Cleared Traditional

K880152 - PAR(TM) BRAND DRUG OF ABUSE CONTROLS

K880152 is an FDA 510(k) clearance for PAR(TM) BRAND DRUG OF ABUSE CONTROLS, manufactured by Medical Analysis Systems, Inc.. The device is a Class 1 Toxicology device with 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

FDA 510(k) Submission Details - K880152

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.

DIF Device Classification - Class 1, General Controls

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 175
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