Cleared Traditional

K800821 - AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY

K800821 is an FDA 510(k) clearance for AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY, manufactured by Calbiochem-Behring Corp.. The device is a Class 2 Immunology device with product code DBM cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K800821 · Calbiochem-Behring Corp. · Immunology device
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Apr 1980
Decision
13d
Days
Class 2
Risk

K800821 is an FDA 510(k) clearance for the AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY. Classified as Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (product code DBM), Class II - Special Controls.

Submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on April 24, 1980 after a review of 13 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 Calbiochem-Behring Corp. devices

FDA 510(k) Submission Details - K800821

510(k) Number K800821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1980
Decision Date April 24, 1980
Days to Decision 13 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
92d faster than avg
Panel avg: 105d · This submission: 13d
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 18
Devices cleared under the same product code (DBM) and FDA review panel - the closest regulatory comparables to K800821.
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
IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT
K800229 · Clinical Sciences, Inc. · Feb 1980
TEST KIT, IIF-AMA
K790295 · Medica Corp. · May 1979
TEST, (IVDP) MITOCHONDRIAL ANTIBODY
K760155 · Zeus Scientific, Inc. · Jul 1976