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

Intended 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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Tosoh Bioscience, Inc.

:

# Abbreviated 510(k) Summary

K111762

# ST AIA-PACK ACTH

| Date: | June 17, 2011 |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Tosoh Bioscience, Inc<br>3600 Gantz Road<br>Grove City, OH 43123 |
| Contact Person: | Judith K. Ogden<br>Director, New Business & Technical Development<br>6000 Shoreline Ct., Ste. 101<br>South San Francisco, CA 94080<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device Name: | ST AIA-PACK DHEA-S Calibrator Set |
| Classification | Class II<br>JIT<br>Clinical Chemistry<br>21 CFR 862.1150 |
| Predicate Device: | k040181<br>Access DHEA-S Calibrators |

ST AIA-PACK DHEA-S Calibrator Set

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### Abbreviated 510(k) Summary

### ST AIA-PACK ACTH

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 DHEA-S CALIBRATOR SET contains human sera with assigned levels of DHEA-S. Calibration should be performed according to the schedule indicated in the TOSOH AIA System Operator's Manual.

2 x 1 mL 0 ug/dL ST AIA-PACK DHEA-S CALIBRATOR (1) Human serum containing no detectable concentration of DHEA-S with sodium azide as a preservative.

| 2 x 1 mL | | |
|-----------------------------------|------|-------|
| ST AIA-PACK DHEA-S CALIBRATOR (2) | 5.0 | µg/dL |
| (approx.) | | |
| ST AIA-PACK DHEA-S CALIBRATOR (3) | 12 | µg/dL |
| (approx.) | | |
| ST AIA-PACK DHEA-S CALIBRATOR (4) | 60 | µg/dL |
| (approx.) | | |
| ST AIA-PACK DHEA-S CALIBRATOR (5) | 300 | µg/dL |
| (approx.) | | |
| ST AIA-PACK DHEA-S CALIBRATOR (6) | 1200 | µg/dL |
| (approx.) | | |

Human serum containing the assigned concentration of DHEA-S (described on each vial) with sodium azide as a preservative.

#### ST AIA-PACK ACTH Calibrator Set

P/N 025322

#### Device Intended 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.

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### Substantial Equivalence:

Comparison between the Tosoh ST AIA-PACK DHEA-S Calibrator Set and the Access DHEA-S Calibrators

| Characteristic | Predicate<br>Access® DHEA-S<br>Calibrators<br>(K040181) | Tosoh ST AIA-PACK<br>DHEA-S Calibrator Set |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Access DHEA-S<br>Calibrators are intended to<br>calibrate the Access DHEA-S<br>assay for the quantitative<br>determination of<br>Dehydroepiandrosterone<br>sulphate levels in human<br>serum and plasma using the<br>Access Immunoassay Systems | The ST AIA-PACK DHEA-S<br>CALIBRATOR SET is<br>intended for IN VITRO<br>DIAGNOSTIC USE ONLY<br>for the calibration of the ST<br>AIA-PACK DHEA-S assay. |
| Analyte | DHEA-S | DHEA-S |
| Analyzer | Beckman Coulter Access<br>Immunoassay System | Tosoh AIA Systems |
| Levels | Six<br>(0, 20, 50, 200, 500 and 1000<br>µg/mL approximately) | Six<br>(0, 5, 12, 60, 300 and 1200<br>µg/mL, approximately) |
| Format | Ready to use liquid calibrators;<br>Six two-mL bottles, one for<br>each of the six calibrator<br>levels. | Ready to use liquid calibrators;<br>Six one-mL bottles, one for<br>each of the six calibrator<br>levels. |
| Assay Protocol | Competitive<br>immunoenzymatic | Same |
| Chemistry | Bovine serum / buffer base<br>with surfactant and<br>preservative | Human serum base with<br>sodium azide preservative |
| Traceability | Traceable to the<br>manufacturer's working<br>calibrators. | Same |
| Matrix | Serum<br>Plasma | Serum<br>Heparinized plasma<br>EDTA plasma<br>Citrated plasma cannot be used |
| Storage | Store in upright and refrigerate<br>at 2 to 10°C. | Store in upright position at 2-<br>8°C when not in use. |
| Stability<br>(un-opened vial) | Stable until the expiration date<br>stated on the label when stored<br>at 2 to10°C. | When stored unopened and<br>refrigerated at 2-8°C, the<br>calibrator set is stable until the<br>expiration date on the label. |
| Stability<br>(opened vial) | Vial is stable at 2 to10°C for<br>28 days after initial use. | The calibrator materials should<br>be used within 1 day of<br>opening, provided the vials are<br>kept tightly sealed and<br>refrigerated at 2-8°C. |
| Shelf-life | 12 months when stored<br>unopened and refrigerated at 2-<br>8°C | 12 months when stored<br>unopened and refrigerated at 2-<br>8°C |
| Calibration Stability | Assay calibration data are<br>valid up to 28 days | Stable up to 90 days |

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### Conclusion:

The Tosoh Bioscience, Inc. ST AIA-PACK DHEA-S Calibrator Set is substantially equivalent to the Access DHEA-S Calibrators k040181 for the in vitro diagnostic use only for the calibration the ST AIA-PACK DHEA-S assay.

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Public Health Service

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Tosoh Bioscience, Inc c/o Ms. Judith K. Ogden 6000 Shoreline Ct., Ste. 101 South San Francisco, CA 94080

AUG 0 5 2011

k111762 Re:

> Trade Name: ST AIA-PACK DHEA-S Calibrator Set Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIT Dated: June 22, 2011 Received: June 23, 2011

Dear Ms. Ogden:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely vours.

C.C.

Courmey Harper. Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Enclosure

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# Indications for Use

| 510(k) Number (if known): | k 111762 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | ST AIA-PACK DHEA-S Calibrator Set |
| Indication For Use: | ST AIA-PACK DHEA-S Calibrator Set is designed for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK DHEA-S assay on Tosoh AIA System Analyzers |

Prescription Use ___ √ -(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)

Qute chulu K111762

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