FDA product code NHT: Assay, Nucleic Acid Amplification, Bacillus Anthracis
NHT is the FDA product code for assay, nucleic acid amplification, bacillus anthracis. It is a Class II device, regulated under 21 CFR 866.3045 and reviewed by the Microbiology panel. FDA has cleared 6 510(k) submissions under NHT, from 4 different applicants. The average 510(k) review took 70 days (median 66). FDA has posted 1 recall for NHT devices.
Definition
An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.
Classification
| Field | Value |
|---|---|
| Device name | Assay, Nucleic Acid Amplification, Bacillus Anthracis |
| Device class | Class II |
| Regulation | 21 CFR 866.3045 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for NHT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 30 |
Compare with all 510(k) review times · Search every NHT clearance
Top NHT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Idaho Technology, Inc. | 3 | 2007-12-20 |
| Centers for Disease Control and Prevention | 1 | 2019-11-07 |
| Centers For Disease Control and Prevention (CDC) | 1 | 2014-05-22 |
| Biofire Diagnostics, Inc. | 1 | 2013-08-05 |
Most recent NHT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192871 | Centers for Disease Control and Prevention | B. anthracis Real-time PCR Assay | 2019-11-07 | 30 |
| K140426 | Centers For Disease Control and Prevention (CDC) | ANTHRACIS REAL-TIME PCR ASSAY | 2014-05-22 | 92 |
| K131930 | Biofire Diagnostics, Inc. | JBAIDS ANTHRAX DETECTION KIT | 2013-08-05 | 39 |
| K072631 | Idaho Technology, Inc. | JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 | 2007-12-20 | 93 |
| K071188 | Idaho Technology, Inc. | MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM | 2007-05-21 | 21 |
Recalls for NHT devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-08-13.
Frequently asked questions
What is FDA product code NHT?
NHT is the FDA product code for assay, nucleic acid amplification, bacillus anthracis. It is a Class II device, regulated under 21 CFR 866.3045 and reviewed by the Microbiology panel.
What device class is NHT?
Class II, regulation 21 CFR 866.3045. Typical premarket route: 510(k).
How long does a 510(k) take for product code NHT?
Across 6 cleared submissions the average was 70 days from receipt to decision (median 66).
Which companies have the most NHT clearances?
Idaho Technology, Inc. (3); Centers for Disease Control and Prevention (1); Centers For Disease Control and Prevention (CDC) (1); Biofire Diagnostics, Inc. (1).
Have NHT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-08-13.
Next steps
- Run an FDA pathway report with predicate devices for product code NHT
- Run a recall and safety report across every NHT manufacturer
- Watch product code NHT 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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