Cleared Traditional

K954831 - ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY

K954831 is an FDA 510(k) clearance for ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY, manufactured by Orgentec. The device is a Class 2 Immunology device with product code LKO cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K954831 · Orgentec · Immunology device
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May 1996
Decision
201d
Days
Class 2
Risk

K954831 is an FDA 510(k) clearance for the ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY. Classified as Anti-rnp Antibody, Antigen And Control (product code LKO), Class II - Special Controls.

Submitted by Orgentec (Windham, US). The FDA issued a Cleared decision on May 8, 1996 after a review of 201 days - an extended review cycle.

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 - K954831

510(k) Number K954831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1995
Decision Date May 08, 1996
Days to Decision 201 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
97d slower than avg
Panel avg: 104d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKO Device Classification - Class 2, Special Controls

Product Code LKO Anti-rnp 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 - LKO Anti-rnp Antibody, Antigen And Control

All 12
Devices cleared under the same product code (LKO) and FDA review panel - the closest regulatory comparables to K954831.
AUTOSTAT II ANTI-SM/RNP ELISA
K990624 · Cogent Diagnotics , Ltd. · Apr 1999
LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207
K984476 · Bio-Rad · Dec 1998
THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K983465 · Zeus Scientific, Inc. · Nov 1998
HYTEC AUTOIMMUNE KITS (RNP)
K954897 · Hycor Biomedical, Inc. · Mar 1996
SYNELISA U1-SNRNP (68KDA)-ANTIBODIES
K930142 · Elias U.S.A., Inc. · May 1993
IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST
K911849 · General Biometrics, Inc. · May 1991