Cleared Traditional

K032826 - MAS PAR TDM

K032826 is the FDA 510(k) clearance for MAS PAR TDM by Medical Analysis Systems, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K032826 · Medical Analysis Systems, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
29d
Days
Class 1
Risk

K032826 is an FDA 510(k) clearance for the MAS PAR TDM. 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 October 9, 2003 after a review of 29 days - a notably fast clearance cycle.

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: 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 Medical Analysis Systems, Inc. devices

Submission Details

510(k) Number K032826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2003
Decision Date October 09, 2003
Days to Decision 29 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
58d faster than avg
Panel avg: 87d · This submission: 29d
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 K032826.
LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)
K033924 · Bio-Rad Laboratories, Inc. · Feb 2004
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454
K033366 · Bio-Rad · Dec 2003
LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)
K033404 · Bio-Rad · Dec 2003
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438
K022707 · Bio-Rad · Aug 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444
K021384 · Bio-Rad · May 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463
K021411 · Bio-Rad · May 2002