Cleared Traditional

K811261 - ANTI-SKIN ANTIBODY TEST SYSTEM (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K811261 · Zeus Scientific, Inc. · Microbiology device
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Aug 1981
Decision
98d
Days
Class 2
Risk

K811261 is an FDA 510(k) clearance for the ANTI-SKIN ANTIBODY TEST SYSTEM. Classified as Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (product code DBL), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1981 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5660 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zeus Scientific, Inc. devices

Submission Details

510(k) Number K811261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1981
Decision Date August 12, 1981
Days to Decision 98 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 102d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 Microbiology devices follow this clearance model.