(132 days)
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.
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 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 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 a 510(k) premarket notification for the "GLP systems Track" device. However, it does not contain the detailed acceptance criteria for performance, the study that proves the device meets those criteria, or information on sample sizes for test/training sets, expert qualifications, or adjudication methods.
The document states that "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 for Chain of Custody of the sample ID, and a Method Comparison study comparing the use of the GLP systems Track to a manual method was also performed. Additionally, Electromagnetic Compatibility and Electrical Safety testing was completed."
This broadly indicates that testing was conducted, but the specific details requested in your prompt (Acceptance Criteria, reported performance, sample sizes, expert involvement, etc.) are absent from this regulatory summary.
Therefore, I cannot populate the table or answer most of your questions based on the information provided.
Here's what I can extract based on the limited information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. | Not specified in this document beyond general statements of meeting requirements. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified.
- Data provenance: "Nonclinical testing was performed on-site at Abbott." The country of origin and retrospective/prospective nature are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The testing mentions "Chain of Custody of the sample ID" and a "Method Comparison study comparing the use of the GLP systems Track to a manual method," but details on ground truth establishment and expert involvement are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not specified. This device is a modular laboratory automation system, not typically a device that involves human readers interpreting results in the same way as, for example, a medical imaging AI. The "human-in-the-loop" aspect does not directly apply here in the context of interpretation improvement assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document presents the "GLP systems Track" as a modular laboratory automation system. Its performance evaluation would likely focus on its ability to automate pre-analytical and post-analytical processing steps accurately and efficiently, rather than "algorithm-only" performance in the sense of a diagnostic AI. A "Method Comparison study comparing the use of the GLP systems Track to a manual method" was performed, which implies a comparison of the automated system's output to a reference method, but details are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "Method Comparison study comparing the use of the GLP systems Track to a manual method," the "manual method" likely serves as the reference or ground truth. No further details are provided on its establishment.
8. The sample size for the training set
- Not specified. (This device is a hardware/software system for lab automation, not an AI model in the common sense that requires a "training set" for machine learning, although its software components would certainly undergo extensive testing and validation.)
9. How the ground truth for the training set was established
- Not applicable/Not specified, as there is no mention of a "training set" in the context of machine learning model development.
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March 10, 2022
Abbott Laboratories Michele Smith-Waheed Associate Director, Regulatory Affairs 100 Abbott Park Rd. Abbott Park, Illinois 60064
Re: K213486
Trade/Device Name: GLP systems Track Regulation Number: 21 CFR 862.2160 Regulation Name: Sodium Test System Regulatory Class: Class II Product Code: JGS, CEM, CGZ, JJE, JQP Dated: October 25, 2021 Received: October 29, 2021
Dear Michele Smith-Waheed:
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.
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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 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, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K213486
Device Name GLP systems Track
Indications for Use (Describe)
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.
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 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.
| 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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Section 5: 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. Applicant Name
Abbott Laboratories 100 Abbott Park Rd. Abbott Park, IL 60064
Primary contact person for all communications:
Michele Smith-Waheed, Associate Director, Regulatory Affairs Core Diagnostics Phone: (972) 518-7645
Secondary contact person for all communications:
Amna Shamim, Senior Regulatory Affairs Specialist Core Diagnostics Phone: (972) 518-6924
Date Summary Prepared: March 08, 2022
This 510(k) (K213486) is being submitted by Abbott Laboratories for the GLP systems Track developed by Abbott Automation Solutions GmbH (AAS).
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II. Device Name
Trade Name: GLP systems Track
Common Name: Laboratory Automation System
| Classification Name | ProductCode | Class | Regulatory Section | Panel |
|---|---|---|---|---|
| Discrete photometricchemistry analyzer forclinical use. | JJE | I | 21 CFR Sec. -862.2160 | Chemistry (75) |
| Calculator/data processingmodule for clinical use. | JQP | I | 21 CFR Sec. -862.2100 | Chemistry (75) |
| Electrode, ion specific,sodium | JGS | II | 21 CFR Sec. -862.1665 | Chemistry (75) |
| Electrode, ion specific,potassium | CEM | II | 21 CFR Sec. -862.1600 | Chemistry (75) |
| Electrode, ion-specific,chloride | CGZ | II | 21 CFR Sec. -862.1170 | Chemistry (75) |
III. Predicate Device
ACCELERATOR APS (K093318)
IV. 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.
V. Intended Use of the Device
1. 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,
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in order to automate sample processing in clinical laboratories. The system consolidates multiple analytical instruments into a unified workflow.
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 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.
2. Special Condition(s) for Use Statement(s)
Prescription use only.
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VI. Comparison of Technological Characteristics
The similarities and differences between the subject device and the predicate device are presented in the following table.
| Characteristics | Subject Device:GLP systems Track(Product Codes JJE, JQP) | Predicate Device:ACCELERATOR APS (K093318)(Product Codes JJE, JQP) | Comparison |
|---|---|---|---|
| IntendedUse/Indications forUse | The GLP systems Track is amodular laboratory automationsystem designed to automatepre-analytical and post-analyticalprocessing, including samplehandling, in order to automatesample processing in clinicallaboratories. The systemconsolidates multiple analyticalinstruments into a unifiedworkflow. | The ACCELERATOR APS is amodular system designed toautomate sample handling andprocessing in the clinicallaboratory. The system allowsconsolidation of multiple clinicalchemistry and immunoassayanalytical instruments into aunified workstation. | Similar(ACCELERATORAPS performsboth pre-analyticaland post-analyticalprocessing.) |
| Principle of AnalyteDetection | An analyzer's detection methodremains the same when interfacedto the GLP systems Track.For example:ARCHITECT/Alinity c systemsutilize photometric andpotentiometric technology foranalyte detection.ARCHITECT/Alinity i systemsutilize chemiluminescent labelswith magnetic microparticle solidphase for analyte detection. | An analyzer's detection methodremains the same when interfacedto the ACCELERATOR APS.For example:ARCHITECT/Alinity c systemsutilize photometric andpotentiometric technology foranalyte detection.ARCHITECT/Alinity i systemsutilize chemiluminescent labelswith magnetic microparticle solidphase for analyte detection. | Same |
| Sample Containers | Primary tubes and secondaryaliquot tubes. | Primary tubes and secondaryaliquot tubes. * | Same |
| Sample Aspiration | Directly from tube presented to theaspiration point by the GLPsystems Track. | Directly from tube presented tothe aspiration point by theACCELERATOR APS. | Same |
| Sample Loading | GLP systems Track Input/OutputModule (IOM) accepts samplesloaded into sample racks. TheBulkLoader Module acceptssamples loaded into the bin.Samples may also be loadeddirectly into any analyzers thatsupport local sample loading. | ACCELERATOR APS IOMaccepts samples loaded intosample racks. Samples may alsobe loaded directly into anyanalyzers that support localsample loading. | Similar(Functionality isthe same, howeverACCELERATORAPS does not havea BulkLoaderModule). |
| Comparison of Subject Device (GLP systems Track) to Predicate Device (ACCELERATOR APS) | |||
|---|---|---|---|
| Characteristics | Subject Device:GLP systems Track(Product Codes JJE, JQP) | Predicate Device:ACCELERATOR APS (K093318)(Product Codes JJE, JQP) | Comparison |
| Sample Pre-Analytics | Centrifugation:GLP systems Track automaticallycentrifuges sample tubes. Samplesmay also be manually centrifugedby lab personnel prior to loadinginto the system. | Centrifugation:ACCELERATOR APSautomatically centrifuges sampletubes. Samples may also bemanually centrifuged by labpersonnel prior to loading intosystem. | Same |
| Decapping:GLP systems Track automaticallydecaps sample tubes. Samples mayalso be manually decapped by labpersonnel prior to loading into thesystem. | Decapping:ACCELERATOR APSautomatically decaps sampletubes. Samples may also bemanually decapped by labpersonnel prior to loading intothe system. | ||
| Aliquoting:GLP systems Track automaticallyaliquots samples from the primarysample to bar coded secondarytubes. | Aliquoting:ACCELERATOR APSautomatically aliquots samplesfrom the primary sample to barcoded secondary tubes.* | ||
| Recapping/Resealing:GLP systems Track automaticallyrecaps sample tubes. Samples mayalso be manually recapped/resealed by lab personnel prior toloading into system.Storage: | Recapping/Resealing:ACCELERATOR APSautomatically reseals sampletubes. Samples may also bemanually recapped/resealed bylab personnel prior to loadinginto the system.Storage: | ||
| GLP systems Track automaticallystores sample tubes intemperature-controlled storage.Samples may also be returned toIOM for lab personnel to manuallystore samples in lab. | ACCELERATOR APSautomatically stores sample tubesin refrigerator storage. Samplesmay also be returned to IOM forlab personnel to manually storesamples in lab. | ||
| Sample Transport | GLP systems Track transportssample CARs identified on thesystem by Near-FieldCommunication (NFC) tags.Samples may also be manuallytransported by lab personnel toanalyzers. | ACCELERATOR APS transportssample carriers identified on thesystem by Radio Frequencyidentification (RFID) tags.Samples may also be manuallytransported by lab personnel toanalyzers. | Similar(NFC tags andRFID tags bothidentify samplecarriers on thesystem using awireless method.) |
| Sample Identification | GLP systems Track reads samplebar codes and electronicallycommunicates sample ID toanalyzers. The analyzer readssample bar codes for samplesloaded directly onto the analyzeror for samples transferred in a rackto the analyzer from the LAS. | ACCELERATOR APS readssample bar codes andelectronically communicates thesample ID to analyzers. Theanalyzer reads sample bar codesfor samples loaded directly ontothe analyzer or for samplestransferred in a rack to theanalyzer from the LAS. | Same |
| Test Orders | Unidirectional from LaboratoryInformation System or middlewareto the analyzer. | Unidirectional from LaboratoryInformation System ormiddleware to the analyzer. | Same |
| Characteristics | Subject Device:GLP svstems Track(Product Codes JJE, JQP) | Predicate Device:ACCELERATOR APS (K093318)(Product Codes JJE, JQP) | Comparison |
| Test Results | Unidirectional from LaboratoryInformation System or middlewarefrom the analyzer. | Unidirectional from LaboratoryInformation System ormiddleware from the analyzer. | Same |
| LAS Communication | GLP systems Track communicatesto the analyzer per each analyzer'sLAS interface specification. | ACCELERATOR APScommunicates to the analyzer pereach analyzer's LAS interfacespecification. | Same |
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*functionality added post-clearance
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VII. 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 for Chain of Custody of the sample ID, and a Method Comparison study comparing the use of the GLP systems Track to a manual method was also performed. Additionally, Electromagnetic Compatibility and Electrical Safety testing was completed.
VIII. Summary of Clinical Performance
This section does not apply.
IX. Conclusion Drawn from Nonclinical Laboratory Studies
The results presented in this 510(k) premarket notification for the subject device, GLP systems Track (List No. 04Z96-51), demonstrates substantial equivalence to the predicate device, ACCELERATOR APS (List No. 07L40, K093318).
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device 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.(b)
Classification. Class II.