Cleared Traditional

K951798 - ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT

K951798 is an FDA 510(k) clearance for ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY..., manufactured by Helix Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K951798 · Helix Diagnostics, Inc. · Immunology device
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Jul 1995
Decision
90d
Days
Class 2
Risk

K951798 is an FDA 510(k) clearance for the ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Helix Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on July 17, 1995 after a review of 90 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 - K951798

510(k) Number K951798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1995
Decision Date July 17, 1995
Days to Decision 90 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
15d faster than avg
Panel avg: 105d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJM Device Classification - Class 2, Special Controls

Product Code LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
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 - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 78
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