FDA product code JJI: Analyzer, Enzyme, For Clinical Use
JJI is the FDA product code for analyzer, enzyme, for clinical use. It is a Class I device, regulated under 21 CFR 862.2500 and reviewed by the Clinical Chemistry panel. FDA has cleared 8 510(k) submissions under JJI, from 6 different applicants. The average 510(k) review took 58 days (median 56). FDA has posted 1 recall for JJI devices.
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Enzyme, For Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2500 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JJI clearance
Top JJI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Rad | 2 | 1997-07-30 |
| Abbott Laboratories | 2 | 1994-12-19 |
| Gilford Instrument Laboratories, Inc. | 1 | 1979-02-22 |
| Olympus Corp. | 1 | 1978-08-14 |
| Biokinetix Corp. | 1 | 1977-09-20 |
1 more applicants have JJI clearances. See the full list in Caduvo.
Most recent JJI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972024 | Bio-Rad | CODA AUTOMATED EIA ANALYZER | 1997-07-30 | 58 |
| K944731 | Abbott Laboratories | ABBOTT IMX 2 ANALYZER | 1994-12-19 | 98 |
| K931970 | Abbott Laboratories | ABBOTT IMX2 ANALYER | 1993-06-16 | 55 |
| K930898 | Bio-Rad | RADIAS AUTOMATED IMMUNOASSAY SYSTEM | 1993-04-21 | 58 |
| K790073 | Gilford Instrument Laboratories, Inc. | ANALYZER, IMPACT 100 | 1979-02-22 | 42 |
Recalls for JJI devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-01-02.
Frequently asked questions
What is FDA product code JJI?
JJI is the FDA product code for analyzer, enzyme, for clinical use. It is a Class I device, regulated under 21 CFR 862.2500 and reviewed by the Clinical Chemistry panel.
What device class is JJI?
Class I, regulation 21 CFR 862.2500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJI?
Across 8 cleared submissions the average was 58 days from receipt to decision (median 56).
Which companies have the most JJI clearances?
Bio-Rad (2); Abbott Laboratories (2); Gilford Instrument Laboratories, Inc. (1); Olympus Corp. (1); Biokinetix Corp. (1).
Have JJI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2007-01-02.
Next steps
- Run an FDA pathway report with predicate devices for product code JJI
- Run a recall and safety report across every JJI manufacturer
- Watch product code JJI 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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