Search Results

The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative determination of constituents in blood and other fluids.

ACE Hemoglobin A1c (HbA1c) Reagent is intended for the quantitative determination of hemoglobin A1c (µmol/L) and total hemoglobin (g/dL) in human EDTA whole blood for the calculation of percent hemoglobin A1c using the ACE Axcel Clinical Chemistry System. The test is intended for use in clinical laboratories or physician office laboratories to monitor long term blood glucose control in individuals with diabetes mellitus. For in vitro diagnostic use only.

The ACE CEDIA T Uptake homogenous enzyme immunoassay is intended for the quantitative determination of unoccupied binding sites of thyroxine-binding proteins in serum using the ACE Axcel Clinical Chemistry System. Measurements of triiodothyronine uptake are used in the diagnosis and treatment of thyroid disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE T4 Reagent is intended for the quantitative determination of total thyroxine (T4) concentration in serum using the ACE Axcel Clinical Chemistry System. Total thyroxine measurements are used in the diagnosis and treatment of thyroid diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Ferritin Reagent is intended for the quantitative determination of ferritin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.

Prior to the ACE Hemoglobin A1c (HbA1c) Reagent assay, whole blood samples require a pretreatment step, which is done on-board the analyzer. The red blood cells in the sample are lysed by the Hemoglobin Denaturant and the hemoglobin chains are hydrolyzed. For determination of HbA1c, a latex agglutination inhibition assay is used. In the absence of HbA1c in the sample, the agglutinator (synthetic polymer containing the immunoreactive portion of HbA1c) in the HbA1c Agglutinator Reagent and the antibody-coated microparticles in the HbA1c Antibody Reagent will agglutinate. The presence of HbA1c in the sample competes for the antibody binding sites and inhibits agglutination. The increase in absorbance, monitored monochromatically at 592 nm, is inversely proportional to the HbA1c present in the sample. For the determination of total hemoglobin, all hemoglobin derivatives in the sample are converted to alkaline hematin. The reaction produces a green colored solution, which is measured bichromatically at 573 nm/692 nm. The intensity of color produced is directly proportional to the total hemoglobin concentration in the sample. The concentrations of both HbA1c and total hemoglobin are measured, the ratio is calculated and the result reported as percent HbA1c.

The CEDIA T Uptake assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously re-associate to form fully active enzyme which, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically. In the assay, enzyme donor thyroxine conjugate binds directly to the unoccupied thyroxine-binding sites in the sample, preventing the spontaneous re-association of the enzyme fragments to form the active enzyme. Thus, thyroxine-binding proteins regulate the amount of β-galactosidase formed from the reassembly of the remaining donor and enzyme acceptor as monitored by the hydrolysis of the substrate o-nitrophenyl-β-galactopyranoside.

The ACE T4 Assay is a homogeneous enzyme immunoassay using ready-to-use liquid ACE T4 Reagent. The assay uses 8-anilino-1-naphthalene sulfonic acid (ANS) to dissociate thyroxine from the plasma binding proteins. Using specific antibodies to thyroxine, this assay is based on the competition of glucose-6-phosphate dehydrogenase (G6PD) labeled thyroxine and the dissociated thyroxine in the sample for a fixed amount of specific antibody binding sites. In the absence of thyroxine from the sample, the thyroxine labeled G6PD in the second reagent is bound by the specific antibody in the first reagent, inhibiting the enzyme's activity. The enzyme G6PD catalyzes the oxidation of glucose-6-phosphate (G6P) with nicotinamide adenine dinucleotide (NAD+) to form 6-phosphogluconate and reduced nicotinamide adenine dinucleotide (NADH). NADH strongly absorbs at 340 nm whereas NAD+ does not. The rate of conversion, determined by measuring the increase in absorbance bichromatically at 340 nm/505 nm during a fixed time interval, is directly proportional to the amount of thyroxine in the sample. The concentration of thyroxine is determined automatically by the ACE Clinical Chemistry System using a logarithmic calibration curve established with calibrators, which are provided separately.

In the Ferritin Assay, serum ferritin, in the presence of anti-ferritin conjugated latex micorparticles, and a buffer promoting aggregation, initiates an antigen-antibody reaction, resulting in the agglutination of the latex microparticles. The agglutination is detected turbidometrically by an absorbance change measured at a wavelength of 592 nm. The magnitude of the absorbance change is proportional to the ferritin concentration in the sample.

The provided text is a 510(k) summary for the Alfa Wassermann Diagnostic Technologies ACE Axcel Clinical Chemistry System and several associated reagents. It describes the devices, their intended uses, and technological characteristics. However, the document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The content of the document focuses on:

• Identification of the device and reagents: Trade names, classifications, common names, and product codes.
• Predicate devices: Listing the previously approved systems and reagents used for comparison in the 510(k) submission.
• Device descriptions: Detailed explanations of the ACE Axcel Clinical Chemistry System's functionality and the biochemical principles of each reagent (HbA1c, CEDIA T Uptake, T4, Ferritin).
• Intended Use/Indications for Use: What each device/reagent is designed to measure and for what clinical purpose.
• Technological Characteristics: Specifications of the analyzer (throughput, reagent capacity, cooling, sample handling, optical system).
• Regulatory approval notice: A letter from the FDA indicating substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets those criteria from the provided text. The requested information about sample sizes, data provenance, expert qualifications, ground truth, MRMC studies, or standalone performance studies is not present in this document.

Ask a specific question about this device

For the assessment of unsaturated thyroid binding proteins in serum or plasma using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems.

The thyroid hormones triiodothyronine (T3) and thyroxine (T4) are bound primarily to thyroxine-binding globulin (TBG) and to a lesser extent thyroxine-binding prealbumin (TBPA) and albumin. The ACS:180 T Uptake assay measures the number of unoccupied binding sites on these proteins and is an indirect indicator of thyroid status.

T Uptake (TU) and total T4 are used to estimate the amount of circulating free T4. The estimate, or the Free Thyroxine Index (FTI), is a normalized measurement that remains relatively constant in healthy individuals and compensates for abnormal levels of binding proteins, which can occur in many different physical conditions.

Drugs or physical conditions that alter the patient's TBG levels or drugs that compete with endogenous T4 and T3 for protein-binding sites alter T Uptake results.

When serum contains high levels of T3 or T4, as in hyperthyroidism, fewer unoccupied binding sites are available. Conversely, in hypothyroidism, more binding sites are available.

The Chiron Diagnostics ACS:180 TUp assay is a double antibody competitive immunoassay using, chemiluminescent technology. The sample is incubated with Lite Reagent, which is composed of acridinium ester-labeled T3-BGG (bovine gamma globulin) and unlabeled T3. The unlabeled T3 in the Lite Reagent fills available thyroid-binding sites in the sample. The acridinium ester-labeled T3-BGG does not bind to the binding proteins in the sample.

The acridinium ester-labeled T3-BGG and unlabeled T3 compete for monoclonal mouse anti-T3 antibody in the Solid Phase. The monoclonal mouse anti-T3 antibody is bound to goat anti-mouse antibody, which is covalently coupled to paramagnetic particles in the Solid Phase. A greater amount of unlabeled T3 binding to the binding proteins in the sample results in more T3-BGG-acridinium ester binding to the monoclonal antibody, an indication of a higher amount of unsaturated binding proteins.

This document describes a medical device called the "Chiron Diagnostics ACS:180 TUp," a thyroid hormone uptake test system.

Here's an analysis of the provided information according to your request:

Acceptance Criteria and Device Performance

The document does not explicitly define "acceptance criteria" for the device's performance in terms of accuracy or precision against a specific threshold. Instead, it presents performance characteristics such as:

• Reference Range: Established for euthyroid individuals.
• Specificity: Cross-reactivity with various compounds.
• Method Comparison: Correlation with an alternate chemiluminescent method.
• Precision: Within-laboratory precision (Total CV).

Given the absence of explicit acceptance criteria, the "Reported Device Performance" below summarizes the results provided for each characteristic.

Table of Acceptance Criteria and Reported Device Performance

Additional Information on the Study:

1. Sample sizes used for the test set and the data provenance:

   • Expected Results (Reference Range): Serum samples from 100 apparently healthy individuals.
   • Method Comparison: 245 samples with T Uptake ratios in the range of 0.57 to 1.68 and total T4 values in the range of 3.7 to 14.1 µg/dL.
   • Precision: 3 samples (tested n=72 each).
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the context implies these are experimental studies conducted by the manufacturer for regulatory submission. It is reasonable to assume these were prospective studies conducted in a controlled environment.

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

   • This device is an in vitro diagnostic assay that measures specific biochemical markers. The "ground truth" for such assays is typically established by comparing its performance against established, often predicate, methods or by demonstrating analytical accuracy and precision based on known concentrations or reference intervals.
   • No human experts are mentioned as establishing ground truth for the test set in the way a radiologist would interpret an image. The "ground truth" for the TUp assay itself is defined by its ability to accurately measure the binding sites and correlate with established clinical interpretations of thyroid status. The "euthyroid" state for the reference range study would have been determined through other clinical and laboratory diagnostics, presumably by medical professionals, but their number and qualifications are not specified in this document.

3. Adjudication method for the test set:

   • Not applicable. This is an in vitro diagnostic device, not an interpretative AI system requiring human adjudication for its outputs.

4. 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 assay, not an imaging device or an AI application designed to assist human readers.

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

   • Yes, this entire study describes the standalone performance of the ACS:180 TUp assay. It is an automated chemiluminescent system designed to provide quantitative results directly from a biological sample.

6. The type of ground truth used:

   • Expected Results: The "ground truth" for establishing the reference range was based on "100 apparently healthy individuals," implying their euthyroid status was confirmed by other clinical and laboratory means.
   • Specificity & Precision: The ground truth for these analytical performance characteristics relates to the known concentrations of compounds and statistical measures of reproducibility around these concentrations.
   • Method Comparison: The ground truth was effectively the "alternate chemiluminescent method" which served as the comparator.

7. The sample size for the training set:

   • This document refers to an in vitro diagnostic device, not a machine learning or AI algorithm in the contemporary sense that would involve distinct "training" datasets for model development. As such, there is no concept of a separate "training set" for an algorithm in this context. The manufacturing process and quality control would involve internal validations and calibration, but not a "training set" as understood in AI/ML.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no specific "training set" for an AI/ML algorithm. For an IVD, the closest analogy would be calibration materials and quality controls, whose "ground truth" is established through highly accurate reference methods and certified reference materials.

Ask a specific question about this device