The Aptus (Automated) Application of the TG Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the
FDA 510(k) K000879 · Zeus Scientific, Inc.
510(k) numberK000879
Submission
- Device name
- The Aptus (Automated) Application of the TG Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the
- Applicant
- Zeus Scientific, Inc.
Branchburg, NJ, US - Received
- March 20, 2000
- Decision date
- May 22, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K182353 | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayLJM · Traditional | Phadia AB | 11/27/2018SE |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISALJM · Traditional | Immco Diagnostics, Inc. | 03/11/2016SE |
| K140493 | Elia SCL-70S ImmunoassayLJM · Traditional | Phadia GmbH | 10/30/2014SE |
| K123880 | Quanta Flash CentromereLJM · Traditional | Inova Diagnostics, Inc. | 02/07/2014SE |
| K131330 | Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test KitLJM · Traditional | Gold Standard Diagnostics | 01/28/2014SE |
| K131185 | Ana Screen Elisa (Igg)LJM · Traditional | Euroimmun US | 07/15/2013SE |
| K083188 | Varelisa Recombi Ana Screen, Model 12 596LJM · Traditional | Phadia US, Inc. | 03/13/2009SE |
| K050967 | Varelisa Recombi CTD Screen, Model 13096LJM · Traditional | Sweden Diagnostics (Germany) GmbH | 06/28/2005SE |
| K050625 | Varelisa Recombi Ana Profile, Model 18496LJM · Traditional | Sweden Diagnostics (Germany) GmbH | 04/26/2005SE |
| K041102 | Immulisa Antinuclear Antibody Screen ElisaLJM · Traditional | Immco Diagnostics, Inc. | 10/26/2004SE |
More from Immco Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMMOB · Traditional | 08/21/2026SE |
| K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSBOBE · Traditional | 05/08/2026SE |
| K250666 | Alegria Flash CTD ScreenLLL · Traditional | 10/22/2025SE |
| K250408 | Alegria Flash ENA ScreenLLL · Traditional | 09/19/2025SE |
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic…MOB · Traditional | 05/07/2025SE |
| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFineKTL · Traditional | 08/31/2023SE |
| K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia…LSR · Traditional | 07/13/2023SE |
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFineDHN · Traditional | 04/29/2022SE |
| K191398 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | 07/29/2019SE |
| K191240 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | 07/29/2019SE |
Questions and answers
When was The Aptus (Automated) Application of the TG Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the cleared by the FDA?
The Aptus (Automated) Application of the TG Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the (K000879) received a 510(k) decision of Substantially Equivalent on May 22, 2000, 63 days after the submission was received.
What is the product code of K000879?
The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.