510(k) Report

510(k) · Cleared

Cleared

Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C

K203245510(k) TraditionalCleared May 4, 2023912-day reviewClass II21 CFR 866.6010

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nucleix, Ltd. · MMW System, Test, Tumor Marker, Monitoring, Bladder

Cleared on May 4, 2023 as substantially equivalent to K013785 (Vysis, 2002) after a 912-day review. Its family tree reaches back 1 generation to 2002.

Decided
May 4, 2023
Review
912 days
Class
Class II
Product code
MMW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K013785 (2002). No later device cites it as a predicate yet.

K013785 · Urovysion Bladder Cancer Recurrence Kit · Vysis · 2002 · recalled200020052010201520202025
K013785 · Urovysion Bladder Cancer Recurrence Kit · Vysis · 2002 · recalled0
  1. Root · 1 generation backK013785 Urovysion Bladder Cancer Recurrence KitVysis · 2002 · Recalled
  2. This deviceK203245 Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck…Nucleix, Ltd. · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K013785Urovysion Bladder Cancer Recurrence KitVysis20021
0 (this device)K203245Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit…Nucleix, Ltd.2023—
FIG. 1 — Lineage of K203245, 2002–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MMW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K013785Urovysion Bladder Cancer Recurrence Kit
Summary page 5
…Class II Classification Panel: Immunology 4. Legally Marketed Predicate Device Abbott Molecular UroVysion™ Bladder Cancer Kit (K013785) 510(k) Summary for Bladder EpiCheck Kit Page 1 of 27 5. Device…
Vysis20021

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.

How does its category compare?

All MMW devices

MMW System, Test, Tumor Marker, Monitoring, Bladder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · MMW

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MMW

Too few MMW 510(k)s in any year since 2007 to give a median.

Recalls per year · MMW

No recall names MMW since 2007.

Adverse event reports per year · MMW

1in 2013

2010: 12011: 12012: 32013: 1
2007high 3 (2012) · low 0 (2007)2025

MAUDE reports naming product code MMW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—01
20110—01
20120—03
20130—01
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20231—00
20240—00
20250—00
20260—0—

What is it indicated for?

Bladder EpiCheck Kit is intended for the qualitative detection of DNA methylation patterns of 15 loci in human DNA that are associated with transitional cell carcinoma of the bladder. The test is performed on voided urine samples and run on the ABI® 7500 Fast Dx Real-Time PCR system.

Bladder EpiCheck Kit is indicated for use as a non-invasive method to monitor for tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with Non-Muscle Invasive Bladder Cancer.

Indications for use as stated in the FDA summary.

Recent decisions in MMW

The MMW category page

  • K033982Modification to Vysis Urovysion Bladder Cancer Recurrence TestVysis · 2004
  • K021231NMP22 Bladderchek Kit, NMP22 Control KitMatritech, Inc. · 2002
  • K013785Urovysion Bladder Cancer Recurrence KitVysis · 20021 recall
  • K011031Vysis Urovysion Bladder Cancer Recurrence KitVysis · 20011 recall
  • K974845Bta Stat Test Prescription Home UseBard Diagnostic Sciences,Inc. · 1998

https://510kreport.com/device/K203245 · printed Nov 6, 2026

Cite this page

510(k) Report. “K203245: Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203245

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026