Simplexa Flu A/B & RSV Direct, Simplexa Flu A/B & RSV Positive Control Pack
FDA 510(k) K120413 · Focus Diagnostics, Inc.
Submission
- Device name
- Simplexa Flu A/B & RSV Direct, Simplexa Flu A/B & RSV Positive Control Pack
- Applicant
- Focus Diagnostics, Inc.
Cypress, CA, US - Received
- February 10, 2012
- Decision date
- July 13, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCC – Respiratory Virus Panel Nucleic Acid Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Specialty
- Microbiology
A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of…
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| 510(k) | Device | Decision |
|---|---|---|
| K152408 | Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control PackOCC · Special | 09/21/2015SE |
| K150962 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackOQO · Traditional | 08/28/2015SE |
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| K142365 | Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control PackOCC · Traditional | 12/05/2014SE |
| K141458 | Simplexa HSV 1&2 Direct/Positive Control PackPGH · Special | 07/01/2014SE |
| K120986 | Stratify JCV DxselectOYP · Traditional | 08/16/2012SE |
| K113433 | Simplexa C. Difficile Universal DirectOMN · Traditional | 04/04/2012SE |
| K102170 | Simplexa Flu A/B & RSVOCC · Traditional | 11/24/2010SE |
| K102314 | 3M Integrated Cycler (110V) & (220V)OOI · Traditional | 10/29/2010SE |
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Questions and answers
When was Simplexa Flu A/B & RSV Direct, Simplexa Flu A/B & RSV Positive Control Pack cleared by the FDA?
Simplexa Flu A/B & RSV Direct, Simplexa Flu A/B & RSV Positive Control Pack (K120413) received a 510(k) decision of Substantially Equivalent on July 13, 2012, 154 days after the submission was received.
What is the product code of K120413?
The FDA product code is OCC – Respiratory Virus Panel Nucleic Acid Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.