Cleared Traditional

K944128 - CALTAG CD4 R-PE MONOCLONAL ANTIBODY

K944128 is the FDA 510(k) clearance for CALTAG CD4 R-PE MONOCLONAL ANTIBODY by Caltag Laboratories, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K944128 · Caltag Laboratories, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
301d
Days
Class 2
Risk

K944128 is an FDA 510(k) clearance for the CALTAG CD4 R-PE MONOCLONAL ANTIBODY. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Caltag Laboratories, Inc. (South San Francisco, US). The FDA issued a Cleared decision on June 20, 1995 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Caltag Laboratories, Inc. devices

Submission Details

510(k) Number K944128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1994
Decision Date June 20, 1995
Days to Decision 301 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
188d slower than avg
Panel avg: 113d · This submission: 301d
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 194
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K944128.
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
OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES
K950626 · Immunotech Corp. · May 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