Cleared Traditional

K860166 - PICOSCALE BLOOD CELL COUNTER

K860166 is an FDA 510(k) clearance for PICOSCALE BLOOD CELL COUNTER, manufactured by Diagnostic Technology, Inc.. The device is a Class 2 Hematology device with product code GKL cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K860166 · Diagnostic Technology, Inc. · Hematology device
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Apr 1986
Decision
77d
Days
Class 2
Risk

K860166 is an FDA 510(k) clearance for the PICOSCALE BLOOD CELL COUNTER, MODEL PS-5. 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 April 4, 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

FDA 510(k) Submission Details - K860166

510(k) Number K860166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1986
Decision Date April 04, 1986
Days to Decision 77 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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.

GKL Device Classification - Class 2, Special Controls

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 82
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K860166.
IL CELLECT 8
K863291 · Instrumentation Laboratory CO · Sep 1986
COULTER COUNTER MODEL S PLUS JUNIOR
K861780 · Coulter Electronics, Inc. · Aug 1986
PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS
K860586 · Diagnostic Technology, Inc. · May 1986
TECHNICON H*1 SYSTEM (HDW)
K853030 · Technicon Instruments Corp. · Feb 1986
PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1
K853036 · Diagnostic Technology, Inc. · Nov 1985
COULTER COUNTER MODEL T-660
K854114 · Coulter Electronics, Inc. · Nov 1985