Cleared Traditional

K974580 - ALLERGEN IMMUNOCAP F256,F245,F207,F202

K974580 is an FDA 510(k) clearance for ALLERGEN IMMUNOCAP F256, 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 63-day FDA review.

K974580 · Pharmacia & Upjohn Co. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
63d
Days
Class 2
Risk

K974580 is an FDA 510(k) clearance for the ALLERGEN IMMUNOCAP F256,F245,F207,F202. 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 February 9, 1998 after a review of 63 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 - K974580

510(k) Number K974580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1997
Decision Date February 09, 1998
Days to Decision 63 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
42d faster than avg
Panel avg: 105d · This submission: 63d
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 K974580.
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
IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE
K973186 · Diagnostic Products Corp. · Sep 1997
UNICAP PHADIATOP
K972364 · Pharmacia, Inc. · Sep 1997
UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82
K972068 · Pharmacia, Inc. · Jul 1997