Cleared Traditional

K930143 - AYNELISA M2-ANTIBODIES

K930143 is an FDA 510(k) clearance for AYNELISA M2-ANTIBODIES, manufactured by Elias U.S.A., Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K930143

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
14d slower than avg
Panel avg: 105d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBM Device Classification - Class 2, Special Controls

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 18
Devices cleared under the same product code (DBM) and FDA review panel - the closest regulatory comparables to K930143.
VIRGO AMA ELISA KIT
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VARELISA M2 ANTIBODIES
K945607 · Elias U.S.A., Inc. · Jan 1995
DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT
K921183 · Shield Diagnostics, Ltd. · Jun 1992
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K831358 · Zeus Scientific, Inc. · Jun 1983
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K810863 · Kallestad Laboratories, Inc. · Apr 1981