LTJ · Class II · 21 CFR 866.6010

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

Leading manufacturers include Siemens Healthcare Diagnostics, 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

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 Review Time

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 →