# K874890: Quantimetrix Urine Dipstick Control

- Pathway: 510(k) (Traditional)
- Applicant: Quantimetrix Medical Industries
- Decided: Jan 21, 1988 after 51 days
- Product code: JJW (Urinalysis Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K142262: Aution Check Plus (2015), 0 descendants of its own

## Recalls of this device
- Sep 17, 2024 · Class II · Z-0138-2025: The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25C. This may lead to delay in patients' results.
- Dec 21, 2017 · Class III · Z-2257-2018: The kits contained an incorrect lot of Dropper Plus Level 1 vials
- Jun 1, 2007 · Not classified · Z-0514-2009: This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.

Source page: https://510kreport.com/device/K874890
Methodology: https://510kreport.com/methodology