Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, N…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K203245 FDA 510(k)
- FDA Product Code
- MMW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.6010 FDA 510(k)
- Regulation Number
- 866.6010 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bladder EpiCheck DNA Extraction Kit (NX899090-01C) is an in vitro diagnostic device classified as a System, Test, Tumor Marker, Monitoring, Bladder. It is designed for the qualitative detection of DNA methylation patterns at 15 specific loci in human DNA, which are associated with transitional cell carcinoma of the bladder. This test leverages molecular analysis to identify biomarkers linked to urothelial carcinoma, enabling non-invasive monitoring of tumor recurrence.
The kit is supplied as a single-use diagnostic tool intended for use with voided urine samples and processed on the ABI 7500 Fast Dx Real-Time PCR system. Mini spin columns within the kit require storage at 2–8°C and must be used before the expiration date printed on the packaging. Authorized for use under FDA 510K clearance (K203245), this device is regulated under 21 CFR 866.6010 and falls under the Medical Specialty of Immunology for administrative classification.
Frequently asked questions
What clinical purpose does the Bladder EpiCheck DNA extraction kit serve in bladder cancer monitoring?
The Bladder EpiCheck DNA extraction kit (NX899090-01C) is designed for the qualitative detection of DNA methylation patterns at 15 specific loci in human DNA, which are linked to transitional cell carcinoma of the bladder. It enables non-invasive monitoring of urothelial carcinoma recurrence by analyzing biomarkers in voided urine samples, helping clinicians track tumor presence without invasive procedures.
How is the Bladder EpiCheck DNA extraction kit supplied, and what storage conditions are required?
The kit is supplied as a single-use diagnostic tool containing mini spin columns for DNA extraction. These components must be stored at 2–8°C and used before the expiration date printed on the packaging. The kit is intended for use with voided urine samples processed on the ABI 7500 Fast Dx Real-Time PCR system for molecular analysis.
Is the Bladder EpiCheck system intended for reuse, or is it designed for single-use per patient?
The Bladder EpiCheck DNA extraction kit (NX899090-01C) is explicitly designed for single-use per patient sample. The mini spin columns and other components are not meant to be reused, ensuring sterility and accuracy for each diagnostic test.
What regulatory pathway was followed for FDA clearance of the Bladder EpiCheck system?
The Bladder EpiCheck system (including the DNA extraction kit, test kit, and software) received FDA 510(k) clearance under the traditional review pathway (K203245). It was classified as substantially equivalent to a predicate device and falls under 21 CFR 866.6010, with administrative classification in the Immunology specialty.
Are there multiple components in the Bladder EpiCheck system, and how do they work together?
Yes, the system consists of three components: the DNA extraction kit (NX899090-01C), the test kit (NX899090-02C), and the Bladder EpiCheck Software (NX899090-03C). The extraction kit isolates DNA from voided urine, the test kit analyzes methylation patterns via real-time PCR on the ABI 7500 Fast Dx system, and the software interprets results to identify biomarkers associated with urothelial carcinoma recurrence.
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: PDF Bladder EpiCheck® Kit - Nucleix, Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck ..., PDF Bladder EpiCheck® Kit - Nucleix
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203245 | Class II | Active |
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Manufacturer
- Manufacturer
- Nucleix , Ltd.
Sources (1)
- FDA 510(k) K203245 24 fields · synced Sep 19, 2026