Product Code: LTJ FDA class 2 21 CFR 866.6010

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

Immunology

The Prostate-Specific Antigen (PSA) assay is an in vitro diagnostic device used to measure PSA levels in blood serum, used as an aid in the management and monitoring of prostate cancer, including detection of recurrence and response to therapy. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification. The product code is LTJ, regulated under 21 CFR 866.6010, within the Immunology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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510(k)s

FEI Numbers

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Basic Information

Product Code: LTJ
Device Class: FDA class 2
Regulation Number: 866.6010
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 34 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251630	Atellica IM Total PSA II (tPSAII)	Jan 05, 2026	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K162378	FREND PSA PLUS (reagent cartridge)	May 17, 2017	Substantially Equivalent	Nanoentek USA, Inc.
K124056	FREND PSA PLUS (REAGENT CARTRIDGE)	May 29, 2013	Substantially Equivalent	Nanoentek, Inc.
K031343	TPSA FLEX REAGENT CARTRIDGE	May 15, 2003	Substantially Equivalent	Dade Behring, Inc.
K022288	COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM	Dec 17, 2002	Substantially Equivalent	Bayer Corp.
K022177	PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	Dec 17, 2002	Substantially Equivalent	Bayer Diagnostics Corp.
K010550	VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428	Apr 24, 2001	Substantially Equivalent	bioMerieux, Inc.
K003963	DIMENSION PSA FLEX REAGENT CARTRIDGE	Feb 28, 2001	Substantially Equivalent	Dade Behring, Inc.
K002376	ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY	Oct 26, 2000	Substantially Equivalent	Bayer Corp.
K003094	FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER	Oct 25, 2000	Substantially Equivalent	Qualigen, Inc.
K002313	COMPLEXED PSA MICROTITER ELISA	Aug 30, 2000	Substantially Equivalent	Oncogene Science, Inc.
K002121	TOTAL PSA MICROTITER ELISA	Aug 30, 2000	Substantially Equivalent	Oncogene Science, Inc.
K994419	FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM	Jun 28, 2000	Substantially Equivalent	Qualisys Diagnostics, Inc.
K994221	BAYER PSA ASSAY	Apr 13, 2000	Substantially Equivalent	Bayer Corp.
K000566	MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS	Mar 09, 2000	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K990234	QUALISYS PSA IMMUNOASSAY	Jul 08, 1999	Substantially Equivalent	Qualisys Diagnostics, Inc.
K984289	VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK	Mar 12, 1999	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K982949	ELECSYS PSA, MODEL 2010	Oct 27, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K982948	ELECSYS PSA, MODEL # ELECSYS 1010	Oct 27, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K981634	BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS	Oct 13, 1998	Substantially Equivalent	Biocircuits Corp.
K981839	ACS:CENTAUR PSA2 IMMUNOASSAY	Aug 12, 1998	Substantially Equivalent	Chiron Diagnostics Corp.
K973244	ACTIVE PSA IRMA (DSL-9700)	Aug 03, 1998	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K973243	ACTIVE PSA ELISA (DSL-10-9700)	Aug 03, 1998	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K980376	THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM	Apr 23, 1998	Substantially Equivalent	Bayer Corp.
K974842	IMMULITE 2000 3RD GENERATION PSA	Apr 21, 1998	Substantially Equivalent	Diagnostic Products Corp.
K980716	ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY	Apr 03, 1998	Substantially Equivalent	Nichols Institute Diagnostics
K974816	ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229	Feb 20, 1998	Substantially Equivalent	Beckman Instruments, Inc.
K974189	ELECSYS PSA (ON ELECSYS 1010)	Jan 06, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K972021	IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)	Oct 31, 1997	Substantially Equivalent	Diagnostic Products Corp.
K973101	PROSTATE SPECIFIC ANTIGEN METHOD	Sep 18, 1997	Substantially Equivalent	Dade Chemistry Systems, Inc.
K972095	IMMULITE 2000 PSA	Aug 22, 1997	Substantially Equivalent	Diagnostic Products Corp.
K964351	ELECSYS PSA ASSAY	Jul 25, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K964595	OPUS PSA TEST SYSTEM	Jun 24, 1997	Substantially Equivalent	Behring Diagnostics, Inc.
K965085	ENZYMUN-TEST PSA	Mar 19, 1997	Substantially Equivalent	Boehringer Mannheim Corp.