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 Hycor Biomedical, Inc..

181
Total
181
Cleared
109d
Avg days
1981
Since
Growing category - 3 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 239d recently vs 107d historically

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

181 devices
1–24 of 181
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 Dec 02, 2011
IMMULISA SCI-70 ANTIBODY ELISA
K113143
Immco Diagnostics, Inc.
Immunology · 38d
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
Cleared Mar 01, 2001
ENA EIA KIT RANGE
K010146
The Binding Site, Ltd.
Immunology · 43d
Cleared Mar 01, 2001
ENA EIA KIT
K010147
The Binding Site, Ltd.
Immunology · 43d
Cleared Feb 23, 2001
ENA SCREEN EIA KIT
K010148
The Binding Site, Ltd.
Immunology · 37d
Cleared Jun 17, 1999
QUANTA LITE ANA ELISA
K991657
Inova Diagnostics, Inc.
Immunology · 35d
Cleared Dec 22, 1998
LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206
K984462
Bio-Rad
Immunology · 6d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S
K983376
Zeus Scientific, Inc.
Immunology · 54d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K983423
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET
K983425
Zeus Scientific, Inc.
Immunology · 50d

About Product Code LLL - Regulatory Context

510(k) Submission Activity

181 total 510(k) submissions under product code LLL since 1981, with 181 receiving FDA clearance (average review time: 109 days).

Submission volume has increased in recent years - 3 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 239 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 →