Cleared Traditional

K870152 - ALLERGEN SPECIFIC CONTROLS

K870152 is an FDA 510(k) clearance for ALLERGEN SPECIFIC CONTROLS, manufactured by 3M Company. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K870152 · 3M Company · Immunology device
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Feb 1987
Decision
24d
Days
Class 2
Risk

K870152 is an FDA 510(k) clearance for the ALLERGEN SPECIFIC CONTROLS. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by 3M Company (Mountain View, US). The FDA issued a Cleared decision on February 6, 1987 after a review of 24 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 3M Company devices

FDA 510(k) Submission Details - K870152

510(k) Number K870152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1987
Decision Date February 06, 1987
Days to Decision 24 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
81d faster than avg
Panel avg: 105d · This submission: 24d
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 K870152.
CAT EPITHELIUM ALLERGEN DISC
K870264 · Incstar Corp. · Feb 1987
ADDITONAL ALLERGENS FOR IGE FAST (TM) TEST
K864104 · 3M Company · Feb 1987
ALLERGEN SPECIFIC IGG4 CONTROL SERA
K870153 · 3M Company · Feb 1987
SPECIFIC IGE FAST(TM) TEST II
K863967 · 3M Company · Dec 1986
BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT
K863743 · Immuno Nuclear Corp. · Dec 1986
3M IGG4 FAST TEST PACKAGE
K863794 · 3M Company · Dec 1986