Poly-Chem 90 Albumin, BUN, Calcium, Carbon Dioxide, Creatinine, and Total Protein Tests
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K110818 FDA 510(k)
- FDA Product Code
- CIX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1035 FDA 510(k)
- Regulation Number
- 862.1035 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Poly-Chem 90 Albumin, BUN, Calcium, Carbon Dioxide, Creatinine, and Total Protein Tests is an in vitro diagnostic reagent system designed for measuring albumin, blood urea nitrogen (BUN), calcium, carbon dioxide, creatinine, and total protein in human serum. Classified as a bromcresol green dye-binding chemistry device, it operates within the field of clinical chemistry to provide quantitative analysis of these biochemical parameters.
This reagent system is intended for use exclusively on the Poly-Chem 90 analyzer in clinical laboratory settings. Supplied as a multi-test kit, it is intended for single-use per the manufacturer’s specifications. The device holds an FDA 510(k) clearance (K110818) under the Traditional pathway, categorized under product code CIX and classified as a Class 2 medical device. No regulatory statements regarding sterility, MRI safety, or reusable components are provided in the available data.
Frequently asked questions
What specific biochemical parameters can the Poly-Chem 90 reagent system measure, and how does it perform these measurements?
The Poly-Chem 90 reagent system is designed to measure albumin, blood urea nitrogen (BUN), calcium, carbon dioxide, creatinine, and total protein in human serum. It uses bromcresol green dye-binding chemistry to provide quantitative analysis of these parameters, enabling clinical laboratories to assess kidney function (BUN, creatinine), electrolyte balance (calcium), acid-base status (carbon dioxide), and protein levels (albumin, total protein).
Is this reagent system compatible with any other analyzers besides the Poly-Chem 90, and what are the storage requirements?
The Poly-Chem 90 reagent system is exclusively intended for use on the Poly-Chem 90 analyzer in clinical laboratory settings. Storage requirements are not explicitly detailed in the provided data, but as a single-use reagent kit, it should be stored according to the manufacturer’s instructions (likely refrigerated or at room temperature, protected from light and moisture) to maintain stability and accuracy.
How is the Poly-Chem 90 reagent system supplied, and is it intended for single-use or repeated use?
The Poly-Chem 90 reagent system is supplied as a multi-test kit designed for single-use per the manufacturer’s specifications. This means each kit is intended for one-time use in the Poly-Chem 90 analyzer, ensuring consistency and reliability in test results without carryover risks from reuse.
What regulatory pathway was followed for FDA clearance, and what classification does this device hold?
The Poly-Chem 90 reagent system received FDA clearance under the Traditional 510(k) pathway (K110818) and is classified as a Class 2 medical device under product code CIX. The clearance was granted as substantially equivalent to a predicate device, and the device falls under the Clinical Chemistry advisory committee (CH).
Are there any specific handling or safety considerations mentioned for this reagent system?
The provided data does not include explicit details on sterility, MRI safety, or reusable components. However, as an in vitro diagnostic reagent system for clinical chemistry, standard laboratory practices for handling biochemical reagents should apply—such as avoiding contamination, proper disposal of used materials, and adherence to manufacturer guidelines for accurate and safe operation on the Poly-Chem 90 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: Poly-chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, and ..., K110818 FDA 510(k) - POLY-CHEM 90 ALBUMIN | Polymedco, Inc., POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110818 | Class II | Active |
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Manufacturer
- Manufacturer
- Polymedco, Inc.
Sources (1)
- FDA 510(k) K110818 24 fields · synced Sep 20, 2026