510(k) · Cleared
Cleared3M Integrated Cycler (110V) & (220V)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Focus Diagnostics, Inc. · OOI Real Time Nucleic Acid Amplification System
Cleared on Oct 29, 2010 as substantially equivalent to K062948 (Cepheid, 2006) after a 74-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Oct 29, 2010
- Review
- 74 days
- Class
- Class II
- Product code
- OOI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K936112 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK936112 Strep B OiaBiostar, Inc. · 1994
- 3 generations backK991828 Strep B OiaBiostar, Inc. · 1999
- 2 generations backK022504 Idi-Strep B AssayInfectio Diagnostic, Inc. · 2002
- 1 generation backK062948 Smart GBS and Smartcycle DX System and Software, Version 1.7BCepheid · 2006
- This deviceK102314 3M Integrated Cycler (110V) & (220V)Focus Diagnostics, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K936112 | Strep B Oia | Biostar, Inc. | 1994 | — |
| −3 | K991828 | Strep B Oia | Biostar, Inc. | 1999 | — |
| −2 | K022504 | Idi-Strep B Assay | Infectio Diagnostic, Inc. | 2002 | — |
| −1 | K062948 | Smart GBS and Smartcycle DX System and Software, Version 1.7B | Cepheid | 2006 | — |
| 0 (this device) | K102314 | 3M Integrated Cycler (110V) & (220V) | Focus Diagnostics, Inc. | 2010 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OOI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OOI device
- #1 K243922 Revogenescore 9.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062948 | Smart GBS and Smartcycle DX System and Software, Version 1.7BSummary page 1…PnlProduct submite numerDate Code(s) SmartCycler Dx system Cepheid K062948 12/08/2006 (83) NJR (assay) I… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K062948.
How does its category compare?
All OOI devicesOOI Real Time Nucleic Acid Amplification System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OOI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OOI
249in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OOI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OOI
524in 2025
MAUDE reports naming product code OOI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 249 | 1 | 0 |
| 2011 | 0 | — | 2 | 5 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 134 |
| 2021 | 0 | — | 4 | 324 |
| 2022 | 1 | — | 4 | 874 |
| 2023 | 1 | — | 1 | 220 |
| 2024 | 0 | — | 1 | 327 |
| 2025 | 1 | — | 0 | 524 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (113 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102314: 3M Integrated Cycler (110V) & (220V).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102314
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026