Cleared Traditional

K950626 - OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES

K950626 is the FDA 510(k) clearance for OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES by Immunotech Corp.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K950626 · Immunotech Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
84d
Days
Class 2
Risk

K950626 is an FDA 510(k) clearance for the OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Immunotech Corp. (Westbrook, US). The FDA issued a Cleared decision on May 5, 1995 after a review of 84 days - a notably fast clearance 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: 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 Immunotech Corp. devices

Submission Details

510(k) Number K950626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1995
Decision Date May 05, 1995
Days to Decision 84 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 113d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 193
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K950626.
CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT
K950742 · Coulter Corp. · Aug 1995
OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES
K952789 · Immunotech Corp. · Aug 1995
COULTER MH025A
K950949 · Coulter Corp. · Jul 1995
ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE)
K932530 · Ortho Diagnostic Systems, Inc. · Apr 1995
ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE
K932531 · Ortho Diagnostic Systems, Inc. · Apr 1995
ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE)
K932532 · Ortho Diagnostic Systems, Inc. · Apr 1995