Cleared Traditional

K000897 - CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE

K000897 is an FDA 510(k) clearance for CALIBRITE PERCP-CY5.5 BEADS AND FACSCOM..., 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 45-day FDA review.

K000897 · Bd Biosciences · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
45d
Days
Class 2
Risk

K000897 is an FDA 510(k) clearance for the CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE. 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 5, 2000 after a review of 45 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.

View all Bd Biosciences devices

FDA 510(k) Submission Details - K000897

510(k) Number K000897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2000
Decision Date May 05, 2000
Days to Decision 45 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 113d · This submission: 45d
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 296
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K000897.
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
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COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
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ADVIA 120 HEMATOLOGY
K003796 · Bayer Corp. · Feb 2001
COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
K993356 · Coulter Corp. · Apr 2000
SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER
K992875 · Sysmex Corp. · Nov 1999
ABX PENTRA 60 HEMATOLOGY ANALYZER
K992511 · Abx Diagnostics · Oct 1999