Cleared Traditional

K000586 - BIOSCANNER TRIGLYCERIDES TEST STRIPS

K000586 is an FDA 510(k) clearance for BIOSCANNER TRIGLYCERIDES TEST STRIPS, manufactured by Polymer Technology Systems, Inc.. The device is a Class 1 Chemistry device with product code JGY cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K000586 · Polymer Technology Systems, Inc. · Chemistry device
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Jul 2000
Decision
132d
Days
Class 1
Risk

K000586 is an FDA 510(k) clearance for the BIOSCANNER TRIGLYCERIDES TEST STRIPS. Classified as Colorimetric Method, Triglycerides (product code JGY), Class I - General Controls.

Submitted by Polymer Technology Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 3, 2000 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1705 - 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 - K000586

510(k) Number K000586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date July 03, 2000
Days to Decision 132 days
Submission Type Traditional
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
44d slower than avg
Panel avg: 88d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

JGY Device Classification - Class 1, General Controls

Product Code JGY Colorimetric Method, Triglycerides
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1705
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 - JGY Colorimetric Method, Triglycerides

All 12
Devices cleared under the same product code (JGY) and FDA review panel - the closest regulatory comparables to K000586.
BIOSCANNER TRIGLYCERIDES TEST STRIPS
K991894 · Polymer Technology Systems, Inc. · May 2000
DNA TRIGLYCERIDE PROCEDURE
K941063 · Data Medical Associates, Inc. · Jul 1994
IL TEST(TM) TRIGLYCERIDE
K931116 · Instrumentation Laboratory CO · Mar 1994
DMA TRIGLYCERIDE (GPO) PROCEDURE
K902202 · Data Medical Associates, Inc. · Jul 1990
TRIGLYCERIDE (GPO) TRINDER REAGENT
K894063 · Sigma Diagnostics, Inc. · Sep 1989
CLINISTAT TRIGLYCERIDES REAGENT TEST
K885134 · Heraeus Kulzer, Inc. · Feb 1989