Cleared Traditional

K261380 - Concentriq AP-Dx

K261380 is an FDA 510(k) clearance for Concentriq AP-Dx, manufactured by Proscia, Inc.. The device is a Class 2 Pathology device with product code QKQ cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K261380 · Proscia, Inc. · Pathology device
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Aug 2026
Decision
100d
Days
Class 2
Risk

K261380 is an FDA 510(k) clearance for the Concentriq AP-Dx. Classified as Digital Pathology Image Viewing And Management Software (product code QKQ), Class II - Special Controls.

Submitted by Proscia, Inc. (Philadelphia, US). The FDA issued a Cleared decision on August 5, 2026 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3700 - 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 Proscia, Inc. devices

FDA 510(k) Submission Details - K261380

510(k) Number K261380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2026
Decision Date August 05, 2026
Days to Decision 100 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 78d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QKQ Device Classification - Class 2, Special Controls

Product Code QKQ Digital Pathology Image Viewing And Management Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.3700
Definition Digital Pathology Image Viewing And Management Software Device Is A Software Intended For Viewing And Management Of Digital Images Of Scanned Surgical Pathology Slides Prepared From Formalin-fixed Paraffin Embedded (ffpe) Tissue. It Is An Aid To The Pathologist To Review And Interpret These Digital Images For The Purposes Of Primary Diagnosis.
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 Peers - QKQ Digital Pathology Image Viewing And Management Software

All 13
Devices cleared under the same product code (QKQ) and FDA review panel - the closest regulatory comparables to K261380.
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PathPresenter Clinical Viewer
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Viewer+
K242244 · Lumea, Inc. · Mar 2025