Cleared Traditional

K810984 - ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST

K810984 is an FDA 510(k) clearance for ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST, manufactured by Immuno-Products Industries. The device is a Class 2 Immunology device with product code DBM cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K810984 · Immuno-Products Industries · Immunology device
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May 1981
Decision
18d
Days
Class 2
Risk

K810984 is an FDA 510(k) clearance for the ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST. Classified as Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (product code DBM), Class II - Special Controls.

Submitted by Immuno-Products Industries (Mchenry, US). The FDA issued a Cleared decision on May 1, 1981 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5090 - 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 Immuno-Products Industries devices

FDA 510(k) Submission Details - K810984

510(k) Number K810984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1981
Decision Date May 01, 1981
Days to Decision 18 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 105d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBM Device Classification - Class 2, Special Controls

Product Code DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5090
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 - DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

All 19
Devices cleared under the same product code (DBM) and FDA review panel - the closest regulatory comparables to K810984.
AYNELISA M2-ANTIBODIES
K930143 · Elias U.S.A., Inc. · May 1993
DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT
K921183 · Shield Diagnostics, Ltd. · Jun 1992
AUTOANTIBODY SCREEN TEST SYSTEM
K831358 · Zeus Scientific, Inc. · Jun 1983
KALLESTAD HEP-2 CELL LINE SUBSTRATE
K810863 · Kallestad Laboratories, Inc. · Apr 1981
AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY
K800821 · Calbiochem-Behring Corp. · Apr 1980
IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT
K800229 · Clinical Sciences, Inc. · Feb 1980