Ana Detect

FDA 510(k) K030929 · Orgentec Diagnostika GmbH

Substantially Equivalent

510(k) numberK030929

Submission

Device name
Ana Detect
Applicant
Orgentec Diagnostika GmbH
Minneapolis, MN, US
Received
March 24, 2003
Decision date
May 2, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5100
Specialty
Immunology

Other 510(k)s with product code LJM

510(k)DeviceApplicantDecision
K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayLJM · Traditional Phadia AB11/27/2018SE
K151559ImmuLisa Enhanced Centromere Antibody ELISALJM · Traditional Immco Diagnostics, Inc.03/11/2016SE
K140493Elia SCL-70S ImmunoassayLJM · Traditional Phadia GmbH10/30/2014SE
K123880Quanta Flash CentromereLJM · Traditional Inova Diagnostics, Inc.02/07/2014SE
K131330Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test KitLJM · Traditional Gold Standard Diagnostics01/28/2014SE
K131185Ana Screen Elisa (Igg)LJM · Traditional Euroimmun US07/15/2013SE
K083188Varelisa Recombi Ana Screen, Model 12 596LJM · Traditional Phadia US, Inc.03/13/2009SE
K050967Varelisa Recombi CTD Screen, Model 13096LJM · Traditional Sweden Diagnostics (Germany) GmbH06/28/2005SE
K050625Varelisa Recombi Ana Profile, Model 18496LJM · Traditional Sweden Diagnostics (Germany) GmbH04/26/2005SE
K041102Immulisa Antinuclear Antibody Screen ElisaLJM · Traditional Immco Diagnostics, Inc.10/26/2004SE

More from Immco Diagnostics, Inc.

510(k)DeviceDecision
K100499Orgentec Rheumatoid Factor EiaDHR · Traditional 10/27/2010SE
K092399Anti-Mutated Citrullinated Vimentin EiaOQZ · Traditional 07/01/2010SE

Questions and answers

When was Ana Detect cleared by the FDA?

Ana Detect (K030929) received a 510(k) decision of Substantially Equivalent on May 2, 2003, 39 days after the submission was received.

What is the product code of K030929?

The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.