Cleared Traditional

K933572 - URINE HEROIN/MORPHINE DIRECT RIA KIT (I...

K933572 is the FDA 510(k) clearance for URINE HEROIN/MORPHINE DIRECT RIA KIT (I... by Immunalysis Corporation. It is a Class 2 Toxicology device (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

Submission Details

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.

Device Classification

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.
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