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For in vitro diagnostic and laboratory professional use.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma (K2-EDTA and K3-EDTA) samples collected on or after 15 days post-symptom onset using the VITROS ECi/ECiO/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator

For use in the calibration of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems for the in vitro qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is a qualitative chemiluminescent immunoassay performed on the VITROS Systems (VITROS ECi/ECiO Immunodiagnostic System, VITROS 3600 Immunodiagnostic System, VITROS 5600 Integrated System and VITROS XT 7600 Integrated System) providing fully automated random-access testing.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is performed using the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls on the VITROS Systems.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack is supplied as ready to use and contains:

• 100 wells coated with 100ng/well of recombinant SARS-CoV-2 spike antigen derived from human cells.
• 18.0 mL assay reagent (buffer with bovine protein stabilizers and antimicrobial agent)
• 20.4 mL conjugate reagent [anti-human IgG (murine monoclonal) conjugated to horseradish peroxidase, 5ng/mL] in buffer with bovine protein stabilizers and antimicrobial agent.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator contains:

• 2 vials of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 1gG Calibrator 0 (anti-SARS-CoV-2 IgG in anti-SARS-CoV-2 IgG negative human serum with antimicrobial agent, 1 mL)
• Lot calibration card
• Protocol card
• 8 calibrator bar code labels

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls contain:

• 3 sets of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls 1 and 2 (defibrinated human plasma with anti-microbial agent, 2 mL). Control 1 is non-reactive and Control 2 is reactive

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is designed for use on the VITROS Systems. The VITROS Systems use the following ancillary reagents (general purpose reagents):

• VITROS Immunodiagnostic Products Signal Reagent
• VITROS Immunodiagnostic Products Universal Wash Reagent

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator (Chemiluminescent Immunoassay)

Purpose: Qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma, intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the performance of the device rather than explicitly stating pre-defined acceptance criteria in a dedicated table. However, we can infer the implicit acceptance criteria from the observed results and the FDA's decision to grant the De Novo request.

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For in vitro diagnostic and laboratory professional use.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of total antibodies to SARS-CoV-2 in human serum and plasma (K-EDTA. K-EDTA and lithium heparin) samples collected on or after 15 days post-symptom onset using the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

For use in the calibration of the VITROS ECi/ECiO/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems for the in vitro qualitative detection of total antibodies to SARS-CoV-2 in human serum and plasma.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total test is a qualitative chemiluminescent immunoassay performed on the VITROS Systems (VITROS ECi/ECiQ Immunodiagnostic System, VITROS 3600 Immunodiagnostic System, VITROS 5600 Integrated System and VITROS XT 7600 Integrated System) providing fully automated random-access testing.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total test is performed using the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator and the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls on the VITROS Systems.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack is supplied as ready to use and contains:

• . 100 coated wells (streptavidin, bacterial; binds ≥3 ng biotin per well; biotin recombinant SARS-CoV-2 antigen 0.1 ug/mL)
• 6.0 mL assay reagent (buffer with bovine protein stabilizers and antimicrobial agent) .
• . 16.2 mL conjugate reagent (HRP-recombinant SARS-CoV-2 antigen) in buffer with bovine protein stabilizers and antimicrobial agent

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator contains:

• . 2 vials of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator (anti-SARS-CoV-2 in anti-SARS-CoV-2 negative human plasma with antimicrobial agent, 1 mL)
• . Lot calibration card
• . Protocol card
• . 8 calibrator bar code labels

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls contain:

• . 3 sets of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls 1 and 2 (defibrinated human plasma with anti-microbial agent, 2 mL). Control 1 is non-reactive and Control 2 is reactive.
  The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total test is designed for use on the VITROS Systems. The VITROS Systems use the following ancillary reagents (general purpose reagents):
• . VITROS Immunodiagnostic Products Signal Reagent
• VITROS Immunodiagnostic Products Universal Wash Reagent .

The document describes the evaluation of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator, a chemiluminescent immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

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

The document does not explicitly state "acceptance criteria" for the clinical performance in a single, clear table with pass/fail thresholds. However, the Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) are the key clinical performance metrics presented. The FDA's decision to grant De Novo status implies that the reported performance met their internal criteria for safety and effectiveness for its intended use.

Here's a summary of the reported clinical performance:

Note: The PPA for samples collected early (0-7 days and 8-14 days post-symptom onset) is considerably lower (e.g., 36.00% to 44.00% for 0-7 days), reflecting the time required for antibody development. The indication for use specifies "samples collected on or after 15 days post-symptom onset," making the PPA for ≥15 days the most relevant for the primary intended use.

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

• Test Set Sample Size:

  • PPA (Clinical Sensitivity Equivalent): 296 samples from individuals with prior SARS-CoV-2 positive RT-PCR results were initially acquired. However, the "Number of Subjects Tested" varies slightly per analyzer, typically around 282-286 for individual system reporting, and 237-239 for the ≥15 days post-symptom onset group which is the most relevant for the device's claims.
  • NPA (Clinical Specificity Equivalent): 513 presumed SARS-CoV-2 negative samples collected prior to the COVID-19 pandemic. The "Presumed Negative" count also varies slightly per analyzer, typically around 505-511.

• Data Provenance:

  • Country of Origin: All samples were collected within the United States.
  • Retrospective or Prospective: The samples were collected retrospectively. Population 1 (positive samples) was collected between April 2020 and April 2021. Population 2 (negative samples) was collected prior to December 2019.

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)

This is an in vitro diagnostic device for antibody detection, not an imaging AI system. Therefore, the "ground truth" for the clinical study was established by RT-PCR test results for SARS-CoV-2 infection (for positive samples) and collection of samples prior to the COVID-19 pandemic (for negative samples). There is no mention of human experts (e.g., pathologists or radiologists) adjudicating the ground truth for this type of test.

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

Not applicable for this type of in vitro diagnostic test where RT-PCR is the comparator and pre-pandemic samples define the negative group. Discrepancy resolution with expert radiologists would be relevant for imaging-based AI studies, not serology tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic (IVD) device for laboratory use, not an AI-assisted diagnostic tool for human readers (e.g., radiologists interpreting images). Its performance is evaluated as a standalone laboratory test.

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

Yes, the clinical performance (PPA and NPA) presented for the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total test is its standalone performance as an automated laboratory assay. There is no human-in-the-loop component for the interpretation or usage of the result beyond the laboratory professional's decision to report the qualitative positive/negative result.

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

• For Positive Samples (PPA): Ground truth was established by prior SARS-CoV-2 positive RT-PCR test results. The document states, "...using a comparator that FDA determined is appropriate (RT-PCR test)."
• For Negative Samples (NPA): Ground truth was established by collection date prior to the widespread outbreak of COVID-19 (i.e., prior to December 2019), deeming them "presumed SARS-CoV-2 negative samples."

8. The sample size for the training set

This document describes the validation of a commercial in vitro diagnostic (IVD) product, not an AI/machine learning model where a distinct 'training set' of patient data in the typical AI sense would be used to train the algorithm. The "training" of this device involves the development and optimization of the chemical reagents, assay parameters, and cutoff values performed internally by the manufacturer (Ortho-Clinical Diagnostics).

The closest equivalent to a "training" activity described in the context of setting the device's operational parameters is the Assay Cut-Off determination study (page 12-13). This study used:

• "a collection of negative samples collected prior to the COVID-19 pandemic"
• "samples collected from individuals with a prior SARS-CoV-2 RT-PCR positive result."

The specific numbers of these samples for the cutoff determination are not explicitly stated, but are implied to be part of the broader pool of samples available to the manufacturer during development. The ROC curve analysis was performed on these samples to optimize sensitivity and specificity at the S/C = 1.00 cutoff.

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

As noted in point 8, this isn't an AI model with a conventional training set. For the "samples" used in the Assay Cut-Off determination (analogous to internal optimization/training data):

• Negative Ground Truth: Established by "negative samples collected prior to the COVID-19 pandemic."
• Positive Ground Truth: Established by "samples collected from individuals with a prior SARS-CoV-2 RT-PCR positive result."

This implies a similar method to the clinical validation set for establishing true positive and true negative status, but performed during the device development phase to define the S/C cutoff.

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VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack:

For in vitro diagnostic use only

For the quantitative measurement of total 25-OH vitamin D in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System.

The results of the VITROS 25-OH Vitamin D Total assay are used in the assessment of Vitamin D sufficiency. Assay results may be used in conjunction with other clinical or laboratory data to assist the clinician in patient management.

VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators:

For in vitro diagnostic use only.

For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH vitamin D in human serum.

The VITROS Immunodiagnostic Products Vitamin D test system comprises three main elements:

• 1. The VITROS Immunodiagnostic range of products. In this case the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack and the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators are required to perform a VITROS Vitamin D test.
• The VITROS Immunodiagnostic and Integrated Systems: Instrumentation, which 2. provides automated use of the immunoassay kits.

The VITROS ECi/ECiQ Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919). This product was updated to the VITROS ECiQ Immunodiagnostic System by addition of a flat panel monitor with an accompanying articulating arm, cosmetic changes to the instrument cabinetry, and with FDA notification in January of 2004.

The VITROS 3600 Immunodiagnostic System: Instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K083173).

The VITROS 5600 Integrated System: Instrumentation, which provides automated use of the immunoassay kits. The VITROS Integrated System was cleared for market by a separate 510(k) pre-market notification (K081543).

• 3. Common reagents used by the VITROS System in each assay: The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
     The VITROS Immunodiagnostic and Integrated Systems and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

The provided 510(k) summary describes the acceptance criteria and performance data for the VITROS® Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack and Calibrators.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a single, consolidated table with pass/fail remarks. Instead, it presents performance study results. The implied acceptance criteria are the demonstrated performance characteristics (e.g., precision, linearity, limit of detection, specificity, and method comparison results meeting statistical thresholds).

Table: Implied Acceptance Criteria and Reported Device Performance

• ECI/ECIQ System 1 Lot 1: 5.5-15.3%
• ECI/ECIQ System 2 Lot 2: 5.4-16.4%
• 3600 System 1 Lot 1: 6.0-16.5%
• 3600 System 1 Lot 3: 4.8-15.8%
• 5600 System 1 Lot 2: 5.6-12.8% |
  | Linearity/Measuring Range | Assay should be linear across the claimed measuring range. | Linear from 12.8 to 126 ng/mL (32.0 to 315 nmol/L). |
  | Limit of Detection (LoD) | LoD should be adequately low for clinical utility. | 8.64 ng/mL (21.6 nmol/L) (with 10% bias at indicated concentrations in 25-OH Vitamin D concentrations of 30-80 ng/mL, with the exception of Paricalcitol (Zemplar). |
  | Specificity (Cross-Reactivity) | Cross-reactivity should be characterized and acceptable. | 25-OH Vitamin D2: 104.9%
  25-OH Vitamin D3: 98.9%
  (Other listed substances showed lower or context-dependent cross-reactivity/bias) |
  | Method Comparison (Correlation with Predicate) | Strong correlation (high 'r' value) and acceptable slopes/intercepts compared to predicate device. | VITROS 5600 vs IDS-iSYS: r = 0.92, Slope CI (0.86-1.12), Intercept CI (-10.2 to -0.53)
  VITROS 3600 vs IDS-iSYS: r = 0.93, Slope CI (0.96-1.22), Intercept CI (-12.4 to -2.95)
  VITROS ECi/ECiQ vs IDS-iSYS: r = 0.94, Slope CI (0.86-1.09), Intercept CI (-14.2 to -4.69) |

2. Sample size used for the test set and the data provenance

• Precision: 3 patient samples and 1 commercial control sample per system/lot condition. Each sample tested as 2 replicates per day, on at least 20 different days (total 80 observations per sample per system/lot combination).
• Linearity: Two pools of patient samples (low and high) were used to create 7 intermediate pools.
• Limit of Detection: 1 blank and 6 low-level samples, with 700 determinations in total.
• Specificity (Interference/Cross-reactivity): Patient samples near 30 ng/mL and 80 ng/mL Vitamin D. The exact number of individual samples for interference testing is not specified, but the cross-reactivity table shows results for specific compounds.
• Method Comparison: A minimum of 117 human serum samples were used.
• Reference Range: 399 apparently healthy adults.
• Data Provenance:
  • For the reference range study, samples came from individuals in the North, South, and Central regions of the United States, collected in both summer and winter. This indicates prospective collection of samples specifically for this study.
  • For other studies (precision, linearity, method comparison), the document mentions "patient samples" and "human serum samples." The specific country of origin or whether these were purely retrospective or prospectively collected is not explicitly stated, but they are clearly human-derived samples.

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

Not applicable. For in vitro diagnostic (IVD) assays like this one, "ground truth" is typically established by reference methods or comparison to a legally marketed predicate device, rather than expert consensus on images or interpretations. The product measures a specific analyte concentration.

4. Adjudication method for the test set

Not applicable. This is an IVD device for quantitative measurement of a biomarker, not a diagnostic imaging device requiring expert adjudication of interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic (IVD) device, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

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

Yes, the device is a standalone in vitro diagnostic (IVD) system. Its performance (e.g., precision, linearity, limit of detection, and quantitative measurements in method comparison studies) represents the "algorithm only" performance, as it directly quantifies 25-OH Vitamin D in human serum samples on automated immunodiagnostic systems without human interpretation of results influencing the measurement itself.

7. The type of ground truth used

The "ground truth" for this quantitative assay is established by:

• Reference measurements/Predicate Device Comparison: The method comparison study uses a legally marketed predicate device, the IDS-iSYS® 25-Hydroxy Vitamin D Assay, as the reference for comparison, and demonstrates substantial equivalence.
• Internal analytical validation: Performance claims (precision, linearity, LoD/LoQ, specificity) are established through rigorous analytical testing against recognized CLSI guidelines, implying accepted analytical standards for correctness.

8. The sample size for the training set

The document does not explicitly mention "training set" or "validation set" in the context of an algorithm. For IVD devices, a "training set" in the machine learning sense is not typically used. Instead, the analytical performance (precision, linearity, etc.) is established using various samples, and calibration is performed using specific calibrators.

• The linearity study used two pools of patient samples.
• The precision study used patient samples and commercial controls.
• The specificity studies used patient samples.

These samples are used to characterize the device's performance, not to "train" an algorithm.

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

Not applicable, as a "training set" in the machine learning sense for an algorithm is not described. For the types of samples used in analytical studies:

• Patient samples: Their ground truth would be their actual 25-OH Vitamin D concentration, as measured by a highly accurate or reference method at the time of study or by the predicate device (as in the method comparison).
• Commercial control samples: These have assigned target values for specific analytes, often established through an internal reference method or inter-laboratory consensus.

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