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Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.

Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin STAT assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.

Device Description

The Elecsys Myoglobin Immunoassay includes two applications of the same reagents with different incubation times of 18 minutes (Myoglobin assay) and 9 minutes (Myoglobin STAT assay). The assay is a two-step sandwich immunoassay, using two different monoclonal antibodies directed against human Myoglobin, with streptavidin microparticles, and electrochemiluminescence detection. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.

AI/ML Overview

The acceptance criteria for the Elecsys Myoglobin Immunoassay and Elecsys Myoglobin STAT Immunoassay, along with the reported device performance, are detailed below. The study proves the device's substantial equivalence to a predicate device (Elecsys Myoglobin STAT assay K983176), rather than establishing new clinical effectiveness. Therefore, the information regarding multi-reader multi-case studies, expert adjudication, and detailed ground truth establishment for novel device performance is not fully applicable in the context of a 510(k) submission for substantial equivalence based on performance characteristics.

1. Table of Acceptance Criteria and the Reported Device Performance

Feature	Acceptance Criteria (Predicate: Elecsys Myoglobin STAT assay K983176 Performance)	Reported Device Performance (Elecsys Myoglobin and Myoglobin STAT)
Measuring Range	15-3000 ng/mL	21-3000 ng/mL
Expected values (Men)	< 72 ng/ml	28-72 ng/ml
Expected values (Women)	< 51 ng/ml	25-58 ng/ml
Repeatability (Myoglobin assay)
@ 32.0 ng/mL	N/A (Predicate points are different)	2.0% CV
@ 87.0 ng/mL	N/A (Predicate points are different)	1.0% CV
@ 1020 ng/mL	N/A (Predicate points are different)	1.8% CV
@ 1194 ng/mL	N/A (Predicate points are different)	1.1% CV
@ 2474 ng/mL	N/A (Predicate points are different)	1.8% CV
Repeatability (Myoglobin STAT assay)
@ 33.9 ng/mL	N/A (Predicate points are different)	1.7% CV
@ 90.1 ng/mL	N/A (Predicate points are different)	1.2% CV
@ 1016 ng/mL	N/A (Predicate points are different)	1.8% CV
@ 1171 ng/mL	N/A (Predicate points are different)	1.1% CV
@ 2468 ng/mL	N/A (Predicate points are different)	2.2% CV
Repeatability (Predicate)
@ 43.0 ng/mL	2.1% CV	N/A
@ 82.5 ng/mL	1.3% CV	N/A
@ 237 ng/mL	2.9% CV	N/A
@ 523 ng/mL	2.9% CV	N/A
@ 672 ng/mL	1.9% CV	N/A
@ 1147 ng/mL	3.4% CV	N/A
@ 3056 ng/mL	5.3% CV	N/A
Intermediate Precision (Total) (Myoglobin assay)
@ 32.0 ng/mL	N/A	2.3% CV
@ 87.0 ng/mL	N/A	1.5% CV
@ 1020 ng/mL	N/A	2.5% CV
@ 1194 ng/mL	N/A	1.8% CV
@ 2474 ng/mL	N/A	2.2% CV
Intermediate Precision (Total) (Myoglobin STAT assay)
@ 33.9 ng/mL	N/A	2.1% CV
@ 90.1 ng/mL	N/A	1.3% CV
@ 1016 ng/mL	N/A	2.2% CV
@ 1171 ng/mL	N/A	1.3% CV
@ 2468 ng/mL	N/A	2.6% CV
Intermediate Precision (Total) (Predicate)
@ 43.0 ng/mL	2.6% CV	N/A
@ 82.5 ng/mL	1.6% CV	N/A
@ 237 ng/mL	3.6% CV	N/A
@ 523 ng/mL	3.8% CV	N/A
@ 672 ng/mL	2.3% CV	N/A
@ 1147 ng/mL	4.0% CV	N/A
@ 3056 ng/mL	6.7% CV	N/A
Method Comparison (Myoglobin assay vs. Predicate)
N	N/A	129
Range	N/A	24 to 2945
Passing/Bablok Slope	1.01 (Predicate to its comparator)	1.03
Passing/Bablok Intercept	-0.135 (Predicate to its comparator)	6.26
Passing/Bablok r	0.996 (Predicate to its comparator)	0.987
Linear Regression Slope	0.997 (Predicate to its comparator)	1.02
Linear Regression Intercept	1.284 (Predicate to its comparator)	14.5
Linear Regression r	0.996 (Predicate to its comparator)	0.999
Deming Regression Slope	N/A	1.00
Deming Regression Intercept	N/A	13.9
Deming Regression r	N/A	0.999
Method Comparison (Myoglobin STAT assay vs. Predicate)
N	N/A	139
Range	N/A	23 to 2523
Passing/Bablok Slope	1.01 (Predicate to its comparator)	1.04
Passing/Bablok Intercept	-0.135 (Predicate to its comparator)	-2.08
Passing/Bablok r	0.996 (Predicate to its comparator)	0.955
Linear Regression Slope	0.997 (Predicate to its comparator)	1.08
Linear Regression Intercept	1.284 (Predicate to its comparator)	-9.60
Linear Regression r	0.996 (Predicate to its comparator)	0.988
Deming Regression Slope	N/A	1.09
Deming Regression Intercept	N/A	-14.6
Deming Regression r	N/A	0.997
Limit of Blank	Not Reported for predicate	18 ng/mL
Limit of Detection	21 ng/mL	21 ng/mL
Limit of Quantitation	Not Reported for predicate	25 ng/mL
Interferences (limitations)	Hemolytic: no effect up to 1.4 g/dL, Biotin: no effect up to 50 ng/mL, Lipemia: no effect up to 2200 mg/dL, Bilirubin: no effect up to 65 mg/dL, Rheumatoid factor: no effect up to 1500 IU/mL	Same as predicate

Note: For the purpose of substantial equivalence, the reported device performance of the new assays is compared to the performance characteristics of the predicate device. Where specific acceptance criteria are not explicitly stated, the presented predicate device's performance often implicitly serves as the benchmark for demonstrating comparable characteristics.

2. Sample sizes used for the test set and the data provenance

Method Comparison (Myoglobin assay): N = 129 samples were used for the test set.
Method Comparison (Myoglobin STAT assay): N = 139 samples were used for the test set.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, given it's a submission for an IVD device, the data for performance characteristics would typically be generated in controlled laboratory settings through prospective testing of manufactured lots and clinical sample comparisons.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in the document. For an in vitro diagnostic (IVD) immunoassay, "ground truth" is typically established by reference methods, comparison with a predicate device, or established scientific principles and accepted standards for analyte detection and quantification, rather than expert human interpretation of imaging or clinical data. The study primarily compares the performance of the new device to a predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation (e.g., radiology images) where human readers may disagree. For an immunoassay, the "ground truth" for comparison is based on quantitative measurements from established methods or the predicate device, not human interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is an immunoassay for quantitative determination of myoglobin, not an AI-assisted diagnostic tool for human readers interpreting cases. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies presented are for the standalone performance of the Elecsys Myoglobin Immunoassay and Elecsys Myoglobin STAT Immunoassay systems. The reported results (e.g., precision, method comparison, limit of detection) reflect the performance of the assay and analyzer without human interpretation of the final quantitative result. Humans are involved in operating the analyzer and interpreting the numerical output, but the "performance" described is the analytical performance of the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance characteristics presented is primarily based on:

Comparison to a predicate device: The Elecsys Myoglobin STAT assay (K983176) serves as the primary comparator.
Internal reference preparations/standards: The Myoglobin STAT assay traceability is against an in-house reference preparation.
Calibrated methods: The predicate device was calibrated against Tina-quant Myoglobin, which in turn was calibrated against a nephelometric method.
Defined analytical methods: E.g., for precision, the coefficient of variation (CV) is calculated based on repeated measurements of control samples or patient samples. For method comparison, it refers to the correlation and agreement with the predicate device's quantitative measurements.

8. The sample size for the training set

This document does not specify a "training set" in the context of machine learning or AI algorithms. For an immunoassay, the development involves optimization of reagents, antibodies, and protocols, often using a large number of samples for validation and calibration curve generation. The provided sample sizes relate to the evaluation of performance characteristics (e.g., N=129 and N=139 for method comparison studies) and are equivalent to "test sets" for analytical validation.

9. How the ground truth for the training set was established

As there is no "training set" in the AI/ML sense, this question is not directly applicable. For the development and calibration of the immunoassay, the "ground truth" for defining the calibration curve and ensuring accurate quantification would be established through a rigorous process involving:

Certified reference materials or secondary reference materials traceable to international standards (if available).
Serial dilutions of known concentrations of myoglobin.
Comparison with established methodologies (e.g., gravimetric, spectrophotometric, or other widely accepted quantitative techniques).
Manufacturer's in-house reference preparations that are carefully characterized and validated.

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