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The Lumipulse G B•R•A•H•M•S PCT is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of PCT (procalcitonin) in human serum and plasma (sodium heparin, sodium citrate or dipotassium EDTA) on the LUMIPULSE G System.

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

· Aid in the risk assessment of critically ill patients on their first day of intensive care unit (ICU) admission for progression to severe sepsis and septic shock.

· 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, using a change in PCT level over time.

· Aid in decision making on antibiotic therapy for patients with suspected or confirmed lower respiratory tract infections (LRTI) - defined as community acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD) – in an inpatient setting or an emergency department.

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

Lumipulse G B.R.A.H.M.S PCT Calibrators set

Lumipulse G B R A H M S PCT Calibrators set is for in vitro diagnostic use in the calibration of Lumipulse G B.R.A.H.M.S.PCT on the LUMIPULSE G System.

Lumipulse G B+R•A•H•M•S PCT is an assay system, including a set of immunoassay reagents, for the quantitative measurement of PCT in specimens based on CLEIA technology by a two-step sandwich immunoassay method on the LUMIPULSE G1200 System.

Lumipulse G B.R.A.H.M.S PCT Immunoreaction Cartridges: | IRC 235058. The Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges consists of 3 x 14 tests. Each kit contains the following:

1.) Antibody-Coated Particle Solution (Liquid when used, 250 µL/Immunoreaction Cartridge) Contains 150 µg/mL anti-PCT monoclonal antibody (mouse) and anti-calcitonin monoclonal antibody (mouse) coated particles, protein stabilizers (bovine and mouse) and chemical stabilizers in 0.15 M sodium chloride/Tris buffer. This solution contains gelatin and turns into gel at 15°C or lower. Preservative: sodium azide.

2.) Enzyme-Labeled Antibody Solution (Liquid, 350 µL/Immunoreaction Cartridge) Contains 0.25 µg/mL alkaline phosphatase (ALP: calf)-labeled anti-katacalcin monoclonal antibody (mouse), protein stabilizers (bovine, calf and mouse) and chemical stabilizers in 0.1 M sodium chloride/MES buffer. Preservative: sodium azide.

Lumipulse G B+R+A+H+M+S PCT Calibrators set |CAL SET 234150, Lyophilized, 2 x 2 Concentrations

Each calibrator kit contains one bottle each of Calibrators 1 - 2, and Reconstituting Solution. The calibrator kit is packaged separately.

CAL 1 0 ng/mL PCT calibrator (2 x 0.5 mL/vial)

CAL 2 100 ng/mL PCT calibrator (2 x 0.5 mL/vial)

Contains procalcitonin in 0.15 M sodium chloride in Tris buffer with protein stabilizer (bovine). Preservative: ProClin 300.

RS Reconstituting Solution: Liquid, 1 x 10 mL Preservative: sodium azide.

These calibrators are lyophilized and have to be prepared by adding exactly 0.5 mL of Reconstituting Solution to each Iyophilized calibrator.

The provided document describes the Lumipulse G B.R.A.H.M.S PCT Immunoreaction Cartridges and its associated calibrator set. This is an in-vitro diagnostic device, not an AI/ML medical device. Therefore, the questions related to AI/ML device acceptance criteria, performance studies (sample sizes, expert usage, adjudication, MRMC studies, standalone performance), and ground truth establishment are not applicable.

However, based on the provided text, the device's analytical performance and comparison studies can be summarized as follows:

1. A table of acceptance criteria and the reported device performance (for Analytical Performance):

The document refers to CLSI protocols for acceptance criteria, specifically for precision, linearity, and analytical specificity. The acceptance criteria themselves are generally implied by meeting the guidelines or by specific thresholds mentioned in conjunction with the results.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Precision (20-day): n=80 for each sample (Control Levels 1-3, Panels 1-8). Data generated at Fujirebio Diagnostics, Inc. (FDI).
• Precision (Lot-to-Lot Reproducibility): n=120 for each sample (Control Levels 1-3, Panels 1-6).
• Precision (Site-to-Site Reproducibility): n=120 for each panel (Control Levels 1-3, Panels 1-6). Performed at "several sites" (implied, typical for site-to-site reproducibility; specific sites or countries not mentioned).
• Linearity/Reportable Range: High and low sample pools created using patient serum samples. Number of samples not specified, but the study was "consistent with the guidelines in the CLSI Protocol EP6-A."
• Detection Limit (LoB/LoD/LoQ): Seven low-level specimens were tested over 3 days using two LUMIPULSE G1200 Systems and two Lumipulse G PCT lots, giving 120 determinations per panel for LoD. Number of unique samples for LoQ not specified, but involved "modeling analysis."
• Analytical Specificity (Interference): Human serum specimen pools (approximately 0.25 and 2.0 ng/mL PCT) supplemented with potentially interfering compounds. Number of individual samples not specified.
• Analytical Specificity (Cross-Reactivity): Human serum specimens (approximately 0.1, 0.25, 0.5, 2.0 and 80 ng/mL PCT) supplemented with potentially cross-reacting compounds. Number of individual samples not specified.
• Method Comparison: n=207 lithium heparin specimens.
• Expected Values/Reference Range: Population of 213 self-reported healthy individuals.

Data Provenance: The document does not explicitly state the country of origin for all patient samples or whether studies were retrospective or prospective, beyond "human serum," "patient serum samples," or "self-reported healthy individuals." The precision studies were conducted at "FDI" (Fujirebio Diagnostics, Inc. in Malvern, PA, USA) and "across several sites."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This is an immunoassay device for quantitative determination of Procalcitonin (PCT), where the "ground truth" is measured analytically by the device itself or compared to a predicate device. It does not involve human interpretation of images or other subjective data that would require expert consensus for ground truth.

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

Not applicable. As described above, this device is a quantitative immunoassay and does not involve human adjudication methods for its analytical performance or comparison studies.

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:

Not applicable. This is an in-vitro diagnostic device, not an AI/ML device, and does not involve human readers interpreting cases.

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

Not applicable. This is an in-vitro diagnostic device, not an AI/ML device. The performance data presented are for the analytical device itself.

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

For the analytical performance studies (precision, linearity, detection limits, specificity), the "ground truth" is typically defined by reference materials, spiked samples with known concentrations, or established analytical methods. For method comparison, the predicate device (B.R.A.H.M.S PCT sensitive KRYPTOR®) serves as the comparator. For establishing expected values, the measured PCT levels in a population of "self-reported healthy individuals" are used.

8. The sample size for the training set:

Not applicable in the context of AI/ML. For analytical performance, the samples used in the various studies (e.g., 20-day precision, lot-to-lot, site-to-site, linearity, detection limits, interference, cross-reactivity) are referred to as test samples or panels to evaluate the device's accuracy and reliability. There is no concept of a "training set" in the AI/ML sense for this type of IVD device.

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

Not applicable, as there is no "training set" in the AI/ML sense. The analytical performance is established through rigorous testing against reference materials and predicate devices following CLSI guidelines.

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