Cleared Traditional

OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL (K953498) - FDA 510(k) Clearance

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

K953498 · Immunotech, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
44d
Days
Class 2
Risk

K953498 is an FDA 510(k) clearance for the OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL. 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 September 8, 1995 after a review of 44 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, Inc. devices

Submission Details

510(k) Number K953498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1995
Decision Date September 08, 1995
Days to Decision 44 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
69d faster than avg
Panel avg: 113d · This submission: 44d
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 379
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K953498.
XR-Series (XR-10, XR-20) Automated Hematology Analyzers
K253212 · Sysmex America, Inc. · May 2026
Athelas Home
K243348 · Athelas, Inc. · Feb 2026
Tru Hematology Test
K251249 · Truvian Sciences, Inc. · Jan 2026
Sysmex XR-Series (XR-10) Automated Hematology Analyzer
K250943 · Sysmex America, Inc. · Jun 2025
Sysmex XR-Series (XR-20) Automated Hematology Analyzer
K251371 · Sysmex America, Inc. · Jun 2025
Alinity h-series System
K243283 · Abbott Laboratories · Feb 2025