Cleared Traditional

K885048 - ACCESS R-CLONE ANA PROFILE ASSAY

K885048 is the FDA 510(k) clearance for ACCESS R-CLONE ANA PROFILE ASSAY by Lipogen, Inc.. It is a Class 2 Immunology device (product code DHC) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K885048 · Lipogen, Inc. · Immunology device
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Jan 1989
Decision
48d
Days
Class 2
Risk

K885048 is an FDA 510(k) clearance for the ACCESS R-CLONE ANA PROFILE ASSAY. Classified as System, Test, Systemic Lupus Erythematosus (product code DHC), Class II - Special Controls.

Submitted by Lipogen, Inc. (Knoxville, US). The FDA issued a Cleared decision on January 24, 1989 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5820 - 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 Lipogen, Inc. devices

Submission Details

510(k) Number K885048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1988
Decision Date January 24, 1989
Days to Decision 48 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 104d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHC System, Test, Systemic Lupus Erythematosus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5820
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 - DHC System, Test, Systemic Lupus Erythematosus

All 8
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