Cleared Traditional

K871194 - I-125 ANTI-MICROSOMAL ANTIBODY IRMA TES...

K871194 is the FDA 510(k) clearance for I-125 ANTI-MICROSOMAL ANTIBODY IRMA TES... by Cronus. It is a Class 2 Immunology device (product code DBL) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K871194 · Cronus · Immunology device
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Apr 1987
Decision
27d
Days
Class 2
Risk

K871194 is an FDA 510(k) clearance for the I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT. Classified as Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (product code DBL), Class II - Special Controls.

Submitted by Cronus (Carlsbad, US). The FDA issued a Cleared decision on April 20, 1987 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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 Cronus devices

Submission Details

510(k) Number K871194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1987
Decision Date April 20, 1987
Days to Decision 27 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 104d · This submission: 27d
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 Immunology 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 K871194.
ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)
K891098 · Immco Diagnostics, Inc. · Mar 1989
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
ANTI-SKIN ANTIBODY TEST SYSTEM
K811261 · Zeus Scientific, Inc. · Aug 1981
KALLESTAD FLORESCENT ANA/AMA/ASMA TEST
K792610 · Kallestad Laboratories, Inc. · Feb 1980