# K012805: Automarqer

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Thorne Research
- Decided: Mar 13, 2002 after 204 days
- Product code: POV (Semen Analysis Device)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920719 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920719: Ivos Analyzer, Hamilton Thorne Research (1992) Summary page 1.

## Indications for use
The AutoMARQERT™ is a differential spectrophotometer/reflectometer for sperm analysis and quantification, using MARQ™ Plus Test Kits.

Source page: https://510kreport.com/device/K012805
Methodology: https://510kreport.com/methodology