SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
FDA 510(k) K233611 · Maine Molecular Quality Controls, Inc.
510(k) numberK233611
Submission
- Device name
- SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
- Applicant
- Maine Molecular Quality Controls, Inc.
Saco, ME, US - Received
- November 13, 2023
- Decision date
- March 26, 2024
- 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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|---|---|---|---|
| K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitPMN · Traditional | Biofire Defense, LLC | 07/17/2026SE |
| K260577 | FilmArray TF Control Panel M527PMN · Traditional | Maine Molecular Quality Controls, Inc. | 05/19/2026SE |
| K260041 | MDx-Chex for BCPPMN · Traditional | Streck, LLC | 03/27/2026SE |
| K254166 | MDx-Chex for BCNPMN · Traditional | Streck | 03/23/2026SE |
| K254167 | MDx-Chex for BCYPMN · Traditional | Streck, LLC | 03/17/2026SE |
| K251526 | FilmArray GI Control Panel M238PMN · Traditional | Maine Molecular Quality Controls, Inc. | 08/14/2025SE |
| K241289 | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlPMN · Special | Maine Molecular Quality Controls, Inc. | 05/30/2024SE |
| K231223 | MDx-Chex for BC-GNPMN · Traditional | Streck | 07/27/2023SE |
| K231221 | MDx-Chex for BC-GPPMN · Traditional | Streck | 07/27/2023SE |
| K230868 | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative…PMN · Special | Maine Molecular Quality Controls, Inc. | 04/13/2023SE |
More from Maine Molecular Quality Controls, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260577 | FilmArray TF Control Panel M527PMN · Traditional | 05/19/2026SE |
| K251526 | FilmArray GI Control Panel M238PMN · Traditional | 08/14/2025SE |
| K241289 | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlPMN · Special | 05/30/2024SE |
| K230868 | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative…PMN · Special | 04/13/2023SE |
| K221253 | SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative ControlPMN · Traditional | 02/03/2023SE |
| K203680 | BioFire JI Control Panel M420PMN · Traditional | 07/22/2022SE |
| K202196 | BioFire RP2.1/RP2.1plus Control Panel M441PMN · Traditional | 06/24/2021SE |
| K200010 | FilmArray BCID2 Control Panel M416PMN · Traditional | 04/02/2020SE |
| K190222 | FilmArray Pneumonia/Pneumoniaplus ControlPMN · Traditional | 05/03/2019SE |
| K173171 | FilmArray RP2/RP2plus Control PanelPMN · Traditional | 11/24/2017SE |
Questions and answers
When was SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) cleared by the FDA?
SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) (K233611) received a 510(k) decision of Substantially Equivalent on March 26, 2024, 134 days after the submission was received.
What is the product code of K233611?
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.