(27 days)
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).
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.
The Alinity i STAT High Sensitivity Troponin-I device is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cardiac troponin I (cTnI) in human plasma (lithium heparin) on the Alinity i system, used as an aid in the diagnosis of myocardial infarction (MI).
The acceptance criteria and device performance are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Device K202525) | Reported Device Performance (Subject Device) |
|---|---|---|
| General Device Characteristic Similarities | ||
| Intended Use and Indications for Use | Quantitative determination of cTnI in human plasma (lithium heparin) on the Alinity i system; aid in MI diagnosis. | Same |
| Specific Analyte Detected | cTnI | Same |
| Methodology | CMIA | Same |
| General Device Characteristic Differences | ||
| Sample Dilution Procedures | Not applicable (N/A) – Sample dilutions not recommended. | Automated dilution (1:30) and Manual dilution (1:30) |
| Reportable Interval (ng/L, pg/mL) | Analytical measuring interval (AMI) = 2.7 - 3600.0; Extended measuring interval (EMI) = N/A; Reportable interval = N/A | AMI = 2.7 – 3600.0; EMI = 3600.0 – 60,000.0; Reportable interval = 2.7 - 60,000.0 |
| Dilution Recovery | N/A (for predicate device) | 98.6% to 115.6% for automated dilution (for samples up to 60,000.0 ng/L) |
| 102.6% to 119.9% for manual dilution (for samples up to 60,000.0 ng/L) |
2. Sample Size Used for the Test Set and Data Provenance
- Dilution Recovery Study: Samples were prepared by volumetrically spiking lithium heparin plasma with purified recombinant human cardiac troponin IC complex.
- Automated Dilution: Each sample was tested in replicates of 5. The total number of unique samples is not explicitly stated, but implies multiple samples across a range up to 60,000.0 ng/L.
- Manual Dilution: The same samples were used, and each dilution was prepared by 2 technicians and tested. Again, the exact number of unique samples is not stated but implies multiple samples.
- Data Provenance: The document does not specify the country of origin for the data. The study appears to be prospective laboratory testing conducted to evaluate the device's performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This device is an in vitro diagnostic immunoassay, and the "ground truth" for the dilution recovery study was established by the known concentration of spiked cTnI in the plasma samples, rather than expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
Not applicable. Given the nature of the dilution recovery study for an immunoassay, an adjudication method for establishing ground truth as typically understood in AI/imaging studies (e.g., 2+1, 3+1) is not relevant. The "ground truth" for recovery was the known spiked concentration.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic immunoassay; therefore, human reader performance or the improvement with AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance testing for dilution recovery was conducted as a standalone algorithm performance without human-in-the-loop performance. The Alinity i system automatically processes samples and measures relative light units to quantify cTnI. The study evaluated the accuracy of dilution performed by the instrument and manually.
7. The Type of Ground Truth Used
The ground truth for the dilution recovery study was known, spiked concentrations of purified recombinant human cardiac troponin IC complex in lithium heparin plasma. This represents an analytical ground truth based on controlled experimental conditions.
8. The Sample Size for the Training Set
The document does not provide information about a training set since this is not an AI/machine learning device that typically requires a large training set. The "subject device" is an immunoassay system, and its performance is evaluated based on its analytical characteristics.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention or indication of a "training set" for this in vitro diagnostic immunoassay.
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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
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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
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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) |
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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
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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.
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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 HighSensitivity Troponin-I |
|---|---|---|
| General Device Characteristic Similarities | ||
| Intended Use andIndications for Use | The Alinity i STAT High SensitivityTroponin-I assay is a chemiluminescentmicroparticle immunoassay (CMIA) used forthe quantitative determination of cardiactroponin I (cTnI) in human plasma (lithiumheparin) on the Alinity i system.The Alinity i STAT High SensitivityTroponin-I assay is to be used as an aid in thediagnosis of myocardial infarction (MI). | Same |
| Specific AnalyteDetected | cTnI | Same |
| Methodology | CMIA | Same |
| General Device Characteristic Differences | ||
| Sample DilutionProcedures | Not applicable (N/A) – Sample dilutions arenot 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 |
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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.
§ 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.