FDA product code JFM: Enzymatic Method, Bilirubin
JFM is the FDA product code for enzymatic method, bilirubin. It is a Class II device, regulated under 21 CFR 862.1110 and reviewed by the Clinical Chemistry panel. FDA has cleared 11 510(k) submissions under JFM, from 8 different applicants. The average 510(k) review took 104 days (median 52). FDA has posted 9 recalls for JFM devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Enzymatic Method, 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 JFM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 59 |
Compare with all 510(k) review times · Search every JFM clearance
Top JFM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wako Chemicals USA, Inc. | 3 | 2005-12-30 |
| Randox Laboratories Limited | 2 | 2016-02-16 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 2017-03-09 |
| Bayer Healthcare, LLC | 1 | 2007-12-07 |
| Beckman Coulter, Inc. | 1 | 2005-12-16 |
3 more applicants have JFM clearances. See the full list in Caduvo.
Most recent JFM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K170065 | Siemens Healthcare Diagnostics, Inc. | ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) | 2017-03-09 | 59 |
| K152343 | Randox Laboratories Limited | Direct Bilirubin | 2016-02-16 | 181 |
| K152344 | Randox Laboratories Limited | Total Bilirubin | 2016-01-28 | 162 |
| K063845 | Bayer Healthcare, LLC | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 | 2007-12-07 | 345 |
| K053132 | Wako Chemicals USA, Inc. | WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 | 2005-12-30 | 52 |
Recalls for JFM devices
9 product recalls in 3 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2023-10-11.
| Year | Recalls |
|---|---|
| 2020 | 4 |
| 2023 | 5 |
Frequently asked questions
What is FDA product code JFM?
JFM is the FDA product code for enzymatic method, bilirubin. It is a Class II device, regulated under 21 CFR 862.1110 and reviewed by the Clinical Chemistry panel.
What device class is JFM?
Class II, regulation 21 CFR 862.1110. Typical premarket route: 510(k).
How long does a 510(k) take for product code JFM?
Across 11 cleared submissions the average was 104 days from receipt to decision (median 52).
Which companies have the most JFM clearances?
Wako Chemicals USA, Inc. (3); Randox Laboratories Limited (2); Siemens Healthcare Diagnostics, Inc. (1); Bayer Healthcare, LLC (1); Beckman Coulter, Inc. (1).
Have JFM devices been recalled?
Yes: 9 product recalls across 3 recall events; the most recent began 2023-10-11.
Next steps
- Run an FDA pathway report with predicate devices for product code JFM
- Run a recall and safety report across every JFM manufacturer
- Watch product code JFM 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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