Identifiers
- 510(k) Number
- K121558 FDA 510(k)
- FDA Product Code
- DCK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5270 FDA 510(k)
- Regulation Number
- 866.5270 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Diazyme HSCRP Point-of-Care Test Kit is a C-Reactive Protein (CRP), Antigen, Antiserum, and Control diagnostic device designed for point-of-care testing. It quantifies high-sensitivity C-reactive protein (hsCRP) levels in human venous whole blood, aiding in the assessment of inflammation and cardiovascular risk.
This kit is intended for use in clinical settings, such as physician offices, by healthcare professionals. It is supplied as a single-use device and requires no special regulatory approval beyond its FDA 510(k) clearance (K121558) under the Immunology advisory committee. The device adheres to Class II regulatory classification and is governed by 21 CFR 866.5270. Storage and handling follow standard point-of-care diagnostic protocols.
Frequently asked questions
What clinical setting is the Diazyme HSCRP POC Test Kit designed for, and who can use it?
The Diazyme HSCRP POC Test Kit is designed for use in clinical settings like physician offices, where healthcare professionals—such as doctors, nurses, or trained medical staff—can perform point-of-care testing. It is not intended for home use or self-administration by patients.
Is the Diazyme HSCRP POC Test Kit single-use or reusable, and how should it be handled?
The kit is explicitly designed as a single-use device, meaning each test requires a new kit. Since it is a point-of-care diagnostic tool, standard protocols for handling single-use diagnostic reagents should be followed, including proper disposal after use to maintain sterility and prevent contamination.
What type of sample does the Diazyme HSCRP POC Test Kit analyze, and how is it quantified?
The kit quantifies high-sensitivity C-reactive protein (hsCRP) levels in human venous whole blood. It is used to assess inflammation and cardiovascular risk by measuring the concentration of CRP, a biomarker linked to these conditions.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for buyers?
The Diazyme HSCRP POC Test Kit received FDA 510(k) clearance (K121558) under the Immunology advisory committee, with a determination of substantial equivalence to a predicate device. This means the device was reviewed for safety and performance against existing, cleared products and meets Class II regulatory standards (21 CFR 866.5270). Buyers can rely on this clearance as evidence of compliance with FDA requirements for diagnostic devices in this category.
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: DIAZYME HSCRP POC TEST KIT (K121558) — FDA 510(k) | Innolitics, hsCRP Assay - diazyme.com, Diazyme Hs Crp Assay Kit / Calibrator Set / Control Set
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121558 | Class II | Active |
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Manufacturer
- Manufacturer
- Diazyme Laboratories
Sources (1)
- FDA 510(k) K121558 24 fields · synced Sep 19, 2026