Search Results

The Emit® 2000 Sirolimus Assay is for the in vitro quantitative analysis of sirolimus in human whole blood as an aid in the management of sirolimus therapy in kidney transplant patients.

The Emit® 2000 Siro/Tacro Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Sirolimus Assay and/or the Emit® 2000 Tacrolimus Assay.

The Emit® 2000 Sirolimus Calibrators are intended for use in the calibration of the Emit® 2000 Sirolimus Assay.

The Emit® 2000 Sirolimus Assay is for in vitro diagnostic use for the quantitative analysis of sirolimus in human whole blood as an aid in the management of sirolimus therapy in kidney transplant patients. The Emit® 2000 Sirolimus Assay is comprised of an antibody reagent, a buffer reagent and an enzyme reagent. This assay contains mouse monoclonal antibodies with a high specificity for sirolimus.

The Emit® 2000 Siro/Tacro Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Sirolimus Assay. The Emit® 2000 Siro/Tacro Sample Pretreatment Reagent is used to pretreat the whole blood samples, calibrators, and controls prior to testing with the Emit® 2000 Sirolimus Assay. The pretreatment process lyses the cells, extracts the sirolimus, and precipitates most of the blood proteins. The pretreated samples are centrifuged, and an aliquot of the resulting supernatant containing sirolimus is then assayed using the Emit® 2000 Sirolimus Assay.

The Emit® 2000 Sirolimus Calibrators are frozen material containing sirolimus in preserved whole blood hemolysate. There are six (6) calibrator levels containing 0, 3, 6, 12, 24 and 36 ng/mL.

Here's a breakdown of the acceptance criteria and study information for the Emit® 2000 Sirolimus Assay, Emit® 2000 Siro/Tacro Sample Pretreatment Reagent, and Emit® 2000 Sirolimus Calibrator, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state pre-defined acceptance criteria values for slope, intercept, or correlation coefficient. However, the reported values are presented as the "result" of the study, implying they met the internal criteria for substantial equivalence to the predicate device and the reference method (LC/MS/MS).

2. Sample Size and Data Provenance

• Test Set Sample Size: 128 samples
• Data Provenance: Samples were from kidney transplant patients and were collected from two external sites. The document does not specify the country of origin, but it implies a clinical setting.
• Retrospective or Prospective: The document does not explicitly state whether the study was retrospective or prospective. Given that samples from kidney transplant patients were used and compared against LC/MS/MS, it is likely a retrospective analysis of existing patient samples where Sirolimus levels were measured by both methods, or a prospective collection for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth

The concept of "experts" to establish ground truth in the context of diagnostic assay comparison is typically applied when the ground truth is subjective (e.g., image interpretation). For this device, which measures a quantitative analyte (Sirolimus), the ground truth is established by a reference method (LC/MS/MS), not by human experts interpreting results. Therefore, this section is not directly applicable in the way it would be for, say, a radiology AI device.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth was established by LC/MS/MS, a laboratory reference method, not by human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not conducted or described. This type of study focuses on comparing the diagnostic performance of human readers, with and without AI assistance, on multiple cases. The Emit® 2000 Sirolimus Assay is a standalone in vitro diagnostic device, not an AI-assisted interpretation system for human readers.

6. Standalone Performance Study

Yes, a standalone performance study was done. The method comparison study directly evaluated the performance of the Emit® 2000 Sirolimus Assay against the LC/MS/MS reference method. This assesses the algorithm's (assay's) performance without human-in-the-loop interaction for result generation, although human operators perform the assay.

7. Type of Ground Truth Used

The type of ground truth used was comparison to a reference method: Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS). LC/MS/MS is considered a "gold standard" or highly accurate method for quantifying Sirolimus in biological samples.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This is a common characteristic of traditional in vitro diagnostic assays, which are developed and validated through analytical studies and method comparisons, rather than "trained" in the machine learning sense. The assay relies on specific reagents (antibodies, enzymes) designed for Sirolimus detection.

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

Not applicable, as no distinct "training set" in the machine learning context is mentioned or implied for this device. The development and optimization of such assays typically involve extensive analytical studies using characterized samples, but these are not referred to as a "training set" with ground truth established in the same manner as for AI/ML algorithms.

Ask a specific question about this device

The SIRO method is an in vitro diagnostic test for the quantitative measurement of Sirolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of Sirolimus are used as an aid in the management of sirolimus therapy in renal transplant patients.
The Sirolimus Calibrator is an in vitro diagnostic product for the calibration of Sirolimus (SIRO) on the Dimension® clinical chemistry system.

The automated Dimension® SIRO method uses an immunoassay technique in which free and sirolimus-bound antibody-enzyme conjugates are separated using magnetic particles. The assay is performed using a method specific Flex® reagent cartridge. The Flex® cartridge contains a pretreatment reagent, antibody-B-galactosidase conjugate, sirolimus immobilized on chromium dioxide particles, chlorophenol red ß-d-galactopyranoside (CPRG) substrate, and diluent to hydrate the tablets.
To perform the SIRO assay, a sample cup (or SSC) containing the whole blood sample to be analyzed and a SIRO Flex® reagent cartridge are placed appropriately on the Dimension® system. The Dimension® system mixes and lyses the whole blood sample. The lysed sample is then mixed with the antibody enzyme conjugate. The sirolimus present in the sample is bound by the sirolimus antibody conjugate reagent. Magnetic particles coated with sirolimus are added to bind free (unbound) antibody-enzyme conjugate. The reaction mixture is then separated magnetically. Following separation, the supernatant containing the sirolimus-antibody-enzyme complex is transferred to another cuvette and mixed with the substrate. B-galactosidase catalyzes the hydrolysis of CPRG (chlorophenol red ß-d-galactopyranoside) to produce CPR (chlorophenol red) that absorbs light maximally at 577 nm. The change in absorbance at 577 nm due to the formation of CPR is directly proportional to the amount of sirolimus in the patient's sample and is measured using a bichromatic (577, 700 nm) rate technique.
The Dimension® Sirolimus Calibrator (DC306) is an in-vitro diagnostic product intended to be used to calibrate the Dimension® Sirolimus method. It is a frozon liquid product packaged as a single vial for each of five levels. The matrix is human whole blood hemolysate with preservatives. Levels 2, 3, 4, and 5 contain sirolimus drug at target values of 5, 10, 20, and 31.5 ng/mL, respectively. Level 1 is a human whole blood hemolysate that does not contain sirolimus drug.

Here's a summary of the acceptance criteria and study details for the Dimension SIRO Flex® reagent cartridge, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Abbott IMx Sirolimus) and uses specific performance characteristics as evidence. While explicit "acceptance criteria" for each performance metric are not strictly defined as numerical thresholds in the provided text beyond the predicate device's performance, the goal is to show comparable or improved performance.

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

• Method Comparison (Test Set for demonstrating agreement with reference method):
  • Sample Size: n = 119 patient samples.
  • Data Provenance: The text states "A split patient sample (EDTA whole blood) method comparison." It does not explicitly state the country of origin or if it was retrospective or prospective, but "split patient sample" implies prospective collection from a patient population specifically for this comparison.
• Reproducibility (Test Set for precision):
  • Sample Size: Not explicitly stated as a single "test set" size. However, for each test level (3 whole blood pools and 2 QC levels), a single test from two independent cups was analyzed twice per day over an unspecified number of days/runs. This is repeated across one internal and two external locations.
  • Data Provenance: Not explicitly stated, though the mention of "one internal and two external locations" suggests it likely involved multiple sites, potentially geographically diverse (though specific countries are not mentioned). It's a prospective study designed to assess precision.

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

• For Method Comparison:
  • The ground truth was established by HPLC/MS (High-Performance Liquid Chromatography/Mass Spectrometry), which is referred to as "the reference method." This is an analytical laboratory technique, not an expert human assessment.
• For Reproducibility:
  • The "ground truth" here is the expected value of the control materials (e.g., "Level 1 Whole Blood Pool" mean 4.41 ng/mL). These values are typically established through extensive testing by the manufacturer using validated methods, not by a panel of experts.

4. Adjudication Method for the Test Set

• For Method Comparison: No adjudication method involving human experts is applicable as the comparison is against an instrumental reference method (HPLC/MS).
• For Reproducibility: No adjudication method is applicable. The data is statistical analysis of repeated measurements of control materials.

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

• This device is an in-vitro diagnostic (IVD) test for measuring a drug concentration (Sirolimus) in whole blood. It is an automated clinical chemistry system.
• Therefore, an MRMC comparative effectiveness study where human "readers" (e.g., clinicians interpreting images or patient data) improve with "AI assistance" is not applicable to this type of device. There is no human interpretation of complex data that the device is intended to assist. The device provides a quantitative numerical result.

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

• Yes, this is a standalone device. The performance data (method comparison, reproducibility) directly reflects the algorithm (the immunoassay technique and automated system) without human intervention in the result generation process. The device performs the measurement and outputs a quantitative value. Clinical interpretation of that value by a physician occurs after the device provides its result, but the device's performance itself is standalone.

7. The Type of Ground Truth Used

• For Method Comparison: Analytical reference method (HPLC/MS).
• For Reproducibility: Established mean values of control materials (whole blood pools and QC materials) through internal validation processes.

8. The Sample Size for the Training Set

• The 510(k) summary does not provide details on a separate "training set" sample size. For IVD devices like this, the development process involves extensive internal testing and optimization of reagents and methods which could be considered "training data" in a broad sense, but it is not typically disclosed with sample sizes in the same way as machine learning models. The data presented here are for the validation of the final device.

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

• As mentioned above, specific "training set" details are not provided. However, generally, for the development of such an immunoassay, the "ground truth" during development would be established similarly to the validation:
  • Reference methods (like HPLC/MS) for accurate quantification of sirolimus.
  • Known concentrations of sirolimus in prepared samples.
  • Patient samples with clinically relevant sirolimus levels.
  • The goal during development (training) would be to optimize reagent concentrations, reaction conditions, and calibration algorithms to achieve accurate and precise measurements against these known or reference values.

Ask a specific question about this device

The ARCHITECT Sirolimus assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sirolimus in human whole blood on the ARCHITECT i System. The ARCHITECT Sirolimus assay is to be used as an aid in the management of renal transplant patients receiving sirolimus therapy.

The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of sirolimus in human whole blood.

The ARCHITECT Sirolimus Whole Blood Precipitation Reagent is for the extraction of sirolimus from samples (human whole blood patient specimens, controls, and ARCHITECT Sirolimus Calibrators) to be tested on the ARCHITECT i System.

The ARCHITECT Sirolimus assay is a delayed one-step immunoassay for the quantitative determination of sirolimus in human whole blood using CMIA technology with flexible assay protocols, referred to as Chemiflex.

Prior to the initiation of the automated ARCHITECT sequence, a manual pretreatment step is performed in which the whole blood sample is extracted with a precipitation reagent, heated, and centrifuged. The supernatant is decanted into a Transplant Pretreatment Tube, which is placedonto the ARCHITECT i System.

Sample, assay diluent, and anti-sirolimus coated paramagnetic microparticles are combined to create a reaction mixture. Sirolimus present in the sample binds to the anti-sirolimus coated microparticles. After a delay, sirolimus acridinium-labeled conjugate is added to the reaction mixture. The sirolimus acridinium-labeled conjucate competes for the available binding sites on the anti-sirolimus coated paramagnetic microparticles. Following an incubation, the microparticles are washed, and pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs),

An indirect relationship exists between the amount of sirolimus in the RLUs detected by the ARCHITECT i System optics.

The provided document describes the ARCHITECT Sirolimus Assay and its performance characteristics, primarily focusing on demonstrating substantial equivalence to a predicate device (ABBOTT IMx® Sirolimus Microparticle Enzyme Immunoassay) and LC/MS/MS as a reference method.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria in a dedicated section with pre-defined thresholds. Instead, it presents the results of equivalence studies against a predicate device and a reference method, implying that the observed performance was deemed acceptable for demonstrating substantial equivalence. For performance characteristics like precision, linearity, and sensitivity, the results are presented, and implicit acceptance is given by stating the achieved values (e.g., "less than or equal to 10%").

Here's a table summarizing the reported device performance from the provided text:

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

• Sample Size for Equivalence Studies:
  • ARCHITECT Sirolimus vs. IMx Sirolimus: 168 observations (specimens).
  • ARCHITECT Sirolimus vs. LC/MS/MS: 167 observations (specimens).
• Data Provenance: "human whole blood specimens from renal transplant patients receiving sirolimus therapy." The country of origin is not specified, but the context of an FDA 510(k) submission typically implies US-based or internationally accepted clinical study protocols. The data is retrospective in the sense that the patients were already receiving therapy and specimens were collected. It's not explicitly stated if it was a prospective collection for this specific study, but it's patient data.

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

This information is not provided in the document. For an immunoassay device like this, ground truth is typically established by comparing against a reference method (like LC/MS/MS) or a previously validated predicate device. Human expert interpretation of results is not usually the primary ground truth for quantitative laboratory assays.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided in the document. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective human interpretation of images or clinical events, where multiple readers' assessments need to be reconciled to form a ground truth. For quantitative assays like the Sirolimus assay, the ground truth is based on the chemical measurement itself, often against a gold standard method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study focuses on the impact of a device on human readers' performance (e.g., radiologists interpreting images using an AI tool). The ARCHITECT Sirolimus Assay is a standalone, quantitative in vitro diagnostic device, not one that assists human readers in making interpretations.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, the studies presented are standalone performance studies. The ARCHITECT Sirolimus Assay, as an immunoassay, works as an "algorithm only" (the automated measurement process produces a quantitative result) without human input during the core measurement process. The results reported (equivalence, precision, linearity, sensitivity, interference, specificity) directly reflect the performance of the device itself.

7. Type of Ground Truth Used:

• Predicate Device Comparison: The ABBOTT IMx® Sirolimus Microparticle Enzyme Immunoassay (K042411) was used as a reference for comparison. While not a "ground truth" in the strictest sense, it's a legally marketed and accepted assay that served as a benchmark for substantial equivalence.
• Reference Method Comparison: LC/MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) was used as a more definitive "ground truth" or reference method for validating the assay's accuracy against a highly sensitive and specific analytical technique.

8. Sample Size for the Training Set:

The document does not provide specific information on the sample size used for the training set. Immunoassays are often developed and optimized using a variety of samples and reagents during the R&D phase, but a distinct "training set" in the machine learning sense is not typically explicitly defined or reported for this type of device in a 510(k) summary. The development process would involve iterative testing and refinement.

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

As the document doesn't detail a specific "training set" or its ground truth, this information is not provided. For immunoassay development, ground truth for initial optimization would similarly be based on established reference methods (like LC/MS/MS) or careful spiking/dilution experiments with known concentrations of the analyte.

Ask a specific question about this device

The IMx Sirolimus assay is an in vitro reagent system for the quantitative determination of sirolimus in human whole blood as an aid in the management of renal transplant patients receiving sirolimus therapy.

The IMx® Sirolimus Calibrators are for the calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood.

The IMx® Sirolimus MODE 1 Calibrator is for the adjustment of the stored calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood.

The IMx® Sirolimus Controls are for the verification of the calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood.

The IMx Sirolimus Whole Blood Precipitation Reagent is for the extraction of sirolimus from samples (whole blood patient specimens, IMx® Sirolimus Calibrators and Controls) to be tested on the IMx® Sirolimus assay.

Microparticle Enzyme Immunoassay (MEIA) for use on Abbott IMx® system.

Assay procedure:

• Incubate the sample with the anti-sirolimus antibody-coated microparticles.
• Add sirolimus alkaline phosphatase conjugate and incubate.
• Transfer to matrix cell.
• Wash to remove unbound substances.
• Add substrate.
• Measure fluorescent product.

This document describes the performance characteristics and acceptance criteria for the Abbott IMx® Sirolimus Microparticle Enzyme Immunoassay (MEIA) test.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

Ask a specific question about this device