The Aptus (Automated) Application of the Rubella Igm Elisa Test System
FDA 510(k) K984180 · Zeus Scientific, Inc.
510(k) numberK984180
Submission
- Device name
- The Aptus (Automated) Application of the Rubella Igm Elisa Test System
- Applicant
- Zeus Scientific, Inc.
Branchburg, NJ, US - Received
- November 23, 1998
- Decision date
- July 20, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LFX – Enzyme Linked Immunoabsorbent Assay, Rubella
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Specialty
- Microbiology
Other 510(k)s with product code LFX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250588 | Access Rubella IgGLFX · Traditional | Beckman Coulter, Inc. | 11/17/2025SE |
| K243168 | Alinity i Rubella IgGLFX · Traditional | Abbott Laboratories | 06/20/2025SE |
| K122397 | Liaison Rubella Igm, Liaison Control Rubella IgmLFX · Traditional | DiaSorin, Inc. | 09/06/2012SE |
| K093101 | Mago 4SLFX · Traditional | Diamedix Corp. | 01/21/2011SE |
| K092587 | Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection SystemLFX · Traditional | Bio-Rad Laboratories | 12/03/2010SE |
| K092322 | Elecsys Rubella Igm ImmunoassayLFX · Traditional | Roche Diagnostics | 03/12/2010SE |
| K080766 | Vidas Rub IggLFX · Traditional | bioMerieux, Inc. | 12/23/2008SE |
| K072617 | Elecsys Rubella Igg ImmunoassayLFX · Traditional | Roche Diagnostics Corp. | 12/05/2008SE |
| K073390 | Diasorin Liason Rubella Igg Assay; Diasorin Liaison Rubella Igg Tri-ControlsLFX · Traditional | DiaSorin, Inc. | 11/21/2008SE |
| K063186 | Athena Multi-Lyte Rubella Igg Test SystemLFX · Traditional | Zeus Scientific, Inc. | 03/21/2007SE |
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| K250408 | Alegria Flash ENA ScreenLLL · Traditional | 09/19/2025SE |
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| 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 Rubella Igm Elisa Test System cleared by the FDA?
The Aptus (Automated) Application of the Rubella Igm Elisa Test System (K984180) received a 510(k) decision of Substantially Equivalent on July 20, 1999, 239 days after the submission was received.
What is the product code of K984180?
The FDA product code is LFX – Enzyme Linked Immunoabsorbent Assay, Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.