FDA product code NTM: Antigen, Inflammatory Response Marker, Sepsis
NTM is the FDA product code for antigen, inflammatory response marker, sepsis. It is a Class II device, regulated under 21 CFR 866.3210 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under NTM, from 2 different applicants. The average 510(k) review took 290 days (median 277). FDA has posted 2 recalls for NTM devices, 1 initiated in the last five years.
Definition
An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Inflammatory Response Marker, Sepsis |
| Device class | Class II |
| Regulation | 21 CFR 866.3210 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NTM clearance
Top NTM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Brahms Aktiengesellschaft | 2 | 2008-03-31 |
| bioMerieux, Inc. | 1 | 2007-10-11 |
Most recent NTM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K070310 | Brahms Aktiengesellschaft | B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM | 2008-03-31 | 424 |
| K071146 | bioMerieux, Inc. | VIDAS B.R.A.H.M.S. PCT ASSAY | 2007-10-11 | 170 |
| K040887 | Brahms Aktiengesellschaft | B-R-A-H-M-S PCT LIA | 2005-01-07 | 277 |
Recalls for NTM devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-11-09.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code NTM?
NTM is the FDA product code for antigen, inflammatory response marker, sepsis. It is a Class II device, regulated under 21 CFR 866.3210 and reviewed by the Microbiology panel.
What device class is NTM?
Class II, regulation 21 CFR 866.3210. Typical premarket route: 510(k).
How long does a 510(k) take for product code NTM?
Across 3 cleared submissions the average was 290 days from receipt to decision (median 277).
Which companies have the most NTM clearances?
Brahms Aktiengesellschaft (2); bioMerieux, Inc. (1).
Have NTM devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2022-11-09.
Next steps
- Run an FDA pathway report with predicate devices for product code NTM
- Run a recall and safety report across every NTM manufacturer
- Watch product code NTM 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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