# P040030: Insite Her-2/Neu Kit

- Pathway: PMA
- Applicant: Biogenex Laboratories, Inc.
- Decided: Dec 22, 2004 after 183 days
- Product code: MVC (System, Test, Her-2/Neu, Ihc)
- Device class: 3
- Recalls of this device: 4 (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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Feb 9, 2006 · Not classified · Z-0606-06: Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result.
- Feb 9, 2006 · Not classified · Z-0607-06: Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result.
- Feb 9, 2006 · Not classified · Z-0609-06: Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result.
- Feb 9, 2006 · Not classified · Z-0608-06: Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result.

Source page: https://510kreport.com/device/P040030
Methodology: https://510kreport.com/methodology