Cleared Traditional

K831987 - EPSILON IGE TEST KIT (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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.