Cleared Traditional

K771993 - AFT SYSTEM

K771993 is the FDA 510(k) clearance for AFT SYSTEM by Calbiochem. It is a Class 2 Immunology device (product code DBM) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K771993 · Calbiochem · Immunology device
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Nov 1977
Decision
12d
Days
Class 2
Risk

K771993 is an FDA 510(k) clearance for the AFT SYSTEM. Classified as Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (product code DBM), Class II - Special Controls.

Submitted by Calbiochem (Mchenry, US). The FDA issued a Cleared decision on November 2, 1977 after a review of 12 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 devices

Submission Details

510(k) Number K771993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1977
Decision Date November 02, 1977
Days to Decision 12 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 104d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 16
Devices cleared under the same product code (DBM) and FDA review panel - the closest regulatory comparables to K771993.
AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY
K800821 · Calbiochem-Behring Corp. · Apr 1980
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