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510(k) K004019

ANA EIA DIAGNOSTIC TEST KIT by The Binding Site, Ltd. — Product Code LJM

K004019 is an FDA 510(k) premarket notification submitted by The Binding Site, Ltd. for the device "ANA EIA DIAGNOSTIC TEST KIT". The FDA issued a decision of Substantially Equivalent on February 15, 2001. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. The Binding Site, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2001
Date Received
December 27, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Device Class
Class II
Regulation Number
866.5100
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 LJM

  • K182353 — EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay (November 27, 2018)
  • K151559 — ImmuLisa Enhanced Centromere Antibody ELISA (March 11, 2016)
  • K140493 — ELIA SCL-70S IMMUNOASSAY (October 30, 2014)
  • K123880 — QUANTA FLASH CENTROMERE (February 7, 2014)
  • K131330 — GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT (January 28, 2014)
  • K131185 — ANA SCREEN ELISA (IGG) (July 15, 2013)
  • K083188 — VARELISA RECOMBI ANA SCREEN, MODEL 12 596 (March 13, 2009)
  • K050967 — VARELISA RECOMBI CTD SCREEN, MODEL 13096 (June 28, 2005)
  • K050625 — VARELISA RECOMBI ANA PROFILE, MODEL 18496 (April 26, 2005)
  • K041102 — IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA (October 26, 2004)

FDA data resources