Cepheid Xpert C. difficile/Epi Control Panel
Device Facts
| Record ID | K190463 |
|---|---|
| Device Name | Cepheid Xpert C. difficile/Epi Control Panel |
| Applicant | Microbiologics, Inc. |
| Product Code | PMN · Microbiology |
| Decision Date | Apr 19, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3920 |
| Device Class | Class 2 |
Indications for Use
The Cepheid Xpert® C. difficile/Epi Control Panel is intended for use as external assayed positive and negative quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Clostridioides (Clostridium) difficile performed with the Cepheid Xpert® C. difficile/Epi assay on the GeneXpert® Dx System. The controls comprise cultured and inactivated Clostridioides (Clostridium) difficile 027-NAP1-B1 as the positive control and Clostridium sordellii as the negative control. The Cepheid Xpert® C. difficile/Epi Control Panel is not intended to replace manufacturer controls provided with the device.
Device Story
External assayed quality control material; lyophilized positive and negative control swabs. Positive control contains heat-inactivated Clostridioides difficile 027/NAP1/B1 strain; negative control contains heat-inactivated Clostridium sordellii. Used in clinical laboratories to monitor DNA extraction, amplification, and detection processes of Cepheid Xpert C. difficile/Epi assay on GeneXpert Dx System. Operators rehydrate swabs in sample reagent; process on GeneXpert instrument. Output consists of qualitative positive/negative results for toxin B (tcdB), binary toxin genes, and tcdC gene deletion. Ensures assay performance and validity of patient test results.
Clinical Evidence
No clinical data. Bench testing only. Reproducibility study conducted at three sites over five days with three lots of controls (n ≥ 90 replicates per control). All replicates produced expected qualitative results. Mean cycle threshold (Ct) and endpoint fluorescence values were consistent across sites, operators, and lots. Stability studies support 18-month shelf-life at 2-25°C and 5-hour in-use stability at 20°C.
Technological Characteristics
Lyophilized swab format; heat-inactivated microbial organisms. Positive control: Clostridioides difficile 027/NAP1/B1. Negative control: Clostridium sordellii. Compatible with GeneXpert Dx System. Standards referenced: CLSI EP25-A (stability), CLSI EP05-A3 (precision).
Indications for Use
Indicated for use as external quality control material for laboratory personnel performing nucleic acid testing for Clostridioides difficile using the Cepheid Xpert C. difficile/Epi assay on the GeneXpert Dx System.
Regulatory Classification
Identification
An assayed quality control material for clinical microbiology assays is a device indicated for use in a test system to estimate test precision or to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device consists of single or multiple microbiological analytes intended for use with either qualitative or quantitative assays.
Special Controls
An assayed quality control material for clinical microbiology assays must comply with the following special controls: (1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate: (i) Analyte concentration; Expected values: (ii) Analyte source: (iii) (iv) Base matrix; (v) Added components; (vi) Safety and handling information; and, (vii) Detailed instructions for use. (2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including: (i) Description of the process for value assignment and validation. (ii) Description of the protocol(s) used to establish stability. (iii) Line data establishing precision/reproducibility. (iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance. (v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method. (vi) Where applicable, detailed documentation related to studies for surrogate controls. (3) Premarket notification submissions must include an adequate mitigation (e.g., realtime stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling. (4) Your 21 CFR 809.10 compliant labeling must include the following: (i) The intended use in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(b)(2) compliant labeling must include the following: (A) Assayed control material analyte(s); (B) Whether the material is intended for quantitative or qualitative assays: (C) Stating if the material is a surrogate control; (D)The system(s), instrument(s), or test(s) for which the quality control material is intended. (ii) The intended use in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(b)(2) compliant labeling must include the following statement: "This product is not intended to replace manufacturer controls provided with the device." (iii)A limiting statement that reads "Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements."
*Classification.* Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate: (i) Analyte concentration; (ii) Expected values; (iii) Analyte source; (iv) Base matrix; (v) Added components; (vi) Safety and handling information; and (vii) Detailed instructions for use. (2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including: (i) Description of the process for value assignment and validation. (ii) Description of the protocol(s) used to establish stability. (iii) Line data establishing precision/reproducibility. (iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance. (v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method. (vi) Where applicable, detailed documentation related to studies for surrogate controls. (3) Premarket notification submissions must include an adequate mitigation (e.g., real-time stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling. (4) Your 21 CFR 809.10 compliant labeling must include the following: (i) The intended use of your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following: (A) Assayed control material analyte(s); (B) Whether the material is intended for quantitative or qualitative assays; (C) Stating if the material is a surrogate control; and (D) The system(s), instrument(s), or test(s) for which the quality control material is intended. (ii) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following statement: “This product is not intended to replace manufacturer controls provided with the device.” (iii) A limiting statement that reads “Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.”
Predicate Devices
- Cepheid Xpert® GBS LB Control Panel (K182472)
