Cleared Traditional

K830214 - AFT SYSTEM III

K830214 is an FDA 510(k) clearance for AFT SYSTEM III, manufactured by Calbiochem-Behring Corp.. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K830214 · Calbiochem-Behring Corp. · Immunology device
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Mar 1983
Decision
44d
Days
Class 2
Risk

K830214 is an FDA 510(k) clearance for the AFT SYSTEM III. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Calbiochem-Behring Corp. (Walker, US). The FDA issued a Cleared decision on March 9, 1983 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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 - K830214

510(k) Number K830214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1983
Decision Date March 09, 1983
Days to Decision 44 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
61d faster than avg
Panel avg: 105d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHN Device Classification - Class 2, Special Controls

Product Code DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

All 70
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K830214.
VIRGO REAGENTS INDIRECT FLUORSCENT
K841127 · Electro-Nucleonics Laboratories, Inc. · Apr 1984
AUTOIMMUNE TEST 1/2/3 SYSTEM
K833119 · Atlantic Antibodies · Nov 1983
IDT ANA STIQ ASSAY
K832383 · Intl. Diagnostic Technology · Aug 1983
ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)
K822681 · Amico Lab, Inc. · Dec 1982
ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K
K822682 · Amico Lab, Inc. · Dec 1982
SERA FOR ANTINUCLEAR ANTIBODIES
K820945 · Centers For Disease Control and Prevention · Oct 1982