Cleared Traditional

K930141 - SYNELISA SM ABS/RNP-SM ABS

K930141 is an FDA 510(k) clearance for SYNELISA SM ABS/RNP-SM ABS, manufactured by Elias U.S.A., Inc.. The device is a Class 2 Immunology device with product code LKP cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K930141 · Elias U.S.A., Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
119d
Days
Class 2
Risk

K930141 is an FDA 510(k) clearance for the SYNELISA SM ABS/RNP-SM ABS. Classified as Anti-sm Antibody, Antigen And Control (product code LKP), Class II - Special Controls.

Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on May 11, 1993 after a review of 119 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 Elias U.S.A., Inc. devices

FDA 510(k) Submission Details - K930141

510(k) Number K930141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1993
Decision Date May 11, 1993
Days to Decision 119 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 105d · This submission: 119d
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 20
Devices cleared under the same product code (LKP) and FDA review panel - the closest regulatory comparables to K930141.
SERAQUEST ANTI-SM/RNP
K980811 · Quest Intl., Inc. · May 1998
ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY
K954830 · Orgentec · May 1996
HYTEC AUTOIMMUNE KITS (SM)
K954896 · Hycor Biomedical, Inc. · Mar 1996
IMMUNOWELL RNP/SM ANTIBODY TEST
K911848 · General Biometrics, Inc. · May 1991
IMMUNOWELL SM ANTIBODY TEST
K911851 · General Biometrics, Inc. · May 1991
DIASTAT ANTI-SM
K905191 · Shield Diagnostics, Ltd. · Dec 1990