Cleared Traditional

K925425 - SPECIFIC IGE EIA-TURBO ASSAY

K925425 is an FDA 510(k) clearance for SPECIFIC IGE EIA-TURBO ASSAY, manufactured by Hycor Biomedical, Inc.. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K925425 · Hycor Biomedical, Inc. · Immunology device
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Jan 1993
Decision
79d
Days
Class 2
Risk

K925425 is an FDA 510(k) clearance for the SPECIFIC IGE EIA-TURBO ASSAY. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Hycor Biomedical, Inc. (Portland, US). The FDA issued a Cleared decision on January 14, 1993 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hycor Biomedical, Inc. devices

FDA 510(k) Submission Details - K925425

510(k) Number K925425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1992
Decision Date January 14, 1993
Days to Decision 79 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 105d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHB Device Classification - Class 2, Special Controls

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 231
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K925425.
ALATOP(R) MICROPLATE ALLERGY SCREEN
K935488 · Diagnostic Products Corp. · Mar 1994
ACCESS SPECIFIC IGE ASSAY
K935876 · Bio-Rad Laboratories, Inc. · Mar 1994
CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY
K923420 · Ciba Corning Diagnostics Corp. · Feb 1993
VENTREX ALLERGEN DISC
K924044 · Hycor Biomedical, Inc. · Dec 1992
VENTREX ALLERGEN DISC
K924209 · Hycor Biomedical, Inc. · Nov 1992
BASELINE CALIBRATION VERIFICATION CONTROLS
K923284 · Hycor Biomedical, Inc. · Sep 1992