Cleared Traditional

K102064 - BD FACS SAMPLE PREP ASSISTANT III (SPA III) (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K102064 · Becton, Dickinson & CO · Hematology device
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Mar 2011
Decision
227d
Days
Class 2
Risk

K102064 is an FDA 510(k) clearance for the BD FACS SAMPLE PREP ASSISTANT III (SPA III). Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Becton, Dickinson & CO (San Jose, US). The FDA issued a Cleared decision on March 7, 2011 after a review of 227 days - an extended review 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: 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.

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Submission Details

510(k) Number K102064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2010
Decision Date March 07, 2011
Days to Decision 227 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
114d slower than avg
Panel avg: 113d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 378
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