FDA product code JTO: Discs, Strips And Reagents, Microorganism Differentiation
JTO is the FDA product code for discs, strips and reagents, microorganism differentiation. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 244 510(k) submissions under JTO, from 50 different applicants. The average 510(k) review took 59 days (median 39). FDA has posted 21 recalls for JTO devices, 13 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Discs, Strips And Reagents, Microorganism Differentiation |
| 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 JTO clearance
Top JTO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Remel Co. | 46 | 1994-05-20 |
| Difco Laboratories, Inc. | 34 | 1996-02-06 |
| Dms Laboratories | 13 | 1983-05-09 |
| Austin Biological Laboratories | 12 | 1984-05-02 |
| E-Y Laboratories, Inc. | 11 | 1994-09-14 |
45 more applicants have JTO clearances. See the full list in Caduvo.
Most recent JTO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050352 | Ameritek Research, LLC | IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT | 2005-09-01 | 202 |
| K970832 | Remel, Inc. | PYR SWAB | 1997-04-24 | 48 |
| K970834 | Remel, Inc. | GRAM SWAB | 1997-04-17 | 41 |
| K970833 | Remel, Inc. | INDOLE SWAB | 1997-04-02 | 26 |
| K970009 | Microbiologics, Inc. | LYFO(TM) DIFFERENTIAL DISK-BACITRACIN | 1997-02-06 | 35 |
Recalls for JTO devices
21 product recalls in 8 recall events; 13 initiated in the last five years and 12 still open. Most recent: 2022-11-09.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2021 | 2 |
| 2022 | 12 |
Frequently asked questions
What is FDA product code JTO?
JTO is the FDA product code for discs, strips and reagents, microorganism differentiation. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is JTO?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JTO?
Across 244 cleared submissions the average was 59 days from receipt to decision (median 39).
Which companies have the most JTO clearances?
Remel Co. (46); Difco Laboratories, Inc. (34); Dms Laboratories (13); Austin Biological Laboratories (12); E-Y Laboratories, Inc. (11).
Have JTO devices been recalled?
Yes: 21 product recalls across 8 recall events; the most recent began 2022-11-09.
Next steps
- Run an FDA pathway report with predicate devices for product code JTO
- Run a recall and safety report across every JTO manufacturer
- Watch product code JTO 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 Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times