Cleared Traditional

K111534 - ABACUS 3CP

K111534 is the FDA 510(k) clearance for ABACUS 3CP by Diatron U.S., Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 427-day FDA review.

K111534 · Diatron U.S., Inc. · Hematology device
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Aug 2012
Decision
427d
Days
Class 2
Risk

K111534 is an FDA 510(k) clearance for the ABACUS 3CP. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Diatron U.S., Inc. (Lenexa, US). The FDA issued a Cleared decision on August 2, 2012 after a review of 427 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Diatron U.S., Inc. devices

Submission Details

510(k) Number K111534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2011
Decision Date August 02, 2012
Days to Decision 427 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
314d slower than avg
Panel avg: 113d · This submission: 427d
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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