# K090201: UA-Cellular for IQ

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Mar 27, 2009 after 59 days
- Product code: JPK (Mixture, Hematology Quality Control)
- Device class: 2
- Regulation: 21 CFR 864.8625
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000076 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053362: Cell-Chex Auto, Streck (2006) Summary page 1.

## Indications for use
UA-Cellular for IQ is an assayed cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment parameters.

Source page: https://510kreport.com/device/K090201
Methodology: https://510kreport.com/methodology