510(k) · Cleared
Recalled · 2006Raichem Calcium (Ocpc) Liquid Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemagen Diagnostics, Inc. · CIC Cresolphthalein Complexone, Calcium
Cleared on Jun 25, 2004 after a 67-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Jun 25, 2004
- Review
- 67 days
- Class
- Class II
- Product code
- CIC
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|---|
| Jun 7, 2006 | Not classified | Z-1176-06 | Other | Falsely low patient and control results may be reported when the reagent has been on-board for less than the 8 hour use period specified in the labeling. |
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?
This reagent is intended for the quantitative determination of Calcium in serum,
heparinized plasma, or urine. For in vitro diagnostic use only.
This calcium test system is a device intended to measure the total calcium level in
serum. Calcium measurements are used in the diagnosis and treatment of parathyroid
disease, a variety of bone diseases, chronic renal disease and tetany (intermittent
muscular contractions or spasms). The intended patient population may be adult,
pediatric, and neonatal.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K041009 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041009: Raichem Calcium (Ocpc) Liquid Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041009
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026