FDA product code GTJ: Antisera, All Groups, N. Meningitidis
GTJ is the FDA product code for antisera, all groups, n. meningitidis. It is a Class II device, regulated under 21 CFR 866.3390 and reviewed by the Microbiology panel. FDA has cleared 16 510(k) submissions under GTJ, from 7 different applicants. The average 510(k) review took 118 days (median 72). FDA has posted 5 recalls for GTJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, All Groups, N. Meningitidis |
| Device class | Class II |
| Regulation | 21 CFR 866.3390 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GTJ clearance
Top GTJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wellcome Diagnostics | 5 | 1986-02-04 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 3 | 1996-05-30 |
| Armkel, LLC | 3 | 1989-02-07 |
| Pharmacia, Inc. | 2 | 1985-10-17 |
| Vitek Systems, Inc. | 1 | 1991-08-12 |
2 more applicants have GTJ clearances. See the full list in Caduvo.
Most recent GTJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952791 | Bd Becton Dickinson Vacutainer Systems Preanalytic | DIRECTIGEN MENINGITIS COMBO TEST | 1996-05-30 | 346 |
| K915330 | Bd Becton Dickinson Vacutainer Systems Preanalytic | DIRECTIGEN MENINGITIS COMBO TEST KIT | 1992-03-23 | 118 |
| K910210 | Vitek Systems, Inc. | SLIDEX MENINGITE-KIT 5 | 1991-08-12 | 209 |
| K885004 | Armkel, LLC | BACTIGEN(R) N. MENINGITIDIS | 1989-02-07 | 68 |
| K870089 | Microscan Div. Baxter Healthcare Corp. | IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT | 1987-03-17 | 67 |
Recalls for GTJ devices
5 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-07-17.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code GTJ?
GTJ is the FDA product code for antisera, all groups, n. meningitidis. It is a Class II device, regulated under 21 CFR 866.3390 and reviewed by the Microbiology panel.
What device class is GTJ?
Class II, regulation 21 CFR 866.3390. Typical premarket route: 510(k).
How long does a 510(k) take for product code GTJ?
Across 16 cleared submissions the average was 118 days from receipt to decision (median 72).
Which companies have the most GTJ clearances?
Wellcome Diagnostics (5); Bd Becton Dickinson Vacutainer Systems Preanalytic (3); Armkel, LLC (3); Pharmacia, Inc. (2); Vitek Systems, Inc. (1).
Have GTJ devices been recalled?
Yes: 5 product recalls across 2 recall events; the most recent began 2026-07-17.
Next steps
- Run an FDA pathway report with predicate devices for product code GTJ
- Run a recall and safety report across every GTJ manufacturer
- Watch product code GTJ 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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