Cleared Traditional

K203245 - Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C (FDA 510(k) Clearance)

Class II Medical Genetics device cleared through predicate-based substantial equivalence.

K203245 · Nucleix , Ltd. · Medical Genetics device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
912d
Days
Class 2
Risk

K203245 is an FDA 510(k) clearance for the Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit,.... Classified as System, Test, Tumor Marker, Monitoring, Bladder (product code MMW), Class II - Special Controls.

Submitted by Nucleix , Ltd. (Rehovot, IL). The FDA issued a Cleared decision on May 4, 2023 after a review of 912 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Medical Genetics FDA review panel, regulated under 21 CFR 866.6010 - the FDA medical genetics device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Medical Genetics submissions.

View all Nucleix , Ltd. devices

Submission Details

510(k) Number K203245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2020
Decision Date May 04, 2023
Days to Decision 912 days
Submission Type Traditional
Review Panel Medical Genetics (MG)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
513d slower than avg
Panel avg: 399d · This submission: 912d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MMW System, Test, Tumor Marker, Monitoring, Bladder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Medical Genetics devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice M. Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT02647112 Completed Interventional Industry-sponsored

Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma

Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma A Multicenter, Prospective Blinded Study

1050
Patients (actual)
6
Sites
Diagnostic
Purpose
Single blind
Masking
Condition studied Bladder Cancer
Study design Single group
Eligibility All sexes · 22 Years+
Principal investigator Shmulik Adler
Sponsor Nucleix Ltd. (industry)
Started 2015-12-01 → Primary completion 2020-12-01
Primary outcome
Sensitivity (the proportion of positives that are correctly identified as such by the gold standard)
Study completed - no results published. This trial concluded in 2020 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov