(82 days)
Not Found
No
The device description details a standard immunoassay procedure (MEIA) and the performance metrics are typical for a laboratory assay, not indicative of AI/ML processing. There is no mention of AI, ML, or image processing.
No
The device is an in vitro diagnostic immunoassay used to measure testosterone levels, which aids in the diagnosis and monitoring of endocrine disorders. It does not directly treat or cure any condition.
Yes
The device is an assay for the quantitative determination of testosterone levels, which is stated to be used clinically to diagnose and differentiate endocrine disorders. The "Intended Use / Indications for Use" section explicitly mentions its use as an aid in the investigation of infertility, hirsutism, and virilization, all of which align with diagnostic purposes.
No
The device description clearly outlines a Microparticle Enzyme Immunoassay (MEIA) which involves physical reagents, incubation steps, washing, and measurement of a fluorescent product. This is a laboratory-based assay with hardware components (the AxSYM System) and chemical reagents, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "quantitative determination of testosterone in human serum and plasma." This involves testing biological samples in vitro (outside the body).
- Indications for Use: The indications describe how the results of the test are used to aid in the diagnosis and investigation of various endocrine disorders and conditions. This is a key characteristic of an IVD.
- Device Description: The description details a "Microparticle Enzyme Immunoassay (MEIA)" which is a laboratory-based test method performed on biological samples.
- Performance Studies: The inclusion of performance metrics like precision, sensitivity, specificity, and interfering substances are standard for IVD devices to demonstrate their analytical performance.
The device is designed to analyze biological samples (serum and plasma) to provide information about a patient's health status, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AxSYM® Testosterone is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of testosterone in human serum and plasma on the AxSYM System.
Testosterone monitoring is used clinically to diagnose and differentiate endocrine disorders. In males, these include hypogonadism, testicular failure, infertility, hypopituitarism and hyperprolactinemia. In females, polycystic ovary syndrome, adrenal hyperplasia, infertility, hirsutism, amenorrhea, obesity and virilization can cause changes in serum testosterone levels.
The AxSYM® Testosterone assay is used as an aid in the investigation of infertility in males and of hirsutism and virilization in females.
The AxSYM® Testosterone Standard Calibrators are for the standard calibration of the AxSYM system when used for the quantitative determination of testosterone in human serum and plasma.
Product codes (comma separated list FDA assigned to the subject device)
JIS, CDZ
Device Description
Competition format. Microparticle Enzyme Immunoassay (MEIA) for use on Abbott AxSYM® system.
Assay procedure:
- Incubate the sample with the antibody-coated microparticles.
- Add testosterone alkaline phosphatase conjugate and incubate.
- Transfer to matrix cell.
- Wash to remove unbound substances.
- Add substrate.
- Measure fluorescent product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum and plasma
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison to Predicate Device:
Precision:
- Submission Device AxSYM® Testosterone: Within-run CV of 3.9% to 8.3%. Total CV of = 0.85ng/ml and = 2.10ng/ml.
- Predicate Device Elecsys® Testosterone: Within-run CV of 0.9% to 4.6%. Total CV of 1.6 to 7.4 % from 0.24 to 7.01 ng/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Functional Sensitivity:
- Submission Device AxSYM® Testosterone:
§ 862.1680 Testosterone test system.
(a)
Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.(b)
Classification. Class I.
0
Axis-Shield Diagnostics Ltd 7th July 2004
SEP 2 9 2004 K041866 - AxSYM®Testosterone
Page 1 of 4
510(k) Summary
Introduction
According to the requirements of 21 CFR 807.92, the following summary of safety and effectiveness provides details to understand the basis for a determination of substantial equivalence.
Submitter name, address, contact
Axis-Shield Diagnostics Ltd. The Technology Park Dundee DD2 1XA Scotland, UK Tel : +44 1382 422000 Fax: +44 1382 422088
| Contact Person: | Susan Leonard |
|---|---|
| Email address: | susan_leonard@uk.axis-shield.com |
| Date Prepared: | July 7th, 2004 |
Device Name
Abbott AxSYM® Testosterone Microparticle Enzyme Immunoassay Proprietary Name: (MEIA) test
Microparticle Enzyme Immunoassay (MEIA) for the determination Common name: of Testosterone.
Classification name: Testosterone test system
Predicate Device
Substantial equivalence to the Roche Elecsys® Testosterone assay (K964889) is claimed.
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Axis-Shield Diagnostics Ltd 7" July 2004
K041866 - AxSYM®Testosterone Page 2 of 4
510(k) Summary
Device Description
Competition format. Microparticle Enzyme Immunoassay (MEIA) for use on Abbott AxSYM® system.
Assay procedure:
- 트 Incubate the sample with the antibody-coated microparticles.
- Add testosterone alkaline phosphatase conjugate and incubate. 1
- Transfer to matrix cell. I
- Wash to remove unbound substances. 배
- 체 Add substrate.
- Measure fluorescent product. . lescein product.
Intended Use
A Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of testosterone in human serum and plasma on the AxSYM System.
Comparison to Predicate Device
The AxSYM®Testosterone immunoassay is substantially equivalent to the Roche Elecsys Testosterone assay cleared under K964889. Both products are intended for use in the
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quantitative determination of testosterone.
The following information is presented in the Premarket Notification [510(k)] for AxSYM Testosterone to support a substantially equivalent determination.
Similarities:
- Intended use
- Operating principles (competitive assay format using antigen-antibody 트 interactions)
- Sample type (serum and plasma)
- 트 Quantitative assay
- For use on automated instruments 비
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Axis-Shield Diagnostics Ltd 7" July 2004
Image /page/2/Picture/1 description: The image shows the text "K041866 - AxSYM®Testosterone Page 3 of 4". The text is black and is on a white background. The text is centered in the image.
510(k) Summary
Comparison to Predicate Device (continued)
Differences:
:
| Parameter | Submission Device
AxSYM® Testosterone | Predicate Device
Elecsys® Testosterone |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology Format | Microparticle Enzyme
Immunoassay (MEIA). | Electrochemiluminescence
Immunoassay (ECLIA). |
| Capture Antibody | Anti-testosterone (mouse, monoclonal) antibody coated microparticles. | Biotinylated monoclonal anti-testosterone antibody (mouse). Becomes bound to streptavidin coated microparticles. |
| Competition Antigen | Testosterone: Alkaline Phosphatase conjugate. | Testosterone derivative labelled with a ruthenium complex. |
| Substrate | 4-Methylumbelliferyl phosphate. | Not applicable. |
| Assay End-Point | Fluorescence | Electrochemiluminescence |
| Quantitation | Results are determined from a standard calibration curve (0, 0.2, 1.0, 2.5, 7.0, 15.0 ng/mL) generated and stored on the instrument. | Results are determined from a calibration curve generated on the instrument via a two-point calibration and a master curve provided via the reagent barcode. |
| Standardisation | Concentration is standardised gravimetrically and confirmed by GCMS (Gas Chromatography Mass Spectrometry). | The method has been standardised via ID-GCMS (Isotope Dilution Gas Chromatography Mass Spectrometry). |
| Reagent stability | Up to stated expiration date when stored at 2-8°C.
2 weeks on-board the AxSYM. | Up to stated expiration date when stored at 2-8°C.
4 weeks on-board the Elecsys 1010.
8 weeks on-board the E170/Elecsys 2010 |
| Parameter | Submission Device
AxSYM® Testosterone | Predicate Device
Elecsys® Testosterone |
| Precision | Within-run CV of 3.9% to 8.3%.
Total CV of $\le$ 14% for samples with testosterone concentrations $\ge$ 0.85ng/ml and $\le$ 10% for samples $\ge$ 2.10ng/ml. | Within-run CV of 0.9% to 4.6%
Total CV of 1.6 to 7.4 % from 0.24 to 7.01 ng/mL. |
| Functional Sensitivity | $\le$ 0.2ng/ml | Not stated |
| Analytical Sensitivity | $\le$ 0.1ng/ml | 0.02ng/ml |
| Analytical Specificity | 25 potential cross-reactants tested.