FDA product code JFP: Electrode, Ion Specific, Calcium
JFP is the FDA product code for electrode, ion specific, calcium. It is a Class II device, regulated under 21 CFR 862.1145 and reviewed by the Clinical Chemistry panel. FDA has cleared 29 510(k) submissions under JFP, 1 in the last five years, from 18 different applicants. The average 510(k) review took 102 days (median 77). FDA has posted 5 recalls for JFP devices.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Ion Specific, Calcium |
| Device class | Class II |
| Regulation | 21 CFR 862.1145 |
| 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 JFP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 59 |
| 2020 | 1 | 269 |
| 2023 | 1 | 266 |
Compare with all 510(k) review times · Search every JFP clearance
Top JFP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nova Biomedical Corp. | 5 | 1996-03-11 |
| Avl Scientific Corp. | 4 | 1998-12-11 |
| Abbott Point of Care, Inc. | 2 | 2023-10-27 |
| Medica Corp. | 2 | 1996-11-27 |
| Amdev, Inc. | 2 | 1990-12-18 |
13 more applicants have JFP clearances. See the full list in Caduvo.
Most recent JFP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230300 | Abbott Point of Care, Inc. | i-STAT CG8+ cartridge with the i-STAT 1 System | 2023-10-27 | 266 |
| K191360 | Abbott Point of Care, Inc. | i-STAT CHEM8+ cartridge with the i-STAT 1 System | 2020-02-14 | 269 |
| K191626 | Nova Biomedical Corporation | Stat Profile Prime ES Comp Plus Analyzer System | 2019-08-16 | 59 |
| K152327 | Medica Corporation | EasyLyte Na/K/Cl/Ca Analyzer | 2016-12-01 | 471 |
| K984299 | Avl Scientific Corp. | AVL OPTI CRITICAL CARE ANALYZER | 1998-12-11 | 10 |
Recalls for JFP devices
5 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-01-06.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code JFP?
JFP is the FDA product code for electrode, ion specific, calcium. It is a Class II device, regulated under 21 CFR 862.1145 and reviewed by the Clinical Chemistry panel.
What device class is JFP?
Class II, regulation 21 CFR 862.1145. Typical premarket route: 510(k).
How long does a 510(k) take for product code JFP?
Across 29 cleared submissions the average was 102 days from receipt to decision (median 77).
Which companies have the most JFP clearances?
Nova Biomedical Corp. (5); Avl Scientific Corp. (4); Abbott Point of Care, Inc. (2); Medica Corp. (2); Amdev, Inc. (2).
Have JFP devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2021-01-06.
Next steps
- Run an FDA pathway report with predicate devices for product code JFP
- Run a recall and safety report across every JFP manufacturer
- Watch product code JFP 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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