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PTS Panels CHOL+HDL+GLU Panel Test Strips

FDA 510(k)

Class II (US FDA 510(k))

510(k) K071507

by Polymer Technology Systems

Identifiers

510(k) Number
K071507 FDA 510(k)
FDA Product Code
NBW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1345 FDA 510(k)
Regulation Number
862.1345 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The PTS Panels CHOL+HDL+GLU Panel Test Strips are in vitro diagnostic test strips classified as Chemistry Analytes, Lipid, Cholesterol, and Glucose, Reagents and Kits (NBW) under the FDA’s nomenclature. These disposable test strips are designed to measure total cholesterol, high-density lipoprotein (HDL) cholesterol, and glucose levels in whole blood samples, supporting clinical assessments of lipid metabolism, cardiovascular risk, and glucose regulation.

Used with compatible analyzers such as the CardioChek PA or CardioChek Plus, these test strips require venous whole blood or capillary fingerstick samples for analysis. Supplied as single-use items, they are intended for professional laboratory or point-of-care settings and require no sterilization beyond manufacturer-provided packaging. The device holds an FDA 510(k) clearance (K071507) under the Clinical Chemistry advisory committee, with a clearance type designated as Special. Storage conditions and expiration are specified by the manufacturer.

Frequently asked questions

What clinical conditions can these test strips help assess?

The PTS CHOL+HDL+GLU Panel Test Strips are designed to measure total cholesterol, high-density lipoprotein (HDL) cholesterol, and glucose levels in whole blood samples. These measurements support clinical assessments of lipid metabolism, cardiovascular risk, and glucose regulation, helping clinicians evaluate patient risk for conditions like atherosclerosis, metabolic syndrome, and diabetes.

What types of blood samples are required for testing?

These test strips require venous whole blood or capillary fingerstick samples for accurate analysis. They are compatible with professional laboratory or point-of-care settings, ensuring reliable results for clinical decision-making.

Are these test strips reusable or single-use?

The PTS CHOL+HDL+GLU Panel Test Strips are strictly single-use disposable items. Each strip is intended for one test only, reducing the risk of contamination and ensuring consistent performance. They do not require additional sterilization beyond the manufacturer-provided packaging.

Which analyzers are compatible with these test strips?

These test strips are designed to work exclusively with compatible Polymer Technology Systems analyzers, such as the CardioChek PA or CardioChek Plus. Always verify compatibility with your specific analyzer model to ensure accurate and reliable results.

How should these test strips be stored, and what determines their expiration?

Storage conditions and expiration dates for the PTS CHOL+HDL+GLU Panel Test Strips are specified by the manufacturer. Proper storage is critical to maintaining accuracy and reliability. Always follow the manufacturer’s instructions for storage and check the expiration date before use to ensure optimal performance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PTS Panels Test Strips and Controls - PTS Diagnostics, PTS Diagnostics PTS PANELS™ CHOL+HDL+GLU Panel Test Strips, PTS Panels® CHOL + HDL + GLU Test Strips | VWR, part of Avantor, PTS Panels CHOL+HDL+GLU Test Strips (15 Tests)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Polymer Technology Systems
FDA Applicant
Polymer Technology Systems, Inc.

Sources (1)

  • FDA 510(k) K071507 24 fields · synced Oct 1, 2026