510(k) · Cleared
ClearedWiener Lab. CA-Color AA, Model 4 X 50 ML Cat.N 1152002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wiener Laboratories Saic · CIC Cresolphthalein Complexone, Calcium
Cleared on Dec 21, 2001 after a 45-day review. The FDA summary names its predicate without a number.
- Decided
- Dec 21, 2001
- Review
- 45 days
- Class
- Class II
- Product code
- CIC
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 CIC? 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? (2)
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 |
|---|---|---|---|
| * | — | Pointe Calcium Reagent Set Named without a submission number | |
| * | — | DMA CALCIUM test system Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All CIC devicesCIC Cresolphthalein Complexone, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIC
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · CIC
Too few CIC 510(k)s in any year since 2007 to give a median.
Recalls per year · CIC
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIC
10in 2025
MAUDE reports naming product code CIC, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 5 |
| 2010 | 0 | — | 2 | 83 |
| 2011 | 0 | — | 0 | 29 |
| 2012 | 0 | — | 0 | 10 |
| 2013 | 1 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 30 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 42 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The “Wiener lab. Ca-Color AA” test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of calcium in human sera, heparinized plasmas and urine on both manual and automated systems. Measurements of calcium are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal diseases and tetany (intermittent muscular contractions or spasms).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013652 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013652: Wiener Lab. CA-Color AA, Model 4 X 50 ML Cat.N 1152002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013652
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026