FDA product code CIX: Bromcresol Green Dye-Binding, Albumin
CIX is the FDA product code for bromcresol green dye-binding, albumin. It is a Class II device, regulated under 21 CFR 862.1035 and reviewed by the Clinical Chemistry panel. FDA has cleared 120 510(k) submissions under CIX, 1 in the last five years, from 87 different applicants. The average 510(k) review took 74 days (median 42); 269 days on average over the last three years. FDA has posted 6 recalls for CIX devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bromcresol Green Dye-Binding, Albumin |
| Device class | Class II |
| Regulation | 21 CFR 862.1035 |
| 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 CIX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 382 |
| 2019 | 1 | 23 |
| 2021 | 2 | 460 |
| 2026 | 1 | 269 |
Compare with all 510(k) review times · Search every CIX clearance
Top CIX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 9 | 1993-12-17 |
| Harleco | 5 | 1981-11-10 |
| Abbott Laboratories | 4 | 1998-06-12 |
| Trace Scientific , Ltd. | 3 | 1995-10-13 |
| Data Medical Associates, Inc. | 3 | 1995-03-01 |
82 more applicants have CIX clearances. See the full list in Caduvo.
Most recent CIX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251157 | Truvian Health | Core Metabolic | 2026-01-09 | 269 |
| K203248 | Abbott Ireland Diagnostics Division | Albumin BCG2 | 2021-11-23 | 384 |
| K200898 | Medicon Hellas S.A | Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin | 2021-09-21 | 536 |
| K191316 | Ortho-Clinical Diagnostics, Inc. | VITROS XT Chemistry Products ALB-TP Slides | 2019-06-07 | 23 |
| K170901 | Biosystems S.A. | ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 | 2018-04-13 | 382 |
Recalls for CIX devices
6 product recalls in 6 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-07-10.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code CIX?
CIX is the FDA product code for bromcresol green dye-binding, albumin. It is a Class II device, regulated under 21 CFR 862.1035 and reviewed by the Clinical Chemistry panel.
What device class is CIX?
Class II, regulation 21 CFR 862.1035. Typical premarket route: 510(k).
How long does a 510(k) take for product code CIX?
Across 120 cleared submissions the average was 74 days from receipt to decision (median 42).
Which companies have the most CIX clearances?
Em Diagnostic Systems, Inc. (9); Harleco (5); Abbott Laboratories (4); Trace Scientific , Ltd. (3); Data Medical Associates, Inc. (3).
Have CIX devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2024-07-10.
Next steps
- Run an FDA pathway report with predicate devices for product code CIX
- Run a recall and safety report across every CIX manufacturer
- Watch product code CIX 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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