ADVIA CHEMISTRY MICROALBUMIN CONTROLS

K052242 · Bayer Healthcare, LLC · JJW · Oct 3, 2005 · Clinical Chemistry

Device Facts

• Record ID: K052242
• Device Name: ADVIA CHEMISTRY MICROALBUMIN CONTROLS
• Applicant: Bayer Healthcare, LLC
• Product Code: JJW · Clinical Chemistry
• Decision Date: Oct 3, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The ADVIA Chemistry Microalbumin Control is intended for in vitro diagnostic use in the control of ADVIA® Chemistry systems for the microalbumin method. For Prescription Use Only

Device Story

ADVIA® Chemistry Microalbumin Controls are human urine-based solutions used as quality control material for the ADVIA® Chemistry systems. The device consists of two levels of control material to monitor the performance of the Microalbumin assay. It is used in clinical laboratory settings by laboratory professionals to verify the accuracy and precision of the analytical system. By comparing the measured values of the control against established target ranges, clinicians ensure the reliability of patient test results, facilitating accurate diagnosis and monitoring of conditions related to microalbuminuria.

Clinical Evidence

No clinical data. Performance was validated through bench testing of stability and control value consistency.

Technological Characteristics

Lyophilized human urine-based solution; two-level control format; intended for use with ADVIA® Chemistry systems. Stability: 28 days at 2-8°C when reconstituted; 24-month shelf life.

Indications for Use

Indicated for in vitro diagnostic use as a quality control material to monitor the precision of ADVIA Chemistry system microalbumin testing procedures.

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

• Urine Controls (K043266)

Submission Summary (Full Text)

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

A. 510(k) Number:
k052242

B. Purpose for Submission:
Marketing of a laboratory control

C. Measurand:
Microalbumin

D. Type of Test:
The product is used as a quality control serum to monitor the precision of laboratory testing procedures.

E. Applicant:
Bayer HealthCare LLC

F. Proprietary and Established Names:
ADVIA® Chemistry Microalbumin Controls

G. Regulatory Information:
1. Regulation section:
21CRF862.1660 Quality control material (assayed and unassayed).
2. Classification:
Class I (reserved)
3. Product code:
JJY
4. Panel:
(75) Chemistry

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H. Intended Use:

1. Intended use(s):

See indications for use below.

2. Indication(s) for use:

The ADVIA Chemistry Microalbumin Control is intended for in vitro diagnostic use in the control of ADVIA® Chemistry systems for the microalbumin method.

3. Special conditions for use statement(s):

For Prescription Use Only

4. Special instrument requirements:

Values are listed for several analyzers

I. Device Description:

The ADVIA Chemistry Microalbumin Control is a human urine based solution containing various constituents.

Human source materials have been screened by FDA approved methods and found to be negative for HBsAg and antibodies to HCV and HIV-1/2.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Randox Urine Controls

2. Predicate 510(k) number(s):

k043266

3. Comparison with predicate:

| Item or Characteristic | Device | Predicate |
| --- | --- | --- |
| Format | Lyophilized mixture of human urine base to which appropriate constituents have been added to achieve specific | Same |

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| Item or Characteristic | Device | Predicate |
| --- | --- | --- |
| | concentration | |
| Constituent Analytes | Microalbumin values only | Multiple analytes |
| Stability | Reconstituted, capped and stored at 2-8°C stable for 28 days
24 months shelf life | Reconstituted urine controls are stable for 8 hours at 25°C and 5 days at 4°C if kept capped in original container and free from contamination or 14 days at -20°C |
| Levels | Two levels | Same |

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

None were referenced in the submission.

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):

The value assignment of the Controls for the two levels were done by a Fitness-For-Use (FFU) study over a period of 4 days. The FFU data was collected with two lots of the Reagents, Calibrators and Controls on two ADVIA® 1650 systems for a total of 128 replicates.

The mean System Specific Values (SSVs) of the two Controls, Level 1 and 2, were then validated by value assignment using a nested testing protocol on the ADVIA® 1650. The nested tested derived mean SSVs compared well with FFU derived mean SSVs and were within 4.8%.

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The FFU study was also done on the ADVIA® 2400 and 1200 systems to compare the 1650 derived mean SSVs with the SSVs derived on the ADVIA® 1200 and the ADVIA® 2400.

Shelf life stability: 24 months.

Open vial stability: 28 days at 2 to 8°C.

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:

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

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O. Conclusion:

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

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