Cleared Traditional

K182078 - MiniCollect K2E K2EDTA Tubes

K182078 is the FDA 510(k) clearance for MiniCollect K2E K2EDTA Tubes by Greiner Bio-One Na, Inc.. It is a Class 2 Hematology device (product code JKA) cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K182078 · Greiner Bio-One Na, Inc. · Hematology device
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Jan 2019
Decision
176d
Days
Class 2
Risk

K182078 is an FDA 510(k) clearance for the MiniCollect K2E K2EDTA Tubes. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Greiner Bio-One Na, Inc. (Monroe, US). The FDA issued a Cleared decision on January 25, 2019 after a review of 176 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1675 - 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 Greiner Bio-One Na, Inc. devices

Submission Details

510(k) Number K182078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2018
Decision Date January 25, 2019
Days to Decision 176 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 113d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Hematology devices follow this clearance model.

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

All 115
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