Cleared Traditional

K061602 - DUET SYSTEM

K061602 is an FDA 510(k) clearance for DUET SYSTEM, manufactured by Bioview , Ltd.. The device is a Class 2 Hematology device with product code JOY cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K061602 · Bioview , Ltd. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
229d
Days
Class 2
Risk

K061602 is an FDA 510(k) clearance for the DUET SYSTEM. Classified as Device, Automated Cell-locating (product code JOY), Class II - Special Controls.

Submitted by Bioview , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on January 23, 2007 after a review of 229 days - an extended review 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: 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.

FDA 510(k) Submission Details - K061602

510(k) Number K061602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2006
Decision Date January 23, 2007
Days to Decision 229 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
116d slower than avg
Panel avg: 113d · This submission: 229d
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 34
Devices cleared under the same product code (JOY) and FDA review panel - the closest regulatory comparables to K061602.
CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
K092868 · CellaVision AB · Nov 2009
CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
K080595 · CellaVision AB · Dec 2008
SCANVIEW, MODEL SC-300
K071398 · Applied Spectral Imaging , Ltd. · Oct 2007
IKONISCOPE ONCOFISH BLADDER TEST SYSTEM
K062755 · Ikonisys, Inc. · Jan 2007
IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM
K061392 · Ikonisys, Inc. · Aug 2006
IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM
K052577 · Ikonisys, Inc. · Jan 2006
K061602 · DUET SYSTEM
Download PDF FDA Summary Bioview , Ltd.