Cleared Traditional

K974842 - IMMULITE 2000 3RD GENERATION PSA

K974842 is an FDA 510(k) clearance for IMMULITE 2000 3RD GENERATION PSA, manufactured by Diagnostic Products Corp.. The device is a Class 2 Immunology device with product code LTJ cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K974842 · Diagnostic Products Corp. · Immunology device
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Apr 1998
Decision
118d
Days
Class 2
Risk

K974842 is an FDA 510(k) clearance for the IMMULITE 2000 3RD GENERATION PSA. Classified as Prostate-specific Antigen (psa) For Management Of Prostate Cancers (product code LTJ), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on April 21, 1998 after a review of 118 days - within the typical 510(k) review window.

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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K974842

510(k) Number K974842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1997
Decision Date April 21, 1998
Days to Decision 118 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 105d · This submission: 118d
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 29
Devices cleared under the same product code (LTJ) and FDA review panel - the closest regulatory comparables to K974842.
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
THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K980376 · Bayer 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
ELECSYS PSA (ON ELECSYS 1010)
K974189 · Boehringer Mannheim Corp. · Jan 1998