# K161521: TAP Blood Collection Device

- Pathway: 510(k) (Traditional)
- Applicant: Seventh Sense Biosystems, Inc.
- Decided: Feb 16, 2017 after 259 days
- Product code: PRJ (Capillary Blood Collection Device For Alternative Site Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945952 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022130: BD Vacutainer Plus PST II Tube, Becton, Dickinson & CO (2002) Summary page 4.

## Most influential descendants
- K190225: TAP Blood Collection Device (2019), 0 descendants of its own

## Indications for use
The TAP Blood Collection® Device is a lithium heparin coated single use device intended to be used to collect capillary blood from the upper arm of adults 21 years of age or older by a healthcare worker. The collected sample is then transported for analysis in a clinical laboratory for determination of Hemoglobin A1c (HbA1c) using tests intended for monitoring glycemic control.

Source page: https://510kreport.com/device/K161521
Methodology: https://510kreport.com/methodology