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., Diagnostic Products Corp. and Dade Behring, Inc..

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 15, 2003
TPSA FLEX REAGENT CARTRIDGE
K031343
Dade Behring, Inc.
Immunology · 16d
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 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 Apr 21, 1998
IMMULITE 2000 3RD GENERATION PSA
K974842
Diagnostic Products Corp.
Immunology · 118d
Cleared Feb 20, 1998
ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
K974816
Beckman Instruments, Inc.
Immunology · 59d
Cleared Jan 06, 1998
ELECSYS PSA (ON ELECSYS 1010)
K974189
Boehringer Mannheim Corp.
Immunology · 60d
Cleared Oct 31, 1997
IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)
K972021
Diagnostic Products Corp.
Immunology · 151d
Cleared Aug 22, 1997
IMMULITE 2000 PSA
K972095
Diagnostic Products Corp.
Immunology · 79d
Cleared Jul 25, 1997
ELECSYS PSA ASSAY
K964351
Boehringer Mannheim Corp.
Immunology · 266d
Cleared Mar 19, 1997
ENZYMUN-TEST PSA
K965085
Boehringer Mannheim Corp.
Immunology · 90d

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 →