Cleared Traditional

K021208 - IMMULITE 2000 MIXED ALLERGEN PANELS

K021208 is an FDA 510(k) clearance for IMMULITE 2000 MIXED ALLERGEN PANELS, manufactured by Diagnostic Products Corp.. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K021208 · Diagnostic Products Corp. · Immunology device
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May 2002
Decision
44d
Days
Class 2
Risk

K021208 is an FDA 510(k) clearance for the IMMULITE 2000 MIXED ALLERGEN PANELS. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on May 30, 2002 after a review of 44 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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K021208

510(k) Number K021208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2002
Decision Date May 30, 2002
Days to Decision 44 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
61d faster than avg
Panel avg: 105d · This submission: 44d
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 230
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K021208.
CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)
K030590 · Hitachi Chemical Diagnostics, Inc. · Mar 2003
IMMULITE 2000 ALLERGEN-SPECIFIC IGE
K023152 · Diagnostic Products Corp. · Dec 2002
IMMULITE 2000 SPECIFIC ALLERGENS
K021206 · Diagnostic Products Corp. · May 2002
IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS)
K013135 · Diagnostic Products Corp. · Oct 2001
IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)
K013134 · Diagnostic Products Corp. · Oct 2001
ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8
K000132 · Pharmacia & Upjohn Co. · Feb 2000