FDA product code CJW: Bromcresol Purple Dye-Binding, Albumin
CJW is the FDA product code for bromcresol purple 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 18 510(k) submissions under CJW, 1 in the last five years, from 15 different applicants. The average 510(k) review took 76 days (median 51). FDA has posted 1 recall for CJW devices.
Classification
| Field | Value |
|---|---|
| Device name | Bromcresol Purple 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 CJW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 52 |
| 2022 | 1 | 471 |
Compare with all 510(k) review times · Search every CJW clearance
Top CJW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 3 | 1998-07-22 |
| Em Diagnostic Systems, Inc. | 2 | 1991-10-09 |
| Abbott Ireland Diagnostics Division | 1 | 2022-03-18 |
| SENTINEL CH. SpA | 1 | 2019-12-19 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 2013-10-16 |
10 more applicants have CJW clearances. See the full list in Caduvo.
Most recent CJW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203530 | Abbott Ireland Diagnostics Division | Albumin BCP2 | 2022-03-18 | 471 |
| K193001 | SENTINEL CH. SpA | Albumin BCP | 2019-12-19 | 52 |
| K132664 | Siemens Healthcare Diagnostics, Inc. | ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR | 2013-10-16 | 50 |
| K021636 | Intersect Systems, Inc. | ALBUMIN REAGENT | 2002-07-17 | 61 |
| K000483 | Randox Laboratories, Ltd. | RANDOX ALBUMIN | 2000-03-31 | 46 |
Recalls for CJW devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-03-18.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code CJW?
CJW is the FDA product code for bromcresol purple 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 CJW?
Class II, regulation 21 CFR 862.1035. Typical premarket route: 510(k).
How long does a 510(k) take for product code CJW?
Across 18 cleared submissions the average was 76 days from receipt to decision (median 51).
Which companies have the most CJW clearances?
Abbott Laboratories (3); Em Diagnostic Systems, Inc. (2); Abbott Ireland Diagnostics Division (1); SENTINEL CH. SpA (1); Siemens Healthcare Diagnostics, Inc. (1).
Have CJW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2019-03-18.
Next steps
- Run an FDA pathway report with predicate devices for product code CJW
- Run a recall and safety report across every CJW manufacturer
- Watch product code CJW 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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