Cleared Traditional

PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS (K860586) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K860586 · Diagnostic Technology, Inc. · Hematology device
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May 1986
Decision
77d
Days
Class 2
Risk

K860586 is an FDA 510(k) clearance for the PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Diagnostic Technology, Inc. (Hauppauge, US). The FDA issued a Cleared decision on May 7, 1986 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Diagnostic Technology, Inc. devices

Submission Details

510(k) Number K860586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1986
Decision Date May 07, 1986
Days to Decision 77 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 113d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
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 - GKL Counter, Cell, Automated (particle Counter)

All 24
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K860586.
CELLECT 8E AUTOMATED BLOOD CELL COUNTERS
K862374 · Instrumentation Laboratory CO · Sep 1986
IL CELLECT 7
K863290 · Instrumentation Laboratory CO · Sep 1986
IL CELLECT 8
K863291 · Instrumentation Laboratory CO · Sep 1986
TECHNICON H*1 SYSTEM (HDW)
K853030 · Technicon Instruments Corp. · Feb 1986
QBC CENTRIFUGAL HEMATOLOGY ANALYZ
K840658 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1984
RDW PARAMETER FOR THE TECHNICON H6000
K834026 · Technicon Instruments Corp. · Jan 1984