Cleared Traditional

K972095 - IMMULITE 2000 PSA

K972095 is the FDA 510(k) clearance for IMMULITE 2000 PSA by Diagnostic Products Corp.. It is a Class 2 Immunology device (product code LTJ) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K972095 · Diagnostic Products Corp. · Immunology device
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Aug 1997
Decision
79d
Days
Class 2
Risk

K972095 is an FDA 510(k) clearance for the IMMULITE 2000 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 August 22, 1997 after a review of 79 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K972095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1997
Decision Date August 22, 1997
Days to Decision 79 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
25d faster than avg
Panel avg: 104d · This submission: 79d
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 K972095.
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
ELECSYS PSA ASSAY
K964351 · Boehringer Mannheim Corp. · Jul 1997
OPUS PSA TEST SYSTEM
K964595 · Behring Diagnostics, Inc. · Jun 1997
ENZYMUN-TEST PSA
K965085 · Boehringer Mannheim Corp. · Mar 1997