Cleared Traditional

MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) (K993377) - FDA 510(k) Clearance

Class I Chemistry device.

K993377 · Polymer Technology Systems, Inc. · Chemistry device
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Jan 2000
Decision
107d
Days
Class 1
Risk

K993377 is an FDA 510(k) clearance for the MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC). Classified as Lipoprotein, High Density, Hdl, Over The Counter (product code NAQ), Class I - General Controls.

Submitted by Polymer Technology Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 13, 2000 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - 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 Polymer Technology Systems, Inc. devices

Submission Details

510(k) Number K993377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1999
Decision Date January 13, 2000
Days to Decision 107 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
19d slower than avg
Panel avg: 88d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NAQ Lipoprotein, High Density, Hdl, Over The Counter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
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.