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510(k) Data Aggregation
(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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