Cleared Traditional

K991048 - ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2

K991048 is an FDA 510(k) clearance for ALLERGEN IMMUNOCAP, manufactured by Pharmacia & Upjohn Co.. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K991048 · Pharmacia & Upjohn Co. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
45d
Days
Class 2
Risk

K991048 is an FDA 510(k) clearance for the ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F.... Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Pharmacia & Upjohn Co. (Westervillle, US). The FDA issued a Cleared decision on May 14, 1999 after a review of 45 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 Pharmacia & Upjohn Co. devices

FDA 510(k) Submission Details - K991048

510(k) Number K991048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1999
Decision Date May 14, 1999
Days to Decision 45 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
60d faster than avg
Panel avg: 105d · This submission: 45d
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 K991048.
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
ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F
K993388 · Pharmacia & Upjohn Co. · Dec 1999
ALASTAT MICROPLATE MIXED ALLERGEN PANELS
K983954 · Diagnostic Products Corp. · Dec 1998
ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3
K982343 · Pharmacia & Upjohn Co. · Sep 1998
ALLERGAN IMMUNO CAP M4, M8, K70
K974350 · Pharmacia, Inc. · Feb 1998