Cleared Traditional

ACCESS(R) TOTAL IGE ASSAY (K930984) - FDA 510(k) Clearance

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

K930984 · Bio-Rad Laboratories, Inc. · Immunology device
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Jun 1993
Decision
104d
Days
Class 2
Risk

K930984 is an FDA 510(k) clearance for the ACCESS(R) TOTAL IGE ASSAY. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on June 9, 1993 after a review of 104 days - within the typical 510(k) review window.

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

View all Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K930984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1993
Decision Date June 09, 1993
Days to Decision 104 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 104d · This submission: 104d
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 Immunology devices follow this clearance model.

Regulatory Peers - DGC Ige, Antigen, Antiserum, Control

All 113
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K930984.
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K231151 · Kenota, Inc. · May 2024
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K214068 · Biokit, S.A. · Feb 2023
Total Immunoglobulin E (IgE)
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ADVIA Centaur Total IgE (tIgE)
K193493 · Siemens Healthcare Diagnostics, Inc. · Jan 2020
ABBOTT IMX IGE
K895914 · Abbott Laboratories · Nov 1989
ABBOTT IGE EIA
K832360 · Abbott Laboratories · Oct 1983