Cleared Traditional

K930247 - HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE

K930247 is the FDA 510(k) clearance for HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code DHC) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K930247 · The Binding Site, Ltd. · Immunology device
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Mar 1993
Decision
50d
Days
Class 2
Risk

K930247 is an FDA 510(k) clearance for the HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE. Classified as System, Test, Systemic Lupus Erythematosus (product code DHC), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on March 10, 1993 after a review of 50 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 The Binding Site, Ltd. devices

Submission Details

510(k) Number K930247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1993
Decision Date March 10, 1993
Days to Decision 50 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
54d faster than avg
Panel avg: 104d · This submission: 50d
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 K930247.
ELIAS DSDNA ABS
K930421 · Elias U.S.A., Inc. · Mar 1993
SLE ANTI-N-DNA LATEX TEST
K810226 · Icl Scientific · Feb 1981
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