Search Results

The LIAISON® N-TACT® PTH Gen II is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of intact human parathyroid hormone in serum, EDTA and Lithium Heparin plasma samples. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. The test is to be performed on the LIAISON® XL Analyzer.

The LIAISON® N-TACT® PTH Gen II Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® N-TACT® PTH Gen II assay.

The LIAISON® N-TACT® PTH Gen II Calibration Verifiers are assayed quality control materials intended for the quantitative verification of calibration and reportable range of the LIAISON® N-TACT® PTH Gen II assay.

The LIAISON® N-TACT® PTH Gen II assay is a modified two-step, two-site sandwich assay that uses two goat polyclonal antibodies for capture and detection of intact PTH. Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of intact PTH present in the calibrators, controls or samples.

LIAISON® N-TACT® PTH Gen II Control set contains:
2 levels controls containing 80% human plasma spiked with 1-84 PTH, and preservatives; 4 vials each level; lyophilized
The target concentration for control level 1 is 20 pg/mL. The target concentration for control Level 2 is 300 pg/mL.
The range of concentrations of each control is reported on the certificate of analysis provided with each LIAISON® N-TACT® PTH Gen II Control set.

LIAISON® N-TACT® PTH Gen II Calibration Verifier set contains:
4 levels containing 80% human plasma spiked with 1-84 PTH, with preservative, . 1 vial each level, lyophilized
The target concentration for cal verifier A is 10 pg/mL. The target concentration for cal verifier B is 150 pg/mL. The target concentration for cal verifier C is 650 pg/mL. The target concentration for cal verifier D is 1600 pg/mL.
The range of concentrations of each calibration verifier is reported on the certificate of analysis provided with each LIAISON® N-TACT® PTH Gen II Calibration Verifier set.

Here's an analysis of the acceptance criteria and study details for the LIAISON® N-TACT® PTH Gen II device based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The 510(k) summary for the LIAISON® N-TACT® PTH Gen II primarily demonstrates substantial equivalence to a predicate device. As such, the "acceptance criteria" are generally implied by the performance of the predicate device and the demonstration that the new device performs comparably or better, meeting established clinical laboratory guidelines. Specific numeric acceptance criteria are not explicitly stated in a "PASS/FAIL" format for each performance characteristic, but rather the study results are presented to show satisfactory performance.

Here's a table summarizing the performance characteristics and their reported results, which implicitly serve as the demonstration of meeting acceptance:

Ask a specific question about this device

The DiaSorin LIAISON® N-TACT® PTH Calibration Verifiers are assayed quality control materials intended for use in the quantitative verification of calibration and reportable range of the LIAISON® N-TACT® PTH Assay when performed on the LIAISON® Analyzer.

The LIAISON® N-TACT® PTH Calibration Verifiers consist of four levels. Each vial contains Iyophilized pooled human plasma spiked with PTH. The calibration verifiers are reconstituted with 2.0 mL of deionized or distilled water, allowed to sit for 10 minutes, and mixed gently before use. The calibration verifier set is provided with targeted PTH concentrations of 20, 150, 350 and 1500 pg/mL. The four levels were chosen to incorporate the range of the LIAISON® N-TACT® PTH Assay and to challenge the decision points of clinical importance for PTH.

The provided document describes a premarket notification for the DiaSorin LIAISON® N-TACT® PTH Calibration Verifiers. This device is an assayed quality control material, not an AI/ML powered device, and therefore the concepts of test sets, ground truth, expert adjudication, MRMC studies, or standalone performance do not apply. The document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance.

Here's an analysis based on the information provided, reinterpreting the "acceptance criteria" and "study" in the context of a quality control material seeking substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (calibration verifiers/quality control materials), the "acceptance criteria" revolve around demonstrating that the new device performs similarly to or meets the requirements for a quality control material and is substantially equivalent to an existing predicate device. The performance is assessed by comparing its characteristics and intended use to the predicate.

Study Proving Acceptance Criteria:

The "study" in this context is a substantial equivalence comparison to a legally marketed predicate device, the LIAISON® N-TACT® PTH Control Set (K033426). The provided text outlines this comparison, highlighting similarities and differences to demonstrate that the new device is as safe and effective as the predicate.

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

This concept is not applicable to this type of regulatory submission. There is no "test set" in the sense of patient data or algorithm performance evaluation. The "sample" here would refer to the characteristics of the calibration verifiers themselves, such as the different levels provided. The data provenance relates to the formulation of the human plasma, but not its origin in terms of "patient data."

• Sample Size: The device consists of four levels of calibration verifiers.
• Data Provenance: The matrix is "pooled human plasma." No specific country of origin or whether it's retrospective/prospective is detailed for the plasma source, as it's a raw material for a control.

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

This concept is not applicable. "Ground truth" in the context of AI/ML or diagnostic claim validation refers to an independent, highly accurate determination of a clinical condition. For a quality control material, the "truth" is the target concentration of PTH within the verifier, established during its manufacturing and assay. This is typically done through certified reference materials and established laboratory methods, not by clinical experts adjudicating cases.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This concept is not applicable. There is no "adjudication" of patient cases or diagnostic outputs for a quality control material.

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 concept is not applicable. This device is a laboratory reagent (calibration verifier), not an AI-powered diagnostic tool used by human readers.

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

This concept is not applicable. This is a reagent, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the LIAISON® N-TACT® PTH Calibration Verifiers would be their assigned target PTH concentrations (20, 150, 350, 1500 pg/mL). These values are established during the manufacturing process using validated analytical methods and reference materials, ensuring the accuracy of the PTH concentration within each level of the verifier. It is not based on expert consensus, pathology, or outcomes data in a clinical sense, but rather on metrological traceability for an in-vitro diagnostic reagent.

8. The Sample Size for the Training Set

This concept is not applicable. There is no "training set" for this type of device.

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

This concept is not applicable. There is no "training set" or corresponding "ground truth" in the AI/ML sense.

Ask a specific question about this device

The LIAISON® N-tact™ PTH Assay is a chemiluminescent immunoassay to be used with the LIAISON® Analyzer for the quantitative determination of intact human parathyroid hormone in serum or EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions.

The LIAISON® N-tact™ PTH Control Set is intended for use as an assayed quality control sample to monitor the accuracy and precision of the DiaSorin LIAISON® N-tact™ PTH immunoassay.

The method for quantitative determination of PTH is a direct, two site, sandwich type chemiluminescence immunoassay (CLIA). Affinity-purified antibody to the 39-84 amino acid sequence of PTH is coated to the solid phase. The second affinity-purified antibody to the 1-34 region is conjugated to an isoluminol derivative. During the incubation, PTH binds to the solid phase, and is subsequently bound by the isolumino! conjugated antibody. After the incubation, the unbound material is removed with a wash cycle. The starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of PTH present in calibrators, controls, or samples.

Here's an analysis of the DiaSorin LIAISON® N-tact™ PTH 510(k) Premarket Notification based on the provided text, focusing on acceptance criteria and study details:

The provided document describes a diagnostic device (immunoassay) for quantitative determination of human parathyroid hormone (PTH), not a device that involves AI or human-in-the-loop performance. Therefore, several sections of your request (e.g., number of experts, adjudication method, MRMC study, human readers, standalone performance, training set details) are not applicable to this type of device and study. The "acceptance criteria" here refer to analytical performance specifications for the assay.

Acceptance Criteria and Reported Device Performance

Ask a specific question about this device