PMN · Class II · 21 CFR 866.3920

FDA Product Code PMN: Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays

Assayed External Quality Control Material To Monitor The Performance Of Microbiology Nucleic Acid Assays For In Vitro Diagnostic Use.

Leading manufacturers include Maine Molecular Quality Controls, Inc., Microbiologics, Inc. and Streck.

32
Total
31
Cleared
135d
Avg days
2016
Since
Stable submission activity - 6 submissions in the last 2 years
Review times improving: avg 84d recently vs 147d historically

FDA 510(k) Cleared Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays Devices (Product Code PMN)

32 devices
1–24 of 32
Cleared May 19, 2026
FilmArray TF Control Panel M527
K260577
Maine Molecular Quality Controls, Inc.
Microbiology · 88d
Cleared Mar 27, 2026
MDx-Chex for BCP
K260041
Streck, LLC
Microbiology · 80d
Cleared Mar 23, 2026
MDx-Chex for BCN
K254166
Streck
Microbiology · 90d
Cleared Mar 17, 2026
MDx-Chex for BCY
K254167
Streck, LLC
Microbiology · 84d
Cleared Aug 14, 2025
FilmArray GI Control Panel M238
K251526
Maine Molecular Quality Controls, Inc.
Microbiology · 87d
Cleared May 30, 2024
SPOTFIRE RSP Pos & Neg Controls
K241289
Maine Molecular Quality Controls, Inc.
Microbiology · 23d
Cleared Mar 26, 2024
SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
K233611
Maine Molecular Quality Controls, Inc.
Microbiology · 134d
Cleared Jul 27, 2023
MDx-Chex for BC-GP
K231221
Streck
Microbiology · 90d
Cleared Jul 27, 2023
MDx-Chex for BC-GN
K231223
Streck
Microbiology · 90d
Cleared Apr 13, 2023
SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control
K230868
Maine Molecular Quality Controls, Inc.
Microbiology · 15d
Cleared Feb 03, 2023
SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
K221253
Maine Molecular Quality Controls, Inc.
Microbiology · 277d
Cleared Jul 22, 2022
BioFire JI Control Panel M420
K203680
Maine Molecular Quality Controls, Inc.
Microbiology · 582d
Cleared Feb 02, 2022
NATtrol BD MAX Vaginal Panel External Controls
K201403
Zeptometrix
Microbiology · 615d
Cleared Jan 19, 2022
MDx-Chex for BCID2
K212576
Streck, Inc.
Microbiology · 156d
Cleared Jun 24, 2021
BioFire RP2.1/RP2.1plus Control Panel M441
K202196
Maine Molecular Quality Controls, Inc.
Microbiology · 323d
Cleared Nov 20, 2020
FilmArray Global Fever Panel External Control Kit
K202382
Biofire Defense, LLC
Microbiology · 92d
Cleared Apr 02, 2020
FilmArray BCID2 Control Panel M416
K200010
Maine Molecular Quality Controls, Inc.
Microbiology · 91d
Cleared Oct 07, 2019
Cepheid Xpert Respiratory Control Panel
K190086
Microbiologics, Inc.
Microbiology · 263d
Cleared Jun 25, 2019
Cepheid Xpert SA Nasal Complete Control Panel
K191168
Microbiologics, Inc.
Microbiology · 55d
Cleared Jun 20, 2019
Cepheid Xpert MRSA NxG Control Panel
K191172
Microbiologics, Inc.
Microbiology · 50d
Cleared May 08, 2019
Cepheid Xpert CT/NG Control Panel
K190223
Microbiologics, Inc.
Microbiology · 92d
Cleared May 03, 2019
FilmArray Pneumonia/Pneumoniaplus Control
K190222
Maine Molecular Quality Controls, Inc.
Microbiology · 87d
Cleared Apr 19, 2019
Cepheid Xpert C. difficile/Epi Control Panel
K190463
Microbiologics, Inc.
Microbiology · 52d
Cleared Nov 08, 2018
Cepheid Xpert GBS LB Control Panel
K182472
Microbiologics, Inc.
Microbiology · 59d

About Product Code PMN - Regulatory Context

510(k) Submission Activity

32 total 510(k) submissions under product code PMN since 2016, with 31 receiving FDA clearance (average review time: 135 days).

Submission volume has remained relatively stable over the observed period, with 6 submissions in the last 24 months.

FDA 510(k) Review Time - PMN Product Code

Recent submissions under PMN have taken an average of 84 days to reach a decision - down from 147 days historically, suggesting improved FDA processing for this classification.

PMN devices are reviewed by the Microbiology panel. Browse all Microbiology devices →