Alegria Flash ENA Screen
FDA 510(k) K250408 · Zeus Scientific
510(k) numberK250408
Submission
- Device name
- Alegria Flash ENA Screen
- Applicant
- Zeus Scientific
Branchburg, NJ, US - Received
- February 13, 2025
- Decision date
- September 19, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LLL – Extractable Antinuclear Antibody, Antigen And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code LLL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253817 | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaLLL · Traditional | Immunodiagnostics Systems Limited | 08/21/2026SE |
| K253367 | EliA CTD 13 ScreenLLL · Traditional | Phadia AB | 06/25/2026SE |
| K250666 | Alegria Flash CTD ScreenLLL · Traditional | Zeus Scientific | 10/22/2025SE |
| K213403 | Aptiva CTD Essential ReagentLLL · Traditional | Inova Diagnostics, Inc. | 09/29/2023SE |
| K190710 | EliA SymphonyS ImmunoassayLLL · Traditional | Phadia AB | 11/29/2019SE |
| K180975 | QUANTA Flash HMGCR ReagentsLLL · Traditional | Inova Diagnostics, Inc. | 06/25/2018SE |
| K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 ControlsLLL · Traditional | Inova Diagnostics, Inc. | 06/01/2016SE |
| K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsLLL · Traditional | Inova Diagnostics, Inc. | 02/12/2016SE |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA…LLL · Traditional | Immco Diagnostics, Inc. | 03/31/2015SE |
| K141328 | Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 ControlsLLL · Traditional | Inova Diagnostics, Inc. | 02/12/2015SE |
More from Inova 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 |
| 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 |
| K190907 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | 07/29/2019SE |
Questions and answers
When was Alegria Flash ENA Screen cleared by the FDA?
Alegria Flash ENA Screen (K250408) received a 510(k) decision of Substantially Equivalent on September 19, 2025, 218 days after the submission was received.
What is the product code of K250408?
The FDA product code is LLL – Extractable Antinuclear Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.