# K200811: cobas u 701 microscopy analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Nov 6, 2020 after 224 days
- Product code: LKM (Counter, Urine Particle)
- Device class: 2
- Regulation: 21 CFR 864.5200
- 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 K022774 (2002). 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)
- K022774: IQ 200 System, Intl. Remote Imaging Systems (2002) Summary page 5.

## Indications for use
The cobas u 701 microscopy analyzer is a fully automated urine microscopy system intended for the in vitro quantitative determination of erythrocytes and leukocytes, the semi-quantitative determination of squamous epithelial cells, bacteria, and hyaline casts and the qualitative determination of non-squamous epithelial cells, crystals, yeasts, pathological casts, mucus and sperm in urine. This system is intended to be used by trained operators in clinical laboratories. All instrument analyte image decisions may be reviewed and reclassified by a trained operator.

Source page: https://510kreport.com/device/K200811
Methodology: https://510kreport.com/methodology