Cleared Traditional

K960091 - ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT

K960091 is an FDA 510(k) clearance for ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED..., manufactured by Helix Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LRM cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K960091 · Helix Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
69d
Days
Class 2
Risk

K960091 is an FDA 510(k) clearance for the ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT. Classified as Anti-dna Antibody (enzyme-labeled), Antigen, Control (product code LRM), Class II - Special Controls.

Submitted by Helix Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on March 20, 1996 after a review of 69 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.

View all Helix Diagnostics, Inc. devices

FDA 510(k) Submission Details - K960091

510(k) Number K960091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1996
Decision Date March 20, 1996
Days to Decision 69 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
36d faster than avg
Panel avg: 105d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRM Device Classification - Class 2, Special Controls

Product Code LRM Anti-dna Antibody (enzyme-labeled), Antigen, 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 - LRM Anti-dna Antibody (enzyme-labeled), Antigen, Control

All 19
Devices cleared under the same product code (LRM) and FDA review panel - the closest regulatory comparables to K960091.
HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY
K962730 · Hycor Biomedical, Inc. · Mar 1997
AUTOSTATTMII ANTI-DSDNA
K952567 · Cogent Diagnotics , Ltd. · Mar 1997
HYTEC AUTOMIMMUNE KIT (DS-DNA)
K954893 · Hycor Biomedical, Inc. · Mar 1996
DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM
K960182 · Mardx Diagnostics, Inc. · Mar 1996
ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY
K952055 · American Laboratory Products Co., Ltd. · Jul 1995
VARELISA COMBINED DNA ANTIBODIES EIA
K944334 · Elias U.S.A., Inc. · Apr 1995