Autoantibody Screen Test System
FDA 510(k) K831358 · Zeus Scientific, Inc.
510(k) numberK831358
Submission
- Device name
- Autoantibody Screen Test System
- Applicant
- Zeus Scientific, Inc.
Mchenry, IL, US - Received
- April 26, 1983
- Decision date
- June 15, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DBM – Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5090
- Specialty
- Immunology
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|---|---|---|---|
| K181556 | EliA M2 ImmunoassayDBM · Traditional | Phadia AB | 07/13/2018SE |
| K163525 | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3)…DBM · Traditional | Inova Diagnostics, Inc. | 09/05/2017SE |
| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISADBM · Traditional | Immco Diagnostics, Inc. | 08/08/2017SE |
| K141375 | Elia M2; Immunoassay, Positive Control 100, Positive Control 250DBM · Traditional | Phadia US, Inc. | 02/13/2015SE |
| K092736 | Euroimmun ANTI-M2-3E Elisa (Igg)DBM · Traditional | Euroimmun Us, Inc. | 09/02/2010SE |
| K052262 | Quanta Lite M2 Ep (MIT3) ElisaDBM · Traditional | Inova Diagnostics, Inc. | 10/27/2005SE |
| K031308 | Rhigene MESACUP-2 Anti-Mitochondria M2 Test, Model 10760DBM · Traditional | Rhigene, Inc. | 09/26/2003SE |
| K030238 | Bindazyme Anti-Mitochondria M2 Iggam Eia KitDBM · Traditional | The Binding Site, Ltd. | 03/24/2003SE |
| K982121 | Enzymatic Mitochondrial Antibody (M2) ReagentDBM · Traditional | Trace Scientific , Ltd. | 09/17/1998SE |
| K971909 | Virgo Ama Elisa KitDBM · Traditional | Hemagen Diagnostics, Inc. | 06/20/1997SE |
More from Hemagen Diagnostics, Inc.
| 510(k) | Device | Decision |
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| K250666 | Alegria Flash CTD ScreenLLL · Traditional | 10/22/2025SE |
| 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 Autoantibody Screen Test System cleared by the FDA?
Autoantibody Screen Test System (K831358) received a 510(k) decision of Substantially Equivalent on June 15, 1983, 50 days after the submission was received.
What is the product code of K831358?
The FDA product code is DBM – Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5090.