(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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 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.