ST AIA-PACK C-PEPTIDE II CALIBRATOR SET

K140648 · Tosoh Bioscience, Inc. · JIT · Apr 10, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140648
• Device Name: ST AIA-PACK C-PEPTIDE II CALIBRATOR SET
• Applicant: Tosoh Bioscience, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Apr 10, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The ST AIA-PACK C-Peptide II Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK C-Peptide II assay.

Device Story

The ST AIA-PACK C-Peptide II Calibrator Set consists of six levels of calibrators (0 to 33 ng/mL) used to calibrate the ST AIA-PACK C-Peptide II assay on Tosoh AIA System analyzers. The set includes one liquid calibrator (0 ng/mL) and five lyophilized calibrators containing C-peptide in a protein matrix with sucrose. The device is used in clinical laboratory settings by trained laboratory personnel. The healthcare provider uses the calibrated assay to measure C-peptide levels in patient samples (urine, serum, EDTA plasma), which aids in clinical decision-making regarding insulin production and diabetes management. The calibrators are standardized against WHO 1st IRP 84/510 to ensure accurate assay performance.

Clinical Evidence

Bench testing only. Stability studies confirmed a 12-month shelf life at 2-8°C and a 1-day in-use stability after reconstitution. Recovery and reproducibility (CV <= 10%) met acceptance criteria (100 +/- 10%) across three lots.

Technological Characteristics

Six-level calibrator set; protein matrix with sucrose; lyophilized (levels 2-6) and liquid (level 1) formats; sodium azide preservative. Standardized against WHO 1st IRP 84/510. Designed for use on Tosoh AIA System analyzers. Storage: 2-8°C.

Indications for Use

Indicated for in vitro diagnostic calibration of the ST AIA-PACK C-Peptide II assay. No specific patient population, age, or gender restrictions are defined for the calibrator itself.

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)

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Tosoh Bioscience, Inc.

K140648

# 510(k) Summary

# ST AIA-PACK C-Peptide II Calibrator Set

Date: Submitter:

March 11, 2014 Tosoh Bioscience, Inc 3600 Gantz Road Grove City, OH 43123

Contact Person:

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

Device Name: Classification:

ST AIA-PACK C-Peptide II Calibrator Set Class II JIT Clinical Chemistry 21 CFR 862.1150

Predicate Device:

K951848 Tosoh Bioscience, Inc. (previously known as Tosoh Medics, Inc.) ST AIA-PACK C-Peptide (Calibrator Set)

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# 510(k) Summary

# ST AIA-PACK C-Peptide II Calibrator Set

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:

2 x 1 mL

ST AIA-PACK C-Peptide II Calibrator (1) 0 ng/mL Protein matrix containing no detectable concentration of C-peptide with sodium azide as a preservative (Liquid).

2 x 1 mL

| ST AIA-PACK C-Peptide II Calibrator (2) | 0.5 | ng/mL (approx.) |
|---------------------------------------------------------------------------------|-----|-----------------|
| ST AIA-PACK C-Peptide II Calibrator (3) | 2 | ng/mL (approx.) |
| ST AIA-PACK C-Peptide II Calibrator (4) | ି | ng/mL (approx.) |
| ST AIA-PACK C-Peptide II Calibrator (5) | 15 | ng/mL (approx.) |
| ST AIA-PACK C-Peptide II Calibrator (6) | 33 | ng/mL (approx.) |
| Protein matrix containing the assigned concentration of C-peptide (described on | | |
| each vial) (Lyophilized). | | |
| | | |

ST AIA-PACK C-Peptide II Calibrator Set

P/N # 025383

The ST AIA-PACK C-Peptide II Calibrator Set is designed specifically for use on the Tosoh AIA Svstem Analyzers which have been previously cleared as a family of instruments under K971103. Only materials obtained from Tosoh should be used. Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on Tosoh materials.

The ST AIA-PACK C-Peptide II Calibrator Set is designed for use with ST AIA-PACK C-Peptide II, ST AIA-PACK C-Peptide Sample Diluting Solution, AIA-PACK C-Peptide Control Set.

## Device Intended Use:

The ST AIA-PACK C-Peptide II Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK C-Peptide II assay.

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Tosoh Bioscience, Inc.

# Substantial Equivalence:

#### Comparison between the Tosoh ST AIA-PACK C-Peptide II Calibrator Set and the Tosoh ST AIA-PACK C-Peptide Calibrator Set

### Similarities

| Characteristic | Tosoh AIA-PACK C-Peptide II<br>Calibrator Set | Predicate<br>Tosoh AIA-PACK C-Peptide<br>Calibrator Set (K951848) |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ST AIA-PACK C-Peptide II<br>Calibrator Set is intended for In Vitro<br>Diagnostic Use Only for the<br>calibration of the ST AIA-PACK C-<br>Peptide II assay. | The AIA-PACK C-Peptide Calibrator<br>Set is intended for In Vitro<br>Diagnostic Use Only for the<br>calibration of the ST AIA-PACK C-<br>Peptide Assays. |
| Analyte | C-Peptide | C-Peptide |
| Analyzer | Tosoh AIA Systems | Tosoh AIA Systems |
| Levels | Six<br>(0, 0.5, 2, 6, 15, 33<br>ng/mL approximately) | Six<br>(0, 0.5, 2.0, 6.0, 15.0, 30<br>ng/mL approximately) |
| Format | Lyophilized<br>Six bottles, one for<br>each of the six calibrator<br>levels | Lyophilized<br>Six bottles, one for<br>each of the six calibrator<br>levels |
| Storage | Store upright and refrigerate at<br>2 to 8°C | Store upright and refrigerate at<br>2 to 8°C |
| Stability<br>(unopened vial) | Stable until the expiration date<br>stated on the label when stored at<br>2 - 8°C | Stable until the expiration date<br>stated on the label when stored at<br>2 -8°C |
| Shelf-life | 12 months when stored unopened<br>and refrigerated at 2-8°C | 12 months when stored unopened<br>and refrigerated at 2-8°C |
| Calibration Stability | Stable up to 90 days | Stable up to 90 days |

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| | | Predicate | |
|----------------------------|----------------------------------------------------------|-----------------------------------------------------------|--|
| Characteristic | Tosoh AIA-PACK C-Peptide II<br>Calibrator Set | Tosoh AIA-PACK C-Peptide<br>Calibrator Set (K951848) | |
| Base | Contains sucrose | Does not contain sucrose | |
| Stability<br>(opened vial) | Vial is stable at 2 - 8°C for<br>1 day after initial use | Vial is stable at 2 - 8°C for<br>7 days after initial use | |

#### Differences

## Summary of Traceability

The ST AIA-PACK C-Peptide II Calibrator Set contains assigned concentrations of Cpeptide. The assigned value is determined on a lot-by-lot basis and is designed to provide an assay calibration range of 0.02 to 30 ng/mL of C-peptide. The calibrators in this set have been standardized against WHO 1ª IRP 84/510.

## Summary of Stability Studies

Three different lots of ST AIA-PACK C-Peptide II Calibrator Set were used as samples for the shelf life stability study. Each specimen was assaved in 5 replicates and the mean and CV % were calculated. The study was initiated within one month from manufacture the evaluated reagents, then assayed at 3, 6, 9, 12 and 13 months after the day of the first assay. The criterion for recovery was within 100 +/- 10%. The criterion for reproducibility (CV %) was </= 10%. The recovery was within 100 +/- 10% and the reproducibility (CV %) was </=10% at 13 months, the shelf life of the ST AIA-PACK C-Peptide II Calibrator Set was set at 12 months at 2-8° C from the date of manufacturing.

The in use stability study for the ST AIA-PACK C-Peptide II Calibrator Set was conducted at one site using one AIA-2000 analyzer and a single lot of calibrator. Three sets of calibrator material were opened and reconstituted at day 0, day 1 and day 2 before the measurement. The reconstituted calibrator vials were sealed and refrigerated for 1 day and 2 days. Urine, serum and EDTA plasma specimens were chosen for this study. Specimen aliquots were stored at less than - 70° C. Each specimen was assayed in 5 replicates. The criterion for recovery was 100 +/- 10%. The criterion for reproducibility (% CV) was </= 10%. Since the recovery and the reproducibility meet the acceptance criteria for 2 days at refrigerator temperature, the in use stability of the ST AIA-PACK C-Peptide II Calibrator Set after reconstitution, was set as 1 day (24 hours).

When stored unopened and refrigerated at 2-8 °C, the Calibrator Set is stable until the expiration date on the label. The calibrators should be used within 1 day of opening or reconstituting, provided the vials are kept tightly sealed and refrigerated at 2-8 °C.

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## Summary of Value Assignment

The primary reference material was prepared by diluting the C-peptide with calibrator base and its value of C-peptide as reference material was assigned based on C-Peptide of Human Insulin, International Reference Reagent using ST AIA-PACK C-Peptide II. The value of the secondary reference material was assigned using the AIA instruments with the primary reference material as calibrator. The value was verified by comparing measured results with those obtained with the previous lot for patient samples. The values of the product calibrator were assigned using the Tosoh AIA instruments with the secondary reference material as calibrator. The values were verified by comparing measured results with those obtained with the previous lot for control materials.

## Conclusion:

The Tosoh Bioscience, Inc. ST AIA-PACK C-Peptide II Calibrator Set is substantially equivalent to the Tosoh Bioscience, Inc. ST AIA-PACK C-Peptide Calibrator Set k951848 for In Vitro Diagnostic Use Only for the calibration of the ST AJA-PACK C-Peptide II assay.

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Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, black font. The text is horizontally oriented and centered. To the left of the text is a logo with a stylized design.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 10, 2014

TOSOH BIOSCIENCE, INC. C/O ROBERT L. WICK 6000 SHORELINE COURT SUITE 101 SOUTH SAN FRANCISCO CA 94080

Re: k140648

Trade/Device Name: ST AIA-PACK C-Peptide II Calibrator Set Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: March 11, 2014 Received: March 13, 2014

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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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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Page 2-Mr. Robert L. Wick

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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. 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/ReportalProblem/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.

Sincercly yours,

# Courtney H. Lias -S

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

#### 510(k) Number (if known) k140648

#### Device Name

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#### ST AIA-PACK C-Peptide II CALIBRATOR SET

#### Indications for Use (Describe)

The ST AIA-PACK C-Peptide II Calibrator Set is intended for In Vitro Diagnostic Use Only for the CT AIA-PACK C-Peptide II assay.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Yung W. Chan -S

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