# K020968: Livesure HCG Urinary Pregnancy Test Strip and Test Card

- Pathway: 510(k) (Traditional)
- Applicant: Pan Probe Biotech, Inc.
- Decided: Jul 15, 2002 after 111 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- Device class: 2
- Regulation: 21 CFR 862.1155
- 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) ABl's SureStepTM hCG Test: named in the summary without a submission number
- (no number) Quidel's QuickVueTM hCG Assay: named in the summary without a submission number

## Indications for use
Pan Probe B,otech (PPB), Inc. LiveSurem Human Chorionic Gonadotropin (LiveSureTMhCG) Rapid Urinary Pregnancy Test Strip and Test Card Immunoassay Devices are in vitro diagnostic (IVD) qualitative screening lateral flow chromatographic immunoassays that are designed for rapid detection of placental hCG related to pregnancy at an expected value cut-off level of 20 mlU of hCG/ml of human urine. These iiveSureTMIVD immunoassay devices for urinary hCG pregnancy screening are designed to give visual, qualitative results and are intended for professional use only. The PPB LiveSureTMhCG Test Strip and Test Card Devices are not intended for quantitative results, nor over-the-counter sales, but provide only professional use preliminary screening data for use to aid in the diagnosis of pregnancy. A clinical diagnosis by a medical professional must be obtained in order to confirm any analytical result, and to rule c : 1 a n y non-pregnancy diseases that can also result in elevated hCG. Clinical considerations and professicnal judgment should be applied to any test result, particularly when preliminary positive results are indicated.

Source page: https://510kreport.com/device/K020968
Methodology: https://510kreport.com/methodology