Cleared Traditional

K940183 - HY-TEC TOTAL IGE ENZYME IMMUNOASSAY

K940183 is the FDA 510(k) clearance for HY-TEC TOTAL IGE ENZYME IMMUNOASSAY by Hycor Biomedical, Inc.. It is a Class 2 Immunology device (product code DGC) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K940183 · Hycor Biomedical, Inc. · Immunology device
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May 1994
Decision
125d
Days
Class 2
Risk

K940183 is an FDA 510(k) clearance for the HY-TEC TOTAL IGE ENZYME IMMUNOASSAY. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on May 17, 1994 after a review of 125 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 Hycor Biomedical, Inc. devices

Submission Details

510(k) Number K940183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1994
Decision Date May 17, 1994
Days to Decision 125 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
21d slower than avg
Panel avg: 104d · This submission: 125d
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 81
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K940183.
BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
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AIA-PACK IGE II ASSAY
K972697 · Tosoh Medics, Inc. · Oct 1997
UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
K964152 · Pharmacia, Inc. · Apr 1997
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