Cleared Traditional

K972364 - UNICAP PHADIATOP

K972364 is the FDA 510(k) clearance for UNICAP PHADIATOP by Pharmacia, Inc.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K972364 · Pharmacia, Inc. · Immunology device
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Sep 1997
Decision
71d
Days
Class 2
Risk

K972364 is an FDA 510(k) clearance for the UNICAP PHADIATOP. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Westervillle, US). The FDA issued a Cleared decision on September 4, 1997 after a review of 71 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, Inc. devices

Submission Details

510(k) Number K972364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1997
Decision Date September 04, 1997
Days to Decision 71 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
33d faster than avg
Panel avg: 104d · This submission: 71d
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 198
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K972364.
ALASTAT MICROPLATE MIXED ALLERGEN PANELS
K983954 · Diagnostic Products Corp. · Dec 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 SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82
K972068 · Pharmacia, Inc. · Jul 1997
HYCOR ALLERGEN DISC
K965094 · Hycor Biomedical, Inc. · May 1997
IMMULITE LATEX-SPECIFIC IGE
K963245 · Diagnostic Products Corp. · Nov 1996