FDA product code CZP: Iga, Antigen, Antiserum, Control
CZP is the FDA product code for iga, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 54 510(k) submissions under CZP, from 40 different applicants. The average 510(k) review took 48 days (median 28). FDA has posted 3 recalls for CZP devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Iga, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CZP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 190 |
Compare with all 510(k) review times · Search every CZP clearance
Top CZP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 3 | 1998-11-04 |
| Boehringer Mannheim Corp. | 3 | 1996-02-09 |
| Kallestad Laboratories, Inc. | 3 | 1986-02-26 |
| Wako Chemicals USA, Inc. | 2 | 2000-01-14 |
| Instrumentation Laboratory CO | 2 | 1996-09-25 |
35 more applicants have CZP clearances. See the full list in Caduvo.
Most recent CZP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K193525 | HORIBA ABX SAS | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M | 2020-06-26 | 190 |
| K060130 | Beckman Coulter, Inc. | IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT | 2006-02-13 | 26 |
| K040435 | Roche Diagnostics Corp. | ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 | 2004-03-10 | 20 |
| K024038 | Dade Behring, Inc. | N LATEX IGA | 2003-02-13 | 69 |
| K993927 | Wako Chemicals USA, Inc. | WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD | 2000-01-14 | 57 |
Recalls for CZP devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-11-01.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code CZP?
CZP is the FDA product code for iga, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is CZP?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code CZP?
Across 54 cleared submissions the average was 48 days from receipt to decision (median 28).
Which companies have the most CZP clearances?
Abbott Laboratories (3); Boehringer Mannheim Corp. (3); Kallestad Laboratories, Inc. (3); Wako Chemicals USA, Inc. (2); Instrumentation Laboratory CO (2).
Have CZP devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2022-11-01.
Next steps
- Run an FDA pathway report with predicate devices for product code CZP
- Run a recall and safety report across every CZP manufacturer
- Watch product code CZP 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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