Cleared Traditional

K955134 - ORGENTEC ENASCREEN ELISA ASSAY

K955134 is an FDA 510(k) clearance for ORGENTEC ENASCREEN ELISA ASSAY, manufactured by Orgentec. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K955134 · Orgentec · Immunology device
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Mar 1996
Decision
132d
Days
Class 2
Risk

K955134 is an FDA 510(k) clearance for the ORGENTEC ENASCREEN ELISA ASSAY. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Orgentec (Windham, US). The FDA issued a Cleared decision on March 20, 1996 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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 Orgentec devices

FDA 510(k) Submission Details - K955134

510(k) Number K955134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1995
Decision Date March 20, 1996
Days to Decision 132 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 104d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

Product Code LLL Extractable Antinuclear Antibody, Antigen And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - LLL Extractable Antinuclear Antibody, Antigen And Control

All 133
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K955134.
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K952076 · Hemagen Diagnostics, Inc. · Jun 1995
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K952077 · Hemagen Diagnostics, Inc. · Jun 1995