FDA product code CIN: Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
CIN is the FDA product code for electrophoretic separation, alkaline phosphatase isoenzymes. It is a Class II device, regulated under 21 CFR 862.1050 and reviewed by the Clinical Chemistry panel. FDA has cleared 26 510(k) submissions under CIN, 1 in the last five years, from 18 different applicants. The average 510(k) review took 95 days (median 60); 210 days on average over the last three years. FDA has posted 7 recalls for CIN devices.
Classification
| Field | Value |
|---|---|
| Device name | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes |
| Device class | Class II |
| Regulation | 21 CFR 862.1050 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CIN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 217 |
| 2024 | 1 | 210 |
Top CIN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helena Laboratories | 5 | 2002-05-06 |
| Hybritech, Inc. | 3 | 1997-09-11 |
| Metra Biosystems, Inc. | 2 | 1998-05-27 |
| Sigma Chemical Co. | 2 | 1977-08-03 |
| Beckman Coulter | 1 | 2024-04-15 |
13 more applicants have CIN clearances. See the full list in Caduvo.
Most recent CIN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232904 | Beckman Coulter | Access Ostase | 2024-04-15 | 210 |
| K200475 | Immunodiagnostic Systems , Ltd. | IDS-iSYS Ostase BAP | 2020-09-30 | 217 |
| K043125 | Orion Diagnostica, OY | ORION DIAGNOSTICA UNIQ PINP RIA | 2005-05-04 | 173 |
| K020625 | Helena Laboratories | SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 | 2002-05-06 | 69 |
| K011113 | Sebia | HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) | 2001-06-13 | 63 |
Recalls for CIN devices
7 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-07-14.
Frequently asked questions
What is FDA product code CIN?
CIN is the FDA product code for electrophoretic separation, alkaline phosphatase isoenzymes. It is a Class II device, regulated under 21 CFR 862.1050 and reviewed by the Clinical Chemistry panel.
What device class is CIN?
Class II, regulation 21 CFR 862.1050. Typical premarket route: 510(k).
How long does a 510(k) take for product code CIN?
Across 26 cleared submissions the average was 95 days from receipt to decision (median 60).
Which companies have the most CIN clearances?
Helena Laboratories (5); Hybritech, Inc. (3); Metra Biosystems, Inc. (2); Sigma Chemical Co. (2); Beckman Coulter (1).
Have CIN devices been recalled?
Yes: 7 product recalls across 4 recall events; the most recent began 2016-07-14.
Next steps
- Run an FDA pathway report with predicate devices for product code CIN
- Run a recall and safety report across every CIN manufacturer
- Watch product code CIN 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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