Cleared Traditional

K042241 - K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C

K042241 is an FDA 510(k) clearance for K-ASSAY TOTAL IGE, manufactured by Kamiya Biomedical Co.. The device is a Class 2 Immunology device with product code DGC cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K042241 · Kamiya Biomedical Co. · Immunology device
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Dec 2004
Decision
113d
Days
Class 2
Risk

K042241 is an FDA 510(k) clearance for the K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Kamiya Biomedical Co. (Tukwila, US). The FDA issued a Cleared decision on December 10, 2004 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 Kamiya Biomedical Co. devices

FDA 510(k) Submission Details - K042241

510(k) Number K042241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2004
Decision Date December 10, 2004
Days to Decision 113 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
8d slower than avg
Panel avg: 105d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DGC Device Classification - Class 2, Special Controls

Product Code DGC Ige, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - DGC Ige, Antigen, Antiserum, Control

All 90
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K042241.
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
K133404 · Phadia AB · Feb 2014
DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH
K063425 · Dade Behring, Inc. · Feb 2007
QUANTIA IGE
K050493 · Biokit, S.A. · Aug 2005
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
K024210 · Beckman Coulter, Inc. · Feb 2003
RANDOX IGE
K010855 · Randox Laboratories, Ltd. · May 2001
SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT
K002560 · The Binding Site, Ltd. · Oct 2000