Cleared Traditional

K162723 - TransFix/EDTA Vacuum Blood Collection Tubes (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K162723 · Caltag Medsystems, Ltd. · Immunology device
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Jun 2017
Decision
266d
Days
Class 2
Risk

K162723 is an FDA 510(k) clearance for the TransFix/EDTA Vacuum Blood Collection Tubes. Classified as Tubes, Vacuum Sample, With Anticoagulant (product code GIM), Class II - Special Controls.

Submitted by Caltag Medsystems, Ltd. (Buckingham, GB). The FDA issued a Cleared decision on June 22, 2017 after a review of 266 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1675 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Caltag Medsystems, Ltd. devices

Submission Details

510(k) Number K162723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2016
Decision Date June 22, 2017
Days to Decision 266 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 104d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GIM Tubes, Vacuum Sample, With Anticoagulant
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 Immunology devices follow this clearance model.

Regulatory Peers - GIM Tubes, Vacuum Sample, With Anticoagulant

All 38
Devices cleared under the same product code (GIM) and FDA review panel - the closest regulatory comparables to K162723.
BD Vacutainer® Citrate Blood Collection Tubes
K240455 · Becton, Dickinson and Company · Oct 2024
BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube
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BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
K213670 · Becton, Dickinson and Company · Aug 2023