MICROALBUMIN MULTI-CALIBRATOR SET

K042243 · Diagnostic Chemicals , Ltd. · JIX · Oct 4, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042243
• Device Name: MICROALBUMIN MULTI-CALIBRATOR SET
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Oct 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

For IN VITRO diagnostic use as a calibrator for the DCL Microalbumin Assay for quantitation of albumin in human urine. For Prescription Use Only

Device Story

The Microalbumin Multi-Calibrator Set is an in vitro diagnostic product used to establish reference points for the DCL Microalbumin Assay. It is intended for professional laboratory use to ensure accurate quantitation of albumin levels in human urine samples. By providing known concentration values, the calibrator allows the assay system to generate a standard curve, enabling the determination of albumin concentrations in patient specimens. This process supports clinical decision-making regarding renal function and the detection of microalbuminuria.

Clinical Evidence

No clinical data. Bench testing only. Stability validated via accelerated studies (12-month shelf life) and ongoing real-time studies. Value assignment validated using internal standards and recovery rates (1.00 +/- 0.03).

Technological Characteristics

Liquid solution calibrator set; 6 levels (1-300 mg/L). Human donor-derived material tested for HBsAG, HCV, and HIV. Traceable to Scripps Lab (Cat # A0213) Human Serum. Stability: 30 days opened at 2-8 °C; 12-month shelf life.

Indications for Use

Indicated for use as a calibrator in the DCL Microalbumin Assay for the quantitative measurement of albumin in human urine specimens.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

{0}

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

A. 510(k) Number:
k042243

B. Purpose for Submission:
New Device

C. Analyte:
Albumin

D. Type of Test:
Quantitative

E. Applicant:
Diagnostic Chemicals Limited

F. Proprietary and Established Names:
Microalbumin Multi-Calibrator Set

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1150 Calibrator
2. Classification:
II
3. Product Code:
JIX
4. Panel:
75

H. Intended Use:
1. Intended use(s):
For IN VITRO diagnostic use as a calibrator for the DCL Microalbumin
Assay for quantitation of albumin in human urine.

2. Indication(s) for use:
For IN VITRO diagnostic use as a calibrator for the DCL Microalbumin
Assay for quantitation of albumin in human urine.

3. Special condition for use statement(s):
For Prescription Use Only

{1}

Page 2 of 4

4. Special instrument Requirements: N/A

I. Device Description:
The Microalbumin Multi-Calibrator set contains 6 levels of 1 mL of liquid solutions corresponding to the following values: 1, 5, 10, 50, 100 and 300 mg/L. The human donor unit used to produce this control was tested by FDA accepted methods and found free of Hepatitis B Surface Antigen (HBsAG), antibody to Hepatitis C (HCV) and antibody to HIV.

J. Substantial Equivalence Information:
1. Predicate device name(s): Kamiya Biomedical Company Microalbumin Calibrator Set
2. Predicate K number(s): K991166
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | For IN VITRO diagnostic use as a calibrator for the DCL Microalbumin Assay for quantitation of albumin in human urine. | The K-Assay microalbumin Calibrator Set is used for the calibration of the K-Assay Microalbumin immunoturbimetric assay for quantitating albumin in urine specimens. |
| Sample | Urine | Urine |
| Matrix | Liquid | Liquid |

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

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 (controls, calibrators, or method): Scripps Lab (Cat # A0213) Human Serum Stability

{2}

Page 3 of 4

Once opened, the calibrators are stable for 30 days when stored at 2-8 °C. An accelerated study was conducted on the Microalbumin Calibrator set to support the shelf life of 12 months. An on-going real time study is being conducted and the Microalbumin Calibrator set is checked at its half life and at 13 months.

Value Assignment

An inhouse standard is used to prepare a calibration curve by diluting it to the desired concentrations. The values of the calibrator concentrations are assigned from multiple readings using DCL Microalbumin reagent on a Hitachi 717 or equivalent analyzer. The acceptable CV % for each sample is 3 percent. The recovery rate of each concentration of the diluted primary standard is 1.00 +/- 0.03. The calibrator lots are validated using the internal standard, serum with a known value, and the previous lot of calibrators. The new lot is acceptable if the sample results fall within 100 +/- 5% of their known values.

d. Detection limit: N/A
e. Analytical specificity: N/A
f. Assay cut-off: N/A

2. Comparison studies:
a. Method comparison with predicate device: N/A
b. Matrix comparison: N/A

3. Clinical studies:
a. Clinical sensitivity: N/A
b. Clinical specificity: N/A
c. Other clinical supportive data (when a and b are not applicable): N/A

4. Clinical cut-off: N/A

5. Expected values/Reference range:

The concentrations of the calibrators in the Microalbumin Multi-Calibrator Set have lot specific values that range from 0 to 300 mg/L.

{3}

Page 4 of 4

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