Jbaids Anthrac Detection System
FDA 510(k) K051713 · Idaho Technology, Inc.
510(k) numberK051713
Submission
- Device name
- Jbaids Anthrac Detection System
- Applicant
- Idaho Technology, Inc.
Salt Lake City, UT, US - Received
- June 27, 2005
- Decision date
- November 18, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Expedited review
- Yes
Device classification
- Product code
- NHT – Assay, Nucleic Acid Amplification, Bacillus Anthracis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3045
- Specialty
- Microbiology
An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.
Other 510(k)s with product code NHT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192871 | B. anthracis Real-time PCR AssayNHT · Special | Centers for Disease Control and Prevention | 11/07/2019SE |
| K140426 | Anthracis Real-Time PCR AssayNHT · Traditional | Centers For Disease Control and Prevention (CDC) | 05/22/2014SE |
| K131930 | Jbaids Anthrax Detection KitNHT · Traditional | Biofire Diagnostics, Inc. | 08/05/2013SE |
| K072631 | Jbaids Plaque Detection Kit, Model JRPD-ASY-0123NHT · Traditional | Idaho Technology, Inc. | 12/20/2007SE |
| K071188 | Modification to Jbaids Anthrax Detection SystemNHT · Special | Idaho Technology, Inc. | 05/21/2007SE |
More from Idaho Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K120267 | Filmarray RP PanelOCC · Traditional | 05/15/2012SE |
| K103207 | Jbaids Q Fever Detection KitOVF · Traditional | 05/20/2011SE |
| K110764 | Filmarray RP PanelOCC · Traditional | 04/27/2011SE |
| K103175 | Filmarray Respiratory Panel (RP)OCC · Traditional | 02/17/2011SE |
| K072631 | Jbaids Plaque Detection Kit, Model JRPD-ASY-0123NHT · Traditional | 12/20/2007SE |
| K072547 | Jbaids Tularemia Detection Kit, Model JRPD-ASY-0124OEH · Traditional | 12/19/2007SE |
| K071188 | Modification to Jbaids Anthrax Detection SystemNHT · Special | 05/21/2007SE |
Questions and answers
When was Jbaids Anthrac Detection System cleared by the FDA?
Jbaids Anthrac Detection System (K051713) received a 510(k) decision of Substantially Equivalent on November 18, 2005, 144 days after the submission was received.
What is the product code of K051713?
The FDA product code is NHT – Assay, Nucleic Acid Amplification, Bacillus Anthracis, a Class II (moderate risk) device regulated under 21 CFR 866.3045.