Cleared Traditional

K831987 - EPSILON IGE TEST KIT

K831987 is an FDA 510(k) clearance for EPSILON IGE TEST KIT, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Microbiology device with product code DGO cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K831987 · Beckman Instruments, Inc. · Microbiology device
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Oct 1983
Decision
115d
Days
Class 2
Risk

K831987 is an FDA 510(k) clearance for the EPSILON IGE TEST KIT. Classified as Ige, Peroxidase, Antigen, Antiserum, Control (product code DGO), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5510 - the FDA microbiology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K831987

510(k) Number K831987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1983
Decision Date October 14, 1983
Days to Decision 115 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 102d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DGO Device Classification - Class 2, Special Controls

Product Code DGO Ige, Peroxidase, 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 Microbiology devices follow this clearance model.

Regulatory Peers - DGO Ige, Peroxidase, Antigen, Antiserum, Control

All 8
Devices cleared under the same product code (DGO) and FDA review panel - the closest regulatory comparables to K831987.
BECKMAN EPSILON(TM) IGE REAGENT KIT
K893125 · Beckman Instruments, Inc. · Jun 1989
ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5
K872801 · Diagnostic Products Corp. · Sep 1987
ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM
K860851 · Nichols Institute Diagnostics · Mar 1986
IMMUNOGLOBULIN E TEST KIT
K800995 · Calbiochem-Behring Corp. · May 1980