Devices descending from DEN150058
33 later devices reach Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level… through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K182472 | Cepheid Xpert GBS LB Control Panel | Microbiologics, Inc. | 2018 | 4 | — |
| +1 | K181711 | BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel | Microbiologics, Inc. | 2018 | 0 | — |
| +1 | K161573 | FilmArray RP EZ Control Panel M265 | Maine Molecular Quality Controls, Inc. | 2016 | 25 | — |
| +1 | K152679 | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level… | Bio-Rad Laboratories | 2016 | 0 | — |
| +2 | K190086 | Cepheid Xpert Respiratory Control Panel | Microbiologics, Inc. | 2019 | 0 | — |
| +2 | K191168 | Cepheid Xpert SA Nasal Complete Control Panel | Microbiologics, Inc. | 2019 | 0 | — |
| +2 | K191172 | Cepheid Xpert MRSA NxG Control Panel | Microbiologics, Inc. | 2019 | 0 | — |
| +2 | K190223 | Cepheid Xpert CT/NG Control Panel | Microbiologics, Inc. | 2019 | 0 | — |
| +2 | K190222 | FilmArray Pneumonia/Pneumoniaplus Control | Maine Molecular Quality Controls, Inc. | 2019 | 8 | — |
| +2 | K173171 | FilmArray RP2/RP2plus Control Panel | Maine Molecular Quality Controls, Inc. | 2017 | 7 | — |
| +2 | K163522 | FilmArray Warrior Control Panel M290 | Maine Molecular Quality Controls, Inc. | 2017 | 7 | — |
| +3 | K202196 | BioFire RP2.1/RP2.1plus Control Panel M441 | Maine Molecular Quality Controls, Inc. | 2021 | 6 | — |
| +3 | K202382 | FilmArray Global Fever Panel External Control Kit | Biofire Defense, LLC | 2020 | 6 | — |
| +3 | K200010 | FilmArray BCID2 Control Panel M416 | Maine Molecular Quality Controls, Inc. | 2020 | 7 | — |
| +4 | K251526 | FilmArray GI Control Panel M238 | Maine Molecular Quality Controls, Inc. | 2025 | 1 | — |
| +4 | K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire… | Biofire Defense, LLC | 2023 | 2 | — |
| +4 | K221253 | SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control | Maine Molecular Quality Controls, Inc. | 2023 | 3 | — |
| +4 | K220870 | BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel | Biofire Defense, LLC | 2022 | 2 | — |
| +4 | K203680 | BioFire JI Control Panel M420 | Maine Molecular Quality Controls, Inc. | 2022 | 0 | — |
| +4 | K212576 | MDx-Chex for BCID2 | Streck, Inc. | 2022 | 5 | — |
| +5 | K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | Biofire Defense, LLC | 2026 | 0 | — |
| +5 | K260577 | FilmArray TF Control Panel M527 | Maine Molecular Quality Controls, Inc. | 2026 | 0 | — |
| +5 | K254167 | MDx-Chex for BCY | Streck, LLC | 2026 | 0 | — |
| +5 | K253653 | Xpert Hemorrhagic Fever | Cepheid | 2026 | 1 | — |
| +5 | K243463 | BIOFIRE FILMARRAY Tropical Fever Panel | Biofire Diagnostics, LLC (Biomerieux) | 2024 | 0 | — |
| +5 | K231221 | MDx-Chex for BC-GP | Streck | 2023 | 1 | — |
| +5 | K231223 | MDx-Chex for BC-GN | Streck | 2023 | 1 | — |
| +5 | K230868 | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative… | Maine Molecular Quality Controls, Inc. | 2023 | 2 | — |
| +6 | K261362 | Xpert Hemorrhagic Fever | Cepheid | 2026 | 0 | — |
| +6 | K260041 | MDx-Chex for BCP | Streck, LLC | 2026 | 0 | — |
| +6 | K254166 | MDx-Chex for BCN | Streck | 2026 | 0 | — |
| +6 | K233611 | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE… | Maine Molecular Quality Controls, Inc. | 2024 | 1 | — |
| +7 | K241289 | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control | Maine Molecular Quality Controls, Inc. | 2024 | 0 | — |