# K071100: Amniscreen Home Detection Liner Kit

- Pathway: 510(k) (Traditional)
- Applicant: Common Sense, Ltd.
- Decided: Oct 15, 2007 after 179 days
- Product code: CEN (Dye-Indicator, Ph (Urinary, Non-Quantitative))
- Device class: 1
- Regulation: 21 CFR 862.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914419 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914419: Amniotest (TM), Pro-Lab, Inc. (1993) Summary page 1.

## Most influential descendants
- K110605: Rom Plus (2011), 0 descendants of its own

## Indications for use
The AmniScreen Home Detection Liner Kit is intended to detect possible leakage of amniotic fluid when vaginal wetness is experienced during pregnancy by indicating pH level. pH levels greater than or equal to 5.2 produce a blue-green color. Patients are instructed to report or show test results to their healthcare provider for interpretation and medical care.

Source page: https://510kreport.com/device/K071100
Methodology: https://510kreport.com/methodology