(63 days)
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 (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 (CMIA) 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.
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.
The provided text describes the 510(k) premarket notification for the GLP systems Track and the Alinity i Total β-hCG Reagent Kit. The focus of the acceptance criteria and study detailed in the document is on the GLP systems Track laboratory automation system, and its ability to maintain the performance of connected analyzers, specifically exemplified with the Alinity i Total β-hCG assay. The document does not provide specific acceptance criteria or performance data for the Alinity i Total β-hCG Reagent Kit as a standalone diagnostic assay; instead, it focuses on the GLP systems Track's compatibility and non-inferiority when integrated with such assays.
Here's a breakdown of the information based on your request:
Acceptance Criteria and Reported Device Performance
The document describes a method comparison study to demonstrate that the GLP systems Track does not negatively impact the performance of connected assays. The acceptance criteria are implicitly defined by the results of this method comparison.
Table of Acceptance Criteria and Reported Device Performance (Implicit for the GLP systems Track):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Goal: Maintain assay performance when samples are processed via the GLP systems Track compared to direct loading. | Method Comparison: |
* **Slope:** 0.99
* **Correlation Coefficient:** 1.00 |
| Ensure acceptable performance for a representative immunoassay. | Demonstrated with the Alinity i Total β-hCG assay. |
Study Details
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of samples. The range of mIU/mL for the tested samples is given as 4.78 to 14,965.80 mIU/mL, indicating a broad range of concentrations were tested.
- Data Provenance: The study was described as "Nonclinical testing was performed on-site at Abbott." This indicates an internal, prospective study. Country of origin is implicitly the US, where Abbott Laboratories is located.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This was a method comparison study for a laboratory automation system, not a diagnostic study requiring human expert interpretation of results to establish ground truth. The "ground truth" was established by comparing direct loading (comparator method) to processing via the GLP systems Track (investigational method) using established laboratory procedures.
-
Adjudication Method for the Test Set:
- Not applicable. As this was a method comparison of automated systems, there was no human adjudication process involved. The comparison was based on quantitative measurements.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is typically for image-based diagnostic aids where human readers interpret cases. This study focused on the performance of a laboratory automation system.
-
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The study assessed the performance of the GLP systems Track (an automated system) without human intervention in the analytical process, demonstrating its ability to deliver results comparable to direct sample loading. The Alinity i Total β-hCG assay itself is a standalone quantitative assay.
-
The Type of Ground Truth Used:
- Reference Method Comparison/Comparator Method. The "ground truth" was established by testing specimens on the Alinity i Total β-hCG assay when front-loaded (the comparator method/reference) and comparing those results to specimens loaded using the GLP systems Track (investigational method). This essentially assumes that the front-loaded method provides the accurate measurement.
-
The Sample Size for the Training Set:
- Not applicable. The GLP systems Track is a mechanical/software automation system designed for sample processing, not an algorithm that undergoes "training" with data in the typical machine learning sense to learn patterns or make predictions. Its "training" would be through engineering design, development, and testing processes. The document does not mention any machine learning or AI components that would require a training set.
-
How the Ground Truth for the Training Set was Established:
- Not applicable. (See point 7).
In summary, the provided document focuses on demonstrating the substantial equivalence of the GLP systems Track to its predicate and its ability to integrate with and maintain the performance of an existing cleared assay (Alinity i Total β-hCG) through a nonclinical method comparison study.
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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
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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
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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.
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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) |
|---|---|---|
| IntendedUse/Indications forUse | The GLP systems Track is a modular laboratoryautomation system designed to automatepre-analytical and post-analytical processing,including sample handling, in order to automatesample processing in clinical laboratories. The systemconsolidates multiple analytical instruments into aunified workflow. | Same |
| Principle of AnalyteDetection | An analyzer's detection method remains the samewhen 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 bythe GLP systems Track. | Same |
| Sample Loading | GLP systems Track Input/Output Module (IOM)accepts samples loaded into sample racks. TheBulkLoader Module accepts samples loaded into thebin. Samples may also be loaded directly into anyanalyzers that support local sample loading. | Same |
| Sample Pre-Analytics | Centrifugation:GLP systems Track automatically centrifuges sampletubes. Samples may also be manually centrifuged bylab personnel prior to loading onto the system.Decapping:GLP systems Track automatically decaps sampletubes. Samples may also be manually decapped by labpersonnel 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 samplesfrom the primary sample to bar coded secondarytubes. | ||
| Recapping:GLP systems Track automatically recaps sampletubes. Samples may also be manually recapped by labpersonnel prior to loading onto system. | ||
| Storage:GLP systems Track automatically stores sample tubesin temperature-controlled storage. Samples may alsobe returned to IOM for lab personnel to manuallystore samples in lab. | ||
| Sample Transport | ||
| Sample Identification | GLP systems Track reads sample bar codes andelectronically communicates sample ID (SID) to someanalyzers. The analyzer reads sample bar codes forsamples loaded directly onto the analyzer or forsamples transferred in a rack to the analyzer from theLaboratory 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 theanalyzer. | Same |
| LAS Communication | GLP systems Track communicates to the analyzer pereach 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.
§ 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.