# K072640: Irispec,CA/CB/CC

- Pathway: 510(k) (Abbreviated)
- Applicant: Iris Diagnostics
- Decided: Dec 21, 2007 after 94 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
Longest line of descent: 1 generation back to K945913 (1995). 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)
- K945913: Irispec Urine Chemistry Control Part a and B, International Remote Imaging Systems (1995) Summary page 1.

## Recalls of this device
- Jul 16, 2024 · Class III · Z-0093-2025: Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunctio
- Nov 18, 2022 · Class II · Z-0777-2023: Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Ch

## Indications for use
IRISpecTM CA/CB/CC is an assayed QC material for monitoring of urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.

Source page: https://510kreport.com/device/K072640
Methodology: https://510kreport.com/methodology