Cleared Traditional

K931368 - MICROTAINER BRAND TUBE WITH EDTA

K931368 is an FDA 510(k) clearance for MICROTAINER BRAND TUBE WITH EDTA, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K931368 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
195d
Days
Class 2
Risk

K931368 is an FDA 510(k) clearance for the MICROTAINER BRAND TUBE WITH EDTA. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on September 28, 1993 after a review of 195 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry 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 Chemistry 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 - K931368

510(k) Number K931368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1993
Decision Date September 28, 1993
Days to Decision 195 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 88d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 Chemistry devices follow this clearance model.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 171
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K931368.
MICROTAINER BRAND TUBE WITH EDTA(K2)
K940905 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1994
DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G
K941159 · International Technidyne Corp. · May 1994
DIRECTDRAW SUPERSERUM-MINI
K935081 · International Technidyne Corp. · Jan 1994
VACUTAINER BRAND LUER ADAPTER
K931367 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1993
VACU-PRO
K922445 · Concord/Portex · Aug 1992
VACUTAINER BRAND LUER ADAPTER
K921520 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1992