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510(k) K030238

BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT by The Binding Site, Ltd. — Product Code DBM

K030238 is an FDA 510(k) premarket notification submitted by The Binding Site, Ltd. for the device "BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT". The FDA issued a decision of Substantially Equivalent on March 24, 2003. The device falls under product code DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5090. The Binding Site, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2003
Date Received
January 23, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5090
Review Panel
IM
Submission Type

Other clearances by The Binding Site, Ltd.

  • K231290 — Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit (January 24, 2024)
  • K140105 — HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA (March 18, 2014)
  • K132555 — HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT (December 20, 2013)
  • K103824 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS (February 27, 2012)
  • K100455 — SPAPLUS ANALYZER (September 3, 2010)
  • K090920 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MOD (December 30, 2009)
  • K092450 — HUMAN IGD KIT FOR USE ON SPAPLUS (December 28, 2009)
  • K083289 — HUMAN BETA-2 MICROGLOBULIN KIT (May 6, 2009)
  • K082129 — HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER (February 10, 2009)
  • K081827 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS (December 19, 2008)

Other clearances for product code DBM

  • K181556 — EliA M2 Immunoassay (July 13, 2018)
  • K163525 — QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT (September 5, 2017)
  • K163133 — ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Anti (August 8, 2017)
  • K141375 — ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 (February 13, 2015)
  • K092736 — EUROIMMUN ANTI-M2-3E ELISA (IGG) (September 2, 2010)
  • K052262 — QUANTA LITE M2 EP (MIT3) ELISA (October 27, 2005)
  • K031308 — RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 (September 26, 2003)
  • K982121 — ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT (September 17, 1998)
  • K971909 — VIRGO AMA ELISA KIT (June 20, 1997)
  • K962452 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA (November 25, 1996)

FDA data resources