Cleared Traditional

K954830 - ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY

K954830 is an FDA 510(k) clearance for ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY, manufactured by Orgentec. The device is a Class 2 Immunology device with product code LKP cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K954830 · Orgentec · Immunology device
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May 1996
Decision
201d
Days
Class 2
Risk

K954830 is an FDA 510(k) clearance for the ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY. Classified as Anti-sm Antibody, Antigen And Control (product code LKP), 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 - K954830

510(k) Number K954830 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.

LKP Device Classification - Class 2, Special Controls

Product Code LKP Anti-sm 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 - LKP Anti-sm Antibody, Antigen And Control

All 18
Devices cleared under the same product code (LKP) and FDA review panel - the closest regulatory comparables to K954830.
THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO
K983420 · Zeus Scientific, Inc. · Nov 1998
SERAQUEST ANTI-SM
K980540 · Quest Intl., Inc. · Jun 1998
SERAQUEST ANTI-SM/RNP
K980811 · Quest Intl., Inc. · May 1998
HYTEC AUTOIMMUNE KITS (SM)
K954896 · Hycor Biomedical, Inc. · Mar 1996
SYNELISA SM ABS/RNP-SM ABS
K930141 · Elias U.S.A., Inc. · May 1993
IMMUNOWELL RNP/SM ANTIBODY TEST
K911848 · General Biometrics, Inc. · May 1991