Teco Homocysteine Enzymatic Assay
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K063701 FDA 510(k)
- FDA Product Code
- LPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1377 FDA 510(k)
- Regulation Number
- 862.1377 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Teco Homocysteine Enzymatic Assay is an in vitro diagnostic device classified as a Urinary Homocystine (Nonquantitative) Test System, designed for the quantitative measurement of total homocysteine in serum or plasma. It employs enzymatic methods to detect homocysteine levels, supporting clinical assessments for hyperhomocysteinemia—a condition linked to cardiovascular risk and metabolic disorders. The assay provides objective data to aid in diagnostic and treatment monitoring within clinical chemistry settings.
This device is supplied as a single-use reagent kit and is intended for use in laboratory environments adhering to clinical chemistry protocols. It is regulated under FDA 510(k) clearance (K063701) and falls under Device Class II (regulation number 862.1377). No MRI safety or sterility specifications are noted in the regulatory submissions, and the assay requires proper storage as per manufacturer instructions to maintain accuracy. Authorisations include multiple FDA registration numbers (e.g., 2030861, 2432235) and product code LPS for filing purposes.
Frequently asked questions
What clinical conditions does the Teco Homocysteine Enzymatic Assay help evaluate?
This assay quantifies total homocysteine levels in serum or plasma, providing objective data to support clinical assessments for hyperhomocysteinemia—a condition associated with increased cardiovascular risk and metabolic disorders. Elevated homocysteine is linked to atherosclerosis, stroke, and other vascular complications, making this test valuable for diagnostic and treatment-monitoring purposes in clinical chemistry settings.
How is the Teco Homocysteine Enzymatic Assay supplied, and is it reusable?
The assay is supplied as a single-use reagent kit, designed exclusively for laboratory use. Single-use ensures consistency and reduces contamination risks, which is critical for accurate homocysteine measurement. Reuse is not recommended or supported by the manufacturer, as it could compromise assay performance and regulatory compliance.
Does the Teco Homocysteine Enzymatic Assay require special storage conditions?
While specific sterility or MRI safety details are not noted in regulatory submissions, the manufacturer’s instructions must be followed for proper storage to maintain assay accuracy. This typically includes protection from extreme temperatures, light exposure, and contamination. Adhering to these guidelines is essential for preserving reagent integrity and ensuring reliable test results.
What regulatory pathway does the Teco Homocysteine Enzymatic Assay follow?
The assay is regulated under the FDA’s 510(k) clearance pathway (K063701) and classified as a Device Class II under regulation number 862.1377. It is intended for use as a quantitative test system for urinary homocystine (nonquantitative) and has been determined substantially equivalent to predicate devices through the Clinical Chemistry advisory committee review process.
Can this assay be used with both serum and plasma samples?
Yes, the Teco Homocysteine Enzymatic Assay is explicitly designed for quantitative measurement of total homocysteine in both serum and plasma samples. This versatility allows laboratories to use the assay across different specimen types while maintaining consistency in diagnostic assessments for hyperhomocysteinemia-related conditions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TECO HOMOCYSTEINE ENZYMATIC ASSAY (K063701) — FDA 510 (k) | Innolitics, PDF REVIEW MEMORANDUM - Food and Drug Administration, PDF DEPARTMENT OF HEALTH &HUMAN SERVICES Public Health Service ZC
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063701 | Class II | Active |
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Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA 510(k) K063701 24 fields · synced Oct 1, 2026