QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307

K072078 · Biokit, S.A. · JZG · Dec 19, 2007 · Immunology

Device Facts

• Record ID: K072078
• Device Name: QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307
• Applicant: Biokit, S.A.
• Product Code: JZG · Immunology
• Decision Date: Dec 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5630
• Device Class: Class 2

Intended Use

The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of beta-2-microglubulin concentration in human serum, plasma (EDTA) or urine on the AEROSET ® Instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease.

Device Story

Quantia Beta-2 Microglobulin is a latex particle-enhanced immunoturbidimetric assay; utilizes polystyrene latex particles coated with rabbit IgG anti-human Beta-2-microglobulin. Device processes human serum, plasma (EDTA), or urine samples on the Abbott AEROSET instrument. When sample mixes with reagent, Beta-2-microglobulin causes agglutination; turbidity measured to quantify concentration. Used in clinical laboratory settings by trained personnel. Output provided in mg/L; aids clinicians in diagnosing active rheumatoid arthritis and kidney disease. Benefits include standardized quantitative assessment of renal function and inflammatory status.

Clinical Evidence

No clinical studies were performed. Analytical performance was established via bench testing, including precision (CLSI EP5-A), linearity (CLSI EP6-A), and interference testing (CLSI EP7-A). Method comparison study using 110 urine samples (range 0.01–18.85 mg/L) demonstrated a slope of 1.088 and correlation coefficient (r) of 0.9894 against the predicate device.

Technological Characteristics

Latex particle-enhanced immunoturbidimetric assay. Reagents: sodium dihydrogen phosphate dihydrate, polyethylene glycol, sodium azide, and polystyrene latex particles coated with rabbit IgG anti-human Beta-2-microglobulin. Dimensions/form factor: 4 bottles R1 (6 mL), 4 bottles R2 (3 mL). Energy source: optical turbidimetry via AEROSET instrument. Connectivity: instrument-specific. Sterilization: not applicable (reagent kit).

Indications for Use

Indicated for patients requiring quantitative determination of beta-2-microglobulin in serum, plasma (EDTA), or urine to aid in the diagnosis of active rheumatoid arthritis and kidney disease.

Regulatory Classification

Identification

A beta-2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

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 § 866.9.

Predicate Devices

• IL Test Beta-2-Microglobulin (K943686)

Submission Summary (Full Text)

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

A. 510(k) Number:
k072078

B. Purpose for Submission:
Addition of the urine matrix to the assay procedure

C. Measurand:
Beta-2-microglobulin

D. Type of Test:
Latex particle enhanced immunoturbidimetric assay

E. Applicant:
Biokit S.A.

F. Proprietary and Established Names:
Quantia Beta-2 Microglobulin

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| System, Test, Beta-2-Microglobulin Immunological (JZG) | Class II | 21 CFR 866.5630, Beta-2-microglobulin immunological test system. | 82 IMMUNOLOGY (IM) |

H. Intended Use:

1. Intended use(s):
The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of beta-2-microglobulin concentration in human serum, plasma (EDTA) or urine on the AEROSET ® Instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease.

The Quantia Beta-2 Microglobulin is intended to be used with the already cleared Quantia PROTEINS Control (k050596) and the Beta-2 Microglobulin Standard (k050613).

2. Indication(s) for use:
Same as Intended Use

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

4. Special instrument requirements:
The reagents are for use on the Abbott AEROSET® instrument

I. Device Description:
The Quantia Beta-2 Microglobulin kit contains 4 bottles of Reagent 1 (R1) (6 mL each) and 4 bottles of Reagent 2 (R2) (3 mL each). R1 buffer is sodium dihydrogen

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phosphate dihydrate with polyethylene glycol and preservative (sodium azide). R2 is a suspension of polystyrene latex particles of uniform size coated with the IgG fraction of rabbit anti-human Beta-2-microglobulin specific serum with preservative (sodium azide).

J. Substantial Equivalence Information:

| Predicate: IL Test Beta-2-Microglobulin | K943686 |
| --- | --- |
| | |
| Similarities: | |
| The Quantia Beta-2 Microglobulin and the IL Test Beta-2-Microglobulin are both manufactured by Biokit and are both intended for the quantitative in vitro diagnostic determination of beta-2-microglobulin. They also use the same methodology: Particle Enhanced Immunoturbidimetry. The Quantia Beta-2 Microglobulin and the IL Test Beta-2-Microglobulin, have the same composition: Latex Reagent Suspension of polystyrene latex particles coated with rabbit IgG anti-human Beta-2 Microglobulin in a buffer containing bovine serum albumin and < 0.1 % w/w sodium azide; and Reaction Buffer Phosphate buffer 40mM containing bovine serum albumin and sodium azide < 0.1 % w/w. | |
| Differences: | |
| Specimen type: both assays can use serum and urine as samples. They differ in the plasma types. The device can use EDTA and the predicate can use EDTA and sodium heparin. | |

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

| STANDARDS |
| --- |
| Title and Reference Number |
| CLSI Interference Testing in Clinical Chemistry; Approved Guideline (EP 7-A) |
| CLSI Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (EP09-A2) |
| CLSI Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline (EP5-A) |

L. Test Principle:

When a sample containing Beta-2 Microglobulin is mixed with the reagent, a clear agglutination occurs which can be measured by turbidimetry. Results are expressed in mg/L of Beta-2-microglobulin based on the 1st WHO International Standard (B2M) established in 1985.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

CLSI EP5-A was followed.

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| Samples/Runs | Mean (mg/L) | CV (%) Within Run | CV (%) Total |
| --- | --- | --- | --- |
| 2/40 | 0.066 | 4.2 | 5.4 |
| 2/40 | 0.094 | 1.7 | 3.1 |
| 2/40 | 0.204 | 1.5 | 2.6 |
| 2/40 | 0.302 | 1.6 | 2.3 |

b. Linearity/assay reportable range:

Linearity was assessed according to CLSI EP6-A. The overall reportable range for serum, plasma and urine is 0.025 to 96 mg/L. The assay was linear from 0.025 to 1.6 mg/L (the reportable range for urine samples) with the automatic rerun capability (Dilution Protocol 2); from 0.25 to 16 mg/L without the automatic rerun capability; and from 16 to 96 mg/L with the automatic rerun capability (Dilution Protocol 1).

Prozone

The manufacturer was asked to run a sample higher than 114 mg/L to demonstrate the instrument give a result of &gt;16 mg/L. They tested samples from 80.4 to 200.9 mg/L. In all cases the instrument gave a result of &gt;96 (serum linearity upper limit) and triggered the Dilution Protocol 1. The assay did not demonstrate prozone effect with specimens up to 200 mg/L.

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

The assay calibrators are standardized against WHO reference material B2M. Stability of the reagents was established at 19 months by testing 4 different lots. Reagents should be stored at 2-8°C.

d. Detection limit:

The limit of quantitation (LOQ) was defined as the minimum quantity of analyte that can be measured with a within-run CV below 20% and an error below 20%. The LOQ for the assay was determined to be 0.25 mg/L without the automatic rerun capability and 0.025 mg/L with the automatic rerun capability for serum, plasma and urine. This was established by running serial dilutions of the 4 mg/L calibrator. Through 0.025 mg/L the %CV ranged from 1.0 to 5.5% and error ranged from 3.8 to 9.3%.

The limit of detection (LOD) was defined as the mean reported value + 2SD for a sample free of analyte. The LOD was determined to be 0.046 mg/L without the rerun capability and 0.025 mg/L (LOQ) with the automatic rerun capability.

e. Analytical specificity:

CLSI guideline EP7-A was followed.

| Substance tested | Concentration (mg/dL) | Outcome |
| --- | --- | --- |
| Conjugated bilirubin | 20.9 | No interference |
| Ascorbic acid | 20 | Interference below 10% |
| Hemoglobin | 23.6 | Interference below 10% |
| Protein (IgG) | 100 | No interference |

Urine pH showed no significant positive or negative influence on the result.

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f. Assay cut-off: See Expected values/Reference range

2. Comparison studies:

a. Method comparison with predicate device: The comparison studies were performed using 110 urine samples with values ranging from 0.01 to 18.85 mg/L. The required specifications were: Slope 1.0 ± 0.20; and correlation coefficient r ≥ 0.950. The following results were obtained:

AEROSET versus ILab 900

| Parameter | Outcome |
| --- | --- |
| Slope | 1.088 (95% CI: 1.061 to 1.127) |
| Intercept | -0.001 (95% CI: -0.003 to 0.002) |
| Range (mg/L) | 0.01- 18.85 |
| Mean x (mg/L) | 2.47 |
| Mean y (mg/L) | 2.467 |
| R | 0.9894 |

b. Matrix comparison: Urine was the only matrix compared.

3. Clinical studies:

a. Clinical Sensitivity: Not determined
b. Clinical specificity: Not determined
c. Other clinical supportive data (when a. and b. are not applicable): Not applicable

4. Clinical cut-off: Not determined

5. Expected values/Reference range: Concentrations of Beta-2-microglobulin in urine from healthy subjects averaged 0.098 mg/L with an upper normal limit of 0.32 mg/L (literature).

N. Proposed Labeling: 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 substantially equivalent decision.