Cleared Traditional

K820088 - AFT SYSTEM PROFICIENCY TESTING PROGRAM

K820088 is an FDA 510(k) clearance for AFT SYSTEM PROFICIENCY TESTING PROGRAM, manufactured by Calbiochem-Behring Corp.. The device is a Class 2 Immunology device with product code DBL cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K820088 · Calbiochem-Behring Corp. · Immunology device
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Jan 1982
Decision
13d
Days
Class 2
Risk

K820088 is an FDA 510(k) clearance for the AFT SYSTEM PROFICIENCY TESTING PROGRAM. Classified as Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (product code DBL), Class II - Special Controls.

Submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1982 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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.

FDA 510(k) Submission Details - K820088

510(k) Number K820088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1982
Decision Date January 26, 1982
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.

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 23
Devices cleared under the same product code (DBL) and FDA review panel - the closest regulatory comparables to K820088.
AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH)
K883915 · Immco Diagnostics, Inc. · Oct 1988
I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT
K871194 · Cronus · Apr 1987
ANTINUCLEAR ANTIBODY SCREEN FLOURESC
K821576 · Immuno-Products Industries · Jun 1982
ANTI-SKIN ANTIBODY TEST SYSTEM
K811261 · Zeus Scientific, Inc. · Aug 1981
ANTI-DS/N-DNA TEST KIT
K801960 · Immuno-Diagnostic Products, Inc. · Oct 1980
KALLESTAD FLORESCENT ANA/AMA/ASMA TEST
K792610 · Kallestad Laboratories, Inc. · Feb 1980
K820088 · AFT SYSTEM PROFICIENCY TESTING PROGRAM
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