# K013323: Tci-31 Lifelong Ovulation Tester

- Pathway: 510(k) (Traditional)
- Applicant: Tci New York
- Decided: Dec 5, 2001 after 61 days
- Product code: CEP (Radioimmunoassay, Luteinizing Hormone)
- Device class: 1
- Regulation: 21 CFR 862.1485
- 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 K953063 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953063: Conceive Ovulation Predictor, Quidel Corp. (1995) Summary page 1.

## Indications for use
The Ovulation Tester is an over-the-counter device intended to detect the most fertile days of a woman’s menstrual cycle by the direct visualization of the characteristic peri-ovulatory ferning pattern in dried saliva. This ferning oocurs due to increased levels of estrogen.

Source page: https://510kreport.com/device/K013323
Methodology: https://510kreport.com/methodology