Simplexa HSV 1&2 Direct/Positive Control Pack
FDA 510(k) K141458 · Focus Diagnostics
510(k) numberK141458
Submission
- Device name
- Simplexa HSV 1&2 Direct/Positive Control Pack
- Applicant
- Focus Diagnostics
Cypress, CA, US - Received
- June 2, 2014
- Decision date
- July 1, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PGH – Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3307
- Specialty
- Microbiology
- Life-sustaining
- Yes
Intended for the qualitative detection and differentiation of HSV-1 and HSV-2 in cerebrospinal fluid (CSF) from patients with signs and symptoms of Herpes Simplex Virus (HSV) central nervous system (CNS) infection. This test is an aid in the diagnosis of HSV-1 and HSV-2 CNS infections in conjunction with other clinical and laboratory findings. Negative results do not preclude HSV-1 or HSV-2…
Other 510(k)s with product code PGH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250050 | miDiagnostics HSV-1&2 CSF TestPGH · Traditional | Midiagnostics NV | 09/30/2025SE |
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Questions and answers
When was Simplexa HSV 1&2 Direct/Positive Control Pack cleared by the FDA?
Simplexa HSV 1&2 Direct/Positive Control Pack (K141458) received a 510(k) decision of Substantially Equivalent on July 1, 2014, 29 days after the submission was received.
What is the product code of K141458?
The FDA product code is PGH – Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel, a Class II (moderate risk) device regulated under 21 CFR 866.3307.