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DiaSys Procalcitonin FS assay is a particle enhanced immunoturbidimetric test intended for the quantitative in vitro determination of procalcitonin (PCT) in human serum and lithium heparin plasma on automated Abbott ARCHITECT c8000 analyzer.

Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids 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.

The TruCal Procalcitonin Calibrator Set is intended for in vitro use for calibration of the DiaSys Procalcitonin FS assay.

TruLab Procalcitonin Bi-Level Controls are an assayed quality control material for monitoring the performance of quantitative in vitro determination of Procalcitonin (PCT) for the DiaSys Procalcitonin FS assay.

For in vitro diagnostic use only.

The DiaSys Procalcitonin FS assay is a particle enhanced turbidimetric immunoassay (PETIA) test for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and lithium heparin plasma on automated photometric systems.

The test utilizes anti-human PCT polyclonal antibodies (goat) covalently bound to polystyrene particles.

PCT in the sample binds to the anti-PCT antibodies on the particles and causes agglutination. The degree of the turbidity caused by agglutination is optically measured at 660 nm by the automated photometric system and is proportional to the amount of PCT in the sample. DiaSys Procalcitonin FS Reagent specifies settings for an automated photometric analyzer, the Abbott ARCHITECT c8000.

The DiaSys TruCal Procalcitonin Calibrator Set is provided in 6 levels, traceable to a commercial assay for use in the calibration of the DiaSys Procalcitonin FS assay.

The DiaSys TruLab Procalcitonin Bi-Level Controls, Levels 1 (low) and 2 (high) are intended for use as quality control for the DiaSys Procalcitonin FS assay.

DiaSys PCT Calibrators and Bi-Level Controls are ready-to-use, stable, aqueous solutions containing recombinant human full-length PCT and biological additives from bovine origin.

Here's a breakdown of the acceptance criteria and study information for the DiaSys Procalcitonin FS assay, extracted and organized from the provided FDA 510(k) clearance letter:

Acceptance Criteria and Reported Device Performance

Study Details:

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

   • Precision/Reproducibility (Total Precision): 3 human serum samples, 3 human plasma samples.
   • Precision/Reproducibility (Within-run Precision): 5 human serum samples, 5 human plasma samples.
   • Linearity/Assay Reportable Range: Stock solutions assayed in quadruplicate.
   • Detection Limits (LOB, LOD, LOQ): Evaluated in human serum and plasma.
   • Interference: Human samples at approximate PCT concentrations of 0.5 and 2.0 ng/mL.
   • Specimen Stability: 15 human samples (serum and lithium heparin plasma).
   • Freeze-Thaw Cycle Stability: 15 human samples (serum and plasma).
   • Method Comparison (Study 1): 120 native patient samples.
   • Method Comparison (Study 2): 210 native patient samples.
   • Matrix Comparison: At least 20 native patient samples (serum and lithium heparin plasma).
   • Data Provenance: Not explicitly stated as retrospective or prospective, nor country of origin for patient/human samples. The nature of "native patient samples" generally implies retrospective analysis of collected clinical samples, but this is not definitively stated.

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

   • Not applicable for this type of in vitro diagnostic device (analyte measurement). The "ground truth" for the test set samples is typically established by reference methods or established values/concentrations for controls/calibrators, rather than expert clinical consensus.

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

   • Not applicable. This is an assay for quantitative measurement of an analyte. "Adjudication" typically refers to the process of multiple readers/experts reviewing images or clinical cases.

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:

   • No. This is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or clinical decision support system. The comparison studies are against a predicate device (another PCT assay), not human readers.

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

   • Yes, the performance listed in the table effectively represents the standalone performance of the DiaSys Procalcitonin FS assay when run on the automated Abbott ARCHITECT c8000 analyzer, without human intervention in the result generation itself. The results are quantitative measurements of the Procalcitonin analyte.

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

   • Analytical Performance: Ground truth is based on known concentrations of analytes in controls and calibrators, and comparative measurements against a legally marketed predicate device (VIDAS B.R.A.H.M.S. PCT ASSAY, K071146).
   • Clinical Efficacy/Impact: The device aids in risk assessment of critically ill patients for progression to severe sepsis and septic shock, "in conjunction with other laboratory findings and clinical assessments." This implies that the actual clinical "ground truth" (e.g., diagnosis of severe sepsis or septic shock, patient outcome) relies on a broader clinical picture, not solely on the PCT measurement. The study primarily focuses on analytical equivalence, not a direct measure of clinical outcomeprediction compared to a gold standard outcome.

7. The sample size for the training set:

   • The document primarily describes validation and verification studies for the device's analytical performance and equivalence to a predicate. It does not mention a "training set" in the context of machine learning or AI algorithm development, as this device appears to be a traditional IVD assay.

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

   • Not applicable, as there is no apparent "training set" in the machine learning sense. The device is a chemical reagent-based assay.

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The Cytovale IntelliSep test is a semi-quantitative test that assesses cellular host response via deformability cytometry of leukocyte biophysical properties and is intended for use in conjunction with clinical assessments and laboratory findings to aid in the early detection of sepsis with organ dysfunction manifesting within the first 3 days after testing. It is indicated for use in adult patients with signs and symptoms of infection who present to the Emergency Department. The test is performed on an EDTA anticoagulated whole blood sample.

The IntelliSep test generates an IntelliSep Index value that falls within one of three discrete interpretation bands based on the probability of sepsis with organ dysfunction manifesting within the first three days after testing. The IntelliSep test represents the probability of the clinical syndrome of sepsis and is intended to be used alongside other clinical information and clinical judgement. It does not identify the causative agent of infection and should not be used as the sole basis to determine the presence of sepsis. The IntelliSep test is intended for in vitro diagnostic use.

The Cytovale IntelliSep test is a short turn-around time (STAT) test, producing results in 10 minutes or less, to aid in the early detection of sepsis with organ dysfunction manifesting within the first 3 days after testing. It assesses the state of immune activation in patients with signs and symptoms of infection who present in the Emergency Department (ED).

The IntelliSep test is run on the Cytovale System, a laboratory benchtop analyzer depicted in Figure 1 and Figure 2.

To run a test, the laboratory operator transfers 100 uL of whole blood into the sample preparation tube which is then placed into the Cytovale System. The system automatically lyses red blood cells, and washes the purified leukocytes in a diluent, producing a total volume of approximately 1mL of prepared sample, which the operator then transfers to the IntelliSep cartridge for analysis on the Cytovale System. A microfluidic deformability cytometry technique is used to measure the biophysical properties of thousands of individual leukocytes in rapid succession. These properties have been shown to differ in quiescent white blood cell populations when compared to those in septic patients, enabling rapid assessment of the host response and the likelihood of having sepsis with organ dysfunction manifesting within the first 3 days after testing.

Based on these measurements, the test provides a single score, the IntelliSep Index (ISI), ranging from 0.1-10.0, stratified into three discrete interpretation bands (Band 2, Band 3) of increasing sepsis likelihood.

The provided document, K250513, focuses on a Special 510(k) submission for modifications to an already cleared device, the Cytovale IntelliSep test (K220991). As such, it does not detail a full clinical study with specific acceptance criteria and performance metrics for initial device clearance. Instead, it aims to demonstrate that the modifications made do not negatively impact the previously established performance of the device.

Therefore, the response below will describe the approach taken to prove the modifications meet the underlying performance requirements, rather than a new standalone clinical study with fresh acceptance criteria.

Key takeaway: The study proves that the modified device maintains identical analytical and clinical performance to the previously cleared device (K220991). The acceptance criteria, in this context, are implicitly tied to the performance claims and limitations established in the original K220991 clearance.

Acceptance Criteria and Study Proving Device Meets Criteria (for Modified Device)

Given that K250513 is a Special 510(k) for device modifications, the "acceptance criteria" here refer to demonstrating that the modified device performs identically to the original cleared device (K220991). The study's goal was to show non-inferiority and preservation of performance.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

The document explicitly states that "raw assay videos from the following performance studies were processed on both the modified device (K250513) and the baseline device (K220991)." This indicates that existing previously collected data from these studies served as the test set.

• Test Set Data Provenance:

  • IntelliSep Clinical Validation Study (CV-CLN-007): The original source of clinical data from K220991 clearance. The document does not specify the country of origin, but generally, clinical validation studies for FDA clearance are conducted in the United States or include diverse sites if international. It was a prospective study for the original clearance.
  • Within Laboratory Precision (CLSI EP05-A3): Data from analytical precision studies.
  • Reproducibility (CLSI EP05-A3): Data from analytical reproducibility studies.
  • Healthy Reference Range (CLSI EP28-A3C): Data for establishing a healthy population reference.
  • Sequestered Data Set: Processed on both devices for comparison. This implies a previously collected, retrospective dataset or a subset of data held separate from training/development.

• Sample Size for Test Set: The document does not specify the sample sizes for these re-analyzed datasets. It refers to the Decision Summary for K220991 for detailed performance claims and limitations, implying sample sizes for these studies would be found there. For a Special 510(k), the key is comparative performance on existing data, not necessarily new, large-scale clinical trials.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set in the context of this Special 510(k) re-analysis.

However, for the original K220991 clinical validation study (CV-CLN-007), the ground truth for sepsis with organ dysfunction would have been established by clinical experts based on:

• Standard clinical definitions (e.g., Sepsis-3 criteria).
• Review of electronic health records, lab findings, clinical assessments, and patient outcomes by qualified physicians (likely intensivists, emergency medicine physicians, or infectious disease specialists).
• This process would have involved their clinical judgment and interpretation of a comprehensive patient profile.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set used in this Special 510(k). This is because the study re-ran previously established data (raw assay videos) through the modified and unmodified systems and compared the device's output directly. The focus was on whether the device's results changed, not on re-evaluating the ground truth diagnoses.

For the original clinical validation study that established the ground truth (CV-CLN-007), it is highly likely that an adjudication process (e.g., by expert clinicians, 2+1 or 3+1 consensus on patient outcomes/diagnosis) was used to establish the gold standard for sepsis with organ dysfunction. However, this is not detailed in the K250513 document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No MRMC study was done or is described in this document. The IntelliSep test is an in vitro diagnostic (IVD) device that provides a quantitative index (IntelliSep Index) and an interpretation band. It is not an imaging AI system that aids human readers in interpretations. Its output is a score, not an image for human reading or analysis. Therefore, an MRMC study is not applicable to this type of device.

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

Yes, the primary evaluation for this device is standalone performance. The IntelliSep test is designed to generate an IntelliSep Index value and associated interpretation bands based on the biophysical properties of leukocytes. It's an automated measurement. For K250513, the core comparison was whether the modified algorithm/hardware produced the same ISI values and interpretation bands as the original algorithm/hardware when given the same raw data. The document explicitly states: "Raw assay videos from the following performance studies were processed on both the modified device (K250513) and the baseline device (K220991). The results were then directly compared to each other..." This confirms a standalone-like comparison of the device's output.

7. The Type of Ground Truth Used

For the foundational clinical performance validation (referenced from CV-CLN-007, originally for K220991), the ground truth for "sepsis with organ dysfunction manifesting within the first 3 days after testing" would have been established using expert consensus based on clinical assessments, laboratory findings, and patient outcomes data. This would align with standard clinical definitions of sepsis (e.g., Sepsis-3 criteria) and involved careful retrospective review of patient charts/records by clinicians and/or adjudication committees to determine the presence or absence of sepsis with organ dysfunction.

For the purpose of this Special 510(k), the "ground truth" was effectively the performance of the predicate device (K220991) on the re-analyzed data. The goal was to show that the modified device produced inputs/outputs identical to that ground truth.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set.

• The IntelliSep test's underlying algorithm (ISI calculation) and the deformability cytometry technique "remain unchanged from K220991." This suggests the core model was trained for the original K220991 submission.
• The modifications described in K250513 relate to software refinements (internal QC metrics, remote log export) and hardware changes (new IAM variant). These modifications would likely involve internal testing and verification/validation using previously established data or internal engineering samples, rather than a new "training set" in the machine learning sense, as the core algorithm itself was not re-trained.
• The comparison against a "sequestered data set" for internal quality control metrics indicates good machine learning practice, suggesting that if any internal model within the QC process was re-trained (which is not explicitly stated), this set would have been held out from that specific training.

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

Since the K250513 document does not describe new training, it relies on the previous K220991 submission. For the original development of the IntelliSep test (prior to K220991), the ground truth for training the algorithm would have been established through a similar process as the clinical test set: expert consensus based on clinical assessments, laboratory findings, and patient outcomes data according to established sepsis criteria. This clinical information would have been associated with the biophysical property measurements from the Cytovale system to enable the algorithm to learn the correlation between leukocyte deformability and sepsis severity/likelihood.

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The TriVerity test is an automated ve in vitro diagnostic test that measures the relative expression levels of host response genes in RNA isolated from whole blood collected in the PAXgene Blood RNA tube using reverse transcription loop-mediated isothermal amplification (RT-LAMP) on the Myrna instrument.

The TriVerity test is indicated for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial infections, viral infections, and non-infectious illness, as well as to determine the likelihood of 7day need for mechanical ventilation, vasopressors, and/or renal replacement with suspected acute infection or suspected sepsis presenting to the emergency department.

The test generates three scores that each fall within one of five discrete interpretation bands based on the increasing likelihood of

1. bacterial infection,

2. viral infection, and

3. severe illness, as defined by the need for mechanical ventilation, vasopressors, and/ or renal replacement therapy (RRT) within seven days.

The TriVerity test is an in vitro diagnostic test for simultaneous amplification and detection of 29 informative host response RNA transcripts and 3 housekeeping transcripts (listed in measurands) using total RNA extracted from human blood. The test has been designed, manufactured, and validated for use on the Myrna instrument. The TriVerity test is performed with a TriVerity cartridge, a single-use, disposable, multi-chambered fluidic cartridge that runs on the Myrna instrument. All processing steps are automated and occur within a TriVerity cartridge, including sample extraction/purification and qRT-LAMP for the detection and relative quantification of the 29 informative host response RNA transcripts and 3 housekeeping transcripts (listed in measurands). All cartridge steps in this process, following the addition of the sample, are fully automated and completely integrated. In approximately 30 minutes, the test generates three scores that each fall within one of five discrete interpretation bands based on the increasing likelihood of

• 1. bacterial infection,
• 2. viral infection, and
• 3. severe illness, as defined by the need for mechanical ventilation, vasopressors, and/or renal replacement therapy (RRT) within seven days.

The specimen used for the TriVerity test is a sample of whole blood collected by venipuncture using the PAXgene blood collection tubes within the PAXgene Blood RNA System (K042613). The cartridge contains all the necessary reagents to perform RNA isolation and subsequent amplification from the sample.

The TriVerity test quantifies the amount of each transcript in the sample based on the detection of fluorescence by the Myrna instrument. The cartridge includes the reagents for reverse transcription and LAMP. All 32 transcripts (and two in cartridge controls) are amplified and quantified. These values are input to two fixed classifiers which output the three separate scores, each with five discrete interpretation bands. The bands reflect monotonically increasing likelihood of bacterial infection, viral infection, and severe illness, as defined by the need for mechanical ventilation, vasopressors, and/or renal replacement therapy (RRT) within seven days.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the TriVerity device:

TriVerity Device Performance Study Summary

The TriVerity test is an automated in vitro diagnostic test that measures the relative expression levels of host response genes in RNA isolated from whole blood. It is indicated for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial infections, viral infections, and non-infectious illness, and to determine the likelihood of 7-day need for mechanical ventilation, vasopressors, and/or renal replacement therapy (RRT) in adult patients with suspected acute infection or suspected sepsis presenting to the emergency department. The device generates three scores (bacterial, viral, and severe illness) each falling within one of five discrete interpretation bands.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance in terms of accuracy metrics (PPA, NPA, Likelihood Ratios, AUROC) and analytical performance (reproducibility, linearity, analytical sensitivity, detection limits, analytical specificity). The acceptance criteria for clinical performance are primarily articulated through performance targets for the "Very Low" and "Very High" interpretation bands, aiming to minimize false negatives and false positives, respectively.

Acceptance Criteria for Clinical Performance (Qualitative, as stated):

• "Very Low" Band PPA ≥95%: Minimize false negative patients.
• "Very High" Band NPA ≥95%: Minimize false positive patients.
• Monotonicity: Likelihood ratios should monotonically increase across interpretation bands.
• Non-overlapping CIs: 80% CIs for likelihood ratios in non-adjacent bands should not overlap.

Note: "Very Low" (VL), "Low" (L), "Moderate" (M), "High" (H), "Very High" (VH). PPA (Positive Percent Agreement), NPA (Negative Percent Agreement), LR (Likelihood Ratio), AUROC (Area Under the Receiver Operating Characteristic curve).

2. Sample Sizes and Data Provenance

• Test Set (Clinical Study - SEPSIS-SHIELD; NCT04094818):
  • Total Consented: 1,441 participants.
  • Evaluable for Diagnostic Endpoint: 1,222 participants (for bacterial and viral infection differentiation).
  • Evaluable for Prognostic Endpoint: 1,120 participants (for severe illness prediction).
  • Provenance: Prospective, multi-center clinical study conducted in twenty-one geographically diverse locations throughout the United States plus one site in Europe.
  • Data Type: Clinical data and biological samples collected from participants with suspected acute infection or suspected sepsis presenting to the emergency department.

3. Number of Experts and Qualifications for Ground Truth

• The document mentions "consensus and forced clinical adjudication" for establishing ground truth for bacterial and viral infections, but it does not specify the number or qualifications of the experts involved in this adjudication process. This information is typically detailed in the study protocol or full clinical study report.

4. Adjudication Method

• Forced Adjudication: All patients were adjudicated as "Yes" and/or "Probable" vs. "No" and/or "Unlikely" for bacterial and viral infection.
• Consensus Adjudication: Only participants with a "certain (Yes or No)" infection status were included. This inherently excludes "Probable" and "Unlikely" cases, leading to a smaller, more definitive ground truth dataset. The document explicitly states that "higher accuracy results were observed when applying the consensus adjudication as the reference standard... due to the exclusion of participants with uncertain (Probable and Unlikely) bacterial infection status."

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

• No MRMC comparative effectiveness study was mentioned in this summary. The device is an in vitro diagnostic test that provides scores, not an AI-assisted diagnostic tool for human readers (e.g., radiology AI). The study focuses on the standalone performance of the device against clinical adjudication and compares its performance to traditional biomarkers (PCT, CRP, WBC, Lactate, qSOFA).

6. Standalone Performance

• Yes, standalone performance was done. The entire clinical study (SEPSIS-SHIELD) evaluates the diagnostic and prognostic performance of the TriVerity test on its own, providing scores that are interpreted by clinicians as an aid for diagnosis and prognosis. The device outputs scores, and its accuracy is measured against clinical ground truth.

7. Type of Ground Truth Used

• Expert Consensus/Clinical Adjudication: For bacterial and viral infection differentiation. This involves clinical assessment and other laboratory findings.
• Outcomes Data: For severe illness prediction, defined as the "need for mechanical ventilation, vasopressors, and/or renal replacement therapy (RRT) within seven days."

8. Sample Size for the Training Set

• The document states that "Illness Severity Score thresholds were set (tuned) using predicted probabilities and ground truths for 399 patient samples collected from Emergency Department settings."
• "Bacterial and Viral Score thresholds were tuned using predicted probabilities and ground truths for 472 patient samples collected from Emergency Department and ICU studies."
• These tuning studies were described as "independent from the final clinical study (INF-04)".

9. How Ground Truth for the Training Set was Established

• The ground truth for the training (tuning) sets was established using "predicted probabilities and ground truths" from patient samples collected from Emergency Department and ICU studies. While the document doesn't explicitly detail the method of ground truth establishment for these specific tuning sets (e.g., expert adjudication, culture results), it implies a similar clinical assessment as used for the test set, given they are designated as "ground truths." It also notes these samples were collected in PAXgene blood tubes and processed on the Myrna instrument using GMP-grade TriVerity cartridges, indicating they were real patient samples with associated clinical outcomes or diagnoses.

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The IVD CAPSULE PSP is a single-use, rapid in vitro diagnostic immunofluorescence assay for the semi-quantitative determination of the concentration of pancreatic stone protein (PSP) in human K2-EDTA (arterial and K3-EDTA (venous) anticoagulated whole blood.

The IVD CAPSULE PSP is to be used on the abioSCOPE in vitro diagnostic analyzer. This diagnostic test is used in conjunction with other clinical assessments and laboratory findings to aid in the early detection of sepsis manifesting within the first 3 days after testing. IVD CAPSULE PSP generates PSP values that fall within one of three discrete Interpretation bands based on increasing likelihood of sepsis.

The test is intended for professional use in clinical laboratory settings. It is indicated for use in adult patients at high risk of sepsis presenting to intensive care units (ICUs).

The IVD CAPSULE PSP is a single-use, semi-quantitative immunofluorescence assay used to determine the concentration of the pancreatic stone protein (PSP) in a human whole blood sample. The test kit contains the following components: Capsule, Special pipette (abioPIPETTE), Vial containing a detection reagent (abioMIX), Desiccant bag. The main component is the capsule, a high impact polystyrene plastic cartridge. The capsule allows dispensing the blood-abioMIX solution onto the loading port with a membrane separator. A second membrane drives the sample by capillary force to nanofluidic biosensors containing a read-out area where PSP is captured by specific antibodies and fluorescently detected. The concentration of captured PSP is proportional to the fluorescence generated by the fluorophore conjugated to the detection antibody. The capsule also contains an RFID tag programmed with biosensor configuration and lot-specific information.

The abioSCOPE is a tabletop diagnostic device that measures analytes in biological samples using test-specific capsules (IVD CAPSULE). It is operated through a high-resolution touchscreen. It is composed of a fully automated fluorescence microscope and a tray for the IVD CAPSULE. The abioSCOPE uses a laser to excite molecular complexes inside the biosensors, leading to fluorescence emission. The abioSCOPE then calculates the concentration of the analyte.

The acceptance criteria and the study proving the device meets these criteria are detailed as follows for the IVD CAPSULE PSP device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided focus on the clinical performance of the device, specifically its ability to classify patients into sepsis risk categories based on PSP concentrations.

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The SeptiCyte RAPID test is a gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood collected in PAXgene Blood RNA Tubes, K2-EDTA blood tubes, or K3-EDTA blood tubes. The SeptiCyte RAPID test is used in conjunction with clinical assessments and other laboratory findings as an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation in patients suspected of sepsis on their first day of ICU admission. The SeptiCyte RAPID test generates a score (SeptiScore) that falls within one of four discrete Interpretation Bands based on the increasing likelihood of infection-positive systemic inflammation. SeptiCyte RAPID is intended for in-vitro diagnostic use on the Biocartis Idylla System.

The SeptiCyte RAPID test is a gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood collected in PAXgene Blood RNA Tubes, K2-EDTA blood tubes, or K3-EDTA blood tubes. The SeptiCyte RAPID test is used in conjunction with clinical assessments and other laboratory findings as an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation in patients suspected of sepsis on their first day of ICU admission. The SeptiCyte RAPID test generates a score (SeptiScore) that falls within one of four discrete Interpretation Bands based on the increasing likelihood of infection-positive systemic inflammation. SeptiCyte RAPID is intended for in-vitro diagnostic use on the Biocartis Idylla System.

The provided document is a 510(k) clearance letter for the SeptiCyte RAPID device, but it does not contain the detailed acceptance criteria, study design, or performance data that would typically be found in a summary of safety and effectiveness or a clinical study report. Therefore, I cannot fully answer your request based only on the provided text.

However, I can extract information about the device's intended use and general context, and explain what kind of information would be needed to answer your questions if it were present.

Based on the provided text:

The document concerns the SeptiCyte RAPID device, a gene expression assay using reverse transcription polymerase chain reaction.

Intended Use: The SeptiCyte RAPID test is used:

• In conjunction with clinical assessments and other laboratory findings.
• As an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation.
• In patients suspected of sepsis on their first day of ICU admission.
• It generates a "SeptiScore" with four discrete Interpretation Bands indicating the increasing likelihood of infection-positive systemic inflammation.
• It's for in-vitro diagnostic use on the Biocartis Idylla System.

To answer your specific questions, the following information would be required from a more detailed submission document (e.g., 510(k) Summary of Safety and Effectiveness):

1. A table of acceptance criteria and the reported device performance

• This would typically include metrics like Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), and possibly AUC, along with the predefined acceptance thresholds for these metrics. The provided document does not include this table.

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

• The document does not specify the sample size for the test set or its provenance (country/retrospective/prospective).

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)

• The document does not provide details on ground truth establishment, expert number, or qualifications.

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

• The document does not describe an adjudication method.

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

• The SeptiCyte RAPID is described as a "gene expression assay" and not explicitly as an AI/CADe/CADx device that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is unlikely for this type of device, unless it has a human interpretation component, which is not evident here. The document does not mention an MRMC study or effect size.

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

• The SeptiCyte RAPID operates by quantifying gene expression to generate a "SeptiScore." This implies a standalone algorithmic assessment based on biological markers. The device is intended to be used "in conjunction with clinical assessments and other laboratory findings," suggesting it provides data for clinicians to interpret, rather than replacing clinical judgment. However, the performance of the device itself (its ability to differentiate sepsis) would be evaluated in a standalone manner. The document does not explicitly state a standalone study was done, but given the nature of the device, its core performance would be standalone.

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

• The document does not specify the type of ground truth used to establish reference for sepsis diagnosis in the study. For sepsis, ground truth is often clinical diagnosis based on a combination of criteria (e.g., Sepsis-3 definitions, physician review, culture results, organ dysfunction).

8. The sample size for the training set

• The document does not mention any details about a training set size.

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

• The document does not mention any details about how the ground truth for a training set was established.

In summary: The provided FDA clearance letter is a regulatory approval notice and lacks the detailed technical and clinical study information required to answer most of your questions. This detailed information would typically be found in the 510(k) "Summary of Safety and Effectiveness" document submitted by the manufacturer to the FDA.

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The MeMed BV test is an automated semi-quantitative immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatic serum and venous whole blood samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. MeMed BV is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients with suspected acute bacterial or viral infection, who have had symptoms for less than seven days. The MeMed BV test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection.

The MeMed BV® ("BV test" or the "test") is an In-Vitro-Diagnostic device that measures in parallel the blood concentrations of TRAIL, IP-10 and CRP. The test consists of an automated analyzer with built-in hardware and software that conduct chemiluminescence based analyte measurements of patient serum and venous whole blood samples and their computational integration (MeMed Key®), and a disposable cartridge that contains the reagents and controls needed to detect the analytes of interest (MeMed BV® cartridge). The test generates an answer to each sample, with a test run time of approximately 15 minutes.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for MeMed BV:

The MeMed BV test is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection in patients presenting to the emergency department or urgent care center, or with samples collected at hospital admission, who have had symptoms for less than seven days. The device generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary details various analytical performance studies and a clinical study to support the expanded indications for use. Key acceptance criteria and reported performance include:

3. Absolute bias

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The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids 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.

The Access PCT assay is a paramaqnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids 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. A description of the reagent pack is provided below.

• R1a: Dynabeads* paramagnetic particles coated with mouse anti-. human Procalcitonin monoclonal antibody in a TRIS buffer with surfactant, protein (bovine), ≤ 0.1% sodium azide, and 0.1% ProClin**300
• R1b: 0.10 N Sodium Hydroxide ●
• R1c: MOPS Buffer with surfactant and protein (bovine, murine), ≤ ● 0.1 % sodium azide, and 0.1% ProClin 300
• R1d: Rat anti-Procalcitonin recombinant alkaline phosphatase . coniugate in a MOPS buffer with surfactant and protein (bovine, murine, recombinant).
  ≤ 0.1% sodium azide, and 0.1% ProClin 300

The device in question is the Access PCT Assay for the Dxl 9000 Access Immunoassay Analyzer, used for the in vitro quantitative determination of procalcitonin (PCT) levels. The study presented aims to demonstrate its substantial equivalence to the previously cleared Access PCT Assay on the Access 2 Immunoassay System (K192271).

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state the specific sample sizes used for each test (e.g., method comparison, imprecision, linearity). It also does not specify the country of origin of the data or whether the data was retrospective or prospective. It states "The study" for imprecision and linearity, suggesting a single study per characteristic. The "Method Comparison" and "Method Concordance" imply patient samples were used to compare results between the new device and the predicate.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is an in vitro diagnostic immunoassay measuring procalcitonin levels. Ground truth is established through analytical validation and comparison to an established predicate device, not through expert review of interpretations.

4. Adjudication Method

Not applicable. As this is an analytical performance study for an immunoassay, adjudication methods typically used for qualitative or imaging-based diagnostics by human readers are not relevant.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic tools where human interpretation is involved. The Access PCT assay is an automated immunoassay.

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

Yes, the studies described represent the standalone performance of the Access PCT assay on the Dxl 9000 Analyzer. The tests (method comparison, imprecision, linearity, LoB, LoD, LoQ) evaluate the analytical performance of the device itself, independent of human interpretation or interaction beyond standard laboratory procedures.

7. Type of Ground Truth Used

The ground truth or reference for comparison in this submission is the measurements obtained from the previously cleared Access PCT assay on the Access 2 Immunoassay System (K192271). For analytical precision, linearity, and limits of detection/quantitation, the "ground truth" is defined by established analytical methods and statistical calculations following guidelines like CLSI EP17-A2.

8. Sample Size for the Training Set

Not applicable. This device is an immunoassay, not an AI/Machine Learning algorithm that undergoes a "training" phase with a specific dataset. Its performance is based on the chemical and biological reactions designed within the assay.

9. How Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the context of this immunoassay. The development of the assay involves optimization of reagents and protocols, but not in the sense of supervised learning from a labeled dataset. The reference for comparison is the predicate device's performance.

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The MeMed BV test is an automated semi-quantitative immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The MeMed BV is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients with suspected acute bacterial or viral infection, who have had symptoms for less than seven days. The MeMed BV test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection.

The Med BV® ("BV Test" or the "Test") is an In-Vitro-Diagnostic device that measures in parallel the blood concentrations of TRAIL, IP-10 and CRP. The Test consists of an automated analyzer with built-in hardware and software that conduct chemiluminescencebased analyte measurements of patient serum samples and their computational integration (MeMed Key®), and a disposable cartridge that contains the reagents and controls needed to detect the analytes of interest (MeMed BV® cartridge). The Test generates an answer to each sample, with a test run time of approximately 15 minutes.

The provided text is a 510(k) Summary for a modified medical device, the MeMed BV. It describes the device, its intended use, technological characteristics, and a comparison to a previously cleared predicate device. However, it explicitly states that the purpose of this specific 510(k) notice is for a modification to the already cleared device, primarily concerning an alternative manufacturing process for a component (Antibody-Alkaline Phosphatase conjugation chemistry) and a new buffer formulation.

The document does not provide detailed acceptance criteria or the full study findings that would typically be presented for a de novo clearance or a 510(k) for a novel device. Instead, it refers to prior studies for the original cleared device and asserts that the modified device's performance is equivalent.

Therefore, many of the requested details about acceptance criteria, detailed study results, sample sizes, ground truth establishment, and expert involvement are not present in the provided document for this specific submission (K222332). The document focuses on demonstrating that the modification does not negatively impact the performance, based on studies referencing the original device's validation.

Here's a breakdown of what can be extracted and what is missing:

1. Acceptance Criteria and Reported Device Performance

The document states: "The modified version of the MeMed BV has been tested according to the methods, protocols, and acceptance criteria used to support the previously 510(k)-cleared device. These methods apply to the device that is the subject of this Special 510(k) and were used in verification and validation ("V&V") of the modifications. The studies tested the performance of the measurement procedure for each individual measurand - CRP, IP-10, and TRAIL, as well as the performance of the measurement procedure for the MeMed BV® test score that is based on the computational integration of the three measurands. Testing included precision/reproducibility, LoQ, linearity, hook effect, interference/cross-reactivity, and method comparison testing. All testing indicated equivalent performance to the 510(k)-cleared MeMed BV."

This document does not list the specific numerical acceptance criteria or detailed results for performance metrics like sensitivity, specificity, or AUC as it is a Special 510(k) for a modification, not an initial clearance. It merely states that the modified device's performance was equivalent to the previously cleared predicate device, and the types of tests conducted for V&V.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on the specific sample sizes used for the test set or the data provenance (country of origin, retrospective/prospective). It refers to the validation done for the previously cleared device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide details on the number or qualifications of experts used to establish ground truth because it's a submission for a modification, not a de novo clearance. Ground truth would have been established during the original device's clearance.

4. Adjudication Method for the Test Set

The document does not provide details on any adjudication method.

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

The document does not mention or describe an MRMC comparative effectiveness study or any effect size related to human readers improving with AI vs. without AI assistance. The MeMed BV is an in-vitro diagnostic (IVD) device measuring biomarkers, not an AI imaging or diagnostic algorithm designed to assist human readers in image interpretation.

6. Standalone (Algorithm Only) Performance Study

The document describes the device as an "automated semi-quantitative immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP)... The MeMed BV test generates a numeric score that falls within discrete interpretation bins." This indicates it is a standalone algorithm in the sense that it processes the biomarker measurements and outputs a score. However, it's not a standalone AI performance study in the context of, for example, a diagnostic imaging algorithm being compared to expert interpretation. It's a measurement technology combined with a computational integration.

The performance studies mentioned ("precision/reproducibility, LoQ, linearity, hook effect, interference/cross-reactivity, and method comparison testing") are typical for standalone IVD device performance.

7. Type of Ground Truth Used

The document indicates the device "is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection." This strongly implies that the ground truth for the original validation studies would have been established based on clinical diagnoses, confirmed microbiological cultures/PCR, and a thorough review of patient outcomes and medical records by expert clinicians. However, the exact methodology for ground truth establishment for the original device is not detailed in this document.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. As this is an IVD device and not explicitly an AI/machine learning model where "training sets" are typically discussed, this information might not be presented in this format, or it would have been part of the original device's clearance. The "computational integration" aspect implies an algorithm, but training details are not given.

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

Similarly, the document does not provide any information on how the ground truth for any training set was established.

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The Cytovale IntelliSep test is a semi-quantitative test that assesses cellular host response via deformability cytometry of leukocyte biophysical properties and is intended for use in conjunction with clinical assessments and laboratory findings to aid in the early detection of sepsis with organ dysfunction manifesting within the first 3 days after testing. It is indicated for use in adult patients with signs and symptoms of infection who present to the Emergency Department. The test is performed on an EDTA anticoagulated whole blood sample.

The IntelliSep test generates an IntelliSep Index value that falls within one of three discrete interpretation bands based on the probability of sepsis with organ dysfunction manifesting within the first three days after testing. The IntelliSep test represents the probability of the clinical syndrome of sepsis and is intended to be used alongside other clinical information and clinical judgement. It does not identify the causative agent of infection and should not be used as the sole basis to determine the presence of sepsis. The IntelliSep test is intended for in vitro diagnostic use.

The Cytovale IntelliSep test is a short turn-around time (STAT) test, producing results in 10 minutes or less, to aid in the early identification of patients at risk for having or developing sepsis within three (3) days of testing. It assesses the state of immune activation in patients with clinical suspicion of infection who present in the Emergency Department (ED).

The IntelliSep test is run on the Cytovale System, a laboratory benchtop analyzer depicted in Figure 1. The Cytovale System is a closed system benchtop analyzer, comprised of three modules: Sample Preparation Module, Cell Imaging Module, and Imaging Analysis Module.

To run a test, the laboratory operator transfers 100 µL of whole blood into the sample preparation tube which is then placed into the Cytovale System. The system automatically lyses red blood cells, and washes the purified leukocytes in a diluent, producing a total volume of approximately 1mL of prepared sample, which the operator then transfers to the IntelliSep cartridge for analysis on the Cytovale System.

A microfluidic deformability cytometry technique is used to measure the biophysical properties of thousands of individual leukocytes in rapid succession. These properties have been shown to differ in quiescent white blood cell populations when compared to those in septic patients, enabling for rapid assessment of the host response and the likelihood of having or developing sepsis. Based on these measurements, the test provides a single score, the IntelliSep Index (ISI), ranging from 0.1-10.0, stratified into three discrete interpretation bands (Band 1, Band 2, Band 3) of sepsis likelihood.

Here's a breakdown of the acceptance criteria and study details for the Cytovale IntelliSep test, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly state pre-defined quantitative acceptance criteria in a pass/fail format for clinical performance endpoints (e.g., a specific PPV or likelihood ratio threshold). Instead, it focuses on demonstrating a clear relationship between the IntelliSep Index (ISI) and the likelihood of sepsis, and the statistical distinctness of the interpretation bands. For analytical performance, criteria are generally established for standard deviations within precision studies and confidence intervals for reproducibility and carry-over.

Here's a table summarizing the reported device performance, categorized by the relevant studies:

Clinical Performance

Implicit Acceptance Criterion: A clear relationship between ISI and the increasing likelihood of sepsis, and statistically distinct interpretation bands (non-overlapping 80% confidence intervals between bands).

Note: The clinical study explicitly states: "It is important to note that the algorithm for calculating the ISI ranges for the interpretation bands were defined based on prior sepsis-focused studies. No information from patients in this study influenced the calculations or interpretation bands of the ISI." and "Irrespective of the comparator scheme chosen, the probability of sepsis in the three ISI IntelliSep test Interpretation Bands was statistically distinct, defined as non-overlapping 80% confidence intervals between the bands." This suggests the demonstration of statistically distinct bands with appropriate clinical trends was the primary clinical performance criterion.

Analytical Performance

Study Details

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

   • Test Set Sample Size: 572 evaluable subjects were included in the primary analyses for clinical performance.
   • Data Provenance: The study was a "blinded, prospective, observational, multicenter cohort study" conducted at five hospitals at four geographically dispersed sites in the United States. The subjects were "representative of the adult population (≥ 18 years of age) typical of those presenting to EDs across the United States."

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

   • Number of Experts: A multi-tiered adjudication process was used:
     • Initially, two independent adjudicators reviewed each case.
     • If there was disagreement, a third adjudicator was involved in a consensus meeting.
   • Qualifications of Experts: Physicians with board certification in Medical or Surgical Critical Care (CC), Infectious Diseases (ID), Emergency Medicine (EM), or Internal Medicine (IM) or related fields, from different institutions. They were not participating as an Investigator in the Study.

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

   • The adjudication method was 2+1 (two independent adjudicators, with a third used for arbitration in case of disagreement).
   • Outcomes were categorized as 'unanimous' (both initial adjudicators agreed), 'consensus' (third adjudicator facilitated agreement), or 'forced' (majority two out of three if consensus couldn't be reached). The performance data is presented for all three schemes (forced, consensus, unanimous).

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:

   • No, an MRMC comparative effectiveness study was not explicitly stated or performed. The study evaluated the IntelliSep test as an aid in conjunction with clinical assessments and laboratory findings, but it did not directly compare human reader performance with and without AI assistance (i.e., IntelliSep test results). The test provides a quantitative index and interpretation bands, not an image for interpretation by human readers.

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

   • Yes, a standalone performance evaluation was done. The IntelliSep test generates an "IntelliSep Index" (ISI) automatically from the measured biophysical properties of leukocytes. The clinical performance section directly assesses the predictive values and likelihood ratios of this automatically generated ISI, independent of real-time human interpretation during the study (treating physicians were unaware of study enrollment and IntelliSep test results). The test is intended for use in conjunction with clinical assessments, but its performance metrics are derived from the algorithm's output itself.

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

   • The ground truth was established through retrospective physician adjudication based on consensus definitions for Sepsis-2 and Sepsis-3. This involved a multi-tiered process by qualified physicians:
     • Collection of detailed patient information (demographics, labs, vitals, medical history, hospital encounter, infectious disease, medications, discharge disposition, SOFA scores, clinical impression).
     • Compilation into a Case Report Summary (CRS).
     • Review by independent adjudicators with arbitration for discordant results.
   • It's a form of expert consensus based on clinical data.

7. The sample size for the training set:

   • The document states: "It is important to note that the algorithm for calculating the ISI ranges for the interpretation bands were defined based on prior sepsis-focused studies. No information from patients in this study influenced the calculations or interpretation bands of the ISI."
   • This implies the training of the algorithm and definition of interpretation bands occurred prior to and separate from this specific clinical validation study. The sample size for the training set is not provided in this document.

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

   • Similar to the point above, the document only mentions that the ISI algorithm and interpretation bands were "defined based on prior sepsis-focused studies."
   • The method for establishing ground truth for those prior training studies is not detailed in this document.

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The Dimension® EXL™ LOCI® BRAHMS Procalcitonin (PCT) assay is an in vitro diagnostic test for the quantitative measurement of procalcitonin in human serum and plasma (lithium heparin, K2EDTA, and K3EDTA) using the Dimension® EXL™ integrated chemistry system with LOCI® Module.

The Dimension EXL LOCI® BRAHMS PCT assay is intended for use in conjunction with other laboratory findings and clinical assessments, 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.

• 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 percentage change in PCT levels over time.

· 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.

· Decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.

The Dimension EXL LOCI BRAHMS PCT assay is a homogeneous sandwich chemiluminescent immunoassay based on LOCI technology. The LOCI reagents include two synthetic bead reagents and one biotinylated anti-procalcitonin (anti-PCT) monoclonal antibody. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitizer dye. The second bead reagent (Chemibeads) is coated with two anti-PCT monoclonal antibodies and contains chemiluminescent dye. Sample is incubated with biotinylated antibody and Chemibeads to form bead-PCT-biotinylated antibody sandwiches. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the procalcitonin (PCT) concentration in the sample.

The provided document describes the performance characteristics of the Dimension® EXL™ LOCI® BRAHMS Procalcitonin (PCT) assay and its equivalence to a predicate device.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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