Product code CIG: 510(k) clearances and predicates
Product code CIG covers Atellica CH Diazo Total Bilirubin (D_TBil). FDA lists 235 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
235 clearances on file under product code CIG. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 1 |
Recent clearances
Newest CIG clearances in the FDA index, with applicant and decision date:
- K251998, Atellica CH Diazo Total Bilirubin (D_TBil), applicant Siemens Healthcare Diagnostics, Inc., decided 2026-02-27. FDA record
- K223078, Atellica® CH Diazo Direct Bilirubin (D_DBil), applicant Siemens Healthcare Diagnostics, Inc., decided 2023-06-12. FDA record
- K222104, Atellica® CH Diazo Total Bilirubin (D_TBil), applicant Siemens Healthcare Diagnostics, Inc., decided 2023-03-20. FDA record
- K223324, Total Bilirubin2, applicant Abbott Ireland Diagnostics Division, decided 2022-12-29. FDA record
- K190807, VITROS XT Chemistry Products TBIL-ALKP Slides, applicant Ortho-Clinical Diagnostics, Inc., decided 2019-04-26. FDA record
- K171401, ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1, applicant Elitechgroup, decided 2017-07-11. FDA record
- K150510, Total Bilirubin, applicant Abbott Laboratories, decided 2015-04-02. FDA record
- K131544, COBAS C BILIRUBIN TOTAL GEN.3, applicant Roche Diagnostics, decided 2013-07-17. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Atellica® CH Diazo Direct Bilirubin (D_DBil), Atellica® CH Diazo Total Bilirubin (D_TBil). Watch new CIG clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code CIG?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent CIG clearances include Atellica CH Diazo Total Bilirubin (D_TBil).
How many 510(k) clearances use product code CIG?
235 at the time this page was generated, from openFDA records.
How do I find a predicate device under CIG?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new CIG clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.