Cleared Traditional

K001900 - ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST

K001900 is an FDA 510(k) clearance for ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST, 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 81-day FDA review.

K001900 · Helix Diagnostics, Inc. · Immunology device
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Sep 2000
Decision
81d
Days
Class 2
Risk

K001900 is an FDA 510(k) clearance for the ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST. 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 September 11, 2000 after a review of 81 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 - K001900

510(k) Number K001900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2000
Decision Date September 11, 2000
Days to Decision 81 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
24d faster than avg
Panel avg: 105d · This submission: 81d
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 20
Devices cleared under the same product code (LRM) and FDA review panel - the closest regulatory comparables to K001900.
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