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Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin).

The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.

Used in conjunction with other laboratory findings and clinical assessments, Elecsys B R A - H M S PCT is intended for use as follows:

· to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock,

· to determine the change in PCT level over time as an aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission,

· to aid in decision making on antibiotic therapy, for inpatients in the emergency department with suspected or confirmed lower respiratory tract infections (LRT) - defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD),

· to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.

The Elecsys BRAHMS PCT assay is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated antibody and antibody labeled with ruthenium as well as an electrochemiluminescence detection system. Procalcitonin (PCT) in the sample reacts with these labeled antibodies to form a sandwich complex. This complex binds to streptavidin coated magnetic microparticles, which are magnetically captured onto an electrode. Application of voltage to the electrode induces chemiluminescence which is measured by a photomultiplier tube. 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. An optional Procalcitonin CalCheck product is also available.

The provided text describes the performance evaluation of the Elecsys BRAHMS PCT device. Here's a breakdown of the acceptance criteria and study details based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for all performance parameters in a singular table. However, it presents claims and then demonstrates performance against those claims, implying these are the acceptance criteria.

2. Sample Size and Data Provenance for Test Set

• Precision: Seven (7) human serum samples and two (2) QC samples.
• Sample Matrix Comparison: A minimum of 40 serum/plasma pairs per sample material (serum, Li-Heparin plasma, K2-EDTA plasma, K3-EDTA plasma).
• Endogenous Interferences: Spiked serum pools.
• Exogenous Interferences (Drugs): Two human serum samples, spiked.
• Analytical Specificity/Cross-reactivity: Native human serum samples, spiked.
• Reagent On-Board Stability: Eight (8) human serum (HS) sample pools.
• Calibration Stability: Fourteen (14) human serum samples.
• LoQ: Seven native human serum (HS) samples. Total of 150 measuring points collected (7 samples measured in five-fold determination for each of 5 days).
• Clinical Performance Evaluation (Method Comparison to Predicate): 496 native human clinical samples.
• Data Provenance: The document states "human serum" and "human clinical samples" without specifying the country of origin. The assays are for "in vitro quantitative determination" using patient samples, implying retrospective collection for these performance studies.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the document. The studies primarily involve analytical performance and method comparison against a predicate device and established laboratory guidelines rather than clinical interpretation by experts for ground truth establishment.

4. Adjudication Method for Test Set

This information is not applicable as the studies are analytical and method comparison, not involving expert adjudication of diagnostic outcomes or images.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided and is not applicable. This device is an in-vitro diagnostic (IVD) assay that quantitatively measures procalcitonin levels, not an AI-assisted diagnostic imaging device requiring human reader interaction.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is an IVD assay, meaning its performance is inherently standalone (algorithm only, or rather, assay-only). The results are quantitative measurements. Human interpretation comes after the device generates the PCT value, in conjunction with other clinical assessments, as indicated in the "Indications for Use." The data presented here (e.g., precision, interference, method comparison) reflects the standalone analytical performance of the assay.

7. Type of Ground Truth Used

• For precision, interference, stability, LoQ, and analytic specificity, the ground truth is based on known spiked concentrations or the reference value/measurement of the analyte in the samples.
• For the method comparison study, the "ground truth" for comparison is the results obtained from the legally marketed predicate device (Elecsys BRAHMS PCT cleared under K173927). This establishes substantial equivalence.

8. Sample Size for the Training Set

This information is not provided. The document describes performance evaluation (testing) of the device. It does not detail the development or training process for the assay's reagents or calibration, which would involve a "training set." For an immunoassay, the "training" equivalent would typically involve assay development and optimization using various known samples and controls, rather than a distinct "training set" as understood in machine learning. Calibration data also serves a role similar to training in defining the dose-response curve.

9. How the Ground Truth for the Training Set Was Established

This information is not provided as the document does not discuss a "training set" in the context of this IVD device. For an immunoassay, ground truth for development (e.g., calibrators) is typically established through careful gravimetric or volumetric preparations, reference methods, and standardization to an international reference material where available (as indicated by "This method has been standardized against the BRAHMS PCT LIA assay" and "Traceability/ Standardization").

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Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin).

The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.

Used in conjunction with other laboratory findings and clinical assessments, Elecsys B.R.A.H.M.S.PCT is intended for use as follows:

· to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock,

· to determine the change in PCT level over time as an aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission,

· to aid in decision making on antibiotic therapy, for inpatients in the emergency department with suspected or confirmed lower respiratory tract infections (LRT) - defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD),

· to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.

The Elecsys BRAHMS PCT assay is a two-step sandwich immunoassay with streptavidin microparticles and an electrochemiluminescence detection system. PCT in the sample reacts with these labeled antibodies to form a sandwich complex. This complex binds to streptavidin coated magnetic microparticles, which are magnetically captured onto an electrode. Application of voltage to the electrode induces chemiluminescence which is measured by a photomultiplier tube. 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. An optional Procalcitonin CalCheck product is also available.

This document describes the Elecsys BRAHMS PCT assay, an in vitro diagnostic immunoassay for the quantitative determination of Procalcitonin (PCT) in human serum and plasma. The K173927 510(k) submission seeks substantial equivalence to the B.R.A.H.M.S. PCT sensitive KRYPTOR® (K171338) for updated Indications for Use.

Acceptance Criteria and Reported Device Performance

Study Information:

1. Sample Size used for the test set and data provenance:

   • Sample Size: 2617 samples were used for the clinical performance evaluation (method comparison to predicate).
   • Data Provenance: Retrospective multicenter testing of PCT from available frozen samples of adult patients (>18 years of age) diagnosed with severe sepsis or septic shock. These patients were enrolled in the BRAHMS MOSES study from the Intensive Care Unit (ICU) or the emergency department, other wards, or directly from out of hospital and subsequently admitted to the ICU.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for the comparative study was based on measurements obtained from the predicate device (B.R.A.H.M.S. PCT sensitive KRYPTOR®). Clinical diagnoses (severe sepsis or septic shock) were based on patient enrollment criteria for the BRAHMS MOSES study, which likely involved clinicians, but specific details on expert involvement in establishing ground truth for the test set's PCT values are not provided.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. The study compares the candidate device's analytical results directly against the predicate device's analytical results. There is no mention of a human adjudication process for resolving discrepancies.

4. 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: Not applicable. This is an analytical performance study comparing an immunoassay device to a predicate immunoassay device, not a human reader or AI-assisted diagnostic study.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Yes, the entire performance evaluation described is a standalone evaluation of the Elecsys BRAHMS PCT assay, an automated immunoassay device, without human-in-the-loop performance influencing the assay results themselves. The results are intended to be used in conjunction with other laboratory findings and clinical assessments.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the method comparison study was the results obtained from the legally marketed predicate device, the B.R.A.H.M.S. PCT sensitive KRYPTOR®. For the clinical context, patients were diagnosed with severe sepsis or septic shock based on the BRAHMS MOSES study criteria, implying clinical and outcomes data were involved in the original classification of these patients.

7. The sample size for the training set: Not applicable. This is an in vitro diagnostic immunoassay, not a machine learning algorithm that typically requires a discrete training set for model development. The assay itself is a chemical and electrochemiluminescence process.

8. How the ground truth for the training set was established: Not applicable, as there is no specific "training set" in the context of an immunoassay for which ground truth would be established in the same way as for a machine learning model. The assay's analytical characteristics and calibration are established through standard laboratory and calibration procedures, which involve reference materials and calibrators. The assay is standardized against the BRAHMS PCT LIA assay.

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