Cleared Traditional

K810226 - SLE ANTI-N-DNA LATEX TEST

K810226 is the FDA 510(k) clearance for SLE ANTI-N-DNA LATEX TEST by Icl Scientific. It is a Class 2 Immunology device (product code DHC) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K810226 · Icl Scientific · Immunology device
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Feb 1981
Decision
13d
Days
Class 2
Risk

K810226 is an FDA 510(k) clearance for the SLE ANTI-N-DNA LATEX TEST. Classified as System, Test, Systemic Lupus Erythematosus (product code DHC), Class II - Special Controls.

Submitted by Icl Scientific (Mchenry, US). The FDA issued a Cleared decision on February 9, 1981 after a review of 13 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 Icl Scientific devices

Submission Details

510(k) Number K810226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1981
Decision Date February 09, 1981
Days to Decision 13 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
91d faster than avg
Panel avg: 104d · This submission: 13d
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 7
Devices cleared under the same product code (DHC) and FDA review panel - the closest regulatory comparables to K810226.
HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE
K930247 · The Binding Site, Ltd. · Mar 1993
ELIAS DSDNA ABS
K930421 · Elias U.S.A., Inc. · Mar 1993
CORDIA N
K800991 · Cordis Corp. · May 1980
CORDIA NP
K800992 · Cordis Corp. · May 1980
IIF-A-N-DNA TEST KIT
K790106 · Medica Corp. · Mar 1979
SYSTEMIC LUPUS
K790257 · Icl Scientific · Mar 1979