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510(k) K052519

SPECTRAL WEST NILE VIRUS IGM STATUS TEST by Spectral Diagnostics, Inc. — Product Code NOP

K052519 is an FDA 510(k) premarket notification submitted by Spectral Diagnostics, Inc. for the device "SPECTRAL WEST NILE VIRUS IGM STATUS TEST". The FDA issued a decision of Substantially Equivalent on November 30, 2006. The device falls under product code NOP (Elisa, Antibody, West Nile Virus), a Class II device regulated under 21 CFR 866.3940. Spectral Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2006
Date Received
September 14, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elisa, Antibody, West Nile Virus
Device Class
Class II
Regulation Number
866.3940
Review Panel
MI
Submission Type

The West Nile Virus ELISA is intended for the detection of IgG and IgM antibodies to West Nile Virus. Specimens may be serum or cerebral spinal fluid from symptomatic patients.

Other clearances by Spectral Diagnostics, Inc.

  • DEN030002 — ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE (June 16, 2003)
  • K030057 — SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST (March 19, 2003)
  • K022409 — SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST (September 30, 2002)
  • K020950 — SPECTRAL'S 2 IN 1 (TNI-MYO) (May 24, 2002)
  • K014105 — SPECTRAL'S TROPONIN I (February 1, 2002)
  • K992127 — CARDIOQUANT TROPONIN I TEST (October 4, 1999)
  • K991447 — CARDIOQUANT CARDIAC ASSESSMENT CONTROLS (June 11, 1999)
  • K982679 — MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST (October 7, 1998)
  • K981474 — CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) (May 7, 1998)
  • K972687 — CARDIAC STATUS CONTROLS/TROPONIN I (July 28, 1997)

Other clearances for product code NOP

  • K153308 — EUROIMMUN Anti-West Nile Virus ELISA (IgM) (August 12, 2016)
  • K153303 — EUROIMMUN Anti-West Nile Virus ELISA (IgG) (August 10, 2016)
  • K041817 — WEST NILE DETECT IGM ELISA (November 19, 2004)
  • K041068 — WEST NILE VIRUS IGG INDIRECT ELISA (October 20, 2004)
  • K041231 — WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M (August 10, 2004)
  • K040854 — WEST NILE VIRUS IGM CAPTURE ELISA (June 30, 2004)
  • K031953 — WEST NILE VIRUS ELISA IGG, MODEL EL0300G (October 22, 2003)
  • K031952 — WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M (October 22, 2003)
  • DEN030004 — WEST NILE VIRUS IGM CAPTURE ELISA (July 8, 2003)

FDA data resources