Cleared Special

K013173 - BIOSCANNER PLUS

Also marketed or referenced as:
LIPID PANEL TEST STRIPS

K013173 is an FDA 510(k) clearance for BIOSCANNER PLUS, manufactured by Polymer Technology Systems, Inc.. The device is a Class 1 Chemistry device with product code CHH cleared through the Special 510(k) pathway after a 28-day FDA review.

K013173 · Polymer Technology Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
28d
Days
Class 1
Risk

K013173 is an FDA 510(k) clearance for the BIOSCANNER PLUS. 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 October 22, 2001 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - 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 - K013173

510(k) Number K013173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2001
Decision Date October 22, 2001
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K013173.
COBAS INTEGRA CHOLESTEROL GEN. 2
K031824 · Roche Diagnostics Corp. · Jul 2003
PTS PANELS LIPID PANEL TEST STRIPS
K023558 · Polymer Technology Systems, Inc. · Nov 2002
PTS PANELS LIPID PANEL TEST STRIPS
K022898 · Polymer Technology Systems, Inc. · Sep 2002
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
K990688 · Polymer Technology Systems, Inc. · Jun 1999
MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220
K981493 · Polymer Technology Systems, Inc. · Jul 1998