DFC · Class II · 21 CFR 866.5600

FDA Product Code DFC: Lipoprotein, Low-density, Antigen, Antiserum, Control

Leading manufacturers include Wako Chemicals USA, Inc., DiaSorin, Inc. and Roche Diagnostics Corp..

43
Total
43
Cleared
107d
Avg days
1977
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 267d recently vs 99d historically

FDA 510(k) Cleared Lipoprotein, Low-density, Antigen, Antiserum, Control Devices (Product Code DFC)

43 devices
1–24 of 43
Cleared Jan 24, 2025
Tina-quant Lipoprotein(a) Gen.2 Molarity
K241220
Roche Diagnostics Operations
Chemistry · 268d
Cleared Dec 22, 2022
Lp(a) Ultra
K211058
SENTINEL CH. SpA
Chemistry · 622d
Cleared Mar 22, 2018
Diazyme Lipoprotein (a) Assay
K180074
Diazyme Laboratories, Inc.
Chemistry · 71d
Cleared Dec 20, 2012
ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
K123046
Siemens Healthcare Diagnostics, Inc.
Chemistry · 83d
Cleared Nov 29, 2012
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190
K122722
Roche Diagnostics
Chemistry · 85d
Cleared Dec 13, 2002
K-ASSAY LP(A) CONTROLS
K023853
Kamiya Biomedical Co.
Immunology · 24d
Cleared Jul 25, 2002
K-ASSAY LP(A) ASSAY
K021660
Kamiya Biomedical Co.
Chemistry · 66d
Cleared Jan 18, 2002
N LATEX LP(A)
K013128
Dade Behring, Inc.
Chemistry · 121d
Cleared Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
K013206
Roche Diagnostics Corp.
Chemistry · 52d
Cleared Nov 13, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
K013207
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Jul 24, 2000
WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA
K001929
Wako Chemicals USA, Inc.
Chemistry · 28d
Cleared Jul 24, 2000
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET
K001931
Wako Chemicals USA, Inc.
Immunology · 28d
Cleared Jul 24, 2000
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO
K001933
Wako Chemicals USA, Inc.
Immunology · 28d
Cleared Jul 24, 2000
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX
K001934
Wako Chemicals USA, Inc.
Immunology · 28d
Cleared Jul 23, 2000
WAKO AUTOKIT LP(A)/DADE DEMENSION
K001919
Wako Chemicals USA, Inc.
Immunology · 30d
Cleared Jul 23, 2000
WAKO AUTOKIT LP(A)/ RA,500/1000,
K001920
Wako Chemicals USA, Inc.
Immunology · 30d
Cleared Jul 23, 2000
WAKO AUTOKIT LP(A)/EXPRESS 550
K001921
Wako Chemicals USA, Inc.
Immunology · 30d
Cleared May 17, 2000
IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB
K000121
Beckman Coulter, Inc.
Chemistry · 120d
Cleared Apr 25, 2000
MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
K001118
DiaSorin, Inc.
Chemistry · 18d
Cleared Nov 17, 1999
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
K993669
DiaSorin, Inc.
Chemistry · 16d
Cleared Apr 14, 1999
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B
K990595
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Apr 02, 1999
SPQ TEST SYSTEM
K982708
DiaSorin, Inc.
Chemistry · 241d
Cleared Mar 09, 1999
WAKO AUTOKIT LP(A)
K981446
Wako Chemicals USA, Inc.
Chemistry · 321d
Cleared Jan 26, 1999
APOB
K983281
Abbott Laboratories
Immunology · 130d

About Product Code DFC - Regulatory Context

510(k) Submission Activity

43 total 510(k) submissions under product code DFC since 1977, with 43 receiving FDA clearance (average review time: 107 days).

Submission volume has increased in recent years - 2 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 - DFC Product Code

Recent submissions under DFC have taken an average of 267 days to reach a decision - up from 99 days historically. Manufacturers should account for longer review timelines in current project planning.

DFC devices are reviewed by the Chemistry panel. Browse all Chemistry devices →