# K131444: UA-Cellular Complete

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Jan 29, 2014 after 254 days
- Product code: JJW (Urinalysis Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K900484 (1990). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023928: Mas UA Control Liquid Assayed Urinalysis Control, Dade Assayed Urinalysis Control, Medical Analysis Systems, Inc. (2002) Summary page 1.
- K080887: Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam Software, Sysmex America, Inc. (2008) Summary page 1.

## Most influential descendants
- K170091: UA-Cellular Complete (2017), 0 descendants of its own

## Indications for use
UA-Cellular Complete is an assayed chemistry and cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment and chemistry parameters on the Sysmex® UP-1000i Automated Urine Particle Analyzer and the Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer utilizing the Clinitek Atlas 10 Reagent Pak. The list of assayed parameters includes: Sysmex UF-1000i:RBC(/µL), WBC(/µL), Epithelial (/µL), Cast, Bacteria (/pL), Crystals, Conductivity (mS/cm) Siemens Clinitek Atlas with Atlas 10 Reagent Pak: Glucose (mg/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Clarity (As Measured)

Source page: https://510kreport.com/device/K131444
Methodology: https://510kreport.com/methodology