FDA product code CDS: Electrode, Ion Specific, Urea Nitrogen
CDS is the FDA product code for electrode, ion specific, urea nitrogen. It is a Class II device, regulated under 21 CFR 862.1770 and reviewed by the Clinical Chemistry panel. FDA has cleared 15 510(k) submissions under CDS, from 15 different applicants. The average 510(k) review took 90 days (median 68). FDA has posted 1 recall for CDS devices.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Ion Specific, Urea Nitrogen |
| Device class | Class II |
| Regulation | 21 CFR 862.1770 |
| 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 CDS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 264 |
Compare with all 510(k) review times · Search every CDS clearance
Top CDS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Epocal, Inc. | 1 | 2018-01-17 |
| Genchem, Inc. | 1 | 2004-12-27 |
| Diamond Diagnostics, Inc. | 1 | 2004-01-30 |
| Hichem Diagnostics | 1 | 1993-04-20 |
| Ilex Corp. | 1 | 1986-04-21 |
10 more applicants have CDS clearances. See the full list in Caduvo.
Most recent CDS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K171247 | Epocal, Inc. | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test | 2018-01-17 | 264 |
| K040973 | Genchem, Inc. | BUN REAGENT | 2004-12-27 | 257 |
| K033056 | Diamond Diagnostics, Inc. | BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT | 2004-01-30 | 123 |
| K925550 | Hichem Diagnostics | HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 | 1993-04-20 | 168 |
| K860543 | Ilex Corp. | BLOOD UREA NITROGEN (BUN) TESTCARD | 1986-04-21 | 67 |
Recalls for CDS devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-10-31.
Frequently asked questions
What is FDA product code CDS?
CDS is the FDA product code for electrode, ion specific, urea nitrogen. It is a Class II device, regulated under 21 CFR 862.1770 and reviewed by the Clinical Chemistry panel.
What device class is CDS?
Class II, regulation 21 CFR 862.1770. Typical premarket route: 510(k).
How long does a 510(k) take for product code CDS?
Across 15 cleared submissions the average was 90 days from receipt to decision (median 68).
Which companies have the most CDS clearances?
Epocal, Inc. (1); Genchem, Inc. (1); Diamond Diagnostics, Inc. (1); Hichem Diagnostics (1); Ilex Corp. (1).
Have CDS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-10-31.
Next steps
- Run an FDA pathway report with predicate devices for product code CDS
- Run a recall and safety report across every CDS manufacturer
- Watch product code CDS 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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