Cleared Traditional

K260235 - CellDx-Tissue

K260235 is an FDA 510(k) clearance for CellDx-Tissue, manufactured by Datar Cancer Genetics Private Limited. The device is a Class 2 Pathology device with product code PZM cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K260235 · Datar Cancer Genetics Private Limited · Pathology device
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Optimized for regulatory review, auditing and printing
May 2026
Decision
106d
Days
Class 2
Risk

K260235 is an FDA 510(k) clearance for the CellDx-Tissue. Classified as Next Generation Sequencing Based Tumor Profiling Test (product code PZM), Class II - Special Controls.

Submitted by Datar Cancer Genetics Private Limited (Nasik, IN). The FDA issued a Cleared decision on May 12, 2026 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.6080 - the FDA pathology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Datar Cancer Genetics Private Limited devices

FDA 510(k) Submission Details - K260235

510(k) Number K260235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2026
Decision Date May 12, 2026
Days to Decision 106 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 77d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

PZM Device Classification - Class 2, Special Controls

Product Code PZM Next Generation Sequencing Based Tumor Profiling Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6080
Definition A Next-generation Sequencing Based Tumor Profiling Test Is A Qualitative In Vitro Diagnostic Test Intended To Detect Mutations In A Broad Panel Of Targeted Genes That Are Somatically Altered In Malignant Neoplasms From Tumor Specimens Obtained From Patients Diagnosed With Malignant Solid Neoplasms Using Targeted Next-generation Sequencing.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.

Regulatory Consultant

Global Quality and Regulatory Services
Abdel B Halim

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.

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