LLL · Class II · 21 CFR 866.5100

FDA Product Code LLL: Extractable Antinuclear Antibody, Antigen And Control

Leading manufacturers include Inova Diagnostics, Inc., Hemagen Diagnostics, Inc. and Diamedix Corp..

182
Total
182
Cleared
110d
Avg days
1981
Since
Growing category - 4 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 246d recently vs 107d historically

FDA 510(k) Cleared Extractable Antinuclear Antibody, Antigen And Control Devices (Product Code LLL)

182 devices
1–24 of 182
Cleared Aug 21, 2026
IDS SS-A/Ro
K253817
Immunodiagnostics Systems Limited
Immunology · 266d
Cleared Jun 25, 2026
EliA CTD 13 Screen
K253367
Phadia AB
Immunology · 268d
Cleared Oct 22, 2025
Alegria Flash CTD Screen
K250666
Zeus Scientific
Immunology · 231d
Cleared Sep 19, 2025
Alegria Flash ENA Screen
K250408
Zeus Scientific
Immunology · 218d
Cleared Sep 29, 2023
Aptiva CTD Essential Reagent
K213403
Inova Diagnostics, Inc.
Immunology · 711d
Cleared Nov 29, 2019
EliA SymphonyS Immunoassay
K190710
Phadia AB
Immunology · 255d
Cleared Jun 25, 2018
QUANTA Flash HMGCR Reagents
K180975
Inova Diagnostics, Inc.
Immunology · 73d
Cleared Jun 01, 2016
QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls
K152635
Inova Diagnostics, Inc.
Immunology · 260d
Cleared Feb 12, 2016
QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols
K151429
Inova Diagnostics, Inc.
Immunology · 260d
Cleared Mar 31, 2015
ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA
K142781
Immco Diagnostics, Inc.
Immunology · 186d
Cleared Feb 12, 2015
QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS
K141328
Inova Diagnostics, Inc.
Immunology · 267d
Cleared Jan 29, 2015
QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS
K141210
Inova Diagnostics, Inc.
Immunology · 265d
Cleared May 07, 2013
QUANTA FLASH ENA7
K122923
Inova Diagnostics, Inc.
Immunology · 225d
Cleared Apr 09, 2013
EUROIMMUN ANTI-ENA POOL ELISA (IGG)
K112996
Euroimmun US
Immunology · 550d
Cleared Dec 02, 2011
IMMULISA SCI-70 ANTIBODY ELISA
K113143
Immco Diagnostics, Inc.
Immunology · 38d
Cleared Jan 15, 2008
ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01
K072149
Phadia US, Inc.
Immunology · 165d
Cleared Mar 13, 2006
FIDIS CONNECTIVE 10, MODEL MX006
K053653
Biomedical Diagnostics (Bmd) SA
Immunology · 73d
Cleared Oct 03, 2005
FIDIS CONNECTIVE 8
K050286
Biomedical Diagnostics (Bmd) SA
Immunology · 238d
Cleared May 31, 2005
ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400
K043067
Bioarray Solutions, Ltd.
Immunology · 204d
Cleared Jul 14, 2004
AESKULISA ENA 6 S
K041753
Aesku Diagnostics
Immunology · 15d
Cleared Mar 08, 2004
QUANTA PLEX SLE PROFILE 8
K040160
Inova Diagnostics, Inc.
Immunology · 45d
Cleared Jun 25, 2003
QUANTA PLEX ENA PROFILE 6
K031450
Inova Diagnostics, Inc.
Immunology · 49d
Cleared Apr 24, 2003
QUANTA PLEX ENA PROFILE 5
K030681
Inova Diagnostics, Inc.
Immunology · 50d
Cleared Jul 27, 2001
QUANTA PLEX ENA PROFILE 4
K011140
Inova Diagnostics, Inc.
Immunology · 105d

About Product Code LLL - Regulatory Context

510(k) Submission Activity

182 total 510(k) submissions under product code LLL since 1981, with 182 receiving FDA clearance (average review time: 110 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LLL Product Code

Recent submissions under LLL have taken an average of 246 days to reach a decision - up from 107 days historically. Manufacturers should account for longer review timelines in current project planning.

LLL devices are reviewed by the Immunology panel. Browse all Immunology devices →