Cleared Traditional

K953116 - WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER

K953116 is the FDA 510(k) clearance for WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER by Intl. Remote Imaging Systems. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K953116 · Intl. Remote Imaging Systems · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
315d
Days
Class 2
Risk

K953116 is an FDA 510(k) clearance for the WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Intl. Remote Imaging Systems (Chatsworth, US). The FDA issued a Cleared decision on May 13, 1996 after a review of 315 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 Intl. Remote Imaging Systems devices

Submission Details

510(k) Number K953116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1995
Decision Date May 13, 1996
Days to Decision 315 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
202d slower than avg
Panel avg: 113d · This submission: 315d
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
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