ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI

K123131 · Tosoh Bioscience, Inc. · MRG · Feb 8, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123131
• Device Name: ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI
• Applicant: Tosoh Bioscience, Inc.
• Product Code: MRG · Clinical Chemistry
• Decision Date: Feb 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1825
• Device Class: Class 2

Intended Use

ST AIA-PACK 25-OH Vitamin D is designed for in vitro diagnostic use only for the quantitative measurement of total 25-hydroxyvitamin D (25-OH vitamin D) in human serum, Na-heparinized or EDTA plasma on TOSOH AIA System Analyzers. The Tosoh ST AIA-PACK 25-OH Vitamin D is intended as an aid in the determination of Vitamin D sufficiency. The ST AIA-PACK 25-OH Vitamin D Calibrator Set is intended for in vitro diagnostic use only for the calibration of the ST AIA-PACK 25-OH Vitamin D assay. The AIA-PACK 25-OH Vitamin D Control Set is intended for in vitro diagnostic use only for performing quality control procedures with the ST AIA-PACK 25-OH Vitamin D assay.

Device Story

The ST AIA-PACK 25-OH Vitamin D is a one-step delayed competitive enzyme immunoassay performed in a test cup. Input: human serum, Na heparinized plasma, or EDTA plasma. Process: sample pretreatment with sodium hydroxide dissociates 25-OH vitamin D from binding proteins; 25-OH vitamin D binds to monoclonal antibody immobilized on magnetic beads; enzyme-labeled 25-OH vitamin D is added to compete for binding sites. After incubation and washing, a fluorogenic substrate (4-methylumbelliferyl phosphate) is added. Output: fluorescence signal inversely proportional to 25-OH vitamin D concentration. Used in clinical laboratories on TOSOH AIA System Analyzers. Results assist clinicians in assessing Vitamin D sufficiency and patient management.

Clinical Evidence

No clinical diagnostic studies performed. Evidence consists of analytical bench testing: precision (CLSI EP5-A2), linearity (CLSI EP6-A), interference (CLSI EP7-A2), and method comparison against the predicate (n=156 samples, Deming slope 0.934, r=0.944). Reference range established using 233 healthy individuals.

Technological Characteristics

Fluorescence immunoassay; uses magnetic beads coated with sheep monoclonal anti-25-OH Vitamin D antibody; enzyme-labeled conjugate (bovine alkaline phosphatase); fluorogenic substrate 4-methylumbelliferyl phosphate (4MUP). Dimensions/form factor: test cups for AIA-2000 analyzer. Connectivity: standalone analyzer. Sterilization: not applicable (reagents). Software: automated analyzer control.

Indications for Use

Indicated for quantitative measurement of total 25-hydroxyvitamin D in human serum, Na-heparinized, or EDTA plasma to aid in determining Vitamin D sufficiency. Contraindicated for use with hemolyzed samples.

Regulatory Classification

Identification

A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.

Special Controls

*Classification.* Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and (2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.

Predicate Devices

• DiaSorin Inc. 25-Hydroxyvitamin D 125I RIA Kit (k983617)

Submission Summary (Full Text)

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ST AIA-PACK 25-OH Vitamin D

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# =123131

### 510(k) Summary

# ST AIA-PACK 25-OH Vitamin D

# FEB 0 8 2013

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Submitter:

Contact Person:

Device Name: Classification:

Device Name: Classification

Device Name: Classification

Predicate Device:

October 3, 2012 Amended: January 7, 2013

Tosoh Bioscience, Inc 3600 Gantz Road Grove City, OH 43123

Robert L. Wick Regulatory Specialist 6000 Shoreline Ct., Ste. 101 South San Francisco, CA 94080 Phone: [phone] Fax: Email: [e-mail]

ST AIA-PACK 25-OH Vitamin D Class II MRG Clinical Chemistry 21 CFR 862.1825

ST AIA-PACK 25-OH Vitamin D Calibrator Set Class II JIT Clinical Chemistry 21 CFR 862.1150

AIA-PACK 25-OH Vitamin D Control Set Class II JJX Clinical Chemistry 21 CFR 862.1660

k983617 DiaSorin Inc. 25-Hydroxyvitamin D 1261 RIA Kit

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# 510(k) Summary

# ST AIA-PACK 25-OH Vitamin D

According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

#### Device Description:

The ST AIA-PACK 25-OH Vitamin D is a one-step delayed competitive enzyme immunoassay which, after sample pretreatment, is performed entirely in the ST AIA-PACK 25-OH Vitamin D test cup. Sample pretreatment reagents (containing sodium hydroxide) disassociate 25-OH vitamin D from its binding proteins in the test sample. 25-0H vitamin D present in the pretreated sample is bound to 25-OH vitamin D-specific monoclonal antibody immobilized on magnetic beads. After that, the enzyme-labeled 25-OH vitamin D is added to the reaction mixture. The enzyme-labeled 25-0H vitamin D competes with 25-0H vitamin D for binding to the antibody on magnetic beads in the reaction mixture.

After the second incubation, the magnetic beads are washed to remove the unbound enzymelabeled 25-OH vitamin D and are then incubated with a fluorogenic substrate, 4methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled 25-OH vitamin D that binds to the beads is inversely proportional to the 25-OH vitamin D concentration in the test sample. A standard curve is constructed, and unknown 25-OH vitamin D concentrations are calculated using this curve.

The following products are required to use the ST AIA-PACK 25-OH Vitamin D P/N 025234 :

| ST AIA-PACK 25-OH Vitamin D Calibrator Set | 025334 |
|----------------------------------------------|--------|
| ST AIA-PACK 25-OH Vitamin D Pretreatment Set | 025734 |
| AIA-PACK 25-OH Vitamin D Control Set | 025434 |

#### Device Intended Use:

ST AIA-PACK 25-OH Vitamin D is designed for in vitro diagnostic use only for the quantitative measurement of total 25-hydroxyvitamin D (25-OH vitamin D) in human serum, Na heparinized or EDTA plasma on TOSOH AIA System Analyzers. The Tosoh ST AIA-PACK 25-OH Vitamin D is intended as an aid in the determination of Vitamin D sufficiency.

#### Calibrators:

The ST AIA-PACK 25-OH Vitamin D Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK 25-OH Vitamin D assay.

#### Controls:

The AIA-PACK 25-OH Vitamin D Control Set is.intended for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK 25-OH Vitamin D assay. ·

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### Substantial Equivalence:

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## Comparison between the Tosoh ST AIA-PACK 25-OH Vitamin D and DiaSorin 25-Hydroxyvitamin D 1251 RIA Kit

### Similarities

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| Parameter | ST AIA-PACK 25-OH Vitamin<br>D | DiaSorin 25-Hydroxyvitamin D<br>125I RIA Kit |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | ST AIA-PACK 25-OH Vitamin D<br>is designed for in vitro diagnostic<br>use only for the quantitative<br>measurement of total 25-<br>hydroxyvitamin D (25-OH<br>vitamin D) in human serum, Na<br>heparinized or EDTA plasma on<br>TOSOH AIA System Analyzers.<br>The Tosoh ST AIA-PACK 25-<br>OH Vitamin D is intended as an<br>aid in the determination of<br>Vitamin D sufficiency. | This kit is intended for the<br>quantitative determination of the<br>25-hydroxy vitamin D (25-OH-D)<br>and other hydroxylated vitamin D<br>metabolites in human serum or<br>plasma to be used in the<br>assessment of vitamin D<br>sufficiency. Assay results should<br>be used in conjunction with other<br>clinical and laboratory data to<br>assist the clinician in making<br>individual patient management<br>decisions in an adult population. |
| Specimen type | EDTA plasma, Na heparinized<br>plasma or serum | Serum or plasma |

#### Calibrator Set

| Parameter | ST AIA-PACK 25-OH Vitamin<br>D Calibrator Set | 25-OH-D3 Calibrators for<br>Diasorin 125I RIA Kit |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Intended use | The ST AIA-PACK 25-OH<br>Vitamin D Calibrator Set is<br>intended for IN VITRO<br>DIAGNOSTIC USE ONLY for<br>the calibration of the ST AIA-<br>PACK 25-OH Vitamin D assay. | The 25-OH-D3 Calibrators is<br>used to calibrate the Diasorin 125I<br>RIA Kit. |
| Matrix | Human serum | Human serum |
| Number of Calibrators | 6 | 6 |

#### Control Set

| Parameter | AIA-PACK 25-OH Vitamin D<br>Control Set | 25-OH-D Controls for Diasorin<br>125I RIA Kit |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Intended use | The AIA-PACK 25-OH Vitamin<br>D Control Set is intended for IN<br>VITRO DIAGNOSTIC USE<br>ONLY for performing quality<br>control procedures with the ST<br>AIA-PACK 25-OH Vitamin D<br>assay. | The 25-OH-D Controls is used for<br>performing quality control with<br>the Diasorin 125I RIA Kit. |
| Matrix | Human serum | Human serum |
| Number of levels | 2 | 2 |

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### Differences

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| Parameter | ST AIA-PACK 25-OH Vitamin<br>D | DiaSorin 25-Hydroxyvitamin D<br>125I RIA Kit |
|--------------------|--------------------------------|----------------------------------------------|
| Assay Technology | Fluorescence Immunosassay | Radioimmunoassay |
| Incubation Time | 10 minute cycle | 110 Minute Cycle |
| Reference range | 10.8 to 54.75 ng/mL | 9.0 - 37.6 ng/mL |
| Limit of detection | 2.6 ng/mL | 1.5 ng/mL |
| Assay Range | 4.0 ng/mL - 120.0 ng/mL | 4.8 ng/mL - 100.0 ng/mL |

#### Calibrator Set

| Parameter | ST AIA-PACK 25-OH Vitamin<br>D Calibrator Set | 25-OH-D3 Calibrators for<br>Diasorin 125I RIA Kit |
|------------------|-----------------------------------------------|---------------------------------------------------|
| Format | Lyophilized | Ready to use liquid |
| Calibrator Range | 0-165 ng/mL | 0-100 ng/mL |

| Parameter | AIA-PACK 25-OH Vitamin D<br>Control Set | 25-OH-D Controls for Diasorin<br>125I RIA Kit |
|-----------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Format | Lyophilized | Ready to use liquid |
| Controls Levels | Two levels at approximately 20<br>and 80 ng/mL of 25-OH vitamin<br>D | Two levels at the low normal (9.0<br>ng/mL) and high normal (37.6<br>ng/mL) |

### PERFORMANCE CHARACTERISTICS

### Precision

The precision for ST AIA-PACK 25-OH Vitamin D was determined based on guidance from CLSI Protocol EP5-A2.

Within- run precision was assessed by assaying three levels of pooled and spiked Na heparinized plasma, EDTA plasma and serum specimens with each lot number and instrument. Estimates of total and within-run precision were obtained from measurements of 2 replicates in a single run, 2 times a day for 20 non-consecutive days for each specimen/reagent/ instrument combination. This equaled a total of 40 runs and 80 determinants for each data set. There were three (3) data sets at each level for each specimen type.

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### Intra-assay (within run) Precision

| Sample | Mean<br>(ng/mL) | Standard<br>Deviation<br>(ng/mL) | Coefficient of<br>Variation<br>(%) |
|------------------|-----------------|----------------------------------|------------------------------------|
| Serum A1 | 16.0 | 1.2 | 7.3 |
| Serum B1 | 36.0 | 1.0 | 2.7 |
| Serum C1 | 94.1 | 1.5 | 1.6 |
| Serum A2 | 21.8 | 0.7 | 3.3 |
| Serum B2 | 44.4 | 1.6 | 3.6 |
| Serum C2 | 98.0 | 1.9 | 2.0 |
| Serum A3 | 21.8 | 0.9 | 4.3 |
| Serum B3 | 46.5 | 1.8 | 3.9 |
| Serum C3 | 103.7 | 2.1 | 2.0 |
| Na Hep Plasma A1 | 15.7 | 0.8 | 4.8 |
| Na Hep Plasma B1 | 32.9 | 0.8 | 2.4 |
| Na Hep Plasma C1 | 75.4 | 1.2 | 1.6 |
| Na Hep Plasma A2 | 21.5 | 1.0 | 4.5 |
| Na Hep Plasma B2 | 47.0 | 1.2 | 2.6 |
| Na Hep Plasma C2 | 102.8 | 1.9 | 1.9 |
| Na Hep Plasma A3 | 21.8 | 1.1 | 5.2 |
| Na Hep Plasma B3 | 50.0 | 1.6 | 3.1 |
| Na Hep Plasma C3 | 108.9 | 1.8 | 1.7 |
| EDTA Plasma A1 | 13.7 | 0.7 | 4.9 |
| EDTA Plasma B1 | 34.7 | 0.9 | 2.7 |
| EDTA Plasma C1 | 71.1 | 1.2 | 1.7 |
| EDTA Plasma A2 | 24.4 | 0.8 | 3.3 |
| EDTA Plasma B2 | 47.4 | 0.9 | 2.0 |
| EDTA Plasma C2 | 105.2 | 1.5 | 1.4 |
| EDTA Plasma A3 | 25.6 | 1.1 | 4.2 |
| EDTA Plasma B3 | 50.3 | 1.0 | 1.9 |
| EDTA Plasma C3 | 110.9 | 1.3 | 1.2 |

ST AIA-PACK 25-OH Vitamin D

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## Total Precision

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| Sample | Mean<br>(ng/mL) | Standard<br>Deviation<br>(ng/mL) | Coefficient of<br>Variation<br>(%) |
|------------------|-----------------|----------------------------------|------------------------------------|
| Serum A1 | 16.0 | 1.2 | 7.4 |
| Serum B1 | 36.0 | 1.3 | 3.7 |
| Serum C1 | 94.1 | 2.2 | 2.3 |
| Serum A2 | 21.8 | 0.8 | 3.8 |
| Serum B2 | 44.4 | 1.5 | 3.3 |
| Serum C2 | 98.0 | 2.0 | 2.0 |
| Serum A3 | 21.8 | 1.3 | 5.8 |
| Serum B3 | 46.5 | 1.8 | 3.9 |
| Serum C3 | 103.7 | 2.4 | 2.3 |
| Na Hep Plasma A1 | 15.7 | 1.0 | 6.4 |
| Na Hep Plasma B1 | 32.9 | 1.4 | 4.1 |
| Na Hep Plasma C1 | 75.4 | 2.2 | 2.9 |
| Na Hep Plasma A2 | 21.5 | 1.0 | 4.4 |
| Na Hep Plasma B2 | 47.0 | 1.5 | 3.3 |
| Na Hep Plasma C2 | 102.8 | 2.7 | 2.7 |
| Na Hep Plasma A3 | 21.8 | 1.1 | 5.2 |
| Na Hep Plasma B3 | 50.0 | 2.0 | 4.0 |
| Na Hep Plasma C3 | 108.9 | 3.3 | 3.0 |
| EDTA Plasma A1 | 13.7 | 0.9 | 6.6 |
| EDTA Plasma B1 | 34.7 | 1.3 | 3.9 |
| EDTA Plasma C1 | 71.1 | 1.9 | 2.7 |
| EDTA Plasma A2 | 24.4 | 1.0 | 4.1 |
| EDTA Plasma B2 | 47.4 | 1.4 | 2.9 |
| EDTA Plasma C2 | 105.2 | 2.3 | 2.2 |
| EDTA Plasma A3 | 25.6 | 1.2 | 4.7 |
| EDTA Plasma B3 | 50.3 | 1.6 | 3.2 |
| EDTA Plasma C3 | 110.9 | 2.8 | 2.5 |

# Controls Precision

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# Intra-assay (within run) Precision

| | Mean<br>(ng/mL) | Pooled SD<br>(ng/mL) | CV<br>(%) |
|---------|-----------------|----------------------|-----------|
| Level 1 | 20.0 | 0.79 | 3.9 |
| Level 2 | 79.1 | 1.63 | 2.1 |

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| | Mean<br>(ng/mL) | Pooled SD<br>(ng/mL) | CV<br>(%) |
|---------|-----------------|----------------------|-----------|
| Level 1 | 20.0 | 1.16 | 5.8 |
| Level 2 | 79.1 | 2.22 | 2.8 |

### Linearity:

The linearity for ST AIA-PACK 25-OH Vitamin D was determined, based on guidance from CLSI protocol EP6-A. The linearity was measured on the AIA-2000 instrument and has been demonstrated to be linear from 4 ng/mL to 150 ng/mL.

#### Correlation

The methods comparison study was determined based on guidance from (EP9-A2).

- a. Method Comparison
A total of 156 unaltered serum specimens were assayed in singleton utilizing the ST AIA-PACK 25-OH Vitamin D assay on the AIA-2000 analyzer and the 25-Hydroxyvitamin D 1251 RIA Kit (Diasorin). The regression analysis for the correlation between the alternate method (x) and the ST AIA-PACK 25-OH Vitamin D (y) is as follows:

| | Deming | Regular |
|----------------|---------------------------------------------------------|------------------------|
| Slope: | 0.934 (0.884 to 0.984) | 0.885 (0.836 to 0.935) |
| Intercept: | 2.53 (0.75 to 4.31) | 3.97 (2.21 to 5.73) |
| Corr Coef (R): | 0.944 | |
| Result Ranges: | Diasorin 4.4 to 103.0 ng/mL<br>Tosoh 6.2 to 103.2 ng/mL | |

### *95% Confidence Intervals are shown in parentheses

#### b. Matrix Comparison

The correlation between serum (x) and Na heparinized plasma (y) on the ST AIA-PACK 25-OH Vitamin D was carried out using 115 unaltered specimens.

| | Deming | Regular |
|----------------|------------------------------------------------------------|------------------------|
| Slope: | 0.993 (0.974 to 1.012) | 0.988 (0.978 to 1.007) |
| Intercept: | -0.390 (-1.13 to 0.36) | -0.20 (-0.94 to 0.55) |
| Corr Coef (R): | 0.995 | |
| Result Ranges: | Na Heparin 11.3 to 112.8 ng/mL<br>Serum 11.0 - 111.1 ng/mL | |

*95% Confidence Intervals are shown in parentheses

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The correlation between serum (x) and EDTA Plasma (y) on the ST AIA-PACK 25-OH Vitamin D was carried out using 115 unaltered specimens.

| | Deming | Regular |
|----------------|------------------------------------------------------|------------------------|
| Slope: | 1.041 (1.020 to 1.062) | 1.034 (1.013 to 1.056) |
| Intercept: | 0.091 (0.09 to 1.73) | 1.14 (0.032 to 1.96) |
| Corr Coef (R): | 0.994 | |
| Result Ranges: | EDTA 11.6 to 111.9 ng/mL<br>Serum 11.0 - 111.1 ng/mL | |

*95% Confidence Intervals are shown in parentheses

### Cross Reactivity

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The following cross reactants were tested on the ST AIA-PACK 25-OH Vitamin D assay by spiking known quantities of the cross reactant in serum specimen.

| Cross-reactants | Cross-reactivity*<br>[mol%] |
|------------------------------------|-----------------------------|
| 25-OH Vitamin D2 (30 ng/mL) | 101.1 |
| 25-OH Vitamin D3 (158.2 ng/mL) | 99.2 |
| 3-epi 25-OH Vitamin D2 (30 ng/mL) | 131.3 |
| 3-epi 25-OH Vitamin D3 (30 ng/mL) | 107.7 |
| 24,25-(OH)2 Vitamin D2 (100 ng/mL) | 5.2 |
| 24,25-(OH)2 Vitamin D3 (100 ng/mL) | 18.1 |
| Vitamin D2 (1000 ng/mL) | 0.5 |
| Vitamin D3 (1000 ng/mL) | <0.1 |
| 1, 25-(OH)2 Vitamin D2 (1.0 ng/mL) | <0.1 |
| 1, 25-(OH)2 Vitamin D3 (1.0 ng/mL) | <0.1 |
| Paricalcitol (2.0 ng/mL) | <0.1 |

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#### Conclusion:

々

The ST AIA-PACK 25-OH Vitamin D recovers >/= 100 % for both 25-OH Vitamin D2 and 3epi- 25-OH Vitamin D3 at 30 ng/mL.

The ST AIA-PACK 25-OH Vitamin D recovers approximately 100 % for 25-OH Vitamin D3 at - 158.2 ng/mL.

The ST AIA-PACK 25-OH Vitamin D had a cross reactivity of 5.2% at 100 ng/mL of 24,25-Dihydroxyvitamin-D2.

The ST AIA-PACK 25-OH Vitamin D did not significantly cross react with 24, 25-(OH)2 Vitamin D3 at 100 ng/mL.

The ST AIA-PACK 25-OH Vitamin D did not significantly cross react with Vitamin D3 and Vitamin D2 at 1000 ng/mL.

The ST AIA-PACK 25-OH Vitamin D did not significantly cross react with 1, 25-(OH)2 Vitamin D3, 1, 25-(OH)2 Vitamin D2 and Paricalcitol at 2.0 ng/mL.

### Reference Ranges

Number of Samples (n) 233 Reference Interval 10.8 - 54.75 ng/mL

The central 95% of the reference range was used to determine the reference interval.

#### Interference

Interference is defined, for the purposes of this study, with recovery outside of 100 +/- 10% of the known concentration of the specimen after the following substances are added to human specimens. Three studies were conducted using EDTA plasma, Na heparinized plasma and serum.´

- Added hemoglobin (up to 11.4 mg/dL) does not interfere with the assay. .
- Conjugated bilirubin (up to 18.4 mg/dL) and free bilirubin (up to 16.8 mg/dL) does not . interfere with the assay.
- Lipemia, as indicated by triglyceride concentration (up to 357 mg/dL), does not interfere . with the assay.

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- Protein, as indicated by human albumin concentration (up to 8.5 g/dL), does not interfere . with the assay.
- Ascorbic acid (up to 20 mg/dL) does not interfere with the assay. .
- EDTA.2K (up to 10 mg/mL) does not interfere with the assay. .
- Sodium Heparin (up to 100 U/mL) does not interfere with the assay. .
- Rheumatoid factor (up to 500 IU/mL) does not interfere with the assay. .

### Limit of Detection and Limit of Quantification

The LoB and LoQ of the ST AIA-PACK 25-OH Vitamin D was determined based on CLSI guideline EP17-A.

The LoB was determined by 60 measurements of 3 different blank specimens. The LoB was the value at the 95th percentile. In this case the LoB was determined to be 1.6 ng/mL.

The LoD was determined by 10 measurements of 6 low level samples. The sample range was chosen to be between LoB and 4xLoB and 3 lots of reagents were utilized. The LoD was determined to be 2.6 ng/mL.

The LoQ was determined by 10 measurements of 18 low level samples and the CV% for each sample was calculated. The samples were selected to be in the range of LoB to 4xLoB. A precision profile was plotted for concentration vs. the CV%. The functional sensitivity at 20% CV was calculated and determined as the LoQ. The LoQ was determined to be 2.9 ng/mL.

The reportable range for the assay is 4.0 - 120 ng/mL.

#### Standards:

| Number | FDA<br>Recognition<br>Number | Revision<br>Date | Title |
|--------|------------------------------|------------------|--------------------------------------------------------------------------------------------------------------------------------|
| EP5-A2 | 7-110 | 10/31/2005 | Evaluation of Precision Performance of<br>Quantitative Measurement Methods;<br>Approved Guideline-Second Edition |
| EP6-A | 7-193 | 03/18/2009 | Evaluation of the Linearity of Quantitative<br>Measurement Procedures: a Statistical<br>Approach: Approved Guideline |
| C28-A3 | 7-202 | 09/08/2009 | Defining, Establishing, and verifying<br>Reference Intervals in the Clinical Laboratory;<br>Approved Guideline - Third Edition |
| EP17-A | 7-194 | 03/18/2009 | Protocols for Determination of Limits of<br>Detection and Limits of Quantitation;<br>Approved Guideline |
| EP9-A2 | 7-92 | 03/08/2004 | Method Comparison and Bias Estimation<br>Using Patient Samples; Approved Guideline-<br>Second Edition |
| EP21-A | 7-174 | 03/18/2009 | Estimation of Total Analytical Error for |

ST AIA-PACK 25-OH Vitamin D

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|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | . |
| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>CONCOLOGICAL<br> |

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### ST AIA-PACK 25-OH Vitamin D

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### Conclusion:

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ﺎﺭ ﺍﻟﻤﺮﺍﺟﻊ ﻓﻲ

The Tosoh Bioscience, Inc. ST AIA-PACK 25-OH Vitamin D is substantially equivalent to the DiaSorin Inc. (k)983617-Hydroxyvitamin D 1251 RIA Kit for in vitro diagnostic use only for the quantitative measurement of total 25-hydroxyvitamin D (25-OH vitamin D) in human serum, Na heparinized or EDTA plasma on TOSOH AIA System Analyzers. The Tosoh ST AIA-PACK 25-OH Vitamin D is intended as an aid in the determination of Vitamin D sufficiency

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/13/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized symbol resembling an abstract human figure or a caduceus, rendered in a simple, flowing line.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

### February 8, 2013

Tosoh Bioscience, Inc c/o Robert L. Wick 6000 Shoreline Court, Suite 101 South San Francisco, CA 94080

Re: k123131

Trade/Device Name: ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system

Regulatory Class: II

Product Code: MRG, JIT, JJX

Dated: January 08, 2013

Received: January 09, 2013

Dear Mr. Wick:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device; subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol C. Benson for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): k123131

Device Name:

ST AIA-PACK 25-OH Vitamin D

ST AIA-PACK 25-OH Vitamin D Calibrator Set

AIA-PACK 25-OH Vitamin D Control Set

Indications For Use:

ST AIA-PACK 25-OH Vitamin D is designed for in vitro diagnostic use only for the quantitative measurement of total 25-hydroxyvitamin D (25-OH vitamin D) in human serum, Na-heparinized plasma or EDTA plasma on TOSOH AIA System Analyzers. The Tosoh ST AIA-PACK 25-OH Vitamin D is intended as an aid in the determination of Vitamin D sufficiency.

The ST AIA-PACK 25-OH Vitamin D Calibrator Set is intended for in vitro diagnostic use only for the calibration of the ST AIA-PACK 25-OH Vitamin D assay.

The AIA-PACK 25-OH Vitamin D Control Set is intended for in vitro diagnostic use only for performing quality control procedures with the ST AIA-PACK 25-OH Vitamin D assay.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Yung W.Chan -S

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

k123131 510(k)

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