Aptiva APS IgA Reagent— 510(k) K243979
Substantially EquivalentInova Diagnostics, Inc.
FDA 510(k) clearance K243979 for Aptiva APS IgA Reagent, Substantially Equivalent on 2026-02-06. Applicant: Inova Diagnostics, Inc.. Device class: 2.
Summary
Inova Diagnostics' Aptiva APS IgA Reagent is filed under product code MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)). The record doesn't describe the reagent beyond its name and that code name.
Class II, 21 CFR 866.5660. Immunology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Inova Diagnostics filed from San Diego, California. The substantially equivalent decision came 410 calendar days after receipt (December 23, 2024 to February 6, 2026).
Clearance details
- Applicant
- Inova Diagnostics, Inc.
- Product code
- Product code MSV
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code MSV
view all- K181329 — EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
- K162788 — ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA
- K152875 — QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls
- K141274 — QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS.
- K112414 — ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
More clearances from Inova Diagnostics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.