FDA product code JSP: Kit, Anaerobic Identification
JSP is the FDA product code for kit, anaerobic identification. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 18 510(k) submissions under JSP, from 12 different applicants. The average 510(k) review took 98 days (median 66). FDA has posted 2 recalls for JSP devices.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Anaerobic Identification |
| 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 JSP clearance
Top JSP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Microbiologics, Inc. | 3 | 1995-05-11 |
| Vitek Systems, Inc. | 3 | 1991-04-03 |
| Innovative Diagnostic Systems, Inc. | 2 | 1988-08-12 |
| Analytical Products, Inc. | 2 | 1983-05-05 |
| Becton Dickinson Microbiology Systems | 1 | 1995-03-07 |
7 more applicants have JSP clearances. See the full list in Caduvo.
Most recent JSP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945487 | Microbiologics, Inc. | LYFO(TM) DIFFERENTIAL DISK | 1995-05-11 | 184 |
| K945489 | Microbiologics, Inc. | LYFO(TM) DIFFERENTIAL DISK | 1995-05-11 | 184 |
| K945488 | Microbiologics, Inc. | LYFO(TM) DIFFERENTIAL DISK | 1995-05-11 | 184 |
| K944528 | Becton Dickinson Microbiology Systems | BBLCRYSTAL ANAEROBE ID SYSTEM | 1995-03-07 | 173 |
| K910666 | Vitek Systems, Inc. | VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION | 1991-04-03 | 51 |
Recalls for JSP devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-03-23.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
Frequently asked questions
What is FDA product code JSP?
JSP is the FDA product code for kit, anaerobic identification. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is JSP?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JSP?
Across 18 cleared submissions the average was 98 days from receipt to decision (median 66).
Which companies have the most JSP clearances?
Microbiologics, Inc. (3); Vitek Systems, Inc. (3); Innovative Diagnostic Systems, Inc. (2); Analytical Products, Inc. (2); Becton Dickinson Microbiology Systems (1).
Have JSP devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2018-03-23.
Next steps
- Run an FDA pathway report with predicate devices for product code JSP
- Run a recall and safety report across every JSP manufacturer
- Watch product code JSP 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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