# K945913: Irispec Urine Chemistry Control Part a and B

- Pathway: 510(k) (Traditional)
- Applicant: International Remote Imaging Systems
- Decided: Apr 5, 1995 after 124 days
- Product code: JJW (Urinalysis Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 2 (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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K072640: Irispec,CA/CB/CC (2007), 0 descendants of its own

## Recalls of this device
- Jul 9, 2012 · Class III · Z-2124-2012: The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control, 101131-12, where the nitrite results read negative for the part B control, which should be positive.
- Apr 29, 2005 · Not classified · Z-0884-05: Nonconformance to performance specifications.

Source page: https://510kreport.com/device/K945913
Methodology: https://510kreport.com/methodology