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510(k) K233611

SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) by Maine Molecular Quality Controls, Inc. — Product Code PMN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2024
Date Received
November 13, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Device Class
Class II
Regulation Number
866.3920
Review Panel
MI
Submission Type

Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.

Other clearances by Maine Molecular Quality Controls, Inc.

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  • K241289 — SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control (May 30, 2024)
  • K230868 — SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP (April 13, 2023)
  • K221253 — SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control (February 3, 2023)
  • K203680 — BioFire JI Control Panel M420 (July 22, 2022)
  • K202196 — BioFire RP2.1/RP2.1plus Control Panel M441 (June 24, 2021)
  • K200010 — FilmArray BCID2 Control Panel M416 (April 2, 2020)
  • K190222 — FilmArray Pneumonia/Pneumoniaplus Control (May 3, 2019)
  • K173171 — FilmArray RP2/RP2plus Control Panel (November 24, 2017)
  • K163522 — FilmArray Warrior Control Panel M290 (March 14, 2017)

Other clearances for product code PMN

  • K251526 — FilmArray GI Control Panel M238 (August 14, 2025)
  • K241289 — SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control (May 30, 2024)
  • K231221 — MDx-Chex for BC-GP (July 27, 2023)
  • K231223 — MDx-Chex for BC-GN (July 27, 2023)
  • K230868 — SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP (April 13, 2023)
  • K221253 — SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control (February 3, 2023)
  • K203680 — BioFire JI Control Panel M420 (July 22, 2022)
  • K201403 — NATtrol BD MAX Vaginal Panel External Controls (February 2, 2022)
  • K212576 — MDx-Chex for BCID2 (January 19, 2022)
  • K202196 — BioFire RP2.1/RP2.1plus Control Panel M441 (June 24, 2021)