(27 days)
Alinity i STAT High Sensitivity Troponin-I (K202525)
Not Found
No
The summary describes a standard immunoassay kit and instrument for measuring cardiac troponin I. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is an in vitro diagnostic (IVD) assay used to aid in the diagnosis of myocardial infarction by measuring cardiac troponin I levels, not to treat a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the assay "is to be used as an aid in the diagnosis of myocardial infarction (MI)". The term "diagnosis" directly indicates a diagnostic purpose.
No
The device description clearly outlines physical components (reagent kit with microparticles and conjugate) which are essential for the device's function, indicating it is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of cardiac troponin I (cTnl) in human plasma" and is to be used "as an aid in the diagnosis of myocardial infarction (MI)." This clearly indicates it's used to test human samples in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details the components of a "Reagent Kit" used for the assay, which are typical components of an IVD.
- Performance Studies: The description of performance studies involving testing "lithium heparin plasma" samples further confirms its use with human biological specimens.
The definition of an IVD is a medical device that is used to examine specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
The Alinity i STAT High Sensitivity Troponin-I assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of cardiac troponin I (cTnl) in human plasma (lithium heparin) on the Alinity i system.
The Alinity i STAT High Sensitivity Troponin-I assay is to be used as an aid in the diagnosis of myocardial infarction (MI).
Product codes (comma separated list FDA assigned to the subject device)
MMI
Device Description
The Alinity i STAT High Sensitivity Troponin-I Reagent Kit contains:
- Microparticles: 1 bottle (6.6 mL per 100 test cartridge / 33.8 mL per 600 test cartridge). Anti-troponin I (mouse, monoclonal) coated microparticles in TRIS buffer with protein (bovine) stabilizer. Minimum concentration: 0.035% solids. Preservative: ProClin 300.
- Conjugate: 1 bottle (6.1 mL per 100 test cartridge / 33.8 mL per 600 test cartridge). Anti-troponin I (mouse-human chimeric, monoclonal) acridinium-labeled conjugate in MES buffer with protein (bovine) stabilizer and human IgG. Minimum concentration: 0.1 mg/L. Preservative: ProClin 300.
Principles of the Procedure:
The Alinity i STAT High Sensitivity Troponin-I assay is an automated, two-step immunoassay for the quantitative determination of cTnI in human plasma (lithium heparin) using CMIA technology.
Sample and anti-troponin I antibody-coated paramagnetic microparticles are combined and incubated. The cTnI present in the sample binds to the anti-troponin I coated microparticles. The mixture is washed. Anti-troponin I 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 a relative light unit (RLU). There is a direct relationship between the amount of cTnI in the sample and the RLU detected by the system optics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. Dilution Recovery
A study was performed based on guidance from Clinical and Laboratory Standards Institute (CLSI) EP34, 1st ed. Samples were prepared by volumetrically spiking lithium heparin plasma with purified recombinant human cardiac troponin IC complex. For automated dilution (performed by the Alinity i instrument at 1:30), each sample was tested in replicates of 5 on 3 separate runs using one reagent lot and 3 instruments. For manual dilution, 2 technicians each prepared 3 separate 1:30 manual dilutions of the same samples and tested each dilution on a separate run using one reagent lot and 2 instruments. For samples up to 60,000.0 ng/L, dilution recovery ranged from 98.6% to 115.6% for automated dilution and 102.6% to 119.9% for manual dilution.
Conclusion:
The results presented in this Special 510(k) demonstrate that the performance of the subject device (Alinity i STAT High Sensitivity Troponin-I with automated and manual dilution) is substantially equivalent to the performance of the predicate device (Alinity i STAT High Sensitivity Troponin-I, K202525).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Alinity i STAT High Sensitivity Troponin-I (K202525)
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
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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" followed by the words "U.S. Food & Drug Administration".
May 4, 2023
Abbott Laboratories Diagnostics Division Judi Wallach Regulatory Affairs Project Manager Dept. 9AA, Building CP01-2, 100 Abbott Park Road Abbott Park, IL 60064
Re: K230994
Trade/Device Name: Alinity i STAT High Sensitivity Troponin-I Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine Phosphokinase/Creatine Kinase Or Isoenzymes Test System Regulatory Class: Class II Product Code: MMI Dated: April 6, 2023 Received: April 7, 2023
Dear Judi Wallach:
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 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
1
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.
Paula V. Caposino -S
Paula Caposino, Ph.D. Acting Deputy Division 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K230994
Device Name Alinity i STAT High Sensitivity Troponin-I
Indications for Use (Describe)
The Alinity i STAT High Sensitivity Troponin-I assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of cardiac troponin I (cTnl) in human plasma (lithium heparin) on the Alinity is ystem.
The Alinity i STAT High Sensitivity Troponin-I assay is to be used as an aid in the diagnosis of myocardial infarction (MI).
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Federal Food, Drug, and Cosmetic Act and 21 CFR 807.92.
I. 510(k) Number
II. Applicant Name
Date summary prepared: May 3, 2023
Abbott Laboratories Diagnostics Division Dept. 9AA, CP01-2 100 Abbott Park Road Abbott Park, IL 60064
Primary contact person for all communications:
Judi Wallach, Abbott Laboratories Diagnostics Division, Regulatory Affairs Project Manager Telephone Number: (224) 667-1132 Fax Number: (224) 667-4836
Secondary contact person for all communications:
Julian Braz, Abbott Laboratories Diagnostics Division, Director, Regulatory Affairs Telephone Number: (224) 330-9230
III. Device Name
Alinity i STAT High Sensitivity Troponin-I
Reagents
Trade Name: Alinity i STAT High Sensitivity Troponin-I Device Classification: Class II Classification Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Governing Regulation: 862.1215
Code: MMI
4
IV. Predicate Device
Alinity i STAT High Sensitivity Troponin-I (K202525)
V. Intended Use of the Device
The Alinity i STAT High Sensitivity Troponin-I assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of cardiac troponin I (cTnl) in human plasma (lithium heparin) on the Alinity i system.
The Alinity i STAT High Sensitivity Troponin-I assay is to be used as an aid in the diagnosis of myocardial infarction (MI).
VI. Description of Device
The Alinity i STAT High Sensitivity Troponin-I Reagent Kit contains:
- . Microparticles: 1 bottle (6.6 mL per 100 test cartridge / 33.8 mL per 600 test cartridge). Anti-troponin I (mouse, monoclonal) coated microparticles in TRIS buffer with protein (bovine) stabilizer. Minimum concentration: 0.035% solids. Preservative: ProClin 300.
- . Conjugate: 1 bottle (6.1 mL per 100 test cartridge / 33.8 mL per 600 test cartridge). Anti-troponin I (mouse-human chimeric, monoclonal) acridinium-labeled conjugate in MES buffer with protein (bovine) stabilizer and human IgG. Minimum concentration: 0.1 mg/L. Preservative: ProClin 300.
Principles of the Procedure
The Alinity i STAT High Sensitivity Troponin-I assay is an automated, two-step immunoassay for the quantitative determination of cTnI in human plasma (lithium heparin) using CMIA technology.
Sample and anti-troponin I antibody-coated paramagnetic microparticles are combined and incubated. The cTnI present in the sample binds to the anti-troponin I coated microparticles. The mixture is washed. Anti-troponin I acridinium-labeled conjugate is added to create a reaction mixture and incubated. Following a wash cycle, Pre-Trigger and Trigger Solutions are added.
5
The resulting chemiluminescent reaction is measured as a relative light unit (RLU). There is a direct relationship between the amount of cTnI in the sample and the RLU detected by the system optics.
VII. Comparison of Technological Characteristics
The Alinity i STAT High Sensitivity Troponin-I assay (subject device) utilizes a CMIA methodology for the quantitative in vitro determination of cTnI and is intended for use on the Alinity i system.
The similarities and differences between the subject device and the predicate device are presented in the following table.
| Characteristics | Cleared Predicate Device:
Alinity i STAT High Sensitivity Troponin-I
(K202525) | Subject Device:
Alinity i STAT High
Sensitivity Troponin-I |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| General Device Characteristic Similarities | | |
| Intended Use and
Indications for Use | The Alinity i STAT High Sensitivity
Troponin-I assay is a chemiluminescent
microparticle immunoassay (CMIA) used for
the quantitative determination of cardiac
troponin I (cTnI) in human plasma (lithium
heparin) on the Alinity i system.
The Alinity i STAT High Sensitivity
Troponin-I assay is to be used as an aid in the
diagnosis of myocardial infarction (MI). | Same |
| Specific Analyte
Detected | cTnI | Same |
| Methodology | CMIA | Same |
| General Device Characteristic Differences | | |
| Sample Dilution
Procedures | Not applicable (N/A) – Sample dilutions are
not recommended for the assay. | Automated dilution (1:30)
Manual dilution (1:30) |
| Reportable Interval
(ng/L, pg/mL) | Analytical measuring interval (AMI) =
2.7 - 3600.0 | AMI = 2.7 – 3600.0 |
| | Extended measuring interval (EMI) = N/A | EMI = 3600.0 – 60,000.0 |
| | Reportable interval = N/A | Reportable interval =
2.7 - 60,000.0 |
6
VIII. Performance Summary
A. Dilution Recoverv
A study was performed based on guidance from Clinical and Laboratory Standards Institute (CLSI) EP34, 1st ed. Samples were prepared by volumetrically spiking lithium heparin plasma with purified recombinant human cardiac troponin IC complex. For automated dilution (performed by the Alinity i instrument at 1:30), each sample was tested in replicates of 5 on 3 separate runs using one reagent lot and 3 instruments. For manual dilution, 2 technicians each prepared 3 separate 1:30 manual dilutions of the same samples and tested each dilution on a separate run using one reagent lot and 2 instruments. For samples up to 60,000.0 ng/L, dilution recovery ranged from 98.6% to 115.6% for automated dilution and 102.6% to 119.9% for manual dilution.
IX. Conclusion Drawn from Nonclinical Laboratory Studies and Clinical Performance
The results presented in this Special 510(k) demonstrate that the performance of the subject device (Alinity i STAT High Sensitivity Troponin-I with automated and manual dilution) is substantially equivalent to the performance of the predicate device (Alinity i STAT High Sensitivity Troponin-I, K202525).
There is no known potential adverse effect to the operator when using this in vitro device according to the Alinity i STAT High Sensitivity Troponin-I reagent package insert instructions.
- Clinical and Laboratory Standards Institute (CLSI). Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking. 1st ed. CLSI Guideline EP34. Wayne, PA: CLSI; 2018.