Cleared Traditional

K930417 - SYNELISA SCL-70 ANTIBODIES

K930417 is the FDA 510(k) clearance for SYNELISA SCL-70 ANTIBODIES by Elias U.S.A., Inc.. It is a Class 2 Immunology device (product code LLL) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K930417 · Elias U.S.A., Inc. · Immunology device
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Apr 1993
Decision
70d
Days
Class 2
Risk

K930417 is an FDA 510(k) clearance for the SYNELISA SCL-70 ANTIBODIES. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on April 6, 1993 after a review of 70 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Elias U.S.A., Inc. devices

Submission Details

510(k) Number K930417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1993
Decision Date April 06, 1993
Days to Decision 70 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
34d faster than avg
Panel avg: 104d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLL Extractable Antinuclear 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 - LLL Extractable Antinuclear Antibody, Antigen And Control

All 117
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K930417.
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K925118 · The Binding Site, Ltd. · Feb 1993
ENA SCREENING CIE KIT FOR DIAGNOSTIC USE
K924262 · The Binding Site, Ltd. · Dec 1992