3M Integrated Cycler (110V) & (220V)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K102314 ↗

FDA Product Code

OOI

Device Class

Class II

Regulation

21 CFR Part 862.2570

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Focus Diagnostics, Inc. →

• What is the 3M Integrated Cycler used for?

  The 3M Integrated Cycler is a real-time nucleic acid amplification system designed for detecting and quantifying nucleic acids in clinical samples, as indicated by its classification under regulation number 862.2570 and product code OOI for clinical chemistry applications.

• What voltage configurations are available for the 3M Integrated Cycler?

  The device is supplied in two configurations: one for 110V operation and another for 220V operation, allowing use in different electrical environments as specified in the device name and authorization details.

• Is the 3M Integrated Cycler a single-use or reusable device?

  The 3M Integrated Cycler is a reusable laboratory instrument intended for repeated use in clinical settings, as it is a nucleic acid amplification system that processes samples via interchangeable consumables, not a disposable test cartridge.

• What regulatory pathway was used for the 3M Integrated Cycler?

  The device received traditional 510(k) clearance from the FDA under submission K102314, demonstrating substantial equivalence to a predicate device, and is classified as a Class II medical device under regulation 862.2570.