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510(k) K980337

DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM by Helix Diagnostics, Inc. — Product Code LJM

K980337 is an FDA 510(k) premarket notification submitted by Helix Diagnostics, Inc. for the device "DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on May 12, 1998. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. Helix Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1998
Date Received
January 28, 1998
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 Helix Diagnostics, Inc.

  • K001900 — ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST (September 11, 2000)
  • K000489 — ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST (April 5, 2000)
  • K960091 — ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT (March 20, 1996)
  • K954723 — ENZYME IMMUNOASSAY ANA SCREENING TEST KIT (December 15, 1995)
  • K954700 — ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT (December 15, 1995)
  • K952253 — ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT (August 24, 1995)
  • K951850 — ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT (July 18, 1995)
  • K951798 — ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT (July 17, 1995)
  • K940588 — ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT (April 20, 1994)
  • K940510 — ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT (April 20, 1994)

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