Cleared Traditional

K954188 - OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC C...

K954188 is the FDA 510(k) clearance for OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC C... by Immunotech Corp.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K954188 · Immunotech Corp. · Hematology device
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Nov 1995
Decision
58d
Days
Class 2
Risk

K954188 is an FDA 510(k) clearance for the OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL. 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 November 3, 1995 after a review of 58 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 K954188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1995
Decision Date November 03, 1995
Days to Decision 58 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
55d faster than avg
Panel avg: 113d · This submission: 58d
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
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