Cleared Traditional

HY-TEC TOTAL IGE ENZYME IMMUNOASSAY (K940183) - FDA 510(k) Clearance

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

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
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 113
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K940183.
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K063425 · Dade Behring, Inc. · Feb 2007
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
K024210 · Beckman Coulter, Inc. · Feb 2003