Cleared Traditional

SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control (K221253) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221253 · Maine Molecular Quality Controls, Inc. · Microbiology device
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Feb 2023
Decision
277d
Days
Class 2
Risk

K221253 is an FDA 510(k) clearance for the SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control. Classified as Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays (product code PMN), Class II - Special Controls.

Submitted by Maine Molecular Quality Controls, Inc. (Saco, US). The FDA issued a Cleared decision on February 3, 2023 after a review of 277 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3920 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Maine Molecular Quality Controls, Inc. devices

Submission Details

510(k) Number K221253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2022
Decision Date February 03, 2023
Days to Decision 277 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 102d · This submission: 277d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3920
Definition Assayed External Quality Control Material To Monitor The Performance Of Microbiology Nucleic Acid Assays For In Vitro Diagnostic Use.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays

All 25
Devices cleared under the same product code (PMN) and FDA review panel - the closest regulatory comparables to K221253.
MDx-Chex for BC-GP
K231221 · Streck · Jul 2023
MDx-Chex for BC-GN
K231223 · Streck · Jul 2023
SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control
K230868 · Maine Molecular Quality Controls, Inc. · Apr 2023
BioFire JI Control Panel M420
K203680 · Maine Molecular Quality Controls, Inc. · Jul 2022
NATtrol BD MAX Vaginal Panel External Controls
K201403 · Zeptometrix · Feb 2022
MDx-Chex for BCID2
K212576 · Streck, Inc. · Jan 2022