Cleared Traditional

K932206 - SYNELISA ANA PROFILE

K932206 is the FDA 510(k) clearance for SYNELISA ANA PROFILE by Elias U.S.A., Inc.. It is a Class 2 Immunology device (product code LJM) cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K932206 · Elias U.S.A., Inc. · Immunology device
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Dec 1993
Decision
211d
Days
Class 2
Risk

K932206 is an FDA 510(k) clearance for the SYNELISA ANA PROFILE. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on December 3, 1993 after a review of 211 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 Elias U.S.A., Inc. devices

Submission Details

510(k) Number K932206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1993
Decision Date December 03, 1993
Days to Decision 211 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
107d slower than avg
Panel avg: 104d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
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 - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 38
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K932206.
SYNELISA ANA TOTAL
K935468 · Elias U.S.A., Inc. · Mar 1994
ELIAS ANA TOTAL
K940641 · Elias U.S.A., Inc. · Mar 1994
AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM
K933267 · Zeus Scientific, Inc. · Dec 1993
SYNELISA RO ABS / LA ABS
K930209 · Elias U.S.A., Inc. · Jun 1993
KALESTAD ANA MICROPLATE EIA
K924087 · Bio-Rad Laboratories, Inc. · Nov 1992
HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)
K915272 · Hemagen Diagnostics, Inc. · Mar 1992