Cleared Traditional

K061392 - IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM

K061392 is an FDA 510(k) clearance for IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST..., manufactured by Ikonisys, Inc.. The device is a Class 2 Hematology device with product code JOY cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K061392 · Ikonisys, Inc. · Hematology device
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Aug 2006
Decision
74d
Days
Class 2
Risk

K061392 is an FDA 510(k) clearance for the IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM. Classified as Device, Automated Cell-locating (product code JOY), Class II - Special Controls.

Submitted by Ikonisys, Inc. (New Haven, US). The FDA issued a Cleared decision on August 1, 2006 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5260 - 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 Ikonisys, Inc. devices

FDA 510(k) Submission Details - K061392

510(k) Number K061392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2006
Decision Date August 01, 2006
Days to Decision 74 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 113d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOY Device Classification - Class 2, Special Controls

Product Code JOY Device, Automated Cell-locating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5260
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 - JOY Device, Automated Cell-locating

All 25
Devices cleared under the same product code (JOY) and FDA review panel - the closest regulatory comparables to K061392.
SCANVIEW, MODEL SC-300
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IKONISCOPE ONCOFISH BLADDER TEST SYSTEM
K062755 · Ikonisys, Inc. · Jan 2007
IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM
K052577 · Ikonisys, Inc. · Jan 2006
MODIFICATION TO DUET SYSTEM
K050840 · Bioview , Ltd. · Aug 2005
AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
K984188 · Chroma Vision Medical Systems, Inc. · Jul 1999