Cleared Traditional

K946335 - OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES

K946335 is an FDA 510(k) clearance for OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONA..., manufactured by Immunotech, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K946335 · Immunotech, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
295d
Days
Class 2
Risk

K946335 is an FDA 510(k) clearance for the OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Immunotech, Inc. (Westbrook, US). The FDA issued a Cleared decision on October 20, 1995 after a review of 295 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Immunotech, Inc. devices

FDA 510(k) Submission Details - K946335

510(k) Number K946335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1994
Decision Date October 20, 1995
Days to Decision 295 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
182d slower than avg
Panel avg: 113d · This submission: 295d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKZ Device Classification - Class 2, Special Controls

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 Hematology devices follow this clearance model.

Regulatory Peers - GKZ Counter, Differential Cell

All 304
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K946335.
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CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER
K951496 · Abbott Laboratories · Oct 1995
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K953448 · Roche Diagnostic Systems, Inc. · Oct 1995