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510(k) K102314

3M INTEGRATED CYCLER (110V) & (220V) by Focus Diagnostics, Inc. — Product Code OOI

K102314 is an FDA 510(k) premarket notification submitted by Focus Diagnostics, Inc. for the device "3M INTEGRATED CYCLER (110V) & (220V)". The FDA issued a decision of Substantially Equivalent on October 29, 2010. The device falls under product code OOI (Real Time Nucleic Acid Amplification System), a Class II device regulated under 21 CFR 862.2570. Focus Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2010
Date Received
August 16, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Real Time Nucleic Acid Amplification System
Device Class
Class II
Regulation Number
862.2570
Review Panel
CH
Submission Type

The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system.

Other clearances by Focus Diagnostics, Inc.

  • K152408 — Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack (September 21, 2015)
  • K150962 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (August 28, 2015)
  • K143651 — Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack (March 18, 2015)
  • K142365 — Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack (December 5, 2014)
  • K141458 — SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK (July 1, 2014)
  • DEN130049 — SIMPLEXA HSV 1&2 DIRECT (March 21, 2014)
  • K120986 — STRATIFY JCV DXSELECT (August 16, 2012)
  • K120413 — SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK (July 13, 2012)
  • K113433 — SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT (April 4, 2012)
  • DEN120008 — STRATIFY JCV(TM) ANTIBODY (January 20, 2012)

Other clearances for product code OOI

  • K243922 — Revogene (March 20, 2025)
  • K222779 — Revogene (January 26, 2023)
  • K220480 — Revogene (July 11, 2022)
  • K170558 — revogene (May 25, 2017)
  • K161495 — ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 (June 30, 2016)
  • K160517 — ARIES System (April 12, 2016)
  • K151917 — ARIES System (October 6, 2015)
  • K151690 — Alere i Instrument, Alere i Influenza A & B, Alere i Strep A (July 16, 2015)
  • K140447 — BD VIPER LT SYSTEM (May 20, 2014)
  • K123955 — QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT (March 8, 2013)

FDA data resources