Search Results

For VIDAS H. pylori IgG:
VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on the instruments of the VIDAS family, for the detection of anti-Helicobacter pylori IgG antibodies in human serum or plasma (EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS HPY assay is intended as an aid in diagnosis of H. pylori infection in an adult symptomatic population.
This device is an in vitro diagnostic medical device for professional use only.

For VIDAS 3:
The VIDAS 3 system is a complete standalone immunodiagnostic system intended for trained and qualified laboratory technicians (daily routine use) and laboratory administrators (application configuration). This device is an in vitro diagnostic medical device for professional use only.

For VIDAS Lyme IgG II:
The VIDAS Lyme IgG II (LYG) assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum (plain or separation gel) or plasma (sodium heparin). It should be used to test patients with a history and/or symptoms of infection with B. burgdorferi. All VIDAS Lyme IgG II positive specimens should be further tested with a Western Blot IgG assay to obtain supportive evidence of infection with B. burgdorfei. This device is an in vitro diagnostic medical device for professional use only.

For VIDAS RUB IgG:
The VIDAS® RUB IgG (RBG) assay uses Enzyme Linked Fluorescent Assay (ELFA) technology on the instruments of the VIDAS family for the in vitro quantitative measurement of IgG antibodies to rubella virus in human serum. The VIDAS RUB IgG (RBG) assay is intended as an aid in the determination of immune status to rubella. The performance of this device has not been established for screening of cord blood, or for neonatal samples. Likewise, performance characteristics of the assay have not been established for immunocompromised or immunosuppressed individuals.
This device is an in vitro diagnostic medical device for professional use only.

For VIDAS TOXO IgM:
The VIDAS® TOXO IgM (TXM) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated enzyme-linked fluorescent immunoassay (ELF A) for the presumptive qualitative detection of anti-Toxoplasma gondii IgM antibodies in human serum, as an aid in the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection. This assay must be performed in conjunction with an anti-Toxoplasma gondii lgG antibody assay. VIDAS TOXO IgM (TXM) assay performance has not been established for prenatal screening or newborn testing. This assay has not been cleared by the FDA for blood/plasma donor screening. This device is an in vitro diagnostic medical device for professional use only.

For VIDAS Human Chorionic Gonadotropin:
The VIDAS® HCG (HCG) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyme linked fluorescent immunoassay (ELFA) for the determination of human Chorionic Gonadotropin (hCG) concentration in human serum or plasma. The VIDAS HCG (HCG) assay is intended to aid in the early detection of pregnancy.
This device is an in vitro diagnostic medical device for professional use only.

For VIDAS T4:
The VIDAS® T4 (T4) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyme-linked fluorescent immunoassay for the determination of human thyroxine (T4) concentration in serum or plasma (heparin). It is intended for use as an aid in the diagnosis and treatment of thyroid disorders. This device is an in vitro diagnostic medical device for professional use only.

For VIDAS Testosterone:
The VIDAS Testosterone (TES) assay is an automated quantitative test for use on the instruments of the VIDAS family for the enzyme immunoassay measure of total testosterone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay). It is intended as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
This device is an in vitro diagnostic medical device for professional use only.

For VIDAS TSH:
The VIDAS® TSH (TSH) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyne-linked fluorescent immunoassay (ELFA) for the determination of human thyroid stimulating hormone- (TSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of thyroid or pituitary disorders.
This device is an in vitro diagnostic medical device for professional use only.

For VIDAS D-Dimer Exclusion II:
VIDAS® D-Dimer Exclusion II™ is an automated quantitative test for use on the instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products (FbDP) in human plasma (sodium citrate, CTAD) using the ELFA technique (Enzyme Linked Fluorescent Assay).
VIDAS D-Dimer Exclusion II is indicated for use in conjunction with a clinical pretest probability assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) disease in outpatients suspected of DVT or PE. This device is an in vitro diagnostic medical device for professional use only.

The VIDAS® 3 instrument is an automated multiparametric immunoassay system, which uses ELFA (Enzyme Linked Fluorescent Assay) technology. The VIDAS 3 system offers primary tube sampling, automated sample dilution, reagent/sample detection and reagent traceability.
The technology used, which is adaptable to a wide range of assays, combines the EIA method with a final fluorescence reading: this technology is known as ELFA (Enzyme Linked Fluorescent Assay). The enzyme used in the VIDAS product range is alkaline phosphatase, which catalyzes the hydrolysis of the substrate 4-methyl umbelliferyl phosphate (4-MUP) into a fluorescent product 4-methyl umbelliferone (4-MU) the fluorescence of which is measured at 450nm. The immunological methods are either indirect ElA, immunocapture, sandwich or competition, all involving a conjugate using the alkaline phosphatase.

This document describes the performance data for several VIDAS assays when used on the VIDAS 3 instrument, comparing them to their performance on the predicate VIDAS instrument. The tests are primarily for establishing substantial equivalence for the new VIDAS 3 instrument and do not typically include detailed acceptance criteria for the assays themselves, which are already established for the predicate devices. The studies focus on method comparison, precision, linearity, and detection limits.

Here's a breakdown of the requested information based on the provided text, focusing on the VIDAS H. pylori IgG assay as a primary example, and generalizing for others where appropriate:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative format for method comparison. Instead, it demonstrates "correlation" and "equivalency" between the new device (VIDAS 3) and the predicate device (VIDAS). For precision, specific CV% ranges are reported.

Here's an example for the VIDAS H. pylori IgG assay's method comparison:

Note: For quantitative assays like VIDAS RUB IgG, VIDAS HCG, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II, method comparison relies on slope, intercept, and correlation coefficient, implying acceptance criteria for these values (e.g., slope close to 1, intercept close to 0, high correlation coefficient). Precision for these assays also includes CV% for various components.

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

• VIDAS H. pylori IgG:

  • Test Set Size: 250 serum samples (positive, equivocal, and negative).
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The study compares performance between two instruments, implying samples are run on both.

• VIDAS Lyme IgG II:

  • Test Set Size: 220 serum samples (positive and negative).
  • Data Provenance: Not explicitly stated.

• VIDAS RUB IgG:

  • Test Set Size (Quantitative Method Comparison): 112 serum samples (ranging from 0 to 225 IU/mL).
  • Test Set Size (Qualitative Method Comparison): 220 serum samples (positive, equivocal, and negative).
  • Test Set Size (CDC Reference Panel): 100 specimens (50 pairs of sera).
  • Data Provenance: Not explicitly stated for general samples. The CDC panel implies a curated and standardized set.

• VIDAS TOXO IgM:

  • Test Set Size: 198 serum samples.
  • Data Provenance: Not explicitly stated.

• VIDAS Human Chorionic Gonadotropin (hCG):

  • Test Set Size: 113 serum samples.
  • Data Provenance: Not explicitly stated.

• VIDAS T4:

  • Test Set Size: 105 serum samples.
  • Data Provenance: Not explicitly stated.

• VIDAS Testosterone:

  • Test Set Size: 172 serum samples.
  • Data Provenance: Not explicitly stated.

• VIDAS TSH:

  • Test Set Size: 179 serum samples.
  • Data Provenance: Not explicitly stated.

• VIDAS D-Dimer Exclusion II:

  • Test Set Size: 219 plasma samples.
  • Data Provenance: Not explicitly stated.

Across all assays, the studies are described as "Method Comparison" and "Precision" studies, which are typically retrospective analyses of patient samples to compare device performance to an established method.

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

This information is not provided in the document. For in vitro diagnostic devices, ground truth is typically established by comparative methods (e.g., predicate device, reference methods, clinical diagnosis, or other laboratory gold standards) rather than expert consensus on individual cases. The document states that performance was evaluated against the predicate device (e.g., "VIDAS H. pylori IgG assay on the VIDAS 3 to the VIDAS H. pylori IgG assay on the VIDAS"). The "ground truth" for these studies is the result obtained from the predicate VIDAS instrument using its established methodology.

For the VIDAS RUB IgG, a "CDC reference panel" and "CDC low-titer rubella antibody standard" are mentioned, where the reference panel sera were "titered by Hemagglutination Inhibition." This implies that the ground truth for this specific part of the study was established by a recognized reference method (Hemagglutination Inhibition) and certified reference materials from the CDC.

4. Adjudication Method for the Test Set

This information is not explicitly provided. For method comparison studies, typically, discordant results between the new device and the predicate device (or reference method) are investigated. However, the exact adjudication process (e.g., by a third, more definitive test, or expert review of patient clinical history) is not detailed. The phrase "results were evaluated according to CLSI EP12-A2" or CLSI EP9 suggests standard statistical methods for agreement or correlation, which do not necessarily involve expert adjudication of individual discrepancies beyond reporting them.

For quantitative assays where method comparison statistics (slope, intercept, correlation coefficient) are used, "outliers" were removed in some cases (e.g., VIDAS RUB IgG quantitative comparison), implying some form of review or statistical exclusion, but not necessarily expert "adjudication" in the sense of clinical decision-making.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes performance studies for in vitro diagnostic instruments and assays, not imaging or similar devices that would typically involve human readers interpreting results. Therefore, an MRMC comparative effectiveness study, which assesses improvements in human interpretation with AI assistance, is not applicable and was not performed.

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

The studies described are for the standalone in vitro diagnostic instruments and their associated assays. These are standalone tests, meaning the algorithm (or assay chemistry in this case) processes the sample and provides a result without direct human interpretation of raw data for diagnosis. The "human-in-the-loop" here refers to trained laboratory technicians operating the instrument and interpreting the final quantitative or qualitative results according to established cut-offs/guidelines, rather than interpreting complex images or signals. The purpose of these studies is to confirm that the new instrument (VIDAS 3) produces equivalent results to the predicate instrument (VIDAS) for these assays.

7. The Type of Ground Truth Used

The primary type of "ground truth" used in these studies is the results obtained from the predicate device (VIDAS instrument) for the same assays. The goal is to demonstrate "substantial equivalence" of the new instrument (VIDAS 3) to the predicate.

For the VIDAS RUB IgG assay, a CDC reference panel where samples were "titered by Hemagglutination Inhibition" served as an additional, external reference for ground truth in a specific subset of testing. This is a form of reference method/standardized panel data.

8. The Sample Size for the Training Set

This information is not explicitly provided in the document. For in vitro diagnostic assays, "training sets" are usually involved in the initial development and optimization of the assay itself (e.g., establishing reagents, parameters, cut-offs). The studies described in this document are focused on the validation and verification of the new instrument's performance with existing, already developed assays, often referred to as "test sets" or "evaluation sets." The assays themselves were presumably developed and "trained" using various sample sets prior to these studies.

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

Since information on a distinct "training set" for the new instrument's validation isn't provided (as the assays were pre-existing), details on its ground truth establishment are also not available in this document. For the development of the original assays, ground truth would have been established through a combination of clinical diagnoses, established reference methods, and correlation with disease status.

Ask a specific question about this device

ACL AcuStar: Automated immunoassay analyzer designed specifically for in vitro diagnostic use in a clinical laboratory. The assay analysis is based on chemiluminescent technology. The system provides results for both direct measurements and calculated parameters.
HemosIL AcuStar D-Dimer: Fully automated chemiluminescent immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL AcuStar as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) and pulmonary embolism (PE)].
HemosIL AcuStar D-Dimer Controls: For the quality control of D-Dimer assay performed on the ACL AcuStar.

ACL AcuStar: The AcuStar is an automated, bench-top system for lab use that measures the analyte amount in blood samples by: Subjecting the blood sample to reagents that cause a reaction with an antigen or antibody in the sample. Placing the cuvettes in a controlled environment to allow the reactants to bind into a complex. Separating out the complex from unused reactants. Treating this complex with a chemical that produces light in proportion to the analyte concentration. Measuring the light output to determine the amount of antibodies or antigens that were in the sample.

HemosIL AcuStar D-Dimer: The HemosIL AcuStar D-Dimer assay is a two-step immunoassay to quantify D-Dimer in human citrated plasma using magnetic particles as solid phase and a chemiluminescent detection system. In the first step, sample, anti-D-Dimer antibody coated magnetic particles, and assay buffer are combined, and the fibrin soluble derivatives containing the D-Dimer domain present in the sample bind to the anti-D-Dimer antibody coated magnetic particles. After magnetic separation and washing, an anti-XDP antibody labeled with isoluminol is added and incubated in a second step. After a new magnetic separation and washing, two triggers are added and the resulting chemiluminescent reaction is measured as relative light units (RLUs) by the ACL AcuStar optical system. The RLUs are directly proportional to the D-Dimer concentration in the sample. The ACL AcuStar D-Dimer assay utilizes a 4 Parameter Logistic Curve (4PLC) fit data reduction method to generate a Master Curve. The Master Curve is predefined lot dependent, and is stored in the instrument through the cartridge barcode. With the measurement of calibrators, the predefined Master Curve is transformed to a new, instrument specific 4PLC Working Curve. The concentration values of the calibrators are included in the calibrator plastic tube barcodes.

HemosIL AcuStar D-Dimer Controls: The Low, High, and Very High D-Dimer Controls are prepared by means of a dedicated process and contain different concentrations of partially purified D-Dimer obtained by digestion of Factor XIIIa cross-linked human fibrin with human plasmin.

Here's a breakdown of the acceptance criteria and the study details for the ACL™ AcuStar™ HemosIL™ AcuStar™ D-Dimer, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The VIDAS® D-Dimer Exclusion assay is an automated quantitative test for use on The VIDAS analyzers for the immunoenzymatic determination of fibrin degradation products (I oDT ) in chrated namal passant as as agent is indicated for Linked Probection with a clinical Pre-test Probability Assessment (PTP) assessment ace in confusionel was venous thrombosis (DVT) and pulmonary embolism (PE) in outpatients suspected of DVT or PE.

The VIDAS® D-Dimer New (DD2) Assay is an automated quantitative test for use on the VIDAS instrument (K891385) for the immunoenzymatic determination of fibrin degradation products (FbDP) in human plasma using the enzyme-linked fluorescent immunoassay (ELFA) technique. The instrument controls all assay steps and assay temperatures. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR), serves as the solid phase as well as a pipettor for the assay. Reagents for the assay are ready-to-use and pre-dispensed in the sealed DD2 Reagent Strips.

This is a summary of the acceptance criteria and study findings for the VIDAS D-Dimer New Assay.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the observed performance in the clinical study, particularly the 100% Negative Predictive Value (NPV) and high sensitivity, which are critical for an exclusion assay. The study aims to demonstrate that the device is effective in ruling out DVT and PE.

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

• Sample Size:

  • Overall: 965 PE suspected patients
  • Low and Intermediate Pre-test Probability: 891 patients
  • High Pre-test Probability: 74 patients
  • Site 1 (Angers University Hospital, France): 284 patients
  • Site 2 (Geneva University Hospital, Switzerland): 430 patients
  • Site 3 (University Hospital, Lausanne, Switzerland): 251 patients

• Data Provenance: Three-site prospective patient management study conducted in:

  • Angers University Hospital, Angers, France
  • Geneva University Hospital, Geneva, Switzerland
  • University Hospital, Lausanne, Switzerland

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test set. However, a "clinical Pre-test Probability Assessment (PTP) model" is mentioned as being used in conjunction with the assay, implying clinical evaluation by medical professionals. For DVT/PE diagnosis, the ground truth typically involves a combination of imaging studies (e.g., CT pulmonary angiography, ventilation-perfusion scan for PE; ultrasound for DVT) and clinical assessment.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for establishing the ground truth diagnoses of PE for the test set.

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

No MRMC comparative effectiveness study is mentioned. This study focuses on the standalone performance of the VIDAS D-Dimer assay in conjunction with a PTP model for DVT/PE exclusion, not on comparing human readers with and without AI assistance.

6. Standalone Performance

Yes, a standalone performance study was conducted. The reported metrics (Sensitivity, Specificity, NPV, PPV) are for the VIDAS D-Dimer New Assay itself, in conjunction with a clinical Pre-test Probability Assessment.

7. Type of Ground Truth Used

The ground truth for the presence or absence of DVT/PE is implicitly clinical diagnosis, likely established through standard diagnostic protocols for DVT and PE (e.g., imaging, clinical probability scores, and follow-up). The prevalence of PE is reported, indicating confirmed diagnoses.

8. Sample Size for the Training Set

The document does not provide information on a specific "training set" sample size. The performance data presented is from a clinical validation study (test set). For an immunoassay like this, the device itself is not "trained" in the same way a machine learning algorithm is. Its performance characteristics are determined by its chemical and biological detection mechanism, which would have been developed and validated internally by the manufacturer, but details of that development (e.g., sample sizes for assay development or internal validation) are not included in this 510(k) summary.

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

As mentioned above, the concept of a separate "training set" with ground truth in the context of an immunoassay is not directly applicable in the same way it is for AI/ML devices. The assay's analytical performance and cutoff values would have been established through laboratory studies during development using known positive and negative samples, but these details are not provided in this regulatory submission.

Ask a specific question about this device

VIDAS® D-Dimer New is an automated, quantitative test for use on the VIDAS analyzer for the immunoenzymatic determination of cross-linked fibrin degradation products (FbDP) containing the D-dimer domain in citrated human plasma using the Enzyme Linked Fluorescent Assay (ELFA) technique. VIDAS D-Dimer New is indicated for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) in outpatients suspected of DVT or PE.

The VIDAS® D-Dimer New (DD2) Assay is an automated quantitative test for use on the VIDAS instrument (K891385) for the immunoenzymatic determination of fibrin degradation products (FbDP) in human plasma using the enzyme-linked fluorescent immunoassay (ELFA) technique. The instrument controls all assay steps and assay temperatures. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR), serves as the solid phase as well as a pipettor for the assay. Reagents for the assay are ready-to-use and pre-dispensed in the sealed DD2 Reagent Strips.

Here's a breakdown of the acceptance criteria and study details for the VIDAS D-Dimer New (DD2) Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are not explicitly stated as numerical thresholds in the provided text. However, for a diagnostic test intended to exclude DVT and PE, very high sensitivity and negative predictive value are paramount to ensure that patients with the condition are not missed. The study results demonstrate 100% sensitivity and 100% negative predictive value, which would be considered excellent performance for this intended use.

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

• Test Set Sample Size:
  • Pulmonary Embolism (PE) / Deep Venous Thrombosis (DVT) Study: 302 patients (initial study mentioned)
  • Deep Vein Thrombosis (DVT) Exclusion Study: 555 patients (after one sample excluded due to volume limitations from an initial 556)
• Data Provenance: Retrospective for the PE/DVT study (frozen samples) and prospective for the DVT exclusion study. The text does not specify the country of origin, but it mentions a "multi-center, prospective cohort study" and "three hospitals," suggesting multiple sites, likely within the same country where the submission was made (US, given the FDA filing).

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

The text does not provide information on the number or qualifications of experts used to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

The text does not explicitly describe an adjudication method for establishing ground truth for the test set. The DVT exclusion study mentions "clinical outcome of the patients" and "serial compression ultrasound (CUS)" for patients with positive D-dimer/high PTP, implying a diagnostic workup to confirm or rule out DVT, but no specific adjudication panel or method (e.g., 2+1) is detailed.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an automated quantitative assay for D-Dimer, not an AI-assisted imaging device or a system that requires human interpretation in the same way. Therefore, the concept of human readers improving with/without AI assistance does not apply here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone study was done. The VIDAS D-Dimer New assay is an "automated quantitative test" and "performed without knowledge of the PTP assessment results and the clinical outcome of the patients." This indicates that the device's performance was evaluated purely on its own diagnostic output (D-dimer levels) against the clinical ground truth. The "human-in-the-loop" aspect comes from the intended use, where the D-Dimer result is used in conjunction with a clinical PTP model for decision-making, but the assay itself is standalone.

7. The Type of Ground Truth Used

The ground truth for the test sets was based on clinical diagnosis/outcomes data.

• For the PE/DVT study, "frequency of venous thromboembolic disease" was determined.
• For the DVT exclusion study, patients "underwent no further diagnostic testing and were followed up for 3 months for development of DVT" if negative D-dimer and low/moderate PTP. Patients with positive D-dimer and/or high PTP "underwent serial compression ultrasound (CUS)." This implies that the presence or absence of DVT was confirmed or ruled out through standard clinical diagnostic methods and follow-up, which serves as the ground truth.

8. The Sample Size for the Training Set

The text does not specify a separate training set or its sample size. This is common for traditional laboratory assays where the "training" involves assay development and optimization, rather than a machine learning training phase on a distinct dataset. The performance data presented is likely from validation studies.

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

Since a distinct "training set" in the context of machine learning is not mentioned, the method for establishing its ground truth is not applicable/not provided in this document. The ground truth for the validation/performance studies was established via clinical diagnosis and follow-up, as described in point 7.

Ask a specific question about this device

The VIDAS® D-Dimer New assay is intended for use as an aid in the diagnosis of deep venous thrombosis and pulmonary embolism disease.

The VIDAS® D-Dimer New (DD2) Assay is an automated quantitative test for use on the VIDAS instrument (K891385) for the immunoenzymatic determination of fibrin degradation products (FbDP) in human plasma using the enzyme-linked fluorescent immunoassay (ELFA) technique. The instrument controls all assay steps and assay temperatures. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR), serves as the solid phase as well as a pipettor for the assay. Reagents for the assay are ready-to-use and pre-dispensed in the sealed DD2 Reagent Strips.

The assay principle combines a two-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR) serves as the solid phase with the anti-FbDP monoclonal (mouse) antibodies P10B5E12C9 adsorbed on its surface, as well as the pipetting device for the assay.

The instrument performs all of the assay steps automatically. The reaction medium is cycled in and out of the SPR several times according to a specified protocol.

The sample is taken and transferred into the well containing the conjugate, which is an alkaline phosphatase-labeled anti-FbDP monoclonal (mouse) antibodies (P2C5A10) The sample/conjugate mixture is cycled in and out of the SPR several times to increase the reaction speed. The antigen binds to antibodies coated on the SPR and to the conjugate forming a "sandwich".

In the second step, the remaining free antigen sites are saturated by cycling the conjugate in the fifth well of the strip in and out of the SPR. Unbound components are eliminated during the washing steps.

Two detection steps are then performed successively. During each step, the substrate (4-Methyl-umbelliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methylumbelliferone), the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of antigen present in the sample.

At the end of the assay, results are automatically calculated by VIDAS in relation to two calibration curves stored in memory corresponding to the two detection steps. A threshold signal determines the choice of the calibration curve to be used for each sample. The results are then printed out.

The acceptance criteria and study proving the device meets them are outlined below:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria for each metric (Sensitivity, Specificity, Negative Predictive Value) prior to presenting results. Instead, it demonstrates the performance of the new DD2 Assay in comparison to the predicate DD Assay. The implicit acceptance criteria appear to be substantial equivalence or improvement over the predicate device.

Ask a specific question about this device