Cleared Traditional

K023971 - VACUETTE TRACE ELEMENTS TUBES

K023971 is an FDA 510(k) clearance for VACUETTE TRACE ELEMENTS TUBES, manufactured by Greiner Bio-One Vacuette North America. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K023971 · Greiner Bio-One Vacuette North America · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
59d
Days
Class 2
Risk

K023971 is an FDA 510(k) clearance for the VACUETTE TRACE ELEMENTS TUBES. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Greiner Bio-One Vacuette North America (Baldwin, US). The FDA issued a Cleared decision on January 27, 2003 after a review of 59 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 - K023971

510(k) Number K023971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2002
Decision Date January 27, 2003
Days to Decision 59 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
29d faster than avg
Panel avg: 88d · This submission: 59d
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 218
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K023971.
IMMUNICON CELLSAVE PRESERVATIVE TUBE
K030596 · Immunicon Corp. · Aug 2003
PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM
K030076 · Biomed Personal Metabolic and Nutritional Testing · Jul 2003
BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341
K030573 · Bd Vacutainer Systems Preanalyical Solutions · May 2003
BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE
K023075 · Bd Vacutainer Systems Preanalyical Solutions · Nov 2002
BD VACUTAINER SST II PLUS TUBES
K023331 · Becton, Dickinson & CO · Nov 2002
MY ALLERGY TEST
K021698 · Immunetech Corporation · Sep 2002
K023971 · VACUETTE TRACE ELEMENTS TUBES
Download PDF FDA Summary Greiner Bio-One Vacue…