FDA product code JJF: Analyzer, Chemistry, Micro, For Clinical Use
JJF is the FDA product code for analyzer, chemistry, micro, for clinical use. It is a Class I device, regulated under 21 CFR 862.2170 and reviewed by the Clinical Chemistry panel. FDA has cleared 57 510(k) submissions under JJF, from 41 different applicants. The average 510(k) review took 85 days (median 48). FDA has posted 13 recalls for JJF devices.
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Chemistry, Micro, For Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2170 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JJF clearance
Top JJF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Instruments, Inc. | 3 | 1993-11-16 |
| Syva Co. | 3 | 1991-06-10 |
| Kone Instruments, Inc. | 3 | 1987-03-13 |
| Technicon Instruments Corp. | 3 | 1985-04-08 |
| Roche Molecular Systems, Inc. | 2 | 2002-02-01 |
36 more applicants have JJF clearances. See the full list in Caduvo.
Most recent JJF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052794 | DiaSorin, Inc. | ETI-MAX 3000 | 2006-03-31 | 179 |
| K040332 | Arkray, Inc. | POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER | 2004-06-16 | 127 |
| K033734 | Roche Diagnostics Corp. | LIGHTCYCLER INSTRUMENT VERSION 1.2 | 2003-12-17 | 19 |
| K013654 | Precision Systems, Inc. | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER | 2002-06-05 | 211 |
| K012966 | Roche Molecular Systems, Inc. | ROCHE COBAS TAQMAN ANALYZER | 2002-02-01 | 150 |
Recalls for JJF devices
13 product recalls in 10 recall events; 0 initiated in the last five years and 2 still open. Most recent: 2018-11-15.
| Year | Recalls |
|---|---|
| 2018 | 2 |
Frequently asked questions
What is FDA product code JJF?
JJF is the FDA product code for analyzer, chemistry, micro, for clinical use. It is a Class I device, regulated under 21 CFR 862.2170 and reviewed by the Clinical Chemistry panel.
What device class is JJF?
Class I, regulation 21 CFR 862.2170. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJF?
Across 57 cleared submissions the average was 85 days from receipt to decision (median 48).
Which companies have the most JJF clearances?
Beckman Instruments, Inc. (3); Syva Co. (3); Kone Instruments, Inc. (3); Technicon Instruments Corp. (3); Roche Molecular Systems, Inc. (2).
Have JJF devices been recalled?
Yes: 13 product recalls across 10 recall events; the most recent began 2018-11-15.
Next steps
- Run an FDA pathway report with predicate devices for product code JJF
- Run a recall and safety report across every JJF manufacturer
- Watch product code JJF 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.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times