Cleared Traditional

K980716 - ADVANTAGE CHEMILUMINESCENCE PROSTATE SP...

K980716 is the FDA 510(k) clearance for ADVANTAGE CHEMILUMINESCENCE PROSTATE SP... by Nichols Institute Diagnostics. It is a Class 2 Immunology device (product code LTJ) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K980716 · Nichols Institute Diagnostics · Immunology device
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Apr 1998
Decision
86d
Days
Class 2
Risk

K980716 is an FDA 510(k) clearance for the ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY. Classified as Prostate-specific Antigen (psa) For Management Of Prostate Cancers (product code LTJ), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on April 3, 1998 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nichols Institute Diagnostics devices

Submission Details

510(k) Number K980716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1998
Decision Date April 03, 1998
Days to Decision 86 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 104d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 22
Devices cleared under the same product code (LTJ) and FDA review panel - the closest regulatory comparables to K980716.
ACTIVE PSA IRMA (DSL-9700)
K973244 · Diagnostic Systems Laboratories, Inc. · Aug 1998
THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K980376 · Bayer Corp. · Apr 1998
IMMULITE 2000 3RD GENERATION PSA
K974842 · Diagnostic Products Corp. · Apr 1998
ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
K974816 · Beckman Instruments, Inc. · Feb 1998
ELECSYS PSA (ON ELECSYS 1010)
K974189 · Boehringer Mannheim Corp. · Jan 1998
IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)
K972021 · Diagnostic Products Corp. · Oct 1997