Cleared Traditional

K811261 - ANTI-SKIN ANTIBODY TEST SYSTEM

K811261 is an FDA 510(k) clearance for ANTI-SKIN ANTIBODY TEST SYSTEM, manufactured by Zeus Scientific, Inc.. The device is a Class 2 Microbiology device with product code DBL cleared through the Traditional 510(k) pathway after a 98-day FDA review.

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

FDA 510(k) Submission Details - K811261

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
Combination Product No
PCCP Authorized No
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.

DBL Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

All 12
Devices cleared under the same product code (DBL) and FDA review panel - the closest regulatory comparables to K811261.
ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC)
K891099 · Immco Diagnostics, Inc. · Mar 1989
AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH)
K883915 · Immco Diagnostics, Inc. · Oct 1988
AFT SYSTEM PROFICIENCY TESTING PROGRAM
K820088 · Calbiochem-Behring Corp. · Jan 1982
KALLESTAD FLORESCENT ANA/AMA/ASMA TEST
K792610 · Kallestad Laboratories, Inc. · Feb 1980