Cleared Special

K014099 - BIOSCANNER PLUS

K014099 is an FDA 510(k) clearance for BIOSCANNER PLUS, manufactured by Polymer Technology Systems, Inc.. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 8-day FDA review.

K014099 · Polymer Technology Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Dec 2001
Decision
8d
Days
Class 2
Risk

K014099 is an FDA 510(k) clearance for the BIOSCANNER PLUS. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Polymer Technology Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on December 21, 2001 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Polymer Technology Systems, Inc. devices

FDA 510(k) Submission Details - K014099

510(k) Number K014099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2001
Decision Date December 21, 2001
Days to Decision 8 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 88d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

NBW Device Classification - Class 2, Special Controls

Product Code NBW System, Test, Blood Glucose, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - NBW System, Test, Blood Glucose, Over The Counter

All 255
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K014099.
ACCU-CHEK ADVANTAGE MODULE
K021513 · Roche Diagnostics Corp. · Jun 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021448 · Roche Diagnostics Corp. · Jun 2002
SOF-TACT DIABETES MANAGEMENT SYSYEM
K012975 · Abbott Laboratories · Feb 2002
MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM
K012014 · Abbott Diabetes Care, Inc. · Dec 2001
ACCU-CHEK ACTIVE TEST SYSTEM
K012324 · Roche Diagnostics Corp. · Dec 2001
BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS
K013203 · Polymer Technology Systems, Inc. · Nov 2001