AmplideX Fragile X Dx & Carrier Screen Kit
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- AmplideX Fragile X Dx & Carrier Screen Kit EUDAMED
- Device Name
- AmplideX Fragile X Dx & Carrier Screen Kit EUDAMED
- Model / Reference
- A01124 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850017493124 EUDAMED
- Basic UDI-DI
- 0850017493A011248A EUDAMED
- Direct Marketing DI
- 00850017493124 EUDAMED
- 510(k) Number
- DEN190023 FDA 510(k)
- FDA Product Code
- OYV FDA 510(k)
- EMDN Code
- W0106010104 FRAGILE X SYNDROME EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5970 FDA 510(k)
- Regulation Number
- 866.5970 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
Clinical & Handling
Sterile
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
Yes
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
The AmplideX Fragile X Dx & Carrier Screen Kit is an Inherited Nucleotide Repeat Disorder DNA Test (per FDA classification OYV) designed to detect and quantify CGG repeat expansions in the FMR1 gene via polymerase chain reaction (PCR) and capillary electrophoresis. It identifies Fragile X syndrome and carrier status by analyzing genomic DNA extracted from peripheral whole blood, enabling precise genetic diagnosis of FMR1-related disorders.
This kit is supplied as an in vitro diagnostic device with FDA 510(k) clearance and IVDR compliance, intended for laboratory use only. It is a single-use reagent kit requiring sterile handling and proper storage per manufacturer instructions. The test does not require MRI compatibility or special environmental conditions, and results are derived from whole blood samples processed according to the included protocol.
Frequently asked questions
What types of samples can be tested with the AmplideX Fragile X Dx & Carrier Screen Kit, and how is the sample processed?
The kit is designed to analyze genomic DNA extracted specifically from peripheral whole blood samples. The test requires processing the blood according to the included protocol, which guides the user through DNA extraction and subsequent analysis via polymerase chain reaction (PCR) and capillary electrophoresis to detect and quantify CGG repeat expansions in the FMR1 gene.
Is the AmplideX Fragile X Dx & Carrier Screen Kit intended for single-use or can it be reused?
The kit is explicitly labeled as a single-use reagent kit, meaning each kit is intended for one test cycle only. Proper sterile handling and adherence to manufacturer instructions are required to ensure accurate and reliable results.
What storage conditions are recommended for the AmplideX Fragile X Dx & Carrier Screen Kit?
While the device data does not specify exact storage conditions, the kit requires proper storage per the manufacturer’s instructions to maintain its integrity. Since it is a single-use reagent kit, it should be stored in a way that prevents contamination and degradation until use, though no special environmental conditions (like temperature or humidity controls) are mentioned.
How does the AmplideX Fragile X Dx & Carrier Screen Kit differ from other Fragile X testing methods?
This kit specifically uses polymerase chain reaction (PCR) and capillary electrophoresis to detect and quantify CGG repeat expansions in the FMR1 gene, which is critical for diagnosing Fragile X syndrome and determining carrier status. Unlike some other methods, it is designed as an in vitro diagnostic device for laboratory use only, providing precise genetic analysis from whole blood samples without requiring additional imaging or specialized equipment beyond standard lab infrastructure.
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: AmplideX® Fragile X Dx & Carrier Screen Kit - Asuragen, FDA Grants Premarket Clearance of Asuragen's AmplideX® Fragile X Dx and ..., AmplideX Fragile X Dx & Carrier Screen Kit - BioCosm
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | DEN190023 | Class II | Active |
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Manufacturer
- Manufacturer
- Asuragen, Inc.
Sources (2)
- FDA 510(k) DEN190023 24 fields · synced Sep 18, 2026
- EUDAMED 54d50fa5-a80e-4ea5-ba7e-d4872d435f85 61 fields · synced Jul 14, 2026