FDA product code CIG: Diazo Colorimetry, Bilirubin
CIG is the FDA product code for diazo colorimetry, bilirubin. It is a Class II device, regulated under 21 CFR 862.1110 and reviewed by the Clinical Chemistry panel. FDA has cleared 235 510(k) submissions under CIG, 4 in the last five years, from 106 different applicants. The average 510(k) review took 71 days (median 51); 245 days on average over the last three years. FDA has posted 19 recalls for CIG devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Diazo Colorimetry, Bilirubin |
| Device class | Class II |
| Regulation | 21 CFR 862.1110 |
| 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 CIG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 60 |
| 2019 | 1 | 28 |
| 2022 | 1 | 59 |
| 2023 | 2 | 250 |
| 2026 | 1 | 245 |
Compare with all 510(k) review times · Search every CIG clearance
Top CIG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 21 | 1993-09-21 |
| Abbott Laboratories | 15 | 2015-04-02 |
| Data Medical Associates, Inc. | 10 | 1995-12-20 |
| Synermed, Inc. | 7 | 1997-09-25 |
| Harleco | 6 | 1978-05-19 |
101 more applicants have CIG clearances. See the full list in Caduvo.
Most recent CIG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251998 | Siemens Healthcare Diagnostics, Inc. | Atellica CH Diazo Total Bilirubin (D_TBil) | 2026-02-27 | 245 |
| K223078 | Siemens Healthcare Diagnostics, Inc. | Atellica® CH Diazo Direct Bilirubin (D_DBil) | 2023-06-12 | 255 |
| K222104 | Siemens Healthcare Diagnostics, Inc. | Atellica® CH Diazo Total Bilirubin (D_TBil) | 2023-03-20 | 245 |
| K223324 | Abbott Ireland Diagnostics Division | Total Bilirubin2 | 2022-12-29 | 59 |
| K190807 | Ortho-Clinical Diagnostics, Inc. | VITROS XT Chemistry Products TBIL-ALKP Slides | 2019-04-26 | 28 |
Recalls for CIG devices
19 product recalls in 15 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-07-30.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 4 |
| 2023 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code CIG?
CIG is the FDA product code for diazo colorimetry, bilirubin. It is a Class II device, regulated under 21 CFR 862.1110 and reviewed by the Clinical Chemistry panel.
What device class is CIG?
Class II, regulation 21 CFR 862.1110. Typical premarket route: 510(k).
How long does a 510(k) take for product code CIG?
Across 235 cleared submissions the average was 71 days from receipt to decision (median 51).
Which companies have the most CIG clearances?
Em Diagnostic Systems, Inc. (21); Abbott Laboratories (15); Data Medical Associates, Inc. (10); Synermed, Inc. (7); Harleco (6).
Have CIG devices been recalled?
Yes: 19 product recalls across 15 recall events; the most recent began 2024-07-30.
Next steps
- Run an FDA pathway report with predicate devices for product code CIG
- Run a recall and safety report across every CIG manufacturer
- Watch product code CIG 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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