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510(k) K031363

QCA (VERSION 3.1) by Cell Analysis, Inc. — Product Code NQN

K031363 is an FDA 510(k) premarket notification submitted by Cell Analysis, Inc. for the device "QCA (VERSION 3.1)". The FDA issued a decision of Substantially Equivalent on February 5, 2004. The device falls under product code NQN (Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity), a Class II device regulated under 21 CFR 864.1860.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2004
Date Received
April 30, 2003
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Device Class
Class II
Regulation Number
864.1860
Review Panel
PA
Submission Type

Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.

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  • K130515 — VIRTUOSO SYSTEM FOR IHC ER (SPI) (November 22, 2013)
  • K121516 — VIRTUOSO SYSTEM FOR IHC HER2 (4B5) (September 26, 2013)
  • K122143 — VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER (September 19, 2013)
  • K111872 — VIRTUOSO SYSTEM FOR IHC P53 (DO-7) (April 19, 2012)
  • K111869 — VIRTUOSO SYSTEM FOR IHC PR (IE2) (March 5, 2012)
  • K092333 — PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 (October 27, 2010)
  • K073677 — SCANSCOPE XT SYSTEM (August 1, 2008)
  • K061613 — VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) (January 10, 2007)

FDA data resources