510(k) · Cleared
Recalled · Class II · 2024Irispec,CA/CB/CC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iris Diagnostics · JJW Urinalysis Controls (Assayed And Unassayed)
Cleared on Dec 21, 2007 as substantially equivalent to K945913 (International Remote Imaging Systems, 1995) after a 94-day review. Its family tree reaches back 1 generation to 1995. It has been recalled 2 times.
- Decided
- Dec 21, 2007
- Review
- 94 days
- Class
- Class I
- Product code
- JJW
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945913 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK945913 Irispec Urine Chemistry Control Part a and BInternational Remote Imaging Systems · 1995 · Recalled
- This deviceK072640 Irispec,CA/CB/CCIris Diagnostics · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945913 | Irispec Urine Chemistry Control Part a and B | International Remote Imaging Systems | 1995 | 2 |
| 0 (this device) | K072640 | Irispec,CA/CB/CC | Iris Diagnostics | 2007 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K945913 | Irispec Urine Chemistry Control Part a and BSummary page 1…substantial equivalence is claimed IRiSpec Urine Chemistry Control Part A and B. Iris Diagnostics, a Division of IRIS International, Inc, Chatsworth, CA 91311 File No. K945913 Description of the proposed device: The proposed IRISpeCTM CA/GB/CC Control is identical in its parts A and B to the unmodifi… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 16, 2024 | Class III | Z-0093-2025 | Under Investigation by firm | 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 conjunction with iChemVELOCITY Urine Chemistry… |
| Nov 18, 2022 | Class II | Z-0777-2023 | Under Investigation by firm | 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 Chemistry Strips PN 800-7212 |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All JJW devicesJJW Urinalysis Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JJW
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJW
Too few JJW 510(k)s in any year since 2007 to give a median.
Recalls per year · JJW
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJW
1in 2022
MAUDE reports naming product code JJW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 1 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 7 | 1 |
| 2013 | 0 | — | 1 | 24 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 2 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072640 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072640: Irispec,CA/CB/CC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072640
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026