Cleared Traditional

K980376 - THE COMPLEXED PSA ASSAY FOR THE BAYER I...

K980376 is the FDA 510(k) clearance for THE COMPLEXED PSA ASSAY FOR THE BAYER I... by Bayer Corp.. It is a Class 2 Immunology device (product code LTJ) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K980376 · Bayer Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
83d
Days
Class 2
Risk

K980376 is an FDA 510(k) clearance for the THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM. Classified as Prostate-specific Antigen (psa) For Management Of Prostate Cancers (product code LTJ), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on April 23, 1998 after a review of 83 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 Bayer Corp. devices

Submission Details

510(k) Number K980376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1998
Decision Date April 23, 1998
Days to Decision 83 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
21d faster than avg
Panel avg: 104d · This submission: 83d
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 K980376.
ELECSYS PSA, MODEL 2010
K982949 · Boehringer Mannheim Corp. · Oct 1998
ACTIVE PSA ELISA (DSL-10-9700)
K973243 · Diagnostic Systems Laboratories, Inc. · Aug 1998
ACTIVE PSA IRMA (DSL-9700)
K973244 · Diagnostic Systems Laboratories, Inc. · Aug 1998
IMMULITE 2000 3RD GENERATION PSA
K974842 · Diagnostic Products Corp. · Apr 1998
ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY
K980716 · Nichols Institute Diagnostics · Apr 1998
ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
K974816 · Beckman Instruments, Inc. · Feb 1998