ST AIA-PACK DHEA-S CALIBRATOR SET

K111762 · Tosoh Bioscience, Inc. · JIT · Aug 5, 2011 · Clinical Chemistry

Device Facts

• Record ID: K111762
• Device Name: ST AIA-PACK DHEA-S CALIBRATOR SET
• Applicant: Tosoh Bioscience, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Aug 5, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The ST AIA-PACK DHEA-S CALIBRATOR SET is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK DHEA-S assay.

Device Story

ST AIA-PACK DHEA-S Calibrator Set consists of six liquid calibrator vials containing human serum with assigned DHEA-S concentrations and sodium azide preservative. Used in clinical laboratory settings to calibrate Tosoh AIA System analyzers for the quantitative determination of DHEA-S in human serum or plasma. Calibration process ensures accuracy of subsequent patient sample measurements. Healthcare providers use the resulting assay output to assess DHEA-S levels, aiding in clinical decision-making related to adrenal function or androgen status.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (shelf-life, open-vial, calibration stability) performed on AIA-1800 analyzers confirmed performance claims. Value assignment validated via 30-replicate testing across multiple reagent lots and analyzers.

Technological Characteristics

Ready-to-use liquid calibrators; human serum base with sodium azide preservative. Six-level set (0, 5, 12, 60, 300, 1200 µg/dL approx). Designed for use on Tosoh AIA System analyzers. Competitive immunoenzymatic assay principle. Refrigerated storage (2-8°C).

Indications for Use

Indicated for in vitro diagnostic use for the calibration of the ST AIA-PACK DHEA-S assay on Tosoh AIA System analyzers.

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.

Predicate Devices

• Access® DHEA-S Calibrators (k040181)

Submission Summary (Full Text)

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

A. 510(k) Number:
k111762

B. Purpose for Submission:
New device

C. Measurand:
Calibrator Set for ST AIA-PACK DHEA-S assay

D. Type of Test:
Calibration materials

E. Applicant:
Tosoh Bioscience, Inc.

F. Proprietary and Established Names:
ST AIA-PACK DHEA-S Calibrator Set

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JIT | Class II | 21 CFR 862.1150
Calibrator | Clinical Chemistry (75) |

H. Intended Use:

1. Intended use(s):
Refer to indication for use below.

2. Indication(s) for use:
The ST AIA-PACK DHEA-S CALIBRATOR SET is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK DHEA-S assay.

3. Special conditions for use statement(s):

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For prescription use

4. Special instrument requirements:

Tosoh AIA System analyzers

I. Device Description:

The ST AIA-PACK DHEA-S CALIBRATOR SET contains ready to use human sera (sodium azide as a preservative) with assigned levels of DHEA-S. Calibration should be performed according to the schedule indicated in the TOSOH AIA System Operator's Manual.

The sponsor declared in the labeling that the material derived from human origin used in the preparations of these calibrators has been tested by FDA-cleared methods and found negative for the presence of HBsAg and antibody to HIV-1 and HCV.

Kit content and target values:

| Level | Target Value (μg/dL) | Volume Provided |
| --- | --- | --- |
| CALIBRATOR (1) | 0 | 2x 1 mL |
| CALIBRATOR (2) | 5.0 | 2x 1 mL |
| CALIBRATOR (3) | 12 | 2x 1 mL |
| CALIBRATOR (4) | 60 | 2x 1 mL |
| CALIBRATOR (5) | 300 | 2x 1 mL |
| CALIBRATOR (6) | 1200 | 2x 1 mL |

J. Substantial Equivalence Information:

1. Predicate device name(s):

Access® DHEA-S Calibrators

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

k040181

3. Comparison with predicate:

| Characteristic | Tosoh ST AIA-PACK DHEA-S Calibrator Set (New Device) | Access® DHEA-S Calibrators (Predicate Device) |
| --- | --- | --- |
| Similarities | | |
| Intended Use/Indications for use | Same | For use in the calibration of DHEA-S assay on the indicated analyzers. |
| Format | Same | Ready to use liquid calibrators |

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| Levels | Same | 6 |
| --- | --- | --- |
| Shelf-life Stability | Same | 12 months at 2-8°C |
| Differences | | |
| Matrix | Human serum | Bovine serum / buffer base with surfactant and preservative |
| Calibration Stability | Up to 90 days | 28 days |
| Open Vial Stability | 2-8°C, 1 day | 2-10°C, 28 days |
| Target Values | 0, 5, 12, 60, 300 and 1200 μg/dL | 0, 20, 50, 200, 500 and 1000 μg/dL |

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

None were 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):

Traceability

The assayed value of each calibrator level was standardized against reference calibrators. The reference calibrators were prepared by weighing dehydroisoandrosterone 3-sulfate sodium salt dihydrate (DHEA) from a commercial vendor into an analyte-free human serum matrix.

Value Assignment:

For each calibrator set lot manufactured, the calibrators are assayed in 5 replicates each on two AIA-1800 analyzers using 3 lots of reagent. The instruments were calibrated using the reference calibrators. The assigned value of each calibrator is the grand mean of 30 determinations of the respective calibrator level.

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# Stability:

Real time testing was performed at one site using one AIA-1800 analyzer. The stability protocol and the acceptance criteria have been reviewed and found to be acceptable.

- Shelf-life stability:
Real time testing result support the package insert claim of 12 months at 2-8°C.

- Open-vial stability:
Real time testing result support the package insert claim that the calibrator set is stable for one day after it had been opened, sealed and stored at 2-8°C.

- Calibration stability:
Real time testing results support the package insert claim of 90 days from the date of calibration.

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

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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.

O. Conclusion:

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

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