Cleared Traditional

K000611 - STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER

K000611 is an FDA 510(k) clearance for STELLER CD61 ASSAY FOR USE ON THE IMAGN..., manufactured by Bd Biosciences. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K000611 · Bd Biosciences · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
85d
Days
Class 2
Risk

K000611 is an FDA 510(k) clearance for the STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Bd Biosciences (San Jose, US). The FDA issued a Cleared decision on May 18, 2000 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K000611

510(k) Number K000611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2000
Decision Date May 18, 2000
Days to Decision 85 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
28d faster than avg
Panel avg: 113d · This submission: 85d
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 380
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K000611.
ADVIA 120 HEMATOLOGY
K003796 · Bayer Corp. · Feb 2001
ABX PENTRA 60C+ HEMATOLOGY ANALYZER
K003677 · Abx Diagnostics · Dec 2000
ABX MICROS CRP
K002646 · Abx Diagnostics · Oct 2000
CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE
K000897 · Bd Biosciences · May 2000
COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
K993356 · Coulter Corp. · Apr 2000
SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER
K992875 · Sysmex Corp. · Nov 1999
K000611 · STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER
Download PDF FDA Summary Bd Biosciences