Search Results

The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.

The ARCHITECT Intact PTH assay is intended to be used as an aid in the differential diagnosis of hpyercalcemia, hypocalcemia and parathyroid disorders.

The ARCHITECT Intact PTH Calibrators are for the ARCHITECT i System when used for the quantitative determination of intact PTH in human serum and plasma.

The ARCHITECT Intact PTH Controls are for the use in quality control to monitor the accuracy and precision of the ARCHITECT Intact PTH assay on the ARCHITECT i System for human serum and plasma.

For in vitro diagnostic use.

The ARCHITECT Intact PTH assay is a two-step sandwich immunoassay for the quantitative determination of intact PTH in human serum and plasma using CM1A technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample, assay diluent, and anti-PTH coated paramagnetic microparticles are combined. Intact PTH present in the sample binds to anti-PTH coated microparticles. After washing, the anti-PTH acridinium-labeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of intact PTH in the sample and the RLUs detected by the ARCHITECT i System optics. The concentration of intact PTH in the sample is determined by comparing the chemiluminescent signal in the reaction to the ARCHITECT Intact PTH calibration.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantifiable acceptance criteria in the typical sense (e.g., minimum sensitivity, specificity, accuracy thresholds). Instead, the primary acceptance criterion appears to be substantial equivalence to the predicate device, the ROCHE® Elecsys Parathyroid Hormone Test System (K992680). The performance is reported in terms of correlation coefficients.

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

• Sample Size: The document does not specify the exact sample size used for the performance comparison studies (non-clinical or clinical). It only states that the ARCHITECT Intact PTH assay 'demonstrated substantially equivalent performance to the Roche Elecsys PTH'.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not provided in the given text. The studies appear to be comparative performance studies against a predicate device, which itself acts as the "ground truth" for comparison, rather than requiring independent expert-established ground truth. This is common for IVD devices where the performance is benchmarked against an existing, approved method.

4. Adjudication Method for the Test Set

This information is not provided in the given text. As the study design is a comparison to a predicate device, a complex adjudication method for establishing ground truth is likely not applicable in the same way it would be for, for example, an imaging AI device interpreting images.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size: This type of study and effect size is not applicable as this is an in vitro diagnostic (IVD) immunoassay device, not an AI device designed to assist human readers (e.g., radiologists). The device itself performs the measurement.

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

Yes, the studies described are inherently standalone performance evaluations of the ARCHITECT Intact PTH assay. The device measures intact PTH quantitatively from human serum and plasma directly. There is no "human-in-the-loop" component in the assay's primary function of determining the hormone concentration. The output is a numerical value, not an interpretation requiring human input for its primary function.

7. The Type of Ground Truth Used

The "ground truth" used for these studies was the performance of the legally marketed predicate device: The ROCHE® Elecsys Parathyroid Hormone Test System (K992680). The ARCHITECT Intact PTH assay's results were compared directly against those produced by the Roche Elecsys PTH system.

8. The Sample Size for the Training Set

This information is not provided in the given text. This device is an immunoassay, not a machine learning or AI algorithm that typically has a separate "training set." The development of the assay (e.g., optimizing reagents, establishing calibration curves) is a different process than "training" an AI model.

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

This information is not provided and is generally not applicable in the context of a traditional immunoassay. For such devices, "ground truth" typically refers to the results obtained from a reference method or validated predicate device during performance evaluation, not a "training set" ground truth in the AI sense. The "ground truth" for calibrators and controls would have been established through a robust process of analytical characterization and traceability to higher-order reference materials, but the document does not detail this.

Ask a specific question about this device