SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control (K221253)
Description
SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control by Maine Molecular Quality Controls, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221253
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control (K221253) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202196 | BioFire RP2.1/RP2.1plus Control Panel M441 | Maine Molecular Quality Controls, Inc. | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230868 | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Co... | Maine Molecular Quality Controls, Inc. | 2023 |
Trace the full predicate network for K221253
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.