Cleared Traditional

K953116 - WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER

K953116 is an FDA 510(k) clearance for WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER, manufactured by Intl. Remote Imaging Systems. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K953116

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
Combination Product No
PCCP Authorized No
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.

GKZ Device Classification - Class 2, Special Controls

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 295
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K953116.
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