Cleared Traditional

K964351 - ELECSYS PSA ASSAY

K964351 is an FDA 510(k) clearance for ELECSYS PSA ASSAY, manufactured by Boehringer Mannheim Corp.. 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.

K964351 · Boehringer Mannheim Corp. · Immunology device
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Jul 1997
Decision
266d
Days
Class 2
Risk

K964351 is an FDA 510(k) clearance for the ELECSYS PSA ASSAY. Classified as Prostate-specific Antigen (psa) For Management Of Prostate Cancers (product code LTJ), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on July 25, 1997 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K964351

510(k) Number K964351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1996
Decision Date July 25, 1997
Days to Decision 266 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
162d slower than avg
Panel avg: 104d · 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 23
Devices cleared under the same product code (LTJ) and FDA review panel - the closest regulatory comparables to K964351.
ELECSYS PSA (ON ELECSYS 1010)
K974189 · Boehringer Mannheim Corp. · Jan 1998
IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)
K972021 · Diagnostic Products Corp. · Oct 1997
IMMULITE 2000 PSA
K972095 · Diagnostic Products Corp. · Aug 1997
OPUS PSA TEST SYSTEM
K964595 · Behring Diagnostics, Inc. · Jun 1997
ENZYMUN-TEST PSA
K965085 · Boehringer Mannheim Corp. · Mar 1997