Search Results

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.

Ask a specific question about this device