Cleared Traditional

K872085 - THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS

K872085 is an FDA 510(k) clearance for THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL ..., manufactured by Immunodiagnostics, Ltd.. The device is a Class 2 Immunology device with product code LSW cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K872085 · Immunodiagnostics, Ltd. · Immunology device
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Sep 1987
Decision
92d
Days
Class 2
Risk

K872085 is an FDA 510(k) clearance for the THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS. Classified as Anti-dna Antibody, Antigen And Control (product code LSW), Class II - Special Controls.

Submitted by Immunodiagnostics, Ltd. (England, U.K., GB). The FDA issued a Cleared decision on September 1, 1987 after a review of 92 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 Immunodiagnostics, Ltd. devices

FDA 510(k) Submission Details - K872085

510(k) Number K872085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1987
Decision Date September 01, 1987
Days to Decision 92 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 105d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LSW Device Classification - Class 2, Special Controls

Product Code LSW Anti-dna 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.