Cleared Traditional

K941328 - TRAK LIQUID CEREBROSPINAL FLUID CONTROL LEVELS 1 & 2 (FDA 510(k) Clearance)

Class I Chemistry device.

K941328 · Medical Analysis Systems, Inc. · Chemistry device
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Aug 1994
Decision
153d
Days
Class 1
Risk

K941328 is an FDA 510(k) clearance for the TRAK LIQUID CEREBROSPINAL FLUID CONTROL LEVELS 1 & 2. 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 August 18, 1994 after a review of 153 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Analysis Systems, Inc. devices

Submission Details

510(k) Number K941328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1994
Decision Date August 18, 1994
Days to Decision 153 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 88d · This submission: 153d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.