Cleared Traditional

K930984 - ACCESS TOTAL IGE ASSAY

K930984 is the FDA 510(k) clearance for ACCESS TOTAL IGE ASSAY by Bio-Rad Laboratories, Inc.. It is a Class 2 Immunology device (product code DGC) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K930984 · Bio-Rad Laboratories, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
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 75
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K930984.
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
K934594 · Ciba Corning Diagnostics Corp. · Apr 1994
COBAS(R) CORE IGE TOTAL EIA
K930890 · Roche Diagnostic Systems, Inc. · Aug 1993
QUANTA LITE MITOCHONDRIA M2 ELISA
K933180 · Inova Diagnostics, Inc. · Aug 1993
ACS TOTAL IGE IMMUNOASSAY
K920372 · Ciba Corning Diagnostics Corp. · Apr 1992
KALLESTEAD TOTAL IGE MICROPLATE KIT
K912800 · Bio-Rad Laboratories, Inc. · Jul 1991
PHARMACIA SPECIFIC IGE CONTROL
K911631 · Pharmacia, Inc. · Apr 1991