FDA product code JXB: Kit, Identification, Yeast
JXB is the FDA product code for kit, identification, yeast. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 16 510(k) submissions under JXB, from 12 different applicants. The average 510(k) review took 90 days (median 68). FDA has posted 6 recalls for JXB devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Identification, Yeast |
| Device class | Class I |
| Regulation | 21 CFR 866.2660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JXB clearance
Top JXB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advandx, Inc. | 2 | 2008-09-12 |
| Remel Co. | 2 | 1994-02-25 |
| Vitek Systems, Inc. | 2 | 1988-06-16 |
| Analytical Products, Inc. | 2 | 1983-04-05 |
| Diagnostic Markers, Inc. | 1 | 2000-02-10 |
7 more applicants have JXB clearances. See the full list in Caduvo.
Most recent JXB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K080719 | Advandx, Inc. | YEAST TRAFFIC LIGHT PNA FISH | 2008-09-12 | 183 |
| K062461 | Advandx, Inc. | C. ALBICANS PNA FISH | 2006-10-25 | 63 |
| K993554 | Diagnostic Markers, Inc. | YEASTEST | 2000-02-10 | 113 |
| K943621 | Innovative Diagnostic Systems, Inc. | RAPID YEAST PLUS SYSTEM | 1995-01-27 | 184 |
| K935124 | Remel Co. | BACTICARD CANDIDA | 1994-02-25 | 120 |
Recalls for JXB devices
6 product recalls in 5 recall events; 3 initiated in the last five years and 2 still open. Most recent: 2022-11-09.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2021 | 1 |
| 2022 | 2 |
Frequently asked questions
What is FDA product code JXB?
JXB is the FDA product code for kit, identification, yeast. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is JXB?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JXB?
Across 16 cleared submissions the average was 90 days from receipt to decision (median 68).
Which companies have the most JXB clearances?
Advandx, Inc. (2); Remel Co. (2); Vitek Systems, Inc. (2); Analytical Products, Inc. (2); Diagnostic Markers, Inc. (1).
Have JXB devices been recalled?
Yes: 6 product recalls across 5 recall events; the most recent began 2022-11-09.
Next steps
- Run an FDA pathway report with predicate devices for product code JXB
- Run a recall and safety report across every JXB manufacturer
- Watch product code JXB 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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