PTS Panels Metabolic Chemistry Panel Test Strips
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K070017 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)
PTS Panels Metabolic Chemistry Panel Test Strips are in vitro diagnostic test strips designed to measure glucose, HDL cholesterol, and triglycerides from fingerstick whole blood samples using dry chemistry technology. The device consolidates three separate tests into a single test strip, utilizing vertical flow technology to provide accurate lipid and glucose values.
The test strips are intended for use with the CardioChek PA analyzer by medical professionals in clinical settings. After applying a 40 µL blood sample to the strip and inserting it into the analyzer, results are obtained in approximately two minutes. The strips are supplied in packs of 15 and are for single-use only.
Frequently asked questions
What is the PTS Panels Metabolic Chemistry Panel Test Strip used for?
The PTS Panels Metabolic Chemistry Panel Test Strip is used to measure glucose, HDL cholesterol, and triglycerides from fingerstick whole blood samples. It consolidates three separate tests into a single strip using dry chemistry and vertical flow technology, providing results in approximately two minutes when used with the CardioChek PA analyzer.
How are the PTS Panels Metabolic Chemistry Panel Test Strips supplied and used?
The test strips are supplied in packs of 15 and are designed for single-use only. Each strip requires a 40 µL fingerstick whole blood sample, which is applied to the strip before insertion into the CardioChek PA analyzer for automated analysis.
What technology do the PTS Panels Metabolic Chemistry Panel Test Strips use to measure analytes?
The strips use dry chemistry technology with vertical flow to measure glucose, HDL cholesterol, and triglycerides from whole blood. This technology enables the consolidation of three tests into one strip, allowing for rapid and accurate results in about two minutes when processed by the CardioChek PA analyzer.
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 Panels Metabolic Chemistry Panel Test Strips, PTS Diagnostics Metabolic Chemistry test strips (15 pcs)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070017 | Class II | Active |
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Manufacturer
- Manufacturer
- Polymer Technology Systems
- FDA Applicant
- Polymer Technology Systems, Inc.
Sources (1)
- FDA 510(k) K070017 24 fields · synced Sep 25, 2026