# K062361: Innovacon HCG Uktra Test Device

- Pathway: 510(k) (Traditional)
- Applicant: Innovacon, Inc.
- Decided: Oct 23, 2006 after 70 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: 5 (0 Class I)
- 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) Fisher Sure-Vue Serum/Urine HCG-STAT: named in the summary without a submission number

## Recalls of this device
- Aug 20, 2026 · Class II · Z-3271-2026: hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
- May 25, 2022 · Class II · Z-1606-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- May 25, 2022 · Class II · Z-1587-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- Apr 16, 2013 · Class II · Z-1401-2013: The firm initiated recall of Alere" hCG Combo Cassette (20/10 mIU/mL) kit PN 92215, lots hCG1110133 and hCG1110135, because an investigation has indicated a portion of these Alere" hCG Combo Cassette 
- Oct 1, 2007 · Not classified · Z-1118-2008: Incorrect results: The Sure-Vue Serum/Urine hCG-STAT test, when interpreted at extended read times, may exhibit sensitivity to patient samples containing hCG at levels well below the cut-off, potentia

## Indications for use
InnovaconTM hCG Ultra Test Device is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. It is for healthcare professionals only.

Source page: https://510kreport.com/device/K062361
Methodology: https://510kreport.com/methodology