Cleared Traditional

K913041 - ANTI-DSDNA ANTIBODY TEST

K913041 is an FDA 510(k) clearance for ANTI-DSDNA ANTIBODY TEST, manufactured by Helix Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K913041 · Helix Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1991
Decision
119d
Days
Class 2
Risk

K913041 is an FDA 510(k) clearance for the ANTI-DSDNA ANTIBODY TEST. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Helix Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on November 5, 1991 after a review of 119 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Helix Diagnostics, Inc. devices

FDA 510(k) Submission Details - K913041

510(k) Number K913041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1991
Decision Date November 05, 1991
Days to Decision 119 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 105d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

Product Code LLL Extractable Antinuclear Antibody, Antigen And 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.

Regulatory Peers - LLL Extractable Antinuclear Antibody, Antigen And Control

All 144
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K913041.
HEMAGEN ENA SCL-70 KIT (EIA METHOD)
K915282 · Hemagen Diagnostics, Inc. · Feb 1992
HEMAGEN ENA SCREENING KIT (EIA METHOD)
K915058 · Hemagen Diagnostics, Inc. · Dec 1991
HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)
K915234 · Hemagen Diagnostics, Inc. · Dec 1991
ANTI-JO-1 MICROASSAY
K911679 · Diamedix Corp. · Sep 1991
HEMAGEN ENA SCREENING KIT
K910232 · Hemagen Diagnostics, Inc. · Mar 1991
QUANTA LITE TM DSDNA
K903898 · Inova Diagnostics, Inc. · Sep 1990