Cleared Traditional

K190225 - TAP Blood Collection Device

K190225 is an FDA 510(k) clearance for TAP Blood Collection Device, manufactured by Seventh Sense Biosystems, Inc.. The device is a Class 2 Chemistry device with product code PRJ cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K190225 · Seventh Sense Biosystems, Inc. · Chemistry device
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Nov 2019
Decision
273d
Days
Class 2
Risk

K190225 is an FDA 510(k) clearance for the TAP Blood Collection Device. Classified as Capillary Blood Collection Device For Alternative Site Collection (product code PRJ), Class II - Special Controls.

Submitted by Seventh Sense Biosystems, Inc. (Medford, US). The FDA issued a Cleared decision on November 5, 2019 after a review of 273 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 Seventh Sense Biosystems, Inc. devices

FDA 510(k) Submission Details - K190225

510(k) Number K190225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2019
Decision Date November 05, 2019
Days to Decision 273 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
185d slower than avg
Panel avg: 88d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PRJ Device Classification - Class 2, Special Controls

Product Code PRJ Capillary Blood Collection Device For Alternative Site Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
Definition A Capillary Blood Collection Device With Or Without Integrated Micro-needles Is A Blood Collection Device Intended To Collect And/or Transport Capillary Whole Blood Specimens For Testing Of Clinical Analytes.
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.