Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3920](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3920) → PMN — Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays # PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays _Microbiology · 21 CFR 866.3920 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN ## Overview - **Product Code:** PMN - **Device Name:** Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays - **Regulation:** [21 CFR 866.3920](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3920) - **Device Class:** 2 - **Review Panel:** [Microbiology](/submissions/MI) - **3rd-party reviewable:** yes ## 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. ## Classification Rationale Class II (special controls). The special controls for this device are: ## 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.” ## Recent Cleared Devices (20 of 30) Showing 20 most recent of 30 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260041](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K260041.md) | MDx-Chex for BCP | Streck, LLC | Mar 27, 2026 | SESE | | [K254166](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K254166.md) | MDx-Chex for BCN | Streck | Mar 23, 2026 | SESE | | [K254167](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K254167.md) | MDx-Chex for BCY | Streck, LLC | Mar 17, 2026 | SESE | | [K251526](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K251526.md) | FilmArray GI Control Panel M238 | Maine Molecular Quality Controls, Inc. | Aug 14, 2025 | SESE | | [K241289](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K241289.md) | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control | Maine Molecular Quality Controls, Inc. | May 30, 2024 | SESE | | [K233611](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K233611.md) | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) | Maine Molecular Quality Controls, Inc. | Mar 26, 2024 | SESE | | [K231223](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K231223.md) | MDx-Chex for BC-GN | Streck | Jul 27, 2023 | SESE | | [K231221](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K231221.md) | MDx-Chex for BC-GP | Streck | Jul 27, 2023 | SESE | | [K230868](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K230868.md) | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control | Maine Molecular Quality Controls, Inc. | Apr 13, 2023 | SESE | | [K221253](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K221253.md) | SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control | Maine Molecular Quality Controls, Inc. | Feb 3, 2023 | SESE | | [K203680](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K203680.md) | BioFire JI Control Panel M420 | Maine Molecular Quality Controls, Inc. | Jul 22, 2022 | SESE | | [K201403](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K201403.md) | NATtrol BD MAX Vaginal Panel External Controls | Zeptometrix | Feb 2, 2022 | SESE | | [K212576](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K212576.md) | MDx-Chex for BCID2 | Streck, Inc. | Jan 19, 2022 | SESE | | [K202196](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K202196.md) | BioFire RP2.1/RP2.1plus Control Panel M441 | Maine Molecular Quality Controls, Inc. | Jun 24, 2021 | SESE | | [K202382](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K202382.md) | FilmArray Global Fever Panel External Control Kit | Biofire Defense, LLC | Nov 20, 2020 | SESE | | [K200010](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K200010.md) | FilmArray BCID2 Control Panel M416 | Maine Molecular Quality Controls, Inc. | Apr 2, 2020 | SESE | | [K190086](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K190086.md) | Cepheid Xpert Respiratory Control Panel | Microbiologics, Inc. | Oct 7, 2019 | SESE | | [K191168](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K191168.md) | Cepheid Xpert SA Nasal Complete Control Panel | Microbiologics, Inc. | Jun 25, 2019 | SESE | | [K191172](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K191172.md) | Cepheid Xpert MRSA NxG Control Panel | Microbiologics, Inc. | Jun 20, 2019 | SESE | | [K190223](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K190223.md) | Cepheid Xpert CT/NG Control Panel | Microbiologics, Inc. | May 8, 2019 | SESE | ## Top Applicants - Maine Molecular Quality Controls, Inc. — 12 clearances - Microbiologics, Inc. — 8 clearances - Streck — 3 clearances - Bio-Rad Laboratories — 2 clearances - Streck, LLC — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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