Cleared Traditional

K941057 - SPECIFIC IGE EIA-ULTRA ASSAY

K941057 is the FDA 510(k) clearance for SPECIFIC IGE EIA-ULTRA ASSAY by Hycor Biomedical, Inc.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K941057 · Hycor Biomedical, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
318d
Days
Class 2
Risk

K941057 is an FDA 510(k) clearance for the SPECIFIC IGE EIA-ULTRA ASSAY. 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 January 20, 1995 after a review of 318 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 K941057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1994
Decision Date January 20, 1995
Days to Decision 318 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
214d slower than avg
Panel avg: 104d · This submission: 318d
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 K941057.
LATEX (K82)
K931746 · Diagnostic Products Corp. · Mar 1995
HY-TEC AUTOMATED EIA SYSTEM
K941278 · Hycor Biomedical, Inc. · Mar 1995
HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT
K943768 · Diagnostic Products Corp. · Mar 1995
IMMULITE ALATOP ALLERGY SCREEN
K941564 · Diagnostic Products Corp. · Dec 1994
ALATOP(R) MICROPLATE ALLERGY SCREEN
K935488 · Diagnostic Products Corp. · Mar 1994
ACCESS SPECIFIC IGE ASSAY
K935876 · Bio-Rad Laboratories, Inc. · Mar 1994