FDA product code JTS: Stains, Microbiologic
JTS is the FDA product code for stains, microbiologic. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Microbiology panel. FDA has cleared 40 510(k) submissions under JTS, from 19 different applicants. The average 510(k) review took 39 days (median 33). FDA has posted 9 recalls for JTS devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Stains, Microbiologic |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | MI — Microbiology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every JTS clearance
Top JTS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Remel Co. | 12 | 1996-03-19 |
| Alpha-Tec Systems, Inc. | 5 | 1989-03-23 |
| Accra Laboratories, Inc. | 4 | 1985-04-29 |
| Scientific Device Laboratory, Inc. | 3 | 1988-10-25 |
| Marion Laboratories, Inc. | 2 | 1978-08-14 |
14 more applicants have JTS clearances. See the full list in Caduvo.
Most recent JTS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K960090 | Remel Co. | CALCOFLUOR WHITE STAIN KIT | 1996-03-19 | 68 |
| K960095 | Remel Co. | BACTIDROP CALCOFLUOR WHITE | 1996-03-19 | 68 |
| K920970 | Remel Co. | BACTIDROP KOH (10%) | 1992-06-09 | 99 |
| K920975 | Remel Co. | BACTIDROP CALCOFLUOR WHITE | 1992-06-09 | 99 |
| K920976 | Remel Co. | BACTIDROP INDIA INK | 1992-06-09 | 99 |
Recalls for JTS devices
9 product recalls in 6 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-02-12.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 3 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code JTS?
JTS is the FDA product code for stains, microbiologic. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Microbiology panel.
What device class is JTS?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JTS?
Across 40 cleared submissions the average was 39 days from receipt to decision (median 33).
Which companies have the most JTS clearances?
Remel Co. (12); Alpha-Tec Systems, Inc. (5); Accra Laboratories, Inc. (4); Scientific Device Laboratory, Inc. (3); Marion Laboratories, Inc. (2).
Have JTS devices been recalled?
Yes: 9 product recalls across 6 recall events; the most recent began 2025-02-12.
Next steps
- Run an FDA pathway report with predicate devices for product code JTS
- Run a recall and safety report across every JTS manufacturer
- Watch product code JTS 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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