Cleared Abbreviated

K030775 - AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM (FDA 510(k) Clearance)

Class II Immunology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K030775 · Immuno Concepts, N.A. , Ltd. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
62d
Days
Class 2
Risk

K030775 is an FDA 510(k) clearance for the AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM. Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Immuno Concepts, N.A. , Ltd. (Dallas, US). The FDA issued a Cleared decision on May 12, 2003 after a review of 62 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Immuno Concepts, N.A. , Ltd. devices

Submission Details

510(k) Number K030775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2003
Decision Date May 12, 2003
Days to Decision 62 days
Submission Type Abbreviated
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 104d · This submission: 62d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LKJ Antinuclear Antibody, Antigen, 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.