Cleared Traditional

K904141 - TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III

K904141 is an FDA 510(k) clearance for TDM PLUS XL ENHANCED LIQ DRUG CONTROL I, manufactured by Medical Analysis Systems, Inc.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K904141 · Medical Analysis Systems, Inc. · Chemistry device
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Nov 1990
Decision
56d
Days
Class 1
Risk

K904141 is an FDA 510(k) clearance for the TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Medical Analysis Systems, Inc. (Camarillo, US). The FDA issued a Cleared decision on November 1, 1990 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry 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

FDA 510(k) Submission Details - K904141

510(k) Number K904141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1990
Decision Date November 01, 1990
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 594
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