Cleared Traditional

K813033 - CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY

K813033 is an FDA 510(k) clearance for CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Hematology device with product code GKG cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K813033 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1982
Decision
163d
Days
Class 2
Risk

K813033 is an FDA 510(k) clearance for the CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY. Classified as Centrifuge, Hematocrit (product code GKG), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on April 9, 1982 after a review of 163 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6400 - 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 Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K813033

510(k) Number K813033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1981
Decision Date April 09, 1982
Days to Decision 163 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 113d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKG Device Classification - Class 2, Special Controls

Product Code GKG Centrifuge, Hematocrit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6400
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.