(58 days)
Not Found
No
The summary describes a standard automated clinical chemistry and immunoassay analyzer system. There is no mention of AI, ML, or any features that would typically involve such technologies for data analysis, interpretation, or system control beyond basic automation. The performance studies focus on standard analytical validation metrics like precision and method comparison.
No
The device is described as an "in vitro diagnostic device" intended for the "in vitro determination of analytes in body fluids" and not for direct therapeutic use.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Alinity ci-series is intended for in vitro diagnostic use only." It further describes its use for the "in vitro determination of analytes in body fluids" and specifies how measurements (e.g., sodium, potassium, glucose) obtained from the device are "used in the diagnosis and treatment of" various medical conditions and disorders.
No
The device description clearly states that the Alinity ci-series is comprised of physical analyzers/processing modules (hardware) in various configurations. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The Alinity ci-series is intended for in vitro diagnostic use only."
- It describes the system as a "clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids."
- It describes the Alinity i System as an analyzer for determining the "presence of antigens, antibodies, and analytes in samples."
- It details the specific analytes measured (sodium, potassium, chloride, glucose, beta-human chorionic gonadotropin) and their use in the diagnosis and treatment of various medical conditions.
These statements clearly indicate that the device is designed to be used outside of the body to examine samples (body fluids) for diagnostic purposes.
N/A
Intended Use / Indications for Use
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.
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.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
DHA, CFR, JGS, CEM, CGZ, JJE
Device Description
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.
SCM (System Control Module): Contains a user interface computer for software interface to the Alinity ci-series and an interface to a host or middleware computer. The power supply operates the user interface computer and the RSM.
RSM (Reagent and Sample Manager): A transport system to load calibrators, controls, specimens, reagents, and onboard solutions. It provides random and continuous access to load and unload sample racks, calibration and control racks, and reagent cartridges. It functions to lift racks and cartridges, move them past the barcode reader, position them for barcode identification, and move them to appropriate processing modules or return them to the loading area.
Alinity i Processing Module: Uses chemiluminescent microparticle immunoassay (CMIA) detection technology to measure analyte concentration. It is an immunoassay analyzer that processes a maximum of 200 CMIA tests per hour and has 47 positions in the reagent carousel for assay reagent cartridges and calibrator/control racks at controlled temperature. Assay processing occurs within a single module, with no difference in execution whether run on a single or multimodule configuration.
Alinity c Processing Module: Uses photometric detection technology for sample absorbance and potentiometric detection technology for electrical potential in samples. An integrated chip technology (ICT) module is used for potentiometric assays (electrolytes) and contains Na+, K+, Cl-, and reference electrodes. It is a chemistry analyzer capable of processing a maximum of 1350 photometric and potentiometric tests per hour and has a reagent carousel with 70 positions. Assay processing occurs within a single module, with no difference in execution whether run on a single or multimodule configuration.
Multimodule Integration Kit: Provides components to physically connect different processing modules, extending the RSM to create a shared load platform for multimodule configurations.
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
Not Found
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)
Nonclinical Performance:
Included 5-day precision and method comparison studies.
EMC and electrical safety testing was completed according to IEC 61326 2 6:2020.
A. Within-Laboratory Precision (5-Day):
- Alinity i Total ß-hCG assay: Equivalent assay performance between investigational method (Alinity ci-series system in a 4-module configuration) and comparator method (Alinity i system in a single module configuration). %CV ranged from 1.2 to 5.0% for samples from 5.25 to 12,850 mIU/mL.
- Alinity c Glucose assay: Equivalent assay performance between investigational method (Alinity ci-series system in a 4-module configuration) and comparator method (Alinity c system in a single module configuration) for serum and urine.
- Serum: %CV ranged from 0.4 to 1.8% for samples from 7 to 688 mg/dL.
- Urine: %CV ranged from 0.6 to 1.3% for samples from 36 to 737 mg/dL.
- Alinity c ICT Sodium assay, Alinity c ICT Potassium assay, and Alinity c ICT Chloride assay: Equivalent assay performance between investigational method (Alinity ci-series system in a 4-module configuration) and comparator method (Alinity c system in a single module configuration).
- Sodium: %CV ranged from 0.3 to 0.5% for samples from 110 to 193 mmol/L.
- Potassium: %CV ranged from 0.5 to 2.7% for samples from 1.9 to 9.0 mmol/L.
- Chloride: %CV ranged from 0.4 to 1.2% for samples from 55 to 140 mmol/L.
B. Method Comparison:
- Alinity i Total ß-hCG assay: Acceptable results when comparing investigational method (Alinity ci-series system in a 4-module configuration) and comparator method (Alinity i system in a single module configuration). Slope was 0.98 and correlation coefficient was 1.00 for samples ranging from 2.74 to 14,998.60 mIU/mL.
- Alinity c Glucose assay: Acceptable results when comparing investigational method (Alinity ci-series system in a 4-module configuration) and comparator method (Alinity c system in a single module configuration) for serum and urine.
- Serum: Slope was 1.00 and correlation coefficient was 1.00 for samples ranging from 14 to 659 mg/dL.
- Urine: Slope was 0.99 and correlation coefficient was 1.00 for samples ranging from 1 to 705 mg/dL.
- Alinity c ICT Sodium assay, Alinity c ICT Potassium assay and Alinity c ICT Chloride assay: Acceptable results when comparing investigational method (Alinity ci-series system in a 4-module configuration) and comparator method (Alinity c system in a single module configuration).
- Sodium: Slope was 1.00 and correlation coefficient was 1.00 for samples ranging from 120 to 198 mmol/L.
- Potassium: Slope was 1.00 and correlation coefficient was 1.00 for samples ranging from 2.3 to 9.6 mmol/L.
- Chloride: Slope was 1.00 and correlation coefficient was 1.00 for samples ranging from 89 to 144 mmol/L.
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.
Alinity i System (K170317), Alinity i Total β-hCG (K170317), Alinity c System (K170316), Alinity c Glucose (K170316), Alinity c ICT Sample Diluent (K170320)
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
§ 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.
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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.
1
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
2
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 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.
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
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
5
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
7
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
8
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.
9
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.
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 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.
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 (Multimodule | ||||
| System) | Predicate Device: | |||
| Alinity i System | ||||
| (K170317) | Predicate Device: | |||
| Alinity c System | ||||
| (K170316) | Comparison | |||
| General Device Characteristics Similarities | ||||
| Methodology | - Alinity i processing module: | |||
| chemiluminescent microparticle | ||||
| immunoassay | ||||
| (CMIA) |
- Alinity c processing module:
Spectrophotometry
(monochromatic and
bichromatic modes of
measurement) | CMIA | Spectrophotometry
(monochromatic
and bichromatic
modes of
measurement) | Same |
| Intended Use
and Indications
for Use | 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. | 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
System is a fully
automated,
random/continuous
access, clinical
chemistry analyzer
intended for the in
vitro determination
of analytes in body
fluids. | Same |
| Comparison of Subject & Predicate Device | | | | |
| | Subject Device:
Alinity ci-series (Multimodule
System) | Predicate Device:
Alinity i System
(K170317) | Predicate Device:
Alinity c System
(K170316) | Comparison |
| | General Device Characteristics Similarities | | | |
| | 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. | | | |
| Principle of
Analyte
Detection | - Alinity i processing module:
utilize chemiluminescent labels
with magnetic microparticle
solid phase for analyte
detection. - Alinity c processing module:
utilize photometric and
potentiometric technology for
analyte detection. | Alinity i systems
utilize
chemiluminescent
labels with
magnetic
microparticle
solid phase for
analyte detection. | Alinity c systems
utilize photometric
and potentiometric
technology for
analyte detection. | Same |
| Sample
Aspiration | Directly from sample tubes,
control bottles within each
independent Alinity i and/or
Alinity c processing modules | Directly from
sample tubes,
control bottles | Directly from
sample tubes,
control bottles | Same |
| Physical
Laboratory
Automation
System (LAS) | Pipettor probe samples from the
back of the individual
processing module | Pipettor probe
samples from the
back of the
individual
processing
module | Pipettor probe
samples from the
back of the
individual
processing module | Same |
| Sample
Transport | - Shared robotic sample handler
customized to system
configuration. Shared transport
system provides random and
continuous access to samples
for each Alinity i or Alinity c
processing module from a
shared load platform. - Moves samples requiring
multiple tests to multiple
independent processing
modules as ordered. - Autoretest capability
- Priority and batch sample
loading | - Robotic sample
handler. Transport
system that has
random and
continuous access
to samples. - Autoretest
capability - Priority and
batch sample
loading | - Robotic sample
handler. Transport
system that has
random and
continuous access
to samples. - Autoretest
capability - Priority and batch
sample loading | Same |
| Comparison of Subject & Predicate Device | | | | |
| | Subject Device:
Alinity ci-series (Multimodule
System) | Predicate Device:
Alinity i System
(K170317) | Predicate Device:
Alinity c System
(K170316) | Comparison |
| General Device Characteristics Similarities | | | | |
| Sample
Identification | 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. | 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. | 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. | Same |
11
12
13
| 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 Microparticle | |
| Immunoassay (CMIA) | Same | |
| Calibration Curve Type | 6-point | |
| 4 Parameter Logistic Curve fit data | ||
| reduction method | ||
| (4PLC, Y-weighted) | Same | |
| Intended Use/Indications for | ||
| Use | 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 (β-hCG) in human serum | ||
| and plasma for the early detection of | ||
| pregnancy 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 in | ||
| TRIS 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 with | ||
| protein (bovine) stabilizers. Minimum | ||
| concentration: 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 adenosine | ||||
| diphosphate (ADP). Glucose-6-phosphate | ||||
| dehydrogenase (G-6-PDH) specifically | ||||
| oxidizes G-6-P to 6-phosphogluconate with the | ||||
| concurrent reduction of nicotinamide adenine | ||||
| dinucleotide (NAD) to nicotinamide adenine | ||||
| dinucleotide reduced (NADH). One micromole | ||||
| of NADH is produced for each micromole of | ||||
| glucose consumed. The NADH produced | ||||
| absorbs light at 340 nm and can be detected | ||||
| spectrophotometrically as an increased | ||||
| absorbance | Same | |||
| Methodology | Spectrophotometry (monochromatic and | |||
| bichromatic modes of measurement) | Same | |||
| Calibration Curve Type | Linear (End up) | Same | ||
| Intended Use | 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. | Same | |||
| Indications for Use | A glucose test system is a device intended to | |||
| measure glucose quantitatively in blood and | ||||
| other body fluids. 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. | Same | |||
| Specimen Type | Human serum, plasma, urine, or CSF | Same | ||
| Specific Analyte Detected | Glucose | Same | ||
| Formulation | R1: Active ingredients: ATP •2Na (9.0 | |||
| mg/mL), NAD (5.0 mg/mL), G-6-PDH (3000 | ||||
| U/L), Hexokinase (15 000 U/L), Preservative: | ||||
| sodium azide (0.05%). | Same |
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| | Subject Device:
Alinity ci-series (Multimodule
System)
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 Curve
Type | Linear (End up) | 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 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. | Same |
| Specimen Type | Human serum, plasma or urine | Same |
| Specific Analyte
Detected | 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.