ELITech Clinical Systems Glucose HK SL, ELICAL 2, ELITROL I and ELITROL II
FDA 510(k)Class II (US FDA 510(k))
by Elitechgroup
Identifiers
- 510(k) Number
- K153644 FDA 510(k)
- FDA Product Code
- CFR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1345 FDA 510(k)
- Regulation Number
- 862.1345 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ELITech Clinical Systems Glucose HK SL, ELICAL 2, ELITROL I, and ELITROL II are in vitro diagnostic reagents designed for the quantitative determination of glucose in human serum, plasma, and urine. These products utilize hexokinase enzymatic methods to measure glucose levels, supporting clinical chemistry applications. They are intended for use on ELITech Clinical Systems analyzers, including the Selectra Pro Series and Vital Scientific Selectra/Flexor platforms.
These reagents are supplied as single-use diagnostic kits for laboratory use, adhering to FDA 510(k) clearance under the Clinical Chemistry advisory committee. They are classified as Class II devices under CFR 862.1345 and are intended for use in regulated clinical settings. Storage and handling follow standard in vitro diagnostic protocols, with no specific MRI safety considerations noted.
Frequently asked questions
What clinical applications do the ELITech Clinical Systems glucose reagents support?
These reagents are designed for the quantitative measurement of glucose levels in human serum, plasma, and urine using hexokinase enzymatic methods. They are specifically intended for clinical chemistry applications, enabling accurate glucose monitoring in regulated laboratory settings. The results support diagnostic and treatment decisions for conditions like diabetes management, hypoglycemia assessment, and metabolic disorders.
Are these reagents single-use or reusable, and how should they be stored?
The ELITech Clinical Systems glucose reagents (GLUCOSE HK SL, ELICAL 2, ELITROL I, and ELITROL II) are supplied as single-use diagnostic kits. This design ensures consistency and sterility for each test, reducing cross-contamination risks. Storage follows standard in vitro diagnostic protocols, which typically involve keeping reagents in a cool, dry place (e.g., 2–8°C) away from direct light until use. Always refer to the manufacturer’s instructions for specific storage conditions and expiration details.
Which ELITech analyzers are compatible with these glucose reagents?
These reagents are exclusively intended for use on ELITech Clinical Systems analyzers, including the Selectra Pro Series and Vital Scientific Selectra/Flexor platforms. Compatibility is critical for accurate results, as the reagents are optimized for the biochemical and analytical performance of these specific systems. Verify analyzer model compatibility with the reagent packaging or manufacturer documentation before use.
How are these reagents classified under FDA regulations?
The ELITech Clinical Systems glucose reagents are classified as Class II devices under CFR 862.1345, indicating moderate regulatory oversight. They have received FDA 510(k) clearance through the Clinical Chemistry advisory committee, demonstrating substantial equivalence to a predicate device. This classification ensures they meet performance standards for safety and effectiveness in clinical chemistry applications while adhering to strict manufacturing and labeling requirements.
Do these reagents require any special handling or safety precautions?
As in vitro diagnostic reagents, these products follow standard handling protocols for clinical chemistry tests, including proper labeling, contamination control, and adherence to laboratory safety guidelines. There are no specific MRI safety considerations noted, but standard precautions for chemical handling (e.g., avoiding skin/eye contact, using personal protective equipment) should be observed. Always follow the manufacturer’s instructions for preparation, usage, and disposal to ensure accuracy and safety.
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: ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL ..., Elitech Clinical Systems Glucose Pap Sl Elitech Clinical Systems Elical ..., In-vitro Diagnostics Company | IVD Product Development
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153644 | Class II | Active |
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Manufacturer
- Manufacturer
- Elitechgroup
Sources (1)
- FDA 510(k) K153644 24 fields · synced Oct 6, 2026