# K190086: Cepheid Xpert Respiratory Control Panel

- Pathway: 510(k) (Traditional)
- Applicant: Microbiologics, Inc.
- Decided: Oct 7, 2019 after 263 days
- Product code: PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays)
- Device class: 2
- Regulation: 21 CFR 866.3920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN150058 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182472: Cepheid Xpert GBS LB Control Panel, Microbiologics, Inc. (2018) Summary page 3.

## Indications for use
The Cepheid Xpert® Respiratory Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Influenza A (H1N1) virus, Influenza A (H3N2) virus, Influenza B virus and Respiratory Syncytial Virus A performed with the Cepheid Xpert® Xpress Flu/RSV assay on the GeneXpert® Instrument System. The controls comprise cultured and inactivated Influenza A (H1N1) virus, Influenza A (H3N2) virus, Influenza B virus and Respiratory Syncytial Virus A as the positive control and Coxsackie virus B1 as the negative control. The Cepheid Xpert® Respiratory Control Panel is not intended to replace manufacturer controls provided with the device.

Source page: https://510kreport.com/device/K190086
Methodology: https://510kreport.com/methodology