Cleared Traditional

K941278 - HY-TEC AUTOMATED EIA SYSTEM

K941278 is the FDA 510(k) clearance for HY-TEC AUTOMATED EIA SYSTEM by Hycor Biomedical, Inc.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 361-day FDA review.

K941278 · Hycor Biomedical, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
361d
Days
Class 2
Risk

K941278 is an FDA 510(k) clearance for the HY-TEC AUTOMATED EIA SYSTEM. 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 March 13, 1995 after a review of 361 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K941278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1994
Decision Date March 13, 1995
Days to Decision 361 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
257d slower than avg
Panel avg: 104d · This submission: 361d
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 K941278.
HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY
K945748 · 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
HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT
K943768 · Diagnostic Products Corp. · Mar 1995
SPECIFIC IGE EIA-ULTRA ASSAY
K941057 · Hycor Biomedical, Inc. · Jan 1995
IMMULITE ALATOP ALLERGY SCREEN
K941564 · Diagnostic Products Corp. · Dec 1994