(132 days)
Not Found
No
The summary describes a laboratory automation system and a clinical chemistry analyzer, focusing on sample handling, processing, and analysis of specific analytes. There is no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The performance studies described are standard verification and validation tests for laboratory equipment.
No
The device is a laboratory automation system and a clinical chemistry analyzer used for in vitro determination of analytes, not for direct therapeutic intervention on a patient.
Yes
The Alinity c System, a component of the GLP systems Track, is a clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids. It is explicitly stated that sodium, potassium, and chloride measurements performed by this system are used in the diagnosis and treatment of various medical conditions, directly indicating a diagnostic purpose.
No
The device description and performance studies clearly indicate the device is a modular laboratory automation system involving hardware components for sample handling, centrifugation, aliquoting, transport, etc., in addition to software.
Based on the provided text, here's an analysis of whether the described devices are IVDs:
-
The Alinity c System: Yes, this is an IVD. The text explicitly states it is "intended for the in vitro determination of analytes in body fluids." It also lists specific analytes (sodium, potassium, chloride) and their clinical significance in diagnosing and treating various conditions. This clearly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
-
The Alinity c ICT (Integrated Chip Technology): Yes, this is an IVD. It is described as being "used for the quantitation of sodium, and chloride in human serum, plasma, or urine on the Alinity c analyzer." Since it's a component used for the in vitro measurement of analytes in human specimens for diagnostic purposes, it falls under the IVD category.
-
The GLP systems Track: No, this is not an IVD itself. The GLP systems Track is described as a "modular laboratory automation system designed to automate pre-analytical and postanalytical processing, including sample handling." While it supports the workflow of IVD analyzers (like the Alinity c System) by preparing and transporting samples, it does not perform the in vitro diagnostic test itself. It's a laboratory automation system that facilitates the use of IVDs.
In summary:
- Alinity c System: IVD
- Alinity c ICT: IVD
- GLP systems Track: Not an IVD (it's a laboratory automation system that supports IVD testing)
N/A
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
JGS, CEM, CGZ, 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
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 862.1665 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
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 | Product
Code | Class | Regulatory Section | Panel |
|-----------------------------------------------------------------|-----------------|-------|---------------------------|----------------|
| Discrete photometric
chemistry analyzer for
clinical use. | JJE | I | 21 CFR Sec. -
862.2160 | Chemistry (75) |
| Calculator/data processing
module 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 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| 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. | The ACCELERATOR APS is a
modular system designed to
automate sample handling and
processing in the clinical
laboratory. The system allows
consolidation of multiple clinical
chemistry and immunoassay
analytical instruments into a
unified workstation. | Similar
(ACCELERATOR
APS performs
both pre-analytical
and post-analytical
processing.) |
| Principle of Analyte
Detection | An analyzer's detection method
remains the same when interfaced
to the GLP systems Track.
For example:
ARCHITECT/Alinity c systems
utilize photometric and
potentiometric technology for
analyte detection.
ARCHITECT/Alinity i systems
utilize chemiluminescent labels
with magnetic microparticle solid
phase for analyte detection. | An analyzer's detection method
remains the same when interfaced
to the ACCELERATOR APS.
For example:
ARCHITECT/Alinity c systems
utilize photometric and
potentiometric technology for
analyte detection.
ARCHITECT/Alinity i systems
utilize chemiluminescent labels
with magnetic microparticle solid
phase for analyte detection. | Same |
| Sample Containers | Primary tubes and secondary
aliquot tubes. | Primary tubes and secondary
aliquot tubes. * | Same |
| Sample Aspiration | Directly from tube presented to the
aspiration point by the GLP
systems Track. | Directly from tube presented to
the aspiration point by the
ACCELERATOR APS. | 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. | ACCELERATOR APS IOM
accepts samples loaded into
sample racks. Samples may also
be loaded directly into any
analyzers that support local
sample loading. | Similar
(Functionality is
the same, however
ACCELERATOR
APS does not have
a BulkLoader
Module). |
| 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 automatically | |||
| centrifuges sample tubes. Samples | |||
| may also be manually centrifuged | |||
| by lab personnel prior to loading | |||
| into the system. | Centrifugation: | ||
| ACCELERATOR APS | |||
| automatically centrifuges sample | |||
| tubes. Samples may also be | |||
| manually centrifuged by lab | |||
| personnel prior to loading into | |||
| system. | Same | ||
| Decapping: | |||
| GLP systems Track automatically | |||
| decaps sample tubes. Samples may | |||
| also be manually decapped by lab | |||
| personnel prior to loading into the | |||
| system. | Decapping: | ||
| ACCELERATOR APS | |||
| automatically decaps sample | |||
| tubes. Samples may also be | |||
| manually decapped by lab | |||
| personnel prior to loading into | |||
| the system. | |||
| Aliquoting: | |||
| GLP systems Track automatically | |||
| aliquots samples from the primary | |||
| sample to bar coded secondary | |||
| tubes. | Aliquoting: | ||
| ACCELERATOR APS | |||
| automatically aliquots samples | |||
| from the primary sample to bar | |||
| coded secondary tubes.* | |||
| Recapping/Resealing: | |||
| GLP systems Track automatically | |||
| recaps sample tubes. Samples may | |||
| also be manually recapped/ | |||
| resealed by lab personnel prior to | |||
| loading into system. | |||
| Storage: | Recapping/Resealing: | ||
| ACCELERATOR APS | |||
| automatically reseals sample | |||
| tubes. Samples may also be | |||
| manually recapped/resealed by | |||
| lab personnel prior to loading | |||
| into the 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. | ACCELERATOR APS | ||
| automatically stores sample tubes | |||
| in refrigerator storage. Samples | |||
| may also be returned to IOM for | |||
| lab personnel to manually store | |||
| samples in lab. | |||
| Sample Transport | GLP systems Track transports | ||
| sample CARs identified on the | |||
| system by Near-Field | |||
| Communication (NFC) tags. | |||
| Samples may also be manually | |||
| transported by lab personnel to | |||
| analyzers. | ACCELERATOR APS transports | ||
| sample carriers identified on the | |||
| system by Radio Frequency | |||
| identification (RFID) tags. | |||
| Samples may also be manually | |||
| transported by lab personnel to | |||
| analyzers. | Similar | ||
| (NFC tags and | |||
| RFID tags both | |||
| identify sample | |||
| carriers on the | |||
| system using a | |||
| wireless method.) | |||
| Sample Identification | GLP systems Track reads sample | ||
| bar codes and electronically | |||
| communicates sample ID to | |||
| 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 LAS. | ACCELERATOR APS reads | ||
| sample bar codes and | |||
| electronically communicates the | |||
| sample ID to 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 LAS. | Same | ||
| Test Orders | Unidirectional from Laboratory | ||
| Information System or middleware | |||
| to the analyzer. | Unidirectional from Laboratory | ||
| Information System or | |||
| middleware 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 Laboratory | ||
| Information System or middleware | |||
| from the analyzer. | Unidirectional from Laboratory | ||
| Information System or | |||
| middleware from the analyzer. | Same | ||
| LAS Communication | GLP systems Track communicates | ||
| to the analyzer per each analyzer's | |||
| LAS interface specification. | ACCELERATOR APS | ||
| communicates to the analyzer per | |||
| each analyzer's LAS interface | |||
| specification. | 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).