Cleared Traditional

K994356 - IMMUNOCYT (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K994356 · Diagnocure, Inc. · Pathology device
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Optimized for regulatory review, auditing and printing
Feb 2000
Decision
62d
Days
Class 2
Risk

K994356 is an FDA 510(k) clearance for the IMMUNOCYT. Classified as System, Test, (ihc), Tumor Marker, Monitoring, Bladder Cancer (product code NBK), Class II - Special Controls.

Submitted by Diagnocure, Inc. (Washington, US). The FDA issued a Cleared decision on February 23, 2000 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1860 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Diagnocure, Inc. devices

Submission Details

510(k) Number K994356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1999
Decision Date February 23, 2000
Days to Decision 62 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 77d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NBK System, Test, (ihc), Tumor Marker, Monitoring, Bladder Cancer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.1860
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.