Cleared Traditional

K880152 - PAR(TM) BRAND DRUG OF ABUSE CONTROLS

K880152 is the FDA 510(k) clearance for PAR(TM) BRAND DRUG OF ABUSE CONTROLS by Medical Analysis Systems, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K880152 · Medical Analysis Systems, Inc. · Toxicology device
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May 1988
Decision
139d
Days
Class 1
Risk

K880152 is an FDA 510(k) clearance for the PAR(TM) BRAND DRUG OF ABUSE CONTROLS. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Medical Analysis Systems, Inc. (Camarillo, US). The FDA issued a Cleared decision on May 31, 1988 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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 Medical Analysis Systems, Inc. devices

Submission Details

510(k) Number K880152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1988
Decision Date May 31, 1988
Days to Decision 139 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
52d slower than avg
Panel avg: 87d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DIF Drug Mixture Control Materials

All 146
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K880152.
LYPHOCHEK URINE TOXICOLOGY CONTROL
K881989 · Bio-Rad · Jun 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW
K881990 · Bio-Rad · Jun 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE
K881991 · Bio-Rad · Jun 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW
K880445 · Bio-Rad · Apr 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE
K880444 · Bio-Rad · Feb 1988
STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III
K874757 · Baxter Healthcare Corp · Feb 1988