Uridyltransferase Kit, 50 Hour (80-4000-13K)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K970277 FDA 510(k)
- FDA Product Code
- KQP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1315 FDA 510(k)
- Regulation Number
- 862.1315 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Fluorescent Procedure (Qualitative) for Galactose-1-Phosphate Uridyltransferase, classified under Clinical Chemistry. It is designed for the qualitative determination of galactose-1-phosphate uridylyltransferase (GALT) activity in whole blood samples collected on saturated filter paper disks, such as S&S 903 or equivalent. The assay relies on fluorescent detection to assess enzyme activity, aiding in the diagnosis of galactosemia caused by GALT deficiency. The kit is intended for use with automated analyzers like the API™ 300 SPOTCHECK® Analyzer or the RFA-300 System.
The Uridyltransferase Kit, 50 Hour (80-4000-13K) is supplied as a reagent kit for laboratory use, requiring no sterilization as it is intended for in vitro diagnostic testing. It is a single-use consumable designed for qualitative analysis, with no MRI safety considerations. The kit is authorized under an FDA 510(k) clearance (K970277) and falls under product code KQP, classified as a Class II device. Storage and handling follow standard laboratory protocols for diagnostic reagents.
Frequently asked questions
What is the Uridyltransferase Kit 50-Hour (80-4000-13K) used for?
This kit is designed for the qualitative determination of galactose-1-phosphate uridylyltransferase (GALT) enzyme activity in whole blood samples collected on saturated filter paper disks, such as S&S 903 or equivalent. It helps diagnose galactosemia caused by GALT deficiency by detecting enzyme activity through fluorescent detection. The assay is intended for use in clinical chemistry laboratories.
How is the Uridyltransferase Kit 50-Hour (80-4000-13K) supplied and intended for use?
The kit is supplied as a reagent kit for laboratory use and is intended for in vitro diagnostic testing. It is a single-use consumable, meaning each kit is designed for one-time use in a specific analysis. The kit is compatible with automated analyzers like the API™ 300 SPOTCHECK® Analyzer or the RFA-300 System, ensuring efficient processing of dried blood spot samples.
Is the Uridyltransferase Kit 50-Hour (80-4000-13K) sterile?
No, the kit is not intended to be sterile. It is designed for in vitro diagnostic use in laboratory settings, where standard aseptic techniques are already applied. Sterility is not required for this type of reagent kit, as it is meant for qualitative analysis rather than invasive or sterile procedures.
Can the Uridyltransferase Kit 50-Hour (80-4000-13K) be reused?
No, the kit is explicitly designed as a single-use consumable. Reusing the kit could compromise the accuracy and reliability of the fluorescent assay results, as the reagents may degrade or become contaminated over time. Each kit is intended for one qualitative analysis cycle only.
How should the Uridyltransferase Kit 50-Hour (80-4000-13K) be stored?
The kit should be stored and handled according to standard laboratory protocols for diagnostic reagents. This typically includes keeping it in a clean, dry environment at room temperature, away from direct sunlight or extreme temperatures. Follow the manufacturer’s instructions for specific storage conditions to ensure reagent stability and accurate test results.
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: URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) (K970277 ... - fda ..., SPOTCHECK Metabolic Kits | Astoria-Pacific, URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) 510 (k)… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K970277 | Class II | Active |
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Manufacturer
- Manufacturer
- Astoria-Pacific, Inc.
Sources (1)
- FDA 510(k) K970277 24 fields · synced Oct 1, 2026