(28 days)
Abbott AxSYM® Ultrasensitive hTSH
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No
The description details a standard immunoassay method and a clinical chemistry system. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The document states that the device "quantitatively measure TSH in human serum and plasma" and that "Measurements of TSH aid in the diagnosis of thyroid or pituitary disorders." This indicates a diagnostic function, not a therapeutic one.
Yes
The device is described as aiding in the diagnosis of thyroid or pituitary disorders by quantitatively measuring TSH in human serum and plasma.
No
The device description clearly outlines a chemical assay method involving reagents, particles, and enzymatic reactions, which are physical components, not software. The device is a laboratory test kit used on a clinical chemistry system, not a standalone software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the method is used to "quantitatively measure TSH in human serum and plasma" and that these measurements "aid in the diagnosis of thyroid or pituitary disorders." This clearly indicates that the device is intended for use on samples taken from the human body to provide information for diagnostic purposes.
- Device Description: The description details a laboratory test method (enzyme immunoassay) performed on biological samples (serum and plasma). This is characteristic of an in vitro diagnostic device.
- Performance Studies: The performance studies describe a comparison with another assay using "clinical patient samples," further confirming its use in a clinical laboratory setting for diagnostic purposes.
The definition of an In Vitro Diagnostic (IVD) device generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits that description.
N/A
Intended Use / Indications for Use
The TSH method is used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to quantitatively measure TSH in human serum and plasma. Measurements of TSH aid in the diagnosis of thyroid or pituitary disorders.
Product codes
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Device Description
The TSH method is a one-step enzyme immunoassay. Sample is incubated with chromium dioxide particles (CrO2) coated with monoclonal antibodies specific for the intact TSH molecule and conjugate reagent [alkaline phosphatase (ALP) labeled monoclonal antibodies specific for the TSH beta subunit] to form a particle/TSH/conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ALP initiates an amplification cascade. ALP dephosphorylates synthetic flavin adenine dinucleotide phosphate (FADP) to give FAD. FAD binds to APO d-amino acid oxidase and converts it to active holo d-amino acid oxidase. Each molecule of holo d-amino acid oxidase then produces multiple molecules of hydrogen peroxide (H2O2), which in the presence of horseradish peroxidase (HRP), converts 3,5-dichloro-2-hydroxybenzenesulfonic acid (DCHBS) and 4-aminoantipyrine (4-AAP) to a colored product that absorbs at 510nm. The color measured is directly proportional to the concentration of TSH present in the patient sample.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Split sample comparison between the TSH method on the Dimension® RxL clinical chemistry system and the Abbott AxSYM® Ultrasensitive hTSH assay gave a correlation coefficient of 0.99, slope of 1.06 and an intercept of -0.03 µIU/mL when tested with 86 clinical patient samples ranging from 30.04 to 49.21 µIU/mL.
Key Metrics
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Predicate Device(s)
Abbott AxSYM® Ultrasensitive hTSH
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.
0
MAR - 3 1997
DADE INTERNATIONAL
Chemistry Systems P.O. Box 6101 Newark, DE 19714
Summary of Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | Rebecca S. Ayash
Dade International Inc.
Building 500, Mailbox 514
P.O. Box 6101
Newark, DE 19714-6101 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | 1/31/97 |
| Name of Product: | Thyroid Stimulating Hormone (TSH) Method |
| FDA Classification Name: | Thyroid Stimulating Hormone Test System |
| Predicate Device: | Abbott AxSYM® Ultrasensitive hTSH |
Device Description: The TSH method is a one-step enzyme immunoassay. Sample is incubated with chromium dioxide particles (CrO2) coated with monoclonal antibodies specific for the intact TSH molecule and conjugate reagent [alkaline phosphatase (ALP) labeled monoclonal antibodies specific for the TSH beta subunit] to form a particle/TSH/conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ALP initiates an amplification cascade. ALP dephosphorylates synthetic flavin adenine dinucleotide phosphate (FADP) to give FAD. FAD binds to APO d-amino acid oxidase and converts it to active holo d-amino acid oxidase. Each molecule of holo d-amino acid oxidase then produces multiple molecules of hydrogen peroxide (H2O2), which in the presence of horseradish peroxidase (HRP), converts 3,5-dichloro-2-hydroxybenzenesulfonic acid (DCHBS) and 4-aminoantipyrine (4-AAP) to a colored product that absorbs at 510nm. The color measured is directly proportional to the concentration of TSH present in the patient sample.
Intended Use: The TSH method is used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to quantitatively measure TSH in human serum and plasma. Measurements of TSH aid in the diagnosis of thyroid or pituitary disorders.
1
Comparison to Predicate Device:
| Item | Dimension® RxL TSH Method | Abbott AxSYM® Ultrasensitive hTSH |
|---|---|---|
| Technology | Sandwich format | |
| monoclonal antibody | ||
| immunoassay | Sandwich format | |
| polyclonal/monoclonal | ||
| antibody immunoassay | ||
| Detection | Colorimetric rate | |
| measurement at 577nm | ||
| and 700nm | Fluorometric endpoint | |
| measurement |
Comments on Substantial
Equivalence: Split sample comparison between the TSH method on the Dimension® RxL clinical chemistry system and the Abbott AxSYM® Ultrasensitive hTSH assay gave a correlation coefficient of 0.99, slope of 1.06 and an intercept of -0.03 µIU/mL when tested with 86 clinical patient samples ranging from 30.04 to 49.21 µIU/mL.
Conclusion: The TSH method for the Dimension® RxL system with the heterogeneous immunoassay module is substantially equivalent in principle and performance to the Abbott AxSYM® Ultrasensitive hTSH Assay based on the split sample comparison summarized above.
Rebecca S. Ayash
Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 2/21/97