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IMMULITE® Pyrilinks-D is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE Automated Analyzer and is designed for the quartitative measurement of deoxypyridinoline (DPD) in urine. It is intended strictly for in vitro diagnostic use in monitoring type 1 collagen resorption changes, especially in bone in post menopausal women diagnosed with osteoporosis and receiving antiresorptive therapy (amino-bisphosphonate).

IMMULITE® Pyrilinks* - D is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer. IMMULITE® Pvrilinks"-D is a solid-phase, chemiluminescent immunoassay for use with the IMMULITE Automated Immunoassay Analyzer. The solid-phase, a polystyrene bead enclosed within an IMMULITE Test Unit, is coated with a monoclonal antibody specific for DPD, The patient sample and alkaline phosphatase-conjugated DPD are simultaneously introduced into the Test Unit, and incubated for approximately 30 minutes at 37°C with intermittent agitation. During this time, DPD in the sample competes with enzyme-labeled DPD for a limited number of antibody-binding sites on the bead. Unbound material is then removed by a centrifygal wash, after which substrate is added and the Test Unit is incubated for a further 10 minutes. The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex-and thus also the photon output, as measured by the luminometer- is inversely proportional to the concentration of DPD in the sample.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:

It's important to note that this document describes a 510(k) premarket notification for an in vitro diagnostic (IVD) device (IMMULITE® Pyrilinks®-D). For IVDs, the "acceptance criteria" and "study" typically revolve around demonstrating substantial equivalence to a predicate device, focusing on analytical performance rather than clinical effectiveness in the same way a therapeutic device might. The "performance equivalence" section addresses this.

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

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

• Sample Size for Test Set: Seventy-five (75) patient urine samples.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, it's typically understood to be retrospective for method comparison studies like this, using archived samples or freshly collected samples specifically for the comparison. The fact that it's "patient urine samples" suggests it's human biological samples.

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

This type of information is generally not applicable for an IVD method comparison study. The "ground truth" here is the measurement obtained by the predicate device (Metra Biosystems® Pyrilinks®-D), not an expert panel's interpretation. The goal is to show the new device performs similarly to an already cleared device, not to independently establish a diagnosis based on expert consensus.

4. Adjudication method for the test set

This is not applicable for this type of IVD method comparison study. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple human readers or experts who are establishing a ground truth for diagnostic imaging or clinical assessment. Here, the "truth" is the quantitative value from the predicate device.

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 is not applicable. This document describes an in vitro diagnostic device, not an AI-assisted diagnostic system where human readers interact with AI. The device directly measures a biomarker in urine.

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

This is implicitly a standalone study, in the sense that the IMMULITE® Pyrilinks®-D assay (the algorithm/methodology) was directly compared to the predicate device, without a specific human-in-the-loop component being evaluated for performance improvement in this section. The "human" element comes in the form of a lab technician operating the analyzer, but their interpretive skill is not being assessed here.

7. The type of ground truth used

The "ground truth" (or reference standard) for this method comparison was the results obtained from the legally marketed predicate device: Metra Biosystems® Pyrilinks®-D. The study aimed to demonstrate that the new device's measurements correlated well with those from the predicate.

8. The sample size for the training set

The document does not explicitly describe a separate "training set" for the method comparison study itself. For an IVD, the "training" of the assay involves developing the reagents, optimizing the assay parameters, and establishing calibration curves during the device's development phase. This information is typically proprietary and not detailed in a 510(k) summary focused on demonstrating substantial equivalence to a predicate. The 75 samples mentioned are for the comparison study.

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

As there's no explicitly described "training set" in the context of the method comparison in this document, the method for establishing its ground truth is not provided. If we interpret "training set" loosely as the data used to develop the IMMULITE® Pyrilinks®-D assay itself, the ground truth would have been established through internal validation studies using reference methods or characterized samples during assay development by Diagnostic Products Corporation. This information is usually not part of the 510(k) summary review.

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DPC's IMMULITE® Pyrilinks"-D is a solid-phase, chemikaninescent enzyme immuneassay for use with the IMMULITE® Automated Analyzer and is designed for the quantitative measurement of deoxyppyridinoline (DPD) in urine. It is intended strictly for in vitro diagnostic use as an indicator of bone resorption.

IMMULITE® Pyrilinks -D is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer. The IMMULITE® Pyrilinks -D assay is designed for the quantitative measurement of deoxypyridinoline in urine It is intended strictly for in vitro diagnostic use as an indicator of bone resorption. IMMULITE Pyrilinks -D is a solid-phase, chemiluminescent immunoassay for use with the IMMULITE Automated Inimunoassay Analyzer. The solid-phase, a polystyrene bead enclosed within an IMMULITE Test Unit, is coated with a monoclonal antibody specific for DPD. The patient sample and alkaline phosphatase-conjugated DPD are simultaneously introduced into the Test Unit, and incubated for approximately 30 minutes at 37°C with intermittent agitation. During this time, DPD in the sample competes with enzyme-labeled DPD for a limited number of antibody-binding sites on the bead. Unbound material is then removed by a centrifugal wash, after which substrate is added and the Test Unit is incubated for a further 10 minutes. The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yead an unstable intermediate. The continuous production of this intermediate results in the sustained of light, thus improving precision by providing a window for multiple readings. The bound complex-and thus also the photon output, as measured by the luminometeris inversely proportional to the concentration of DPD in the sample.

The provided document describes the safety and effectiveness summary for the IMMULITE® Pyrilinks -D device, focusing on its substantial equivalence to a predicate device, Metra Biosystems "Pyrilinks"-D.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state pre-defined acceptance criteria (e.g., a specific r-value or a range of acceptable mean differences). Instead, it presents a method comparison study to demonstrate "Performance Equivalence" and "substantially equivalent results" to the predicate device. The performance is assessed through linear regression analysis.

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

• Sample Size for Test Set: Seventy-five (75) patient urine samples.
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, but the phrasing "was compared to" for patient samples suggests a retrospective or cross-sectional comparison of existing or freshly collected samples.

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

This information is not provided. The "ground truth" for this type of immunoassay comparison is typically the result from the predicate device itself, which is assumed to be accurate. There's no mention of a separate expert panel establishing ground truth for the DPD concentrations.

4. Adjudication method for the test set

This information is not applicable and not provided. Imunoassay results are quantitative measurements, not subjective interpretations requiring adjudication.

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 is not an MRMC comparative effectiveness study involving human readers or AI. It is a direct comparison between two diagnostic devices. Therefore, this information is not applicable and not provided.

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

This statement refers to the performance of a diagnostic device (an immunoassay analyzer), which operates as a standalone system to quantify DPD in urine. There is no "human-in-the-loop" component in the sense of interpretative assistance; the device directly measures and reports DPD concentrations. The performance data presented (linear regression, r-value, mean concentrations) are reflective of this standalone device's output.

7. The type of ground truth used

The "ground truth" in this study is the measurement of deoxypyridinoline (DPD) in urine samples obtained from the predicate device, Metra Biosystems® Pyrilinks®-D. The study aims to demonstrate that the new IMMULITE® Pyrilinks®-D device provides results that are substantially equivalent to those of the established predicate device.

8. The sample size for the training set

The document does not mention a separate "training set" for the IMMULITE® Pyrilinks®-D in the context of this 510(k) summary. Immunoassays are developed and validated using a different process than machine learning algorithms, which typically involve distinct training and test sets. For this type of device, the "training" (development and optimization) would have been part of the product's R&D phase, not a specific "training set" as understood in AI studies.

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

As there is no separate "training set" described in the provided summary, information on how its ground truth was established is not applicable and not provided. The focus of the 510(k) summary is on demonstrating equivalence to an existing device using a test set of patient samples.

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