Alinity i Total ß-hCG Reagent Kit, GLP systems Track
Device Facts
| Record ID | K230937 |
|---|---|
| Device Name | Alinity i Total ß-hCG Reagent Kit, GLP systems Track |
| Applicant | Abbott Laboratories |
| Product Code | DHA · Clinical Chemistry |
| Decision Date | Jun 5, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1155 |
| Device Class | Class 2 |
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. 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.
Device Story
GLP systems Track is a modular laboratory automation system (LAS) for clinical laboratories; automates pre-analytical/post-analytical sample processing including barcoding, decapping, centrifugation, aliquoting, transport, recapping, and storage. Integrates with Alinity i and Alinity ci-series analyzers. Input/Output Module (IOM) or BulkLoader accepts samples; system transports samples via CARs identified by NFC tags. Alinity i Total β-hCG assay uses chemiluminescent microparticle immunoassay (CMIA) technology; sample and anti-β-hCG coated paramagnetic microparticles incubated; β-hCG binds to microparticles; acridinium-labeled conjugate added; chemiluminescent reaction measured as relative light units (RLUs). RLU output directly proportional to β-hCG concentration. System provides automated workflow consolidation; reduces manual handling; improves laboratory efficiency. Healthcare providers use quantitative/qualitative results for pregnancy detection.
Clinical Evidence
No clinical data. Bench testing only. Verification and validation included software and hardware testing, chain of custody verification, and electromagnetic compatibility (EMC) testing. A method comparison study compared front-loaded specimens versus specimens processed via the GLP systems Track using the Alinity i Total β-hCG assay; results showed a slope of 0.99 and a correlation coefficient of 1.00 for samples ranging from 4.78 to 14,965.80 mIU/mL.
Technological Characteristics
Modular laboratory automation system; includes input/output modules, bulk loaders, centrifuges, decappers, aliquoters, recappers, and storage modules. Connectivity: interfaces with laboratory analyzers via LAS interface specifications; communicates with LIS/middleware for test orders and results. Operates on automated sample transport and identification via bar code reading. Materials: standard laboratory automation components. Sterilization: not applicable (non-patient contacting).
Indications for Use
Indicated for use in clinical laboratories to automate pre- and post-analytical sample processing (handling, centrifugation, aliquoting, decapping, recapping, transport, storage) and for the quantitative/qualitative determination of β-hCG in human serum and plasma for pregnancy detection.
Regulatory Classification
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. 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.
Predicate Devices
- GLP systems Track (K213486)
Related Devices
- K213486 — GLP systems Track · Abbott Laboratories · Mar 10, 2022
- K093318 — ACCELERATOR APS · Abbott Laboratories · Feb 19, 2010
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY AND INSTRUMENT
## I Background Information:
A 510(k) Number
K230937
B Applicant
Abbott Laboratories
C Proprietary and Established Names
GLP systems Track, Alinity i Total β-hCG Reagent Kit
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DHA | Class II | 21 CFR 862.1155 - Human chorionic gonadotropin (HCG) test system | CH - Clinical Chemistry |
| JJE | Class I | 21 CFR 862.2160 - Discrete Photometric Chemistry Analyzer For Clinical Use | CH - Clinical Chemistry |
| JQP | Class I | 21 CFR 862.2100 - Calculator/data processing module for clinical use | CH - Clinical Chemistry |
## II Submission/Device Overview:
### A Purpose for Submission:
The submission is to obtain clearance for the GLP systems Track, a laboratory automation system (LAS) used with clinical chemistry and immunoassay systems such as the Alinity i system and the Alinity ci series.
The manufacturer uses the performance of Total β-hCG assay to compare results obtained from specimens when the same analyzer pipette aspirated either from the instrument front (manual-loaded) or from the instrument back (GLP systems Track loaded).
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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B Measurand:
Total beta human chorionic gonadotropin (β-hCG)
C Type of Test:
Quantitative and qualitative, chemiluminescent microparticle immunoassay
III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) 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.
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.
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.
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C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
D Special Instrument Requirements:
Alinity i system and Alinity ci series
IV Device/System Characteristics:
A 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, decapping of samples, centrifugation, aliquoting of samples, transport of samples between processes (modules), and delivery of samples to one or more Abbott and third Party commercially available laboratory analyzers, capping of samples, and storage of samples. Each module includes a built-in touchscreen, a user interface that functions as a central operating and display element. Due to the modular nature of the LAS, customers may select modules and configurations to fit their laboratory needs.
Alinity i Total β-hCG Reagent Kit
The Alinity i Total β-hCG Reagent Kit consists of magnetic microbeads coated with anti-β-hCG monoclonal antibody in TRIS buffer with protein (bovine) stabilizers and anti-hCG monoclonal antibody labeled with acridinium in MES buffer with protein (bovine) stabilizers. The Reagent Kit is composed of two cartridges, and each cartridge contains two vials (microparticle antibody and conjugate antibody) and a spacer (empty cartridge).
B Principle of Operation:
The Alinity i Total β-hCG assay is a two-step immunoassay for the quantitative and qualitative determination of β-hCG in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology. Sample and anti-β-hCG coated paramagnetic microparticles are combined and incubated. The β-hCG present in the sample binds to the anti-β-hCG coated microparticles. The mixture is washed. Anti-β-hCG acridinium-labeled conjugate is added to create a reaction mixture and incubated. Following a wash cycle, Pre-Trigger and Trigger Solutions are added. The resulting chemiluminescent reaction is measured as relative light units (RLUs). There is a direct relationship between the amount of β-hCG in the sample and the RLUs detected by the system optics.
C Instrument Description Information:
1. Instrument Name:
GLP systems Track
2. Specimen Identification:
Barcode identification of patient samples. GLP systems Track reads sample bar codes and electronically communicates sample identification number to the analyzers.
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3. Specimen Sampling and Handling:
The patient’s sample tubes are loaded onto the GLP systems Track Input/Output Module (IOM) or BulkLoader Module to be centrifuged, de-capped, aliquoted, recapped and stored. The sample bar codes are read to direct the sample to a specific analyzer.
4. Calibration:
Provided in k170317 (Alinity i Total $\beta$-hCG Reagent Kit, Alinity i System)
5. Quality Control:
Provided in k170317 (Alinity i Total $\beta$-hCG Reagent Kit, Alinity i System)
This medical device product has functions subject to FDA premarket review as well as functions that are not subject to FDA premarket review. For this application, if the product has functions that are not subject to FDA premarket review, FDA assessed those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review or they are included as a labeled positive impact that was considered in the assessment of the functions subject to FDA premarket review.
V Substantial Equivalence Information:
A Predicate Device Name(s):
B Alinity i Total $\beta$-hCG Reagent Kit, GLP systems Track
C Predicate 510(k) Number(s):
K170317, K213486
D Comparison with Predicate(s):
Assay Predicate
| Device & Predicate Device(s): | K230937 | K170317 |
| --- | --- | --- |
| Device Trade Name | Alinity i Total β-hCG Reagent Kit | Alinity i Total β-hCG Reagent Kit |
| General Device Characteristic Similarities | | |
| 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 ($\beta$-hCG) in human serum and plasma for the early detection of pregnancy on the Alinity i analyzer. | Same |
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K230937 - Page 5 of 9
| General Device Characteristic Differences | | |
| --- | --- | --- |
| Sample Process | Using GLP systems Track | Directly loaded |
# Instrument Predicate
| Device & Predicate Device(s): | K230937 | K213486 |
| --- | --- | --- |
| Device Trade Name | GLP systems Track | GLP systems Track |
| General Device Characteristic Similarities | | |
| 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. | Same |
| | Decapping: GLP systems Track automatically decaps sample tubes. Samples may also be manually decapped by lab personnel prior to loading onto the system. | |
| | Aliquoting: GLP systems Track automatically aliquots samples from the primary sample to bar coded secondary tubes. | |
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| Device & Predicate Device(s): | K230937 | K213486 |
| --- | --- | --- |
| Device Trade Name | GLP systems Track | GLP systems Track |
| General Device Characteristic Similarities | | |
| | 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 | GLP systems Track transports samples via CARs identified on the system by near-field communication (NFC) tags. Samples may also be manually transported by lab personnel to analyzers. | Same |
| 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 |
| General Device Characteristic Differences | | |
| Analyzer | Alinity i System; Alinity ci-series | Alinity c System |
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VI Standards/Guidance Documents Referenced:
CLSI EP09c 3rd Edition-Measurement Procedure Comparison and Bias Estimation Using Patient Samples
EN 61326-1: 2021 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 1: General requirements
EN 61326-2-6: 2021 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
Provided in k170317 (Alinity i Total β-hCG Reagent Kit, Alinity i System)
2. Linearity:
Provided in k170317 (Alinity i Total β-hCG Reagent Kit, Alinity i System)
3. Analytical Specificity/Interference:
Provided in k170317 (Alinity i Total β-hCG Reagent Kit, Alinity i System)
4. Assay Reportable Range:
Provided in k170317 (Alinity i Total β-hCG Reagent Kit, Alinity i System)
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Provided in k170317 (Alinity i Total β-hCG Reagent Kit, Alinity i System)
6. Detection Limit:
Provided in k170317 (Alinity i Total β-hCG Reagent Kit, Alinity i System)
7. Assay Cut-Off:
Provided in k170317 (Alinity i Total β-hCG Reagent Kit, Alinity i System)
8. Accuracy (Instrument):
Not applicable
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9. Carry-Over:
Provided in k170317 (Alinity i Total $\beta$-hCG Reagent Kit, Alinity i System)
B Comparison Studies:
1. Method Comparison with Predicate Device:
A method comparison study was performed based on recommendations in CLSI EP09c. The method comparison study was performed to demonstrate equivalence between results from specimens that were loaded using the GLP systems Track (investigational method) and on the same Alinity ci-series where specimens were loaded in the front (comparator method). A total of 117 native human serum samples spanning the measuring range of the Alinity i Total $\beta$-hCG (beta human chorionic gonadotropin) assay were tested. For both methods (i.e., investigational and comparator), samples were tested in singlicate using one lot of reagents, calibrators, and controls on one Alinity ci-series instrument over the course of three non-consecutive days. Only samples with results that were within the measuring interval of the Alinity i Total $\beta$-hCG assay were included in the analysis. A Deming regression analysis was performed using all samples by comparing the result from the investigational method versus the result from the comparator method. The regression analysis result is summarized in the table below:
| N | Range Tested Candidate (mIU/mL) | Range Tested Comparator (mIU/mL) | Slope | Slope 95% CI | Intercept | Intercept 95% CI | Correlation Coefficient R |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 117 | [4.43, 14965.80] | [4.78, 14828.09] | 0.99 | [0.99, 1.00] | -0.16 | [-1.24, 0.92] | 1.00 |
2. Matrix Comparison:
Provided in k170317 (Alinity i Total $\beta$-hCG Reagent Kit, Alinity i System)
C Clinical Studies:
1. Clinical Sensitivity:
Not applicable.
2. Clinical Specificity:
Not applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable.
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D Clinical Cut-Off:
Not applicable.
E Expected Values/Reference Range:
Provided in k170317 (Alinity i Total $\beta$-hCG Reagent Kit, Alinity i System)
F Other Supportive Instrument Performance Characteristics Data:
Provided in k170317 (Alinity i Total $\beta$-hCG Reagent Kit, Alinity i System)
VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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