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Albu Trol, Low Model 108.001.002; Albu Trol, High Model 108.002.002

FDA 510(k)EUDAMED

Class I (US FDA 510(k))

510(k) K060215

by Eurotrol B.V.

Identifiers

510(k) Number
K060215 FDA 510(k)
FDA Product Code
JJX FDA 510(k)
Models / Variants
Albu Trol, Low, Model 108.001.002 FDA 510(k)EUDAMED
Albu Trol, High 108.002.002 FDA 510(k)EUDAMED

Classification

Device Class
Class I FDA 510(k)
Legislation / Framework
21 CFR Part 862.1660 FDA 510(k)
Regulation Number
862.1660 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Albu Trol, Low Model 108.001.002 and Albu Trol, High Model 108.002.002 are assayed urine albumin control materials classified as Single (Specified) Analyte Controls. These devices consist of human urine spiked with human albumin at two distinct concentrations (~25 mg/L for the Low model and ~75 mg/L for the High model) to serve as reference standards for quantitative testing.

Supplied in 1.0 mL dropper bottles, these controls are intended for use in clinical chemistry settings to verify the precision and accuracy of urine albumin testing systems, such as the HemoCue Urine Albumin and HemoCue Albumin 201 systems. They are single-use, non-sterile materials with no MRI safety considerations. Authorized under FDA 510(k) clearance (K060215) and the In Vitro Diagnostic Medical Devices Directive (IVDD), these controls are distributed by Eurotrol B.V.

Frequently asked questions

What are the Albu Trol controls specifically designed to verify in urine albumin testing systems?

The Albu Trol controls (Low Model 108.001.002 and High Model 108.002.002) are designed to verify the precision and accuracy of urine albumin testing systems like the HemoCue Urine Albumin and HemoCue Albumin 201. They achieve this by providing two distinct human urine samples spiked with human albumin at concentrations of approximately 25 mg/L (Low) and 75 mg/L (High), serving as reference standards for quantitative testing.

Are the Albu Trol controls sterile, and how should they be stored?

The Albu Trol controls are non-sterile and supplied in 1.0 mL dropper bottles. Since they are single-use, they should be stored in a cool, dry place away from direct sunlight or extreme temperatures. Always check the label for expiration dates and handle them with care to avoid contamination before use.

What is the regulatory pathway for these controls, and which advisory committee reviewed them?

The Albu Trol controls were authorized through FDA 510(k) clearance (K060215) under the Traditional 510(k) review pathway, classified as substantially equivalent to a predicate device. They were reviewed by the Clinical Chemistry (CH) advisory committee and fall under product code JJX (In Vitro Diagnostic Product—Chemistry Analytes). Additionally, they comply with the In Vitro Diagnostic Medical Devices Directive (IVDD).

Can these controls be reused, and what is the intended clinical chemistry application?

No, the Albu Trol controls are single-use only and must not be reused after opening. They are Single (Specified) Analyte Controls intended exclusively for clinical chemistry settings to validate the performance of urine albumin testing systems, ensuring reliable results for diagnostic purposes.

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: Albu Trol, Low, Model 108.001.002; Albu Trol, High 108.002.002, PDF ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 510 (k ..., Eurotrol AlbuTrol AlbuTrol Level 2 Eurotrol AlbuTrol® is an assayed ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Eurotrol B.V.

Sources (2)

  • FDA 510(k) K060215 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026