# K221253: SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control

- Pathway: 510(k) (Traditional)
- Applicant: Maine Molecular Quality Controls, Inc.
- Decided: Feb 3, 2023 after 277 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: 4 generations back to DEN150058 (2016). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202196: BioFire RP2.1/RP2.1plus Control Panel M441, Maine Molecular Quality Controls, Inc. (2021) Summary page 4.

## Most influential descendants
- K230868: SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control (2023), 2 descendants of its own
- K233611: SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) (2024), 1 descendant of its own
- K241289: SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control (2024), 0 descendants of its own

## Indications for use
SPOTFIRE® RSP Positive Control is intended for use as an external positive assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Adenovirus, seasonal Coronavirus, Coronavirus SARS-CoV-2, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE® Respiratory (R) Panel performed on the BIOFIRE® SPOTFIRE® System. SPOTFIRE RSP Positive Control is comprised of in vitro RNA transcripts and stabilizing solution and is designed for and intended to be used solely with the BIOFIRE SPOTFIRE R Panel. This product is not intended to replace manufacturer internal controls provided with the device. Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements. SPOTFIRE® RSP Negative Control is intended for use as an external negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Adenovirus, seasonal Coronavirus, Coronavirus SARS-CoV-2, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE® Respiratory (R) Panel performed on the BIOFIRE® SPOTFIRE® System. SPOTFIRE RSP Negative Control is comprised of a solution that does not contain target analytes and is designed for and intended to be used solely with the BIOFIRE SPOTFIRE R Panel. This product is not intended to replace manufacturer internal controls provided with the device. Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.

Source page: https://510kreport.com/device/K221253
Methodology: https://510kreport.com/methodology