Cleared Traditional

K900173 - HYCOR ACCUPINCH MORPHINE TEST

K900173 is the FDA 510(k) clearance for HYCOR ACCUPINCH MORPHINE TEST by Hycor Biomedical, Inc.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K900173 · Hycor Biomedical, Inc. · Toxicology device
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Mar 1990
Decision
77d
Days
Class 2
Risk

K900173 is an FDA 510(k) clearance for the HYCOR ACCUPINCH MORPHINE TEST. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on March 30, 1990 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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: 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 Hycor Biomedical, Inc. devices

Submission Details

510(k) Number K900173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1990
Decision Date March 30, 1990
Days to Decision 77 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 87d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 136
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K900173.
EMIT(R) II OPIATE ASSAY
K902577 · Syva Co. · Jul 1990
MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT
K902194 · Immunotech Corp. · Jul 1990
MILENIA(TM) OPIATES
K901577 · Diagnostic Products Corp. · May 1990
COAT-A-COUNT(TM) FENTANYL (TKFN1)
K891605 · Diagnostic Products Corp. · Sep 1989
ABUSCREEN FP FOR MORPHINE
K890888 · Roche Diagnostic Systems, Inc. · Mar 1989
ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE
K882496 · Roche Diagnostic Systems, Inc. · Sep 1988