Cleared Traditional

K933572 - URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)

K933572 is an FDA 510(k) clearance for URINE HEROIN/MORPHINE DIRECT RIA KIT (I..., manufactured by Immunalysis Corporation. The device is a Class 2 Toxicology device with product code DOE cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K933572 · Immunalysis Corporation · Toxicology device
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Apr 1994
Decision
257d
Days
Class 2
Risk

K933572 is an FDA 510(k) clearance for the URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125). Classified as Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. (product code DOE), Class II - Special Controls.

Submitted by Immunalysis Corporation (Glendale, US). The FDA issued a Cleared decision on April 6, 1994 after a review of 257 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3640 - the FDA toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Immunalysis Corporation devices

FDA 510(k) Submission Details - K933572

510(k) Number K933572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1993
Decision Date April 06, 1994
Days to Decision 257 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 87d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DOE Device Classification - Class 2, Special Controls

Product Code DOE Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3640
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 Toxicology devices follow this clearance model.

Regulatory Peers - DOE Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep.

All 8
Devices cleared under the same product code (DOE) and FDA review panel - the closest regulatory comparables to K933572.
INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST
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