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IDS ACTH II assay is an automated in vitro diagnostic device intended for the quantitative, determination of ACTH in human K2 and K3 EDTA plasma on the IDS system. Results are to be used in conjunction with other clinical and laboratory data as an aid in the assessment of pituitary and adrenal gland function and the differential diagnosis of hyper- and hypo-cortisolism.

The IDS ACTH II assay consists of a reagent cartridge. The reagent cartridge contains multiple reagents:

• MP: Magnetic particles coated with mouse monoclonal anti-ACTH antibody and buffer containing phosphate with blocking proteins and ProClin 300 as preservative.
• R1: Mouse monoclonal anti-ACTH antibody labelled with an acridinium ester derivative, in buffer containing phosphate with BSA and ProClin 300 as preservative.
• R2: Buffer containing phosphate with blocking proteins and ProClin 300 as preservative.

The provided text describes the performance characteristics of the IDS ACTH II assay, which is an automated in vitro diagnostic device for the quantitative determination of ACTH in human K2 and K3 EDTA plasma. The study aims to demonstrate that the device meets the acceptance criteria for various analytical performance parameters.

Here's a breakdown of the requested information:

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

The document does not explicitly state "acceptance criteria" as a separate column for each test. Instead, it describes the methodology used to determine each performance characteristic and then presents the results. Based on the context and the nature of these studies, the reported values often serve as the demonstrated "performance" which, by the conclusion of the 510(k) summary, are deemed sufficient to support substantial equivalence. For analytical characteristics like Linearity, Interference, and Cross-Reactivity, the document does specify thresholds for acceptable performance.

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ST AIA-PACK ACTH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of adrenocorticotropic hormone (ACTH) in human EDTA plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.

ST AIA-PACK ACTH Calibrator Set is designed for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK ACTH assay on Tosoh AIA System Analyzers

ST AIA-PACK ACTH Control Set is designed for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK ACTH assay on Tosoh AIA System Analyzers

The ST AIA-PACK ACTH is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK ACTH test cups. ACTH present in the test sample is bound with anti-ACTH goat polyclonal antibody immobilized on magnetic beads and enzyme-labeled anti-ACTH goat polyclonal antibody. The magnetic beads are washed to remove unbound enzyme-labeled anti-ACTH goat polyclonal antibody and are then incubated with a fluorogenic substrate, 4methylumbelliferyl phosphate (4MUP). The enzyme alkaline phosphatase causes oxidation of 4MUP to 4MU. 4MU is excited at 365 nm and comes to ground state at 448 nm releasing florescent energy. The amount of florescent energy is measured by the detector.

The amount of enzyme-labeled anti-ACTH goat polyclonal antibody that binds to the beads is directly proportional to the ACTH concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.

The ST AIA-PACK ACTH assay is designed to quantitatively measure adrenocorticotropic hormone (ACTH) in human EDTA plasma for in vitro diagnostic use. The following information details the acceptance criteria and the studies conducted to demonstrate the device's performance, as outlined in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance:

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Elecsys ACTH Assay: Immunoassay for the in vitro quantitative determination of adrenocorticotropic hormone (ACTH) in human EDTA plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E 170 (Elecsys module) immunoassay analyzers. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushings syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.

Elecsys ACTH CalSet is used for calibrating the quantitative Elecsys ACTH assay on the Elecsys immunoassay analyzers.

Elecsys ACTH CalCheck: For use in the verification of the calibration established by the Elecsys ACTH reagent on Elecsys 1010/2010 and MODULAR E170 immunoassay analyzers.

Elecsys PreciControl ACTH is used for quality control of the Elecsys ACTH immunoassay on the Elecsys immunoassay analyzers.

(1) The Elecsys ACTH Assay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.
(2) The Elecsys ACTH CalSet is a lyophilized product consisting of equine serum with added ACTH in two concentration range. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
(3) The Elecsys ACTH CalCheck is a lyophilized product consisting of buffered equine serum with added ACTH. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
(4) The Elecsys PreciControl ACTH is a lyophilized product consisting of equine serum with added ACTH in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Note: The reagent, calibrator, calibration verification material and the quality control are all packaged separately.

This document describes the Elecsys ACTH Immunoassay, CalSet, CalCheck, and PreciControl ACTH. The study focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria with acceptance criteria and a study to prove it.

However, based on the provided text, we can extract the reported performance of the device and compare it to the predicate device, which implicitly serves as a benchmark for "acceptance." The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds for the Elecsys ACTH system, but rather presents its performance characteristics and compares them to legally marketed predicate devices to establish substantial equivalence.

Here's an attempt to structure the information in the requested format, acknowledging the limitations of the provided text which is a 510(k) summary focused on substantial equivalence rather than a detailed performance study report:

1. Table of Acceptance Criteria and Reported Device Performance

Since no explicit "acceptance criteria" are given for the Elecsys ACTH Immunoassay, the table below presents its reported performance characteristics and compares them to the predicate Immulite ACTH assay, as demonstrating comparable performance to a legally marketed device is the basis for 510(k) clearance. The implied "acceptance criteria" for a 510(k) submission is that the new device performs acceptably and substantially equivalently to the predicate.

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The Scantibodies Laboratory, Inc. Adrenocorticotropic Hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands, such as Cushing's syndrome, and the ectopic ACTH syndrome.

ACTH Immunoradiometric (IRMA) Assay

The provided document is a 510(k) clearance letter from the FDA for a device called "ACTH Immunoradiometic (IRMA) Assay" manufactured by Scantibodies Laboratory, Inc. This letter primarily confirms the substantial equivalence of the device to legally marketed predicate devices.

However, the document does not contain the specific acceptance criteria, study details, or performance data that would typically be found in a study report or a more detailed submission. It states that the FDA "reviewed your Section 510(k) premarket notification" and deemed the device substantially equivalent. The information provided is primarily administrative and regulatory.

Therefore, based solely on the provided text, I cannot generate the requested information about acceptance criteria, detailed study design, sample sizes, ground truth establishment, or multi-reader multi-case studies because that specific data is not present in this regulatory clearance letter.

To provide the requested information, a different document, such as a summary of safety and effectiveness, the 510(k) submission itself, or a published study report, would be needed.

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The Scantibodies Laboratory, Inc. Adrenocorticotropic Hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands, such as Cushing's syndrome, adrenocortical insufficiency and the ectopic ACTH syndrome.

ACTH Immunoradiometric (IRMA) Assav

This appears to be a 510(k) premarket notification approval letter for a medical device (ACTH Immunoradiometric (IRMA) Assay) and not a study report. Therefore, the provided text does not contain the detailed information required to describe acceptance criteria and a study proving device performance in the manner requested.

Specifically, the document is an FDA letter stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not contain:

• A table of acceptance criteria and reported device performance.
• Details on sample size, data provenance, or ground truth establishment for a test set.
• Information on expert adjudication or qualifications.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information on standalone algorithm performance.
• Details on the sample size or ground truth for a training set.

The document only states the "Indications For Use" of the ACTH IRMA Assay.

Therefore, I cannot provide the requested information based on the input text.

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The intended use of this product is the quantitative determination of ACTH [Adrenocorticotropic Hormone] in human EDTA plasma. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).

Quantitative determination of ACTH in human EDTA plasma. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).

The provided text describes the Sangui BioTech, Inc. ACTH ELISA kit and its substantial equivalence to a predicate device. The information primarily focuses on the device's technical characteristics and the study conducted to demonstrate its performance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion, though not explicitly stated as a numerical threshold in the document, is implied by the goal of demonstrating substantial equivalency to the predicate device. The primary performance metric used to establish this is the correlation coefficient (R) between the proposed device and the predicate device.

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

• Sample Size for Test Set: One hundred seventeen (117) patient plasma samples.
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: Not specified in the provided text. It is simply stated that "patient plasma analyzed using both the proposed device and the predicate device."

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

This information is not provided in the text. The study compares the proposed device's performance against a "predicate device" (Nichols Institute Diagnostics ACTH Radioisotopic Assay), not against a 'ground truth' established by human experts in the traditional sense of a diagnostic interpretation study. The predicate device's results are effectively the reference standard in this comparison.

4. Adjudication Method for the Test Set

This information is not applicable/not provided in the context of this type of study. The study compares quantitative results from two devices, 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 information is not applicable/not provided. The study is a comparison of two in vitro diagnostic (IVD) kits, not an AI-assisted diagnostic imaging or interpretation study involving human readers.

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

This study is inherently a standalone performance assessment of the device (an ELISA kit) as it's an in vitro diagnostic test. The device itself performs the quantitative determination; there is no human-in-the-loop component for the device's operation in the context of this evaluation. The comparison is between two automated assay systems.

7. The Type of Ground Truth Used

In this context, the "ground truth" or reference standard for comparison is the results obtained from the predicate device: Nichols Institute Diagnostics ACTH Radioisotopic Assay. The data used for comparison ranged from 1.5 to 1,045 pg/mL of ACTH as measured by the predicate device.

8. The Sample Size for the Training Set

This information is not provided and is generally not applicable to the evaluation of an ELISA kit in the same way it would be for a machine learning algorithm. An ELISA kit is a biochemical assay, not an algorithm that requires a "training set" to learn from data.

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

This information is not applicable as there is no "training set" for an ELISA kit in the context of its development and validation.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device