Cleared Traditional

K002456 - MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992

K002456 is an FDA 510(k) clearance for MICROTAINER BRAND SODIUM FLUORIDE/EDTA ..., manufactured by Becton Dickinson Vacutainer Systems. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K002456 · Becton Dickinson Vacutainer Systems · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
84d
Days
Class 2
Risk

K002456 is an FDA 510(k) clearance for the MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Becton Dickinson Vacutainer Systems (Franklin Lake, US). The FDA issued a Cleared decision on November 2, 2000 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K002456

510(k) Number K002456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2000
Decision Date November 02, 2000
Days to Decision 84 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
5d faster than avg
Panel avg: 89d · This submission: 84d
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 239
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K002456.
SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
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BD VACUTAINER SAFETY COAGULATION TUBE
K013971 · Becton, Dickinson & CO · Feb 2002
VACUETTE EVACUATED BLOOD COLLECTION TUBES
K011699 · Greiner Bio-One Vacuette North America · Jun 2001
VACUETTE WITH PPACK
K002777 · Greiner Vacuette North America, Inc. · Oct 2000
APPRAISE-CARDIO SAMPLE COLLECTION KIT
K993787 · Osborn Group, Inc. · Apr 2000
SAMPLOK
K000777 · Itl Corporation Pty, Ltd. · Apr 2000
K002456 · MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992
Download PDF FDA Summary Becton Dickinson Vacu…