Analette Chemistry Analyzer & Medical Analysis Systems Reagents
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K022072 FDA 510(k)
- FDA Product Code
- CIX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1035 FDA 510(k)
- Regulation Number
- 862.1035 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Analette Chemistry Analyzer is a bench-top clinical chemistry analyzer designed for quantitative analysis of analytes in serum, plasma, or urine samples. It operates as an open-system device, enabling compatibility with various commercial reagents, including those from Medical Analysis Systems. This analyzer performs automated biochemical assays to monitor physiological conditions and disease states, providing measurable results for clinical interpretation.
Intended for use in clinical laboratory settings, the Analette Chemistry Analyzer is operated by trained laboratory personnel. It is supplied as a reusable instrument with compatible single-use reagents, adhering to FDA 510(k) clearance under the Clinical Chemistry advisory committee. The device is classified as Class II (510(k) K022072) and regulated under 21 CFR 862.1035. Storage and handling follow standard laboratory protocols for biochemical analyzers, with no specific MRI safety considerations noted.
Frequently asked questions
What is the Analette Chemistry Analyzer used for?
The Analette Chemistry Analyzer is designed for quantitative analysis of biochemical analytes in serum, plasma, or urine samples. It automates biochemical assays to monitor physiological conditions and disease states, providing measurable results for clinical interpretation in laboratory settings. This helps clinicians track patient health metrics like electrolyte levels, glucose, lipids, and other markers critical for diagnosis and treatment.
Is the Analette Chemistry Analyzer reusable or single-use?
The Analette Chemistry Analyzer itself is a reusable bench-top instrument, while its reagents are supplied as single-use consumables. This design allows for cost-effective operation over time, as the analyzer can be used repeatedly with compatible single-use reagents from various manufacturers, including Medical Analysis Systems. The single-use reagents ensure sterility and consistency for each test run.
What types of reagents are compatible with the Analette Chemistry Analyzer?
The Analette Chemistry Analyzer operates as an open-system device, meaning it is compatible with a wide range of commercial reagents, including those from Medical Analysis Systems. This flexibility allows laboratories to select reagents based on their specific testing needs, such as measuring albumin, glucose, electrolytes, or other biochemical analytes. The analyzer’s design ensures compatibility with these reagents while maintaining accuracy and reliability.
How should the Analette Chemistry Analyzer be stored?
Storage and handling of the Analette Chemistry Analyzer follow standard laboratory protocols for biochemical analyzers. The device should be stored in a clean, dry environment protected from extreme temperatures, humidity, and direct sunlight. Reagents should be stored according to their individual manufacturer instructions, typically in a refrigerator or at room temperature, depending on the type. Proper storage ensures the analyzer’s performance and the integrity of test results.
What regulatory pathway does the Analette Chemistry Analyzer follow?
The Analette Chemistry Analyzer is cleared by the FDA under a 510(k) submission (K022072) and classified as a Class II device under 21 CFR 862.1035. It was reviewed by the Clinical Chemistry Advisory Committee and determined to be substantially equivalent to a predicate device. This regulatory pathway ensures the device meets safety and performance standards for clinical use in laboratories, operated by trained personnel.
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: Precision Systems Analette Chemistry Analyzer & Medical Analysis ..., About Us - precisionsystemsinc.com, 9008 ANALETTE II Open System Bench-Top Chemistry Analyzer
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K022072 | Class II | Active |
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Manufacturer
- Manufacturer
- Precision Systems, Inc.
Sources (1)
- FDA 510(k) K022072 24 fields · synced Oct 1, 2026