Cleared Traditional

K905162 - QUIDEL TOTAL IGE POSITIVE CONTROL SERUM

K905162 is the FDA 510(k) clearance for QUIDEL TOTAL IGE POSITIVE CONTROL SERUM by Quidel Corp.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K905162 · Quidel Corp. · Immunology device
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Jan 1991
Decision
59d
Days
Class 2
Risk

K905162 is an FDA 510(k) clearance for the QUIDEL TOTAL IGE POSITIVE CONTROL SERUM. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on January 14, 1991 after a review of 59 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 Quidel Corp. devices

Submission Details

510(k) Number K905162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1990
Decision Date January 14, 1991
Days to Decision 59 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 104d · This submission: 59d
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 146
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K905162.
CAP SYSTEM RAST ASM/RIA AND ASM/FEIA
K910517 · Pharmacia, Inc. · Mar 1991
VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY
K905636 · Ventrex Laboratories, Inc. · Feb 1991
SPECIFIC ALLERGEN MODULES FOR ALASTAT ALLERGEN IGE
K910075 · Diagnostic Products Corp. · Jan 1991
POSITIVE CONTROL PAD ALLERGEN/FOOD ALLERGEN SCREEN
K905176 · Quidel Corp. · Dec 1990
TURBO-RAST SPECIFIC IGE ASSAY
K904330 · Ventrex Laboratories, Inc. · Dec 1990
ALRGN SET
K903637 · Ciba Corning Diagnostics Corp. · Nov 1990