(220 days)
K 92093
No
The description details a standard enzyme immunoassay for measuring homocysteine levels, with no mention of AI or ML technologies in the device description, performance studies, or key metrics.
No.
The "Axis Homocysteine Enzyme Immunoassay" is intended for quantitative measurement and assists in diagnosis, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocysteinuria."
No
The device description clearly outlines a laboratory immunoassay kit that involves chemical reactions and detection methods, indicating it is a hardware-based diagnostic test, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of total L-homocysteine in human serum or plasma." This involves testing biological samples in vitro (outside the body).
- Purpose: The device "can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocysteinuria." This clearly indicates a diagnostic purpose.
- Device Description: The description details a laboratory-based assay using enzymatic conversion and immunoassay techniques to analyze components of a biological sample.
These characteristics align perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Axis Homocysteine Enzyme Immunoassay is intended for the quantitative measurement of total L-homocysteine in human serum or plasma.
The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocysteinuria.
Product codes (comma separated list FDA assigned to the subject device)
JJX, LPS, DFC
Device Description
The Axis Homocysteine Enzyme Immunoassay is designed for the quantitative determination of total homocysteine in plasma or serum.
In the Axis " Homocysteine Enzyme Immunoassay, protein bound homocysteine is reduced to free homocysteine, enzymatically converted to S-adenosyl-L-homocysteine (SAH), and detected in competitive immunoassay with monoclonal anti-SAH antibody.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the Axis® Homocysteine Enzyme Immunoassay was evaluated for precision, measuring range, accuracy and limit of quantification. The precision studies were done according to NCCLS Evaluation protocol. Vol. 12, No. 4, EP5-T2. Using this protocol. precision of the system was determined using Low, Medium and High controls. The Within-run %CV for the Low was 7.3%, for the Medium 6.8%, and for the High 5.2%. Total precision was 9.3% for the Low, 8.1% for the Medium and 7.1% for the High. The assay is linear within the measuring range: 2 - 50 umol/L and has a limit of homocysteine quantification of
§ 862.1377 Urinary homocystine (nonquantitative) test system.
(a)
Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a handwritten alphanumeric string. The string is "K980907". The characters are written in black ink on a white background.
OCT 16 1998
510(k) Summary
Axis® Homocysteine Enzyme Immunoassay
:
1
510(k) Summarv
Axis Homocysteine Enzyme Immunoassay
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The Axis Homocysteine Enzyme Immunoassay is designed for the quantitative determination of total homocysteine in plasma or serum.
Homocysteine is a thiol-containing amino acid produced by the intracellular demethylation of methionine. Homocysteine is metabolized to either cysteine or to methionine. In the vitamin Bo dependent trans-sulphuration pathway homocysteine is irreversibly catabolised to cysteine. A major part of homocysteine is remethylated to methionine, mainly by the folate and cobalamindependent enzyme methionine synthase. Homocysteine accumulates in the cell and is exported to the circulation when these reactions are impaired. Homocysteine circulates in plasma mostly in its oxidized form bound to proteins and is measured as total homocysteine (tHcy) the sum of free and protein bound fractions.
In the Axis " Homocysteine Enzyme Immunoassay, protein bound homocysteine is reduced to free homocysteine, enzymatically converted to S-adenosyl-L-homocysteine (SAH), and detected in competitive immunoassay with monoclonal anti-SAH antibody.
There are several 510(k) cleared methods for measurement of amino acids'13 . All these methods are based on HPLC separation and either traditional post-column derivitization (LKB, Beckman) or pre-column derivitization (Waters). Homocysteine can be analyzed using a traditional HPLC method with post-column derivatization. For example, Poele-Pothoff et al used a traditional system with 3 hours analysis for this purpose (LKB analyzer). Sera were reduced using dithiotreitol, then proteins were precipitated as would normally be done for this instrument. Candito et al also published an analysis of homocysteine using a Beckman Amino Acid Analyzer, after reduction with dithiotreitol. Both of these methods are based on earlier work by Andersson , which used a modified separation on an amino acid analyzer.
To establish substantial equivalence to an existing device, and thus establish the safety and effectiveness of the Axis® Homocysteine Enzyme Immunoassay, the Axis® Homocysteine Enzyme Immunoassay was compared to the University of Bergen Homocysteine by HPLC method'. This method uses pre-column derivatization and permits rapid analysis. In the work of Poele-Pothoff, a similar pre-column method was compared to an amino acid analyzer method and was shown to give an excellent correlation.
The performance of the Axis® Homocysteine Enzyme Immunoassay was evaluated for precision, measuring range, accuracy and limit of quantification. The precision studies were done according to NCCLS Evaluation protocol. Vol. 12, No. 4, EP5-T2. Using this protocol. precision of the system was determined using Low, Medium and High controls. The Within-run %CV for the Low was 7.3%, for the Medium 6.8%, and for the High 5.2%. Total precision was
2
9.3% for the Low, 8.1% for the Medium and 7.1% for the High. The assay is linear within the measuring range: 2 - 50 umol/L and has a limit of homocysteine quantification of