FDA product code CIC: Cresolphthalein Complexone, Calcium
CIC is the FDA product code for cresolphthalein complexone, calcium. It is a Class II device, regulated under 21 CFR 862.1145 and reviewed by the Clinical Chemistry panel. FDA has cleared 99 510(k) submissions under CIC, from 71 different applicants. The average 510(k) review took 62 days (median 48). FDA has posted 10 recalls for CIC devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cresolphthalein Complexone, Calcium |
| Device class | Class II |
| Regulation | 21 CFR 862.1145 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CIC clearance
Top CIC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 7 | 1993-09-27 |
| Pointe Scientific, Inc., | 3 | 1992-05-13 |
| Technicon Instruments Corp. | 3 | 1990-04-19 |
| Abbott Laboratories | 3 | 1989-09-25 |
| Diagnostic Chemicals, Ltd. (Usa) | 3 | 1988-04-18 |
66 more applicants have CIC clearances. See the full list in Caduvo.
Most recent CIC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K130870 | Hitachi Chemical Diagnostics, Inc. | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) | 2013-05-02 | 34 |
| K083339 | Siemens Healthcare Diagnostics, Inc. | DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) | 2009-03-09 | 117 |
| K070249 | Horiba Abx | ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H | 2007-04-26 | 90 |
| K053401 | Arkray, Inc. | SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS | 2006-03-24 | 108 |
| K050077 | Arkray, Inc. | SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS | 2005-02-15 | 34 |
Recalls for CIC devices
10 product recalls in 7 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2021-10-22.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code CIC?
CIC is the FDA product code for cresolphthalein complexone, calcium. It is a Class II device, regulated under 21 CFR 862.1145 and reviewed by the Clinical Chemistry panel.
What device class is CIC?
Class II, regulation 21 CFR 862.1145. Typical premarket route: 510(k).
How long does a 510(k) take for product code CIC?
Across 99 cleared submissions the average was 62 days from receipt to decision (median 48).
Which companies have the most CIC clearances?
Em Diagnostic Systems, Inc. (7); Pointe Scientific, Inc., (3); Technicon Instruments Corp. (3); Abbott Laboratories (3); Diagnostic Chemicals, Ltd. (Usa) (3).
Have CIC devices been recalled?
Yes: 10 product recalls across 7 recall events; the most recent began 2021-10-22.
Next steps
- Run an FDA pathway report with predicate devices for product code CIC
- Run a recall and safety report across every CIC manufacturer
- Watch product code CIC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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