Cleared Traditional

K883915 - AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/...

K883915 is an FDA 510(k) clearance for AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/..., 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 33-day FDA review.

K883915 · Immco Diagnostics, Inc. · Immunology device
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Oct 1988
Decision
33d
Days
Class 2
Risk

K883915 is an FDA 510(k) clearance for the AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH). 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 October 19, 1988 after a review of 33 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 - K883915

510(k) Number K883915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1988
Decision Date October 19, 1988
Days to Decision 33 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
71d faster than avg
Panel avg: 104d · This submission: 33d
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 K883915.
MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT
K902237 · Medica Corp. · Jul 1990
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
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