LTJ · Class II · 21 CFR 866.6010

FDA Product Code LTJ: Prostate-specific Antigen (psa) For Management Of Prostate Cancers

Leading manufacturers include Boehringer Mannheim Corp., Bayer Corp. and Diagnostic Products Corp..

34
Total
34
Cleared
122d
Avg days
1997
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 222d recently vs 119d historically

FDA 510(k) Cleared Prostate-specific Antigen (psa) For Management Of Prostate Cancers Devices (Product Code LTJ)

34 devices
1–24 of 34
Cleared Jan 05, 2026
Atellica IM Total PSA II (tPSAII)
K251630
Siemens Healthcare Diagnostics, Inc.
Immunology · 222d
Cleared May 17, 2017
FREND PSA PLUS (reagent cartridge)
K162378
Nanoentek USA, Inc.
Immunology · 266d
Cleared May 29, 2013
FREND PSA PLUS (REAGENT CARTRIDGE)
K124056
Nanoentek, Inc.
Immunology · 149d
Cleared May 15, 2003
TPSA FLEX REAGENT CARTRIDGE
K031343
Dade Behring, Inc.
Immunology · 16d
Cleared Dec 17, 2002
PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022177
Bayer Diagnostics Corp.
Immunology · 167d
Cleared Dec 17, 2002
COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
K022288
Bayer Corp.
Immunology · 155d
Cleared Apr 24, 2001
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
K010550
bioMerieux, Inc.
Immunology · 57d
Cleared Feb 28, 2001
DIMENSION PSA FLEX REAGENT CARTRIDGE
K003963
Dade Behring, Inc.
Immunology · 68d
Cleared Oct 26, 2000
ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY
K002376
Bayer Corp.
Immunology · 83d
Cleared Jun 28, 2000
FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM
K994419
Qualisys Diagnostics, Inc.
Immunology · 182d
Cleared Apr 13, 2000
BAYER PSA ASSAY
K994221
Bayer Corp.
Immunology · 120d
Cleared Mar 09, 2000
MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS
K000566
Ortho-Clinical Diagnostics, Inc.
Immunology · 16d
Cleared Jul 08, 1999
QUALISYS PSA IMMUNOASSAY
K990234
Qualisys Diagnostics, Inc.
Immunology · 164d
Cleared Mar 12, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK
K984289
Ortho-Clinical Diagnostics, Inc.
Immunology · 101d
Cleared Oct 27, 1998
ELECSYS PSA, MODEL # ELECSYS 1010
K982948
Boehringer Mannheim Corp.
Immunology · 67d
Cleared Oct 27, 1998
ELECSYS PSA, MODEL 2010
K982949
Boehringer Mannheim Corp.
Immunology · 67d
Cleared Oct 13, 1998
BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS
K981634
Biocircuits Corp.
Immunology · 158d
Cleared Aug 12, 1998
ACS:CENTAUR PSA2 IMMUNOASSAY
K981839
Chiron Diagnostics Corp.
Immunology · 78d
Cleared Aug 03, 1998
ACTIVE PSA ELISA (DSL-10-9700)
K973243
Diagnostic Systems Laboratories, Inc.
Immunology · 339d
Cleared Aug 03, 1998
ACTIVE PSA IRMA (DSL-9700)
K973244
Diagnostic Systems Laboratories, Inc.
Immunology · 339d
Cleared Apr 23, 1998
THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K980376
Bayer Corp.
Immunology · 83d
Cleared Apr 21, 1998
IMMULITE 2000 3RD GENERATION PSA
K974842
Diagnostic Products Corp.
Immunology · 118d
Cleared Apr 03, 1998
ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY
K980716
Nichols Institute Diagnostics
Immunology · 86d
Cleared Feb 20, 1998
ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
K974816
Beckman Instruments, Inc.
Immunology · 59d

About Product Code LTJ - Regulatory Context

510(k) Submission Activity

34 total 510(k) submissions under product code LTJ since 1997, with 34 receiving FDA clearance (average review time: 122 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LTJ Product Code

Recent submissions under LTJ have taken an average of 222 days to reach a decision - up from 119 days historically. Manufacturers should account for longer review timelines in current project planning.

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