Cleared Traditional

K060375 - BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166

K060375 is an FDA 510(k) clearance for BD MULTITEST 6-COLOR TBNK REAGENT WITH ..., 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 113-day FDA review.

K060375 · Bd Biosciences · Hematology device
Download Printable Device Report (PDF)
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Jun 2006
Decision
113d
Days
Class 2
Risk

K060375 is an FDA 510(k) clearance for the BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166. 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, 2006 after a review of 113 days - within the typical 510(k) review window.

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.

View all Bd Biosciences devices

FDA 510(k) Submission Details - K060375

510(k) Number K060375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2006
Decision Date June 06, 2006
Days to Decision 113 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
At panel average
Panel avg: 113d · This submission: 113d
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
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