Cepheid Xpert CT/NG Control Panel
FDA 510(k) K190223 · Microbiologics, Inc.
510(k) numberK190223
Submission
- Device name
- Cepheid Xpert CT/NG Control Panel
- Applicant
- Microbiologics, Inc.
St. Cloud, MN, US - Received
- February 5, 2019
- Decision date
- May 8, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PMN – Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3920
- Specialty
- Microbiology
Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.
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Questions and answers
When was Cepheid Xpert CT/NG Control Panel cleared by the FDA?
Cepheid Xpert CT/NG Control Panel (K190223) received a 510(k) decision of Substantially Equivalent on May 8, 2019, 92 days after the submission was received.
What is the product code of K190223?
The FDA product code is PMN – Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays, a Class II (moderate risk) device regulated under 21 CFR 866.3920.