Cleared Traditional

K864579 - MINOS AUTOMATIC CELL COUNTER

K864579 is an FDA 510(k) clearance for MINOS AUTOMATIC CELL COUNTER, manufactured by Abx, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K864579

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.

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 304
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K864579.
QBC SYSTEM HEMOGLOBIN
K874427 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1988
SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER
K873734 · Toa Medical Electronics USA, Inc. · Nov 1987
CELL-DYN 610 HEMATOLOGY ANALYZER
K872761 · Abbott Diagnostics · Aug 1987
COULTER COUNTER MODEL S-PLUS STKR
K871837 · Coulter Electronics, Inc. · Jul 1987
SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY.
K871600 · Toa Medical Electronics USA, Inc. · Jun 1987
CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER
K870233 · Abbott Diagnostics · Mar 1987