# K102314: 3M Integrated Cycler (110V) & (220V)

- Pathway: 510(k) (Traditional)
- Applicant: Focus Diagnostics, Inc.
- Decided: Oct 29, 2010 after 74 days
- Product code: OOI (Real Time Nucleic Acid Amplification System)
- Device class: 2
- Regulation: 21 CFR 862.2570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K936112 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062948: Smart GBS and Smartcycle DX System and Software, Version 1.7B, Cepheid (2006) Summary page 1.

## Indications for use
The Integrated Cycler and accompanying Studio Software are intended for in vitro diagnostic use in conjunction with legally marketed SimplexaTM reagent kits and assay protocols labeled for in vitro diagnostic use. The Integrated Cycler is a rapid real-time Polymerase Chain Reaction (PCR) thermocycler used for identification of nucleic acid from prepared biological samples. The instrument utilizes disc media to contain and to process samples. The instrument uses real-time flourometric detection to identify targets within the sample wells. The instrument's operation parameters are controlled by the use of an external personal computer and associated software. This instrument is intended to be used by laboratory professionals trained in laboratory techniques and in a laboratory environment.

Source page: https://510kreport.com/device/K102314
Methodology: https://510kreport.com/methodology