Cleared Traditional

Aptiva CTD Essential Reagent

K213403 · Inova Diagnostics, Inc. · Immunology
Sep 2023
Decision
711d
Days
Class 2
Risk

About This 510(k) Submission

K213403 is an FDA 510(k) clearance for the Aptiva CTD Essential Reagent, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on September 29, 2023, 711 days after receiving the submission on October 18, 2021. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K213403 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2021
Decision Date September 29, 2023
Days to Decision 711 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LLL — Extractable Antinuclear Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

Similar Devices — LLL Extractable Antinuclear Antibody, Antigen And Control

All 179
Alegria Flash CTD Screen
K250666 · Zeus Scientific · Oct 2025
Alegria Flash ENA Screen
K250408 · Zeus Scientific · Sep 2025
EliA SymphonyS Immunoassay
K190710 · Phadia AB · Nov 2019
QUANTA Flash HMGCR Reagents
K180975 · Inova Diagnostics, Inc. · Jun 2018
QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls
K152635 · Inova Diagnostics, Inc. · Jun 2016
QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols
K151429 · Inova Diagnostics, Inc. · Feb 2016