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510(k) K060176

EL-ACL SCREEN; EL-ACL IGM, IGG, IGA by Theratest Laboratories, Inc. — Product Code MID

K060176 is an FDA 510(k) premarket notification submitted by Theratest Laboratories, Inc. for the device "EL-ACL SCREEN; EL-ACL IGM, IGG, IGA". The FDA issued a decision of Substantially Equivalent on February 7, 2006. The device falls under product code MID (System, Test, Anticardiolipin Immunological), a Class II device regulated under 21 CFR 866.5660. Theratest Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2006
Date Received
January 23, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Anticardiolipin Immunological
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

Other clearances by Theratest Laboratories, Inc.

  • K090753 — THERATEST EL-ANTI-CCP/2 (March 5, 2010)
  • K090760 — THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-12 (September 3, 2009)
  • K071692 — THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS (November 5, 2007)
  • K061376 — EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 (July 20, 2006)
  • K051066 — THERATEST EL-ANA PROFILES (October 7, 2005)
  • K040291 — EL-ANA PROFILES: ANTI-CHROMATIN (March 11, 2004)
  • K024151 — EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P (February 6, 2003)
  • K024031 — THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE (February 6, 2003)
  • K002559 — EL-ANA PROFILES-2K1 (September 12, 2000)
  • K982150 — EL-ANA PROFILES: EL-ENA/4 (August 13, 1998)

Other clearances for product code MID

  • K223093 — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent (December 17, 2024)
  • K131821 — ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY (December 23, 2013)
  • K130528 — BIOPLEX 2200 APLS IGM (October 21, 2013)
  • K120817 — QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA (February 26, 2013)
  • K113020 — IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) (October 25, 2012)
  • K103834 — BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS (March 30, 2012)
  • K102425 — ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM (December 12, 2011)
  • K091845 — CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM (June 7, 2010)
  • K092181 — HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS (March 11, 2010)
  • K040463 — AESKULISA CARDIOLIPIN AGM (May 12, 2004)

FDA data resources