Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190 +1 more model
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K122722 FDA 510(k)
- FDA Product Code
- DFC FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5600 FDA 510(k)
- Regulation Number
- 866.5600 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cobas C Tina-quant Lipoprotein (a) Gen 2 Assay is an in vitro diagnostic test designed for the quantitative determination of lipoprotein (a) in human serum and plasma. It is utilized on Roche Hitachi cobas c systems to assist in the evaluation of lipid metabolism disorders and the assessment of atherosclerotic cardiovascular disease.
This device is supplied as an assay kit alongside the Preciset Lp (a) Gen 2 Calibrator Set. It has received FDA 510(k) clearance and is classified under regulation number 866.5600 for use in clinical laboratory settings.
Frequently asked questions
What is the primary clinical use of this assay?
This assay is designed for the quantitative determination of lipoprotein (a) in human serum and plasma. It is used by clinical laboratories to assist in the evaluation of lipid metabolism disorders and the assessment of atherosclerotic cardiovascular disease.
What components are included in this diagnostic kit?
The product is supplied as an assay kit that includes the Cobas C Tina-quant Lipoprotein (a) Gen 2 Assay (model 05852625190) and the Preciset Lp (a) Gen 2 Calibrator Set (model 05852641160).
On which systems is this assay performed?
This assay is specifically designed for use on Roche Hitachi cobas c systems, ensuring compatibility and performance within the clinical laboratory environment.
Has this device received regulatory clearance?
Yes, this device has received FDA 510(k) clearance under regulation number 866.5600, confirming it has been reviewed and cleared for use in clinical laboratory settings.
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: LPA2, Tina-quant Lipoprotein (a) Gen.2 - Roche Diagnostics USA, LPA2, Tina-quant Lipoprotein (a) Gen.2 - Roche Diagnostics USA, Cobas C Tina-quant Lipoprotein (A) Gen 2 Assay Model 05852625190 ..., method-sheet-cobas - elabdoc-prod.roche.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122722 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics
Sources (1)
- FDA 510(k) K122722 24 fields · synced Sep 24, 2026