# K973310: TBD* One-Step Ovulation Predictor Test

- Pathway: 510(k) (Traditional)
- Applicant: Armkel, LLC
- Decided: Oct 27, 1997 after 54 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) FIRST RESPONSE® Ovulation Predictor Test: named in the summary without a submission number

## Indications for use
The TBD One-Step Ovulation Predictor Test is an at-home ovulation predictor test marketed over-the-counter (OTC) to lay consumers. The TBD One-Step Ovulation Predictor Test detects 1!13 presence of }.mman luteinizing hormone (hLH) in the urine as an aid in the prediction of ovulation.

Source page: https://510kreport.com/device/K973310
Methodology: https://510kreport.com/methodology