# K022335: Allgrad and ALLGRAD100

- Pathway: 510(k) (Traditional)
- Applicant: <Genx> Intl., Inc.
- Decided: Aug 23, 2002 after 36 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- Recalls of this device: 1 (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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Aug 18, 2020 · Class II · Z-3029-2020: Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

## Indications for use
AllGrad cell separation media is intended for use in assisted reproduction techniques.

Source page: https://510kreport.com/device/K022335
Methodology: https://510kreport.com/methodology