Cleared Traditional

K162378 - FREND PSA PLUS (reagent cartridge)

K162378 is an FDA 510(k) clearance for FREND PSA PLUS (reagent cartridge), manufactured by Nanoentek USA, Inc.. The device is a Class 2 Immunology device with product code LTJ cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K162378 · Nanoentek USA, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
266d
Days
Class 2
Risk

K162378 is an FDA 510(k) clearance for the FREND PSA PLUS (reagent cartridge). Classified as Prostate-specific Antigen (psa) For Management Of Prostate Cancers (product code LTJ), Class II - Special Controls.

Submitted by Nanoentek USA, Inc. (Pleasanton, US). The FDA issued a Cleared decision on May 17, 2017 after a review of 266 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nanoentek USA, Inc. devices

FDA 510(k) Submission Details - K162378

510(k) Number K162378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2016
Decision Date May 17, 2017
Days to Decision 266 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 105d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LTJ Device Classification - Class 2, Special Controls

Product Code LTJ Prostate-specific Antigen (psa) For Management Of Prostate Cancers
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - LTJ Prostate-specific Antigen (psa) For Management Of Prostate Cancers

All 30
Devices cleared under the same product code (LTJ) and FDA review panel - the closest regulatory comparables to K162378.
Atellica IM Total PSA II (tPSAII)
K251630 · Siemens Healthcare Diagnostics, Inc. · Jan 2026
FREND PSA PLUS (REAGENT CARTRIDGE)
K124056 · Nanoentek, Inc. · May 2013
TPSA FLEX REAGENT CARTRIDGE
K031343 · Dade Behring, Inc. · May 2003
PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022177 · Bayer Diagnostics Corp. · Dec 2002
COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
K022288 · Bayer Corp. · Dec 2002
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
K010550 · bioMerieux, Inc. · Apr 2001