Cleared Traditional

K930143 - AYNELISA M2-ANTIBODIES

K930143 is the FDA 510(k) clearance for AYNELISA M2-ANTIBODIES by Elias U.S.A., Inc.. It is a Class 2 Immunology device (product code DBM) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K930143 · Elias U.S.A., Inc. · Immunology device
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May 1993
Decision
119d
Days
Class 2
Risk

K930143 is an FDA 510(k) clearance for the AYNELISA M2-ANTIBODIES. Classified as Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (product code DBM), 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 866.5090 - 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 K930143 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
15d slower than avg
Panel avg: 104d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5090
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 - DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

All 14
Devices cleared under the same product code (DBM) and FDA review panel - the closest regulatory comparables to K930143.
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