Cleared Traditional

K891098 - ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGU...

K891098 is an FDA 510(k) clearance for ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGU..., manufactured by Immco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DBL cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K891098 · Immco Diagnostics, Inc. · Immunology device
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Mar 1989
Decision
20d
Days
Class 2
Risk

K891098 is an FDA 510(k) clearance for the ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS). Classified as Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (product code DBL), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on March 22, 1989 after a review of 20 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 Immco Diagnostics, Inc. devices

FDA 510(k) Submission Details - K891098

510(k) Number K891098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1989
Decision Date March 22, 1989
Days to Decision 20 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 104d · This submission: 20d
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 Immunology devices follow this clearance model.

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

All 14
Devices cleared under the same product code (DBL) and FDA review panel - the closest regulatory comparables to K891098.
ANTI-RETICULIN ANTIBODY (ARA) TEST
K913360 · Immco Diagnostics, Inc. · Sep 1994
ANTI-ENDOMYSIAL ANTIBODY TEST
K912551 · Immco Diagnostics, Inc. · Jun 1993
MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT
K902237 · Medica Corp. · Jul 1990
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