Cleared Traditional

K930281 - SYNELISA JO-1 ANTIBODIES

K930281 is an FDA 510(k) clearance for SYNELISA JO-1 ANTIBODIES, manufactured by Elias U.S.A., Inc.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K930281 · Elias U.S.A., Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Apr 1993
Decision
75d
Days
Class 2
Risk

K930281 is an FDA 510(k) clearance for the SYNELISA JO-1 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 75 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.

FDA 510(k) Submission Details - K930281

510(k) Number K930281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1993
Decision Date April 06, 1993
Days to Decision 75 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
30d faster than avg
Panel avg: 105d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

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 181
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K930281.
ELISA-DOXA JO-1
K924950 · Advanced Biological Products, Inc. · May 1993
ELISA-DOXA COMBI-4
K924951 · Advanced Biological Products, Inc. · May 1993
ELISA-DOXA COMBI-6
K924952 · Advanced Biological Products, Inc. · May 1993
SYNELISA SCL-70 ANTIBODIES
K930417 · Elias U.S.A., Inc. · Apr 1993
RHEUMELISA II JO-1 ANTIBODY TEST KIT
K930757 · Biowhittaker Molecular Applications, Inc. · Mar 1993
RHEUMELISA II SCL-70 ANTIBODY TEST KIT
K930130 · Biowhittaker Molecular Applications, Inc. · Mar 1993
K930281 · SYNELISA JO-1 ANTIBODIES
Download PDF Elias U.S.A., Inc.