FDA product code JSS: Kit, Identification, Enterobacteriaceae
JSS is the FDA product code for kit, identification, enterobacteriaceae. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 49 510(k) submissions under JSS, from 29 different applicants. The average 510(k) review took 91 days (median 50). FDA has posted 9 recalls for JSS devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Identification, Enterobacteriaceae |
| 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 JSS clearance
Top JSS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advandx, Inc. | 7 | 2013-07-21 |
| Vitek Systems, Inc. | 3 | 1988-09-16 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 3 | 1986-09-30 |
| Becton Dickinson Microbiology Systems | 2 | 1993-03-11 |
| Roche Diagnostic Systems, Inc. | 2 | 1992-09-11 |
24 more applicants have JSS clearances. See the full list in Caduvo.
Most recent JSS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150031 | Miacom Diagnostics GmbH | hemoFISH Masterpanel | 2015-10-01 | 266 |
| K123418 | Advandx, Inc. | GRAM-NEGATIVE QUICKFISH BC | 2013-07-21 | 257 |
| K101558 | Advandx, Inc. | GNR TRAFFIC LIGHT PNA FISH | 2010-12-16 | 195 |
| K092236 | Advandx, Inc. | E.COLI/P. AERUGINOSA PNA FISH | 2009-12-16 | 146 |
| K092393 | Advandx, Inc. | EK/P. AERUGINOSA PNA FISH | 2009-09-01 | 27 |
Recalls for JSS devices
9 product recalls in 9 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2022-11-09.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code JSS?
JSS is the FDA product code for kit, identification, enterobacteriaceae. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is JSS?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JSS?
Across 49 cleared submissions the average was 91 days from receipt to decision (median 50).
Which companies have the most JSS clearances?
Advandx, Inc. (7); Vitek Systems, Inc. (3); Bd Becton Dickinson Vacutainer Systems Preanalytic (3); Becton Dickinson Microbiology Systems (2); Roche Diagnostic Systems, Inc. (2).
Have JSS devices been recalled?
Yes: 9 product recalls across 9 recall events; the most recent began 2022-11-09.
Next steps
- Run an FDA pathway report with predicate devices for product code JSS
- Run a recall and safety report across every JSS manufacturer
- Watch product code JSS 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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