# K190225: TAP Blood Collection Device

- Pathway: 510(k) (Traditional)
- Applicant: Seventh Sense Biosystems, Inc.
- Decided: Nov 5, 2019 after 273 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: 3 generations back to K945952 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161521: TAP Blood Collection Device, Seventh Sense Biosystems, Inc. (2017) Summary page 4.

## 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). The TAP Blood Collection® Device is for measurement of HbA1c on blood specimens which can be collected by self-administration of the TAP Device by a layperson or by a healthcare worker in a healthcare setting. The collected sample is then transported for analysis in a clinical laboratory for determination of Hemoglobin Alc (HbA1c) using tests intended for monitoring glycemic control.

Source page: https://510kreport.com/device/K190225
Methodology: https://510kreport.com/methodology