Cleared Traditional

K945748 - HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY

K945748 is the FDA 510(k) clearance for HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY by Hycor Biomedical, Inc.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K945748 · Hycor Biomedical, Inc. · Immunology device
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Jun 1995
Decision
196d
Days
Class 2
Risk

K945748 is an FDA 510(k) clearance for the HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on June 7, 1995 after a review of 196 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - 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 K945748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1994
Decision Date June 07, 1995
Days to Decision 196 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
92d slower than avg
Panel avg: 104d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHB System, Test, Radioallergosorbent (rast) Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
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 - DHB System, Test, Radioallergosorbent (rast) Immunological

All 187
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K945748.
QUICKVUE ONE-STEP ALLERGEN SCREEN
K950728 · Quidel Corp. · Oct 1995
ALASTAT MICROPLATE LATEX-SPECIFIC IGE ALLERGEN
K953014 · Diagnostic Products Corp. · Aug 1995
SPECIFIC IGE ULTRA-EIA
K945884 · Hycor Biomedical, Inc. · Jun 1995
ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA ALTERNATA WHICH ARE SPECIFIC IGEZR
K950629 · Bio-Rad Laboratories, Inc. · May 1995
LATEX (K82)
K931746 · Diagnostic Products Corp. · Mar 1995
HY-TEC AUTOMATED EIA SYSTEM
K941278 · Hycor Biomedical, Inc. · Mar 1995