Cleared Traditional

K965085 - ENZYMUN-TEST PSA

K965085 is an FDA 510(k) clearance for ENZYMUN-TEST PSA, 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 90-day FDA review.

K965085 · Boehringer Mannheim Corp. · Immunology device
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Optimized for regulatory review, auditing and printing
Mar 1997
Decision
90d
Days
Class 2
Risk

K965085 is an FDA 510(k) clearance for the ENZYMUN-TEST PSA. Classified as Prostate-specific Antigen (psa) For Management Of Prostate Cancers (product code LTJ), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 19, 1997 after a review of 90 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K965085

510(k) Number K965085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1996
Decision Date March 19, 1997
Days to Decision 90 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
14d faster than avg
Panel avg: 104d · This submission: 90d
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.