Cleared Traditional

K081213 - BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010

K081213 is an FDA 510(k) clearance for BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010, 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 106-day FDA review.

K081213 · Bd Biosciences · Hematology device
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Aug 2008
Decision
106d
Days
Class 2
Risk

K081213 is an FDA 510(k) clearance for the BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010. 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 August 14, 2008 after a review of 106 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 - K081213

510(k) Number K081213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2008
Decision Date August 14, 2008
Days to Decision 106 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
7d faster than avg
Panel avg: 113d · This submission: 106d
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 K081213.
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
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K081890 · Sysmex America, Inc. · Oct 2008
SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER
K081610 · Sysmex America, Inc. · Aug 2008
FLOWCARE TLG REAGENT
K081526 · Beckman Coulter, Inc. · Aug 2008
SYSMEX XE-5000
K071967 · Sysmex America, Inc. · Nov 2007
CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554
K071681 · Beckman Coulter, Inc. · Oct 2007