FREND PSA PLUS (reagent cartridge)

Q: What is the product code of K162378?

The FDA product code is LTJ – Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers, a Class II (moderate risk) device regulated under 21 CFR 866.6010.

FDA 510(k) K162378 · Nanoentek USA, Inc.

Substantially Equivalent

510(k) numberK162378

Submission

Device name: FREND PSA PLUS (reagent cartridge)
Applicant: Nanoentek USA, Inc.
Pleasanton, CA, US
Received: August 24, 2016
Decision date: May 17, 2017
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LTJ – Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.6010
Specialty: Immunology

Other 510(k)s with product code LTJ

510(k)	Device	Applicant	Decision
K251630	Atellica IM Total PSA II (tPSAII)LTJ · Traditional	Siemens Healthcare Diagnostics, Inc.	01/05/2026SE
K124056	Frend Psa Plus (Reagent Cartridge)LTJ · Traditional	Nanoentek, Inc.	05/29/2013SE
K031343	Tpsa Flex Reagent CartridgeLTJ · Special	Dade Behring, Inc.	05/15/2003SE
K022288	Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module…LTJ · Traditional	Bayer Corp.	12/17/2002SE
K022177	Prostate Specific Antigen (Psa) Assay for the Advia Integrated Modular SystemLTJ · Traditional	Bayer Diagnostics Corp.	12/17/2002SE
K010550	Vidas Total Prostate Specific Antigen (Tpsa), Model 30 428LTJ · Traditional	bioMerieux, Inc.	04/24/2001SE
K003963	Dimension Psa Flex Reagent CartridgeLTJ · Traditional	Dade Behring, Inc.	02/28/2001SE
K002376	Advia: Centaur and Acs: 180 Cpsa AssayLTJ · Traditional	Bayer Corp.	10/26/2000SE
K003094	Fastpack Psa Immunoassay, Fastpack AnalyzerLTJ · Special	Qualigen, Inc.	10/25/2000SE
K002313	Complexed Psa Microtiter ElisaLTJ · Traditional	Oncogene Science, Inc.	08/30/2000SE

More from Oncogene Science, Inc.

510(k)	Device	Decision
K162754	FREND Vitamin D Test SystemMRG · Traditional	01/12/2017SE
K153577	FREND Testosterone Test SystemCDZ · Traditional	10/14/2016SE
K152422	FREND Free T4 Test SystemCEC · Traditional	02/17/2016SE
K131928	Frend TSH (Reagent Cartridge)JLW · Traditional	03/14/2014SE

Questions and answers

When was FREND PSA PLUS (reagent cartridge) cleared by the FDA?

FREND PSA PLUS (reagent cartridge) (K162378) received a 510(k) decision of Substantially Equivalent on May 17, 2017, 266 days after the submission was received.

What is the product code of K162378?

The FDA product code is LTJ – Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers, a Class II (moderate risk) device regulated under 21 CFR 866.6010.