VITROS Intact PTH II Reagent Pack
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221197 FDA 510(k)
- FDA Product Code
- CEW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1545 FDA 510(k)
- Regulation Number
- 862.1545 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The VITROS Intact PTH II Reagent Pack is a radioimmunoassay reagent pack designed for the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (K2-EDTA, lithium heparin, or sodium heparin). Classified as a radioimmunoassay device, it employs immunodiagnostic technology to detect and quantify iPTH levels, supporting clinical chemistry applications.
This reagent pack is intended for use with the automated VITROS ECi, ECiQ, 3600, 5600, XT, and 7600 Integrated Immunodiagnostic Systems. It is supplied as a single-use reagent pack and has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II device (FDA regulation number 862.1545). No third-party review or CE marking is indicated in the provided data.
Frequently asked questions
What is the VITROS Intact PTH II Reagent Pack used for?
The VITROS Intact PTH II Reagent Pack is designed for the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma samples collected with K2-EDTA, lithium heparin, or sodium heparin. It employs radioimmunoassay technology to detect and accurately quantify iPTH levels, aiding in clinical chemistry applications such as diagnosing and monitoring parathyroid disorders.
Which VITROS systems is this reagent pack compatible with?
This reagent pack is specifically intended for use with the following automated VITROS Integrated Immunodiagnostic Systems: ECi, ECiQ, 3600, 5600, XT, and 7600. Compatibility ensures accurate and reliable measurement of iPTH levels within these platforms.
Is the VITROS Intact PTH II Reagent Pack single-use or reusable?
The VITROS Intact PTH II Reagent Pack is designed for single-use only. This ensures sterility, consistency, and safety for each measurement, reducing the risk of contamination or degradation between uses.
What sample types can be analyzed with this reagent pack?
This reagent pack is approved for use with human serum and plasma samples collected using K2-EDTA, lithium heparin, or sodium heparin anticoagulants. The compatibility with these sample types ensures accurate and reliable detection of intact parathyroid hormone (iPTH).
What regulatory pathway was followed for this device?
The VITROS Intact PTH II Reagent Pack received FDA 510(k) clearance under the Traditional pathway, classified as a Class II device under FDA regulation number 862.1545. This pathway confirms that the device is substantially equivalent to a legally marketed predicate device, ensuring its safety and effectiveness for its intended use.
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: VITROS Immunodiagnostic Products Intact PTH II Reagent Pack (K221197 ..., PDF K221197 - Food and Drug Administration, Ortho-Clinical VITROS Immunodiagnostics Products Intact PTH, PDF VITROS® Immunodiagnostic Products Intact Parathyroid Hormone (iPTH)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221197 | Class II | Active |
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Manufacturer
- Manufacturer
- Ortho-Clinical Diagnostics
- FDA Applicant
- Ortho Clinical Diagnostics
Sources (1)
- FDA 510(k) K221197 24 fields · synced Oct 1, 2026