Cleared Traditional

K040693 - PTS PANELS LDL CHOLESTEROL TEST STRIPS

K040693 is an FDA 510(k) clearance for PTS PANELS LDL CHOLESTEROL TEST STRIPS, manufactured by Polymer Technology Systems, Inc.. The device is a Class 1 Chemistry device with product code MRR cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K040693 · Polymer Technology Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
111d
Days
Class 1
Risk

K040693 is an FDA 510(k) clearance for the PTS PANELS LDL CHOLESTEROL TEST STRIPS. Classified as System, Test, Low Density, Lipoprotein (product code MRR), Class I - General Controls.

Submitted by Polymer Technology Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 6, 2004 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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 - K040693

510(k) Number K040693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2004
Decision Date July 06, 2004
Days to Decision 111 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
23d slower than avg
Panel avg: 88d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

MRR Device Classification - Class 1, General Controls

Product Code MRR System, Test, Low Density, Lipoprotein
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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 - MRR System, Test, Low Density, Lipoprotein

All 21
Devices cleared under the same product code (MRR) and FDA review panel - the closest regulatory comparables to K040693.
DIRECT LDL CHOLESTEROL, MODEL L530-60H
K051121 · Teco Diagnostics · Aug 2005
LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40
K041927 · Diagnostic Chemicals , Ltd. · Nov 2004
VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II
K041720 · Ortho-Clinical Diagnostics, Inc. · Aug 2004
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
K022772 · Hemagen Diagnostics, Inc. · Sep 2002
DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131
K020724 · Dade Behring, Inc. · May 2002
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
K014103 · Beckman Coulter, Inc. · Jan 2002