Cleared Traditional

K771523 - LATELET RETENTION COLUMN

K771523 is an FDA 510(k) clearance for LATELET RETENTION COLUMN, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Hematology device with product code JBZ cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K771523 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
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Nov 1977
Decision
106d
Days
Class 2
Risk

K771523 is an FDA 510(k) clearance for the LATELET RETENTION COLUMN. Classified as Study, Platelet Adhesive (product code JBZ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on November 22, 1977 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 864.6650 - 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 - K771523

510(k) Number K771523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1977
Decision Date November 22, 1977
Days to Decision 106 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
7d faster than avg
Panel avg: 113d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JBZ Device Classification - Class 2, Special Controls

Product Code JBZ Study, Platelet Adhesive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6650
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.