(338 days)
Elecsys Troponin I Immunoassay: Immunoassay for the in vitro quantitative determination of cardiac troponin I in human serum and plasma. The Elecsys Troponin I assay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and MODULAR Analytics E170 immunoassay analyzers.
Elecsys Troponin I STAT Immunoassay: Immunoassay for the in vitro quantitative determination of cardiac troponin I in human serum and plasma. The Elecsys Troponin I STAT assay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys analyzers.
Elecsys PreciControl Troponin is used for quality control of the Elecsys Troponin I and Elecsys Troponin I STAT immunoassays on the Elecsys and MODULAR Analytics E170 Analyzers.
The Elecsys Troponin I CalSet is used for calibrating the quantitative Elecsys Troponin I assay on the Elecsys and MODULAR Analytics E170 analyzers.
The Elecsys Troponin I STAT CalSet is used for calibrating the quantitative Elecsys Troponin I STAT assay on the Elecsys analyzers.
1.) The Elecsys Troponin I immunoassay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.
2.) The Elecsys Troponin I STAT immunoassay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.
3.) The Elecsys PreciControl Troponin is a lyophilized product consisting of human serum with added Troponin T and Troponin I in two concentration ranges. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
4.) The Elecsys Troponin I CalSet is a lyophilized product consisting of human serum with added Troponin I in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
5.) The Elecsys Troponin I STAT CalSet is a lyophilized product consisting of human serum with added Troponin I in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Note: The reagent, calibrator, and quality control materials are all packaged separately.
The provided 510(k) summary for K082699 describes the Elecsys Troponin I and Elecsys Troponin I STAT immunoassays, along with their associated control and calibrator products. The submission aims to demonstrate substantial equivalence to predicate devices. However, it's important to note that this document does not describe acceptance criteria in the traditional sense of performance targets that trigger a pass/fail for a device. Instead, it presents performance data for the device and compares various features to a predicate device to establish substantial equivalence.
Here's an analysis of the provided information, framed to address your questions where applicable, and highlighting what's not explicitly stated in the document:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, this document doesn't provide explicit "acceptance criteria" for the Elecsys Troponin I assays. It presents performance characteristics and compares them to a predicate device (Beckman Coulter Access AccuTnI Immunoassay, K021814) to establish substantial equivalence. The "reported device performance" columns below are the actual measured values from the studies. The "Acceptance Criteria" cells are left blank as they were not specified in the document.
Elecsys Troponin I STAT Assay (Main Assay)
| Feature | Acceptance Criteria | Reported Device Performance (Elecsys Troponin I STAT Assay) | Reported Predicate Device Performance (Beckman Coulter Access AccuTnI Assay, K021814) |
|---|---|---|---|
| Intended Use / Indication for Use | (Not specified) | Immunoassay for in vitro quantitative determination of cardiac troponin I in human serum and plasma; aids in diagnosis of myocardial infarction. For use on Elecsys analyzers. | Immunoassay for quantitative determination of cTnI in human serum and plasma; aids in diagnosis and treatment of myocardial infarction and cardiac muscle damage; aids in risk stratification of patients with unstable angina or non-ST segment elevation acute coronary syndromes. For use on Access Immunoassay Systems. |
| Assay Protocol | (Not specified) | Sandwich Principle | Sandwich Principle |
| Detection Protocol | (Not specified) | Electrochemiluminescence | Chemiluminescence |
| Traceability / Standardization | (Not specified) | Standardized against the Beckman Coulter Access AccuTnI assay. | Not stated. |
| Calibration Interval | (Not specified) | Once per reagent lot (renewed after 1 month/28 days, or 7 days on analyzer). | Every 56 days. |
| Sample Type | (Not specified) | Human serum and plasma | Human serum and plasma |
| Reagent Stability (Unopened) | (Not specified) | Up to stated expiration date (2-8°C) | Up to stated expiration date (2-8°C) |
| Reagent Stability (After Opening) | (Not specified) | 4 weeks (2-8°C), 2 weeks on analyzers | 56 days (2-10°C) |
| Calibrator | (Not specified) | Elecsys Troponin I STAT CalSet | Access AccuTnI Calibrators |
| Controls | (Not specified) | Elecsys PreciControl Troponin | Commercial control material |
| Expected values (Age 20-79) | (Not specified) | 5 mg/day) require 8-hour wait. Rare anti-streptavidin and ruthenium interference. Use with clinical findings. | No interference from bilirubin (up to 40 mg/dL), fibrinogen (up to 1000 mg/dL), triglycerides (up to 1000 mg/dL), hemoglobin (up to 500 mg/dL), human serum albumin (up to 6000 mg/dL). |
Elecsys Troponin I Assay (18 Minute) - (Similar to STAT, but with slight differences in precision and method comparison)
| Feature | Acceptance Criteria | Reported Device Performance (Elecsys Troponin I Assay) | Reported Predicate Device Performance (Beckman Coulter Access AccuTnI Assay, K021814) |
|---|---|---|---|
| Precision (Repeatability) | (Not specified) | 5.3% CV @ 0.322 ng/mL; 5.2% CV @ 0.425 ng/mL; 2.7% CV @ 17.6 ng/mL; 7.0% CV @ 0.340 ng/mL; 2.6% CV @ 18.0 ng/mL | Within Run: 4.03% CV @ 0.56 ng/mL; 3.06% CV @ 7.31 ng/mL; 3.29% CV @ 30.55 ng/mL; 4.42% CV @ 0.42 ng/mL; 3.42% CV @ 1.34 ng/mL |
| Precision (Intermediate) | (Not specified) | 8.7% CV @ 0.322 ng/mL; 7.3% CV @ 0.425 ng/mL; 4.7% CV @ 17.6 ng/mL; 8.0% CV @ 0.340 ng/mL; 4.4% CV @ 18.0 ng/mL | Between Run: 2.97% CV @ 0.56 ng/mL; 4.12% CV @ 7.31 ng/mL; 6.07% CV @ 30.55 ng/mL; 2.71% CV @ 0.42 ng/mL; 2.75% CV @ 1.34 ng/mL. |
| Total Imprecision: 5.01% CV @ 0.56 ng/mL; 5.13% CV @ 7.31 ng/mL; 6.90% CV @ 30.55 ng/mL; 5.19% CV @ 0.42 ng/mL; 4.39% CV @ 1.34 ng/mL | |||
| Method Comparison (N, Range, Regression) | (Not specified) | N = 115; Range = 0.34 - 24.62 ng/mL | |
| Passing/Bablok: y = 0.9743x - 0.00172, tau = 0.9616 | |||
| Linear Regression: y = 0.9934x - 0.0623, r = 0.9934 | |||
| Deming Regression: y = 1x - 0.1080, r = 0.9971 | N = 157; Range = 0.03 - 44.89; Intercept = - 1.039 ng/mL; Slope = 0.932; r = 0.980 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Method Comparison (Elecsys Troponin I STAT Assay): N = 114
- Method Comparison (Elecsys Troponin I Assay): N = 115
- Precision Studies: Not explicitly stated as a single "test set" sample size. The precision studies involved multiple samples at different concentration levels, tested repeatedly (within-run, between-run, between-day) across different sites (US Site 1, US Site 2, EU Site 1). The number of replicates for each sample at each site is not detailed.
- Data Provenance: The document explicitly mentions "US Site 1", "US Site 2", and "EU Site 1" for precision studies, indicating data from both the United States and Europe. The "Method Comparison" studies do not explicitly state the country of origin but are generally part of clinical trials or validation studies related to regulatory submissions. The studies are assumed to be prospective or generated specifically for the submission, but this is not explicitly stated as retrospective or prospective for all data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the 510(k) summary. These are in-vitro diagnostic immunoassays for quantitative determination of a biomarker; the "ground truth" for method comparison is typically the result from a well-established predicate device or a reference method, not established by human experts in the way it would be for an imaging AI device.
4. Adjudication Method for the Test Set
This information is not applicable/not provided for this type of IVD immunoassay. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, not for quantifying a biomarker in a lab assay. The "gold standard" for comparison is often the predicate device itself or a recognized reference method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable as the device is an in-vitro diagnostic immunoassay, not an AI or imaging device that involves human readers.
6. Standalone Performance
Yes, the performance data presented (precision, linearity, method comparison, limits of detection/quantitation, interference) represents the standalone performance of the Elecsys Troponin I assays themselves. The comparison to the predicate device validates its performance relative to an already marketed and accepted device. Human interaction is limited to operating the analyzer and performing necessary calibration/quality control, not interpreting the results in a "human-in-the-loop" AI context.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation of the Elecsys Troponin I immunoassays is established by:
- Comparison to a Predicate Device: The method comparison studies directly compare the results of the Elecsys assays to the Beckman Coulter Access AccuTnI assay (K021814). This predicate device serves as the de-facto "ground truth" for demonstrating substantial equivalence.
- Analytical Standards: The determination of Limits of Blank (LoB), Limits of Detection (LoD), Limits of Quantitation (LoQ), and precision are based on established statistical methods and analytical standards in laboratory medicine, often using spiked samples or reference materials.
- Clinical Significance: The "expected values" and cut-off levels are derived from population studies and clinical guidelines related to troponin levels in the diagnosis of myocardial infarction.
8. Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning or AI models. For an in-vitro diagnostic immunoassay like the Elecsys Troponin I, the development process involves extensive analytical validation studies, but these are not typically referred to as "training sets" in the AI sense. The document does not specify a "training set" size. The samples used for initial development, optimization, and early validation are not detailed here.
9. How the Ground Truth for the Training Set Was Established
As discussed in point 8, the concept of a "training set" doesn't directly apply here in the AI context. For the analytical validation studies (e.g., precision, linearity), the "ground truth" (or target values) for samples would be established through:
- Gravimetric or Volumetric Preparations: For spiked samples, known concentrations of troponin I would be added to a matrix.
- Reference Methods: Comparison to established, highly accurate reference methods, if available, for specific analytical parameters.
- Predicate Device Results: For method comparison, the results from the predicate device are considered the comparative "truth."
The document does not detail how the "ground truth" for these various analytical studies was established beyond mentioning standardization against the predicate device.
§ 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.