(63 days)
Not Found
No
The summary describes a laboratory automation system and associated analyzers and assays. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on automating sample handling and analysis using established technologies like chemiluminescent immunoassay.
No.
The device is a laboratory automation system designed for processing samples in clinical laboratories, which is an in vitro diagnostic use, not for directly treating patients.
Yes
Explanation: The "Alinity ci-series" and "Alinity i System" are both described as being "intended for in vitro diagnostic use only" or used to "determine the presence of antibodies, and analytes in samples," which are diagnostic purposes. The "Alinity i Total β-hCG Reagent Kit" is also explicitly stated as being used for the "determination of beta-human chorionic gonadotropin (ß-hCG) in human serum and plasma for the early detection of pregnancy," which is a diagnostic function. The GLP systems Track automates the processing of samples for these diagnostic systems.
No
The device description explicitly states it is a "modular laboratory automation system (LAS)" and describes hardware components and processes like centrifugation, aliquoting, decapping, and transport of samples. The performance studies also mention both "software and hardware verification".
Based on the provided text, let's analyze whether the GLP systems Track is an IVD.
Here's the breakdown:
- Intended Use / Indications for Use: The GLP systems Track is described as a "modular laboratory automation system designed to automate pre-analytical and post-analytical processing, including sample handling, in order to automate sample processing in clinical laboratories." It consolidates analytical instruments but doesn't perform the diagnostic test itself.
- Device Description: The description details the automation of sample preparation and distribution processes (bar code identification, centrifugation, aliquoting, transport, delivery to analyzers, capping, storage). It explicitly states it delivers samples to "1 or more Abbott and Third Party commercially available laboratory analyzer(s)".
- Alinity i Total β-hCG Reagent Kit: This is clearly an IVD, as it's a "chemiluminescent microparticle immunoassay (CMIA) used for the quantitative and qualitative determination of beta-human chorionic gonadotropin (ß-hCG) in human serum and plasma for the early detection of pregnancy".
- Alinity i system: This is described as a "fully automated analyzer" that uses CMIA technology to "determine the presence of antibodies, and analytes in samples." This is the instrument that performs the diagnostic test.
- Alinity ci-series: This explicitly states it is "intended for in vitro diagnostic use only." It's a system comprised of the Alinity i and Alinity c analyzers.
- Performance Studies: The performance study focuses on the GLP systems Track's ability to handle samples for the Alinity i Total β-hCG assay and deliver comparable results to a different loading method. It doesn't evaluate the diagnostic performance of the GLP systems Track itself.
- Predicate Device: The predicate device is listed as "K213486; GLP systems Track". This indicates that the GLP systems Track itself has been previously cleared by the FDA.
Conclusion:
The GLP systems Track is a laboratory automation system that supports in vitro diagnostic testing by automating the pre-analytical and post-analytical steps of sample handling and delivery to analyzers. However, it does not perform the diagnostic test itself. The diagnostic tests are performed by the connected analyzers (like the Alinity i system) using IVD reagents (like the Alinity i Total β-hCG Reagent Kit).
Therefore, while the GLP systems Track is a crucial component of an automated IVD workflow, the GLP systems Track itself is not an IVD. It's a laboratory automation system that facilitates IVD testing.
The fact that the predicate device is also listed as "GLP systems Track" further supports this, as it indicates the regulatory classification is for the automation system, not a diagnostic test.
N/A
Intended Use / Indications for Use
GLP systems Track:
The GLP systems Track is a modular laboratory automation system designed to automate pre-analytical and postanalytical processing, including sample handling, in order to automate sample processing in clinical laboratories. The system consolidates multiple analytical instruments into a unified workflow.
Alinity i Total beta-hCG Reagent Kit:
The Alinity i Total beta-hCG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative and qualitative determination of beta-human chorionic gonadotropin (beta-hCG) in human serum and plasma for the early detection of pregnancy on the Alinity i analyzer.
Alinity i system:
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 (CMA) technology is used to determine the presence of antibodies, and analytes in samples.
Alinity ci-series:
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 Almity c processing modules, or a combination of up to four of 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, climical 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 antibodies, and analytes in samples.
Product codes (comma separated list FDA assigned to the subject device)
DHA, JJE, JQP
Device Description
The GLP systems Track is a modular laboratory automation system (LAS) used to perform multiple pre-analytical and post-analytical steps to automate sample preparation and distribution processes in clinical laboratories. These processes include bar code identification of samples, centrifugation, aliquoting of samples, decapping of samples, transport of samples between processes (modules), delivery of samples to 1 or more Abbott and Third Party commercially available laboratory analyzer(s), capping of samples, and storage of samples. Due to the modular nature of the LAS, customers may select modules and configurations to fit their laboratory needs.
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 testing was performed on-site at Abbott to ensure the product met the requirements and aligned with the quality system. This testing included design verification, including both software and hardware verification, as well as design validation. Testing was performed to demonstrate chain of custody of the sample ID. A method comparison study was performed utilizing specimens on the Alinity i Total beta-hCG assay. Specimens that were front-loaded (comparator method, Alinity ci multimodule configuration) versus specimens loaded using the GLP systems Track (investigational method, Alinity ci multimodule configuration) were tested and determined to be acceptable. The slope was 0.99 and the correlation coefficient was 1.00 for samples ranging from 4.78 to 14,965.80 mIU/mL using the Total beta-hCG assay. The Alinity i Total beta-hCG assay is a representative immunoassay available for use with the connected system. However, performance is not limited to use with this assay. Additionally, electromagnetic compatibility (EMC) testing was completed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The slope was 0.99 and the correlation coefficient was 1.00 for samples ranging from 4.78 to 14,965.80 mIU/mL using the Total beta-hCG assay.
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.
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.
June 5, 2023
Abbott Laboratories Melissa Vaughan Director, Regulatory Affairs 1915 Hurd Drive Irving, Texas 75038
Re: K230937
Trade/Device Name: Alinity i Total β-hCG Reagent Kit, GLP systems Track Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: DHA, JJE, JQP Dated: March 31, 2023 Received: April 3, 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.
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
1
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 medical devices and radiation-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 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) K230937
Device Name
GLP systems Track; Alinity i Total b-hCG Reagent Kit
Indications for Use (Describe)
GLP systems Track:
The GLP systems Track is a modular laboratory automation system designed to automate pre-analytical and postanalytical processing, including sample handling, in order to automate sample processing in clinical laboratories. The system consolidates multiple analytical instruments into a unified workflow.
Alinity i Total β-hCG Reagent Kit:
The Alinity i Total {}-hCG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative and qualitative determination of beta-human chorionic gonadotropin (ß-hCG) in human serum and plasma for the early detection of pregnancy on the Alinity i analyzer.
Alinity i system:
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 (CMA) technology is used to determine the presence of antibodies, and analytes in samples.
Alinity ci-series:
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 Almity c processing modules, or a combination of up to four of 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, climical 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 antibodies, and analytes in samples.
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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510(k) Summary
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act of 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:
Sandhya Katta, Regulatory Affairs Manager Core Diagnostics Phone: (972) 518-7801 Cell: (469) 469-1054 Email: sandhya.katta(@abbott.com
Date Summary Prepared: June 05, 2023
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III. Device Name
GLP systems Track
Device Classification: Class I Classification Name: Discrete photometric chemistry analyzer for clinical use. Governing Regulation: 862.2160 Product Code: JJE
Device Classification: Class I Classification Name: Calculator/data processing module for clinical use. Governing Regulation: 862.2100 Product Code: JQP
Alinity i Total β-hCG Reagent Kit
Device Classification: Class II Classification Name: Human chorionic gonadotropin (HCG) test system Governing Regulation: 862.1155 Product Code: DHA
IV. Predicate Device
GLP systems Track (K213486)
V. Device Description
A. GLP systems Track
The GLP systems Track is a modular laboratory automation system (LAS) used to perform multiple pre-analytical and post-analytical steps to automate sample preparation and distribution processes in clinical laboratories. These processes include bar code identification of samples, centrifugation, aliquoting of samples, decapping of samples, transport of samples between processes (modules), delivery of samples to 1 or more Abbott and Third Party commercially available laboratory analyzer(s), capping of samples, and storage of samples. Due to the modular nature of the LAS, customers may select modules and configurations to fit their laboratory needs.
6
The GLP systems Track was previously cleared under K213486 with the purpose of using the laboratory automation system with clinical laboratory analyzers such as Alinity c system.
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VI. Intended Use of the Device
GLP Systems Track
The GLP systems Track is a modular laboratory automation system designed to automate pre-analytical and post-analytical processing, including sample handling, in order to automate sample processing in clinical laboratories. The system consolidates multiple analytical instruments into a unified workflow.
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 (β-hCG) in human serum and plasma for the early detection of pregnancy on the Alinity i analyzer.
Alinity i System
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.
Alinity ci-series
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.
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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.
VII. Comparison of Technological Characteristics
The similarities and differences between the subject device and the predicate device are presented in the following table. There is no difference between the subject and predicate devices' indications for use.
| Characteristics | Subject Device:
GLP systems Track (Product Codes, JJE, JQP) | Predicate Device:
GLP systems Track
(Product Codes JJE, JQP)
(K213486) |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Intended
Use/Indications for
Use | The GLP systems Track is a modular laboratory
automation system designed to automate
pre-analytical and post-analytical processing,
including sample handling, in order to automate
sample processing in clinical laboratories. The system
consolidates multiple analytical instruments into a
unified workflow. | Same |
| Principle of Analyte
Detection | An analyzer's detection method remains the same
when interfaced to the GLP systems Track. | Same |
| Sample Containers | Primary tubes and secondary aliquot tubes. | Same |
| Sample Aspiration | Directly from tube presented to the aspiration point by
the GLP systems Track. | Same |
| Sample Loading | GLP systems Track Input/Output Module (IOM)
accepts samples loaded into sample racks. The
BulkLoader Module accepts samples loaded into the
bin. Samples may also be loaded directly into any
analyzers that support local sample loading. | Same |
| Sample Pre-Analytics | Centrifugation:
GLP systems Track automatically centrifuges sample
tubes. Samples may also be manually centrifuged by
lab personnel prior to loading onto the system.
Decapping:
GLP systems Track automatically decaps sample
tubes. Samples may also be manually decapped by lab
personnel prior to loading onto the system.
Aliquoting: | Same |
Comparison of Subject Device (GLP systems Track) to Predicate Device (GLP systems Track)
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| Characteristics | Subject Device:
GLP systems Track (Product Codes, JJE, JQP) | Predicate Device:
GLP systems Track
(Product Codes JJE, JQP)
(K213486) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| | GLP systems Track automatically aliquots samples
from the primary sample to bar coded secondary
tubes. | |
| | Recapping:
GLP systems Track automatically recaps sample
tubes. Samples may also be manually recapped by lab
personnel prior to loading onto system. | |
| | Storage:
GLP systems Track automatically stores sample tubes
in temperature-controlled storage. Samples may also
be returned to IOM for lab personnel to manually
store samples in lab. | |
| | Sample Transport | |
| Sample Identification | GLP systems Track reads sample bar codes and
electronically communicates sample ID (SID) to some
analyzers. The analyzer reads sample bar codes for
samples loaded directly onto the analyzer or for
samples transferred in a rack to the analyzer from the
Laboratory Automation System (LAS). | Same |
| Test Orders | Unidirectional from Laboratory Information System
(LIS) or middleware to the analyzer. | Same |
| Test Results | Unidirectional to LIS or middleware from the
analyzer. | Same |
| LAS Communication | GLP systems Track communicates to the analyzer per
each analyzer's LAS interface specification. | Same |
VIII. Summary of Nonclinical Performance
Nonclinical testing was performed on-site at Abbott to ensure the product met the requirements and aligned with the quality system. This testing included design verification, including both software and hardware verification, as well as design validation. Testing was performed to demonstrate chain of custody of the sample ID. A method comparison study was performed utilizing specimens on the Alinity i Total ß-hCG assay. Specimens that were front-loaded (comparator method, Alinity ci multimodule configuration) versus specimens loaded using the GLP systems Track (investigational method, Alinity ci multimodule configuration) were tested and determined to be acceptable. The slope was 0.99 and the correlation coefficient was 1.00 for samples ranging from 4.78 to 14,965.80 mIU/mL using the Total ß-hCG assay. The Alinity i Total ß-hCG assay is a representative immunoassay available for use with the connected system. However, performance is not limited to use with this assay. Additionally, electromagnetic compatibility (EMC) testing was completed.
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IX. Summary of Clinical Performance
This section does not apply.
X. Conclusion Drawn from Nonclinical Laboratory Studies
The submitted information in this premarket notification is complete and supports a substantial equivalence determination.