Cleared Traditional

K872280 - MODIFIED PHADEBAS RAST/PHADEZYM RAST

K872280 is an FDA 510(k) clearance for MODIFIED PHADEBAS RAST/PHADEZYM RAST, manufactured by Pharmacia, Inc.. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K872280 · Pharmacia, Inc. · Immunology device
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Oct 1987
Decision
113d
Days
Class 2
Risk

K872280 is an FDA 510(k) clearance for the MODIFIED PHADEBAS RAST/PHADEZYM RAST. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on October 7, 1987 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 866.5750 - 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: 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 Pharmacia, Inc. devices

FDA 510(k) Submission Details - K872280

510(k) Number K872280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1987
Decision Date October 07, 1987
Days to Decision 113 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
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.

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 231
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K872280.
IGE IMMUNO RESPONSE TEST (IRT) COMP. FOR MOD. RAST
K873814 · Incstar Corp. · Oct 1987
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS
K873193 · Pharmacia, Inc. · Oct 1987
BAHIA ALLERGEN DISC
K873648 · Incstar Corp. · Oct 1987
RED TOP ALLERGEN DISC
K873486 · Incstar Corp. · Oct 1987
IGE IMMUNO RESPONSE TEST (IRT) CALIBRATOR UNIT
K873676 · Incstar Corp. · Oct 1987
RRT SHORT RAGWEED TEST KIT
K873406 · Incstar Corp. · Sep 1987