Cleared Traditional

K892421 - MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST

K892421 is an FDA 510(k) clearance for MODIFIED ACCESS R-CLONE ANA/RF SCREENIN..., manufactured by Lipogen, Inc.. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K892421 · Lipogen, Inc. · Immunology device
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May 1989
Decision
29d
Days
Class 2
Risk

K892421 is an FDA 510(k) clearance for the MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Lipogen, Inc. (Knoxville, US). The FDA issued a Cleared decision on May 9, 1989 after a review of 29 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 - K892421

510(k) Number K892421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1989
Decision Date May 09, 1989
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 105d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJM Device Classification - Class 2, Special Controls

Product Code LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
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 - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 111
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K892421.
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K895995 · Lipogen, Inc. · Oct 1989
RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES
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ANTI-SM MICROASSAY
K894894 · Diamedix Corp. · Aug 1989
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K874195 · Lipogen, Inc. · Mar 1988
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K875246 · Lipogen, Inc. · Feb 1988
ANTINUCLEAR ANTIBODY TEST
K872839 · Cappel Diagnostics, Inc. · Oct 1987
K892421 · MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST
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