Cleared Traditional

K864579 - MINOS AUTOMATIC CELL COUNTER

K864579 is the FDA 510(k) clearance for MINOS AUTOMATIC CELL COUNTER by Abx, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K864579 · Abx, Inc. · Hematology device
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Jul 1987
Decision
238d
Days
Class 2
Risk

K864579 is an FDA 510(k) clearance for the MINOS AUTOMATIC CELL COUNTER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Abx, Inc. (Ringoes, US). The FDA issued a Cleared decision on July 16, 1987 after a review of 238 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Abx, Inc. devices

Submission Details

510(k) Number K864579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1986
Decision Date July 16, 1987
Days to Decision 238 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 113d · This submission: 238d
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
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K864579.
CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER
K874763 · Instrumentation Laboratory CO · Feb 1988
QBC BLOOD BANK SYSTEM
K874147 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1988
QBC SYSTEM HEMOGLOBIN
K874427 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1988
COULTER COUNTER MODEL S-PLUS STKR
K871837 · Coulter Electronics, Inc. · Jul 1987
TECHNICON H*1 SYSTEM (MPXI)
K853027 · Technicon Instruments Corp. · Feb 1986
TECHNICON H*1 SYSTEM LOBULARITY INDX/LFT SHIFT FLA
K853029 · Technicon Instruments Corp. · Jan 1986