Cleared Traditional

K990688 - MTM BIOSCANNER C TEST STRIPS

K990688 is an FDA 510(k) clearance for MTM BIOSCANNER C TEST STRIPS, manufactured by Polymer Technology Systems, Inc.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K990688 · Polymer Technology Systems, Inc. · Chemistry device
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Jun 1999
Decision
119d
Days
Class 1
Risk

K990688 is an FDA 510(k) clearance for the MTM BIOSCANNER C TEST STRIPS. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Polymer Technology Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 24, 1999 after a review of 119 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

FDA 510(k) Submission Details - K990688

510(k) Number K990688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1999
Decision Date June 24, 1999
Days to Decision 119 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 88d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

CHH Device Classification - Class 1, General Controls

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
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.

Regulatory Peers - CHH Enzymatic Esterase--oxidase, Cholesterol

All 137
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K990688.
PTS PANELS LIPID PANEL TEST STRIPS
K022898 · Polymer Technology Systems, Inc. · Sep 2002
BIOSCANNER PLUS
K013173 · Polymer Technology Systems, Inc. · Oct 2001
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP
K992803 · Sigma Diagnostics, Inc. · Sep 1999
MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220
K981493 · Polymer Technology Systems, Inc. · Jul 1998
CHOL
K981652 · Abbott Laboratories · Jun 1998
CHOL
K981476 · Abbott Laboratories · Jun 1998