Cleared Traditional

K831377 - IGE RADIOIMMUNOASSAY KIT

K831377 is the FDA 510(k) clearance for IGE RADIOIMMUNOASSAY KIT by American Diagnostic Corp.. It is a Class 2 Chemistry device (product code DGC) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K831377 · American Diagnostic Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1983
Decision
36d
Days
Class 2
Risk

K831377 is an FDA 510(k) clearance for the IGE RADIOIMMUNOASSAY KIT. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by American Diagnostic Corp. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5510 - the FDA in vitro diagnostics and chemistry 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 American Diagnostic Corp. devices

Submission Details

510(k) Number K831377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1983
Decision Date June 02, 1983
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DGC Ige, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 Chemistry devices follow this clearance model.

Regulatory Peers - DGC Ige, Antigen, Antiserum, Control

All 68
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K831377.
ABBOTT IGE EIA
K832360 · Abbott Laboratories · Oct 1983
ALLERGEN CONTROL INHALENT
K832218 · Ventrex Laboratories, Inc. · Sep 1983
ALLERCOAT ALLERGEN DISCS
K831326 · Kallestad Laboratories, Inc. · Jun 1983
VENTRE/ZYME IGE KIT
K831485 · Ventrex Laboratories, Inc. · Jun 1983
NEW ALLERGEN DISCS FOR USE IN VAST VENT
K830817 · Ventrex Laboratories, Inc. · Apr 1983
PHADEBAS RAST ALLERGEN DISCS
K823841 · Pharmacia, Inc. · Jan 1983