Cleared Special

K071141 - BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 (FDA 510(k) Clearance)

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K071141 · Bd Biosciences · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
43d
Days
Class 2
Risk

K071141 is an FDA 510(k) clearance for the BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402. 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 June 6, 2007 after a review of 43 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bd Biosciences devices

Submission Details

510(k) Number K071141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2007
Decision Date June 06, 2007
Days to Decision 43 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 113d · This submission: 43d
Pathway characteristics
Modification to existing cleared device.

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

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