ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002

K060215 · Eurotrol B.V. · JJX · Mar 24, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060215
• Device Name: ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002
• Applicant: Eurotrol B.V.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Albutrol is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue Urine Albumin and HemoCue Albumin 201 Systems. For Prescription use only.

Device Story

AlbuTrol is an assayed urine albumin control material; consists of human urine with human albumin at two levels (~25 mg/L and ~75 mg/L). Supplied in 1.0 mL dropper bottles. Used by healthcare professionals in clinical settings to verify precision and accuracy of HemoCue Urine Albumin and HemoCue Albumin 201 systems. Operation involves dispensing a drop onto a hydrophobic surface; sample drawn into microcuvette via capillary force; microcuvette inserted into system for measurement. Provides a stable, physiologically relevant control to ensure system performance, aiding in reliable clinical decision-making for albumin testing.

Clinical Evidence

No clinical data. Bench testing only. Stability testing (opened and unopened) and value assignment protocols were reviewed and found acceptable.

Technological Characteristics

Matrix: Human urine containing human-derived albumin. Form factor: 1.0 ml liquid vials. Analyte: Albumin (single). Target concentrations: 25 mg/L and 75 mg/L. Storage: 2-8°C. No electronic or software components.

Indications for Use

Indicated for professional use as an assayed quality control material to verify precision and accuracy of HemoCue Urine Albumin and HemoCue Albumin 201 systems.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• MAS® UA Control (K023928)

Submission Summary (Full Text)

{0}

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k060215

B. Purpose for Submission:
Clearance of new device

C. Measurand:
Assayed Controls for urine albumin assays

D. Type of Test:
Not applicable. This submission is for clearance of controls.

E. Applicant:
Eurotrol B.V.

F. Proprietary and Established Names:
AlbuTrol Controls (Low and High)

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) | Class I | 21 CFR 862.1660, Quality control material (assayed and unassayed). | 75 CLINICAL CHEMISTRY (CH) |

H. Intended Use:

1. Intended use(s):
See Indications for Use below.

2. Indication(s) for use:
Albutrol is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue Urine Albumin and HemoCue Albumin 201 Systems.

3. Special conditions for use statement(s):
For Prescription use only.

4. Special instrument requirements:
HemoCue Albumin Urine Albumin and HemoCue 201 Systems

I. Device Description:

{1}

The controls are prepared from human urine and contain other human source material. Components of the controls which are derived from human source material have been tested and found to be nonreactive for HBsAg, anti-HCV and HIV. Each Human Urine Albumin control kit contains 2 bottles of controls (a 1.0 ml fill volume per bottle) with the following target concentrations (Low and High): 25 and 75 mg/L.

## J. Substantial Equivalence Information:

| Predicate | k023928 |
| --- | --- |
| Describe the item being compared | |
| MAS UA Control | |
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Levels | Low and High | Same |
| Matrix | Human Albumin in human urine | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Constituents | Single, Albumin | Multiple, including microalbumin, specific gravity, pH, glucose, bilirubin, ketones, creatinine, and protein. |
| Analyzer | HemoCue Urine Albumin and HemoCue Albumin 201 Systems | Multiple commercially marketed analyzers |
| Procedures | Quantitative | Qualitative and Semi-quantitative |

## K. Standard/Guidance Document Referenced (if applicable):

None referenced.

## L. Test Principle:

Not applicable.

## M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:
Not applicable

b. Linearity/assay reportable range:
Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

{2}

The AlbuTrol Low and High controls are prepared from human urine and contain other human source material. The values are assigned from replicate analysis on the factory-calibrated HemoCue Urine Albumin and HemoCue Albumin 201 Systems. Below is information from a representative lot of AlbuTrol Low and High Controls on the two systems.

HemoCue Urine Albumin system: Low 25 ± 9 mg/L and High 72 ± 23 mg/L

HemoCue Albumin 201 system: Low 25 ± 9 mg/L and High 75 ± 23 mg/L

**Opened Vial Stability:**

The AlbuTrol Controls are stable for 30 days after opening when stored at 2 to 8°C. Protocols and acceptance criteria for stability testing were described and found to be acceptable.

**Unopened Vial Stability:**

The AlbuTrol Controls are stable for 9 months when stored at 2 to 8°C. Protocols and acceptance criteria for stability testing were described and found to be acceptable.

**d. Detection limit:**

Not applicable

**e. Analytical specificity:**

Not applicable

**f. Assay cut-off:**

Not applicable

**2. Comparison studies:**

**a. Method comparison with predicate device:**

Not applicable

**b. Matrix comparison:**

Not applicable

**3. Clinical studies:**

**a. Clinical Sensitivity:**

Not applicable

**b. Clinical specificity:**

Not applicable

**c. Other clinical supportive data (when a. and b. are not applicable):**

Not applicable

**4. Clinical cut-off:**

Not applicable

**5. Expected values/Reference range:**

Not applicable

**N. Proposed Labeling:**

{3}

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

**O. Conclusion:**
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.**