Cleared Traditional

K953671 - ORGEN TEC ANTI-DSDNA ELISA ASSAY

K953671 is an FDA 510(k) clearance for ORGEN TEC ANTI-DSDNA ELISA ASSAY, manufactured by Orgentec. The device is a Class 2 Immunology device with product code LRM cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K953671 · Orgentec · Immunology device
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Nov 1995
Decision
94d
Days
Class 2
Risk

K953671 is an FDA 510(k) clearance for the ORGEN TEC ANTI-DSDNA ELISA ASSAY. Classified as Anti-dna Antibody (enzyme-labeled), Antigen, Control (product code LRM), Class II - Special Controls.

Submitted by Orgentec (Windham, US). The FDA issued a Cleared decision on November 9, 1995 after a review of 94 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 - K953671

510(k) Number K953671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1995
Decision Date November 09, 1995
Days to Decision 94 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
10d faster than avg
Panel avg: 104d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRM Device Classification - Class 2, Special Controls

Product Code LRM Anti-dna Antibody (enzyme-labeled), Antigen, 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 - LRM Anti-dna Antibody (enzyme-labeled), Antigen, Control

All 16
Devices cleared under the same product code (LRM) and FDA review panel - the closest regulatory comparables to K953671.
HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY
K962730 · Hycor Biomedical, Inc. · Mar 1997
AUTOSTATTMII ANTI-DSDNA
K952567 · Cogent Diagnotics , Ltd. · Mar 1997
HYTEC AUTOMIMMUNE KIT (DS-DNA)
K954893 · Hycor Biomedical, Inc. · Mar 1996
ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY
K952055 · American Laboratory Products Co., Ltd. · Jul 1995
VARELISA COMBINED DNA ANTIBODIES EIA
K944334 · Elias U.S.A., Inc. · Apr 1995
VARELISA DSDNA ANTIBODIES (FARR VERSION)
K950031 · Elias U.S.A., Inc. · Mar 1995