibration CurveType	Linear (End up)	Same
Intended Use/ Indications for Use	The Alinity c ICT (IntegratedChip Technology) is used for thequantitation of sodium, potassium,and chloride in human serum,plasma, or urine on the Alinity canalyzer.Sodium measurements are used inthe diagnosis and treatment ofaldosteronism (excessive secretionof the hormone aldosterone),diabetes insipidus (chronicexcretion of large amounts ofdilute urine, accompanied byextreme thirst), adrenalhypertension, Addison's disease(caused by destruction of theadrenal glands), dehydration,inappropriate antidiuretichormone secretion, or otherdiseases involving electrolyteimbalance.Potassium measurements are usedto monitor electrolyte balance inthe diagnosis and treatment ofdiseases conditions characterizedby low or high blood potassiumlevels.Chloride measurements are usedin the diagnosis and treatment ofelectrolyte and metabolicdisorders such as cystic fibrosisand diabetic acidosis.	Same
Specimen Type	Human serum, plasma or urine	Same
Specific AnalyteDetected	Sodium, potassium, and chloride	Same
Formulation	Active Ingredient: Buffer	Same

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VIII. Summary of Nonclinical Performance

Nonclinical testing included 5-day precision and method comparison studies which were completed using assays that were cleared with the Alinity i System (K170317) and Alinity c System (K170316, K170320) to demonstrate the equivalent performance between the single module configuration and multimodule configurations. Additionally, electromagnetic compatibility (EMC) and electrical safety testing was completed.

EMC testing was completed according to IEC 61326 2 6:2020. Electrical equipment for measurement, control and laboratory use EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment. Where applicable, modules were immunity tested beyond the requirements per IEC 61326 2-6:2020 to more closely align with the levels required per IEC 60601 1 2:2014 + A1:2020, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances - Requirements and tests.

A. Within-Laboratory Precision (5-Day)

The Alinity i Total ß-hCG assay demonstrated equivalent assay performance for within-laboratory precision between the investigational method (Alinity ci-series system in a 4-module configuration) and the comparator method (Alinity i system in a single module configuration). For samples from 5.25 to 12,850 mIU/mL, the %CV ranged from 1.2 to 5.0%.

The Alinity c Glucose assay demonstrated equivalent assay performance for within-laboratory precision between the investigational method (Alinity ci-series system in a 4-module configuration) and the comparator method (Alinity c system in a single module configuration) using the serum and urine application. For serum samples from 7 to 688 mg/dL, the %CV ranged from 0.4 to 1.8%. For urine samples from 36 to 737 mg/dL, the %CV ranged from 0.6 to 1.3%.

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The Alinity c ICT Sodium assay, Alinity c ICT Potassium assay, and Alinity c ICT Chloride assay demonstrated equivalent assay performance for within-laboratory precision between the investigational method (Alinity ci-series system in a 4-module configuration) and the comparator method (Alinity c system in a single module configuration). For sodium samples from 110 to 193 mmol/L, the %CV ranged from 0.3 to 0.5%. For potassium samples from 1.9 to 9.0 mmol/L, the %CV ranged from 0.5 to 2.7%. For chloride samples from 55 to 140 mmol/L, the %CV ranged from 0.4 to 1.2%.

B. Method Comparison

The method comparison results were determined to be acceptable when comparing the investigational method (Alinity ci-series system in a 4-module configuration) and the comparator method (Alinity i system in a single module configuration) when using the Alinity i Total ß-hCG assay. The slope was 0.98 and the correlation coefficient was 1.00 for samples ranging from 2.74 to 14,998.60 mIU/mL using the Alinity i Total ß- hCG assay.

The method comparison results were determined to be acceptable when comparing the investigational method (Alinity ci-series system in a 4-module configuration) and the comparator method (Alinity c system in a single module configuration) when using the Alinity c Glucose assay serum and urine application. The slope was 1.00 and the correlation coefficient was 1.00 for samples ranging from 14 to 659 mg/dL using the Alinity c Glucose serum assay.The slope was 0.99 and the correlation coefficient was 1.00 for samples ranging from 1 to 705 mg/dL using the Alinity c Glucose urine assay.

The method comparison results were determined to be acceptable when comparing the investigational method (Alinity ci-series system in a 4-module configuration) and the comparator method (Alinity c system in a single module configuration) when using the Alinity c ICT Sodium assay, Alinity c ICT Potassium assay and Alinity c ICT Chloride assay. The slope was 1.00 and the correlation coefficient was 1.00 for samples ranging from 120 to 198 mmol/L using the sodium assay. The slope was 1.00 and the correlation coefficient was 1.00 for samples ranging from 2.3 to 9.6 mmol/L using the

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potassium assay. The slope was 1.00 and the correlation coefficient was 1.00 for samples ranging from 89 to 144 mmol/L using the chloride assay.

IX. Conclusion Drawn from Nonclinical Laboratory Studies and Clinical Performance

The information submitted in this premarket notification is complete and supports a substantial equivalence determination.

Regulation Number and Section

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.