ST AIA-PACK PROG II Calibrator Set

K143144 · Tosoh Bioscience, Inc. · JIT · Dec 3, 2014 · Clinical Chemistry

Device Facts

• Record ID: K143144
• Device Name: ST AIA-PACK PROG II Calibrator Set
• Applicant: Tosoh Bioscience, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Dec 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

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

Device Story

ST AIA-PACK PROG II Calibrator Set consists of six liquid calibrator levels (0 to 45 ng/mL) containing progesterone in a human serum matrix with sodium azide preservative. Designed for use on Tosoh AIA System Analyzers (e.g., AIA-2000) to calibrate the ST AIA-PACK PROG II assay. Calibrator values are assigned via a multi-step traceability process using USP reference standards and verified through replicate testing on Tosoh analyzers. Used by laboratory professionals in clinical settings to ensure accurate quantification of progesterone levels in patient samples. Benefits include standardized assay performance and reliable clinical decision-making for progesterone-related diagnostics.

Clinical Evidence

Bench testing only. Stability studies (real-time and open-vial) confirmed 6-month shelf life and 1-day open-vial stability at 2-8°C. Value assignment validation performed on Tosoh AIA-2000 analyzers using 5 replicates per level; results showed precision (CV) ranging from 1.8% to 5.8%, meeting the <10% acceptance criterion.

Technological Characteristics

Liquid calibrator set; six levels (0, 0.5, 1.5, 5.0, 15, 45 ng/mL approx.); human serum matrix; sodium azide preservative. Traceable to USP reference standards. 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 PROG II assay for the measurement of progesterone in human serum and heparinized plasma.

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

December 3, 2014

TOSOH BIOSCIENCE, INC. c/o ROBERT WICK REGULATORY SPECIALIST 6000 SHORELINE COURT, STE. 101 SOUTH SAN FRANCISCO CA 94080

Re: K143144

Trade/Device Name: ST AIA-PACK PROG II Calibrator Set Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: October 31, 2014 Received: November 3, 2014

Dear Mr. Robert 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. Wick

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Katherine Serrano -S

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) K143144

Device Name ST AIA-PACK PROG II Calibrator Set

Indications for Use (Describe) The ST AIA-PACK PROG II Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK PROG II assay.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) Summary (k)143144 ST AIA-PACK PROG II Calibrator Set

## SAFETY AND EFFECTIVENESS AS REQUIRED BY 1. 21 CFR 807.92

This Summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirement 21 CFR 807.92.

#### SUBMITTER NAME AND ADDRESS 2.

Date of Summary Preparation: Submitter:

November 20, 2014 Tosoh Bioscience, Inc 3600 Gantz Road Grove City, OH 43123

Contact Person:

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

## 510K NUMBER, DEVICE PROPRIETARY NAME, 3. COMMON NAME, PURPOSE FOR THE SUBMISSION, REGULATORY CLASSIFICATION, PANEL, PRODUCT CODE, AND 21 CFR NUMBER.

| 510k No.: | K143144 |
|---------------------------|------------------------------------|
| Device Proprietary Name: | ST AIA-PACK PROG II Calibrator Set |
| Purpose of Submission: | Labeling Change |
| Regulatory Classification | Calibrator, Secondary |
| Common Name: | Progesterone Test System |
| Classification: | Class II |
| Product Code: | JIT |
| Panel: | Clinical Chemistry |
| 21 CFR Number: | 21 CFR 862.1150 |

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## PREDICATE DEVICE PROPRIETARY NAMES AND 4. 510 (K) NUMBERS

Predicate Device Number: Predicate: Manufacturer:

K933269 ST AIA-PACK PROG (Calibrator Set) Tosoh Bioscience, Inc. (previously known as Tosoh Medics, Inc.)

#### INTENDED USE 5.

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

#### DEVICE DESCRIPTION 6.

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 PROG II Calibrator (1) | 0 | ng/mL |
|----------------------------------------------------------------------------------------------------------------|-----|-----------------|
| Protein matrix containing no detectable concentration of PROG with sodium<br>azide as a preservative (Liquid). | | |
| 2 x 1 mL ST AIA-PACK PROG II Calibrator (2) | 0.5 | ng/mL (approx.) |
| ST AIA-PACK PROG II Calibrator (3) | 1.5 | ng/mL (approx.) |
| ST AIA-PACK PROG II Calibrator (4) | 5.0 | ng/mL (approx.) |
| ST AIA-PACK PROG II Calibrator (5) | 15 | ng/mL (approx.) |
| ST AIA-PACK PROG II Calibrator (6) | 45 | ng/mL (approx.) |

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

## ST AIA-PACK PROG II Calibrator Set

P/N # 025339

The ST AIA-PACK PROG II Calibrator Set is designed specifically for use on the Tosoh AIA System 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 PROG II Calibrator Set is designed for use with ST AIA-PACK PROG II and ST AIA-PACK PROG II Sample Diluting Solution.

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Tosoh Bioscience, Inc.

#### PREDICATE COMPARISON TABLE 7.

Substantial Equivalence:

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

#### Similarities

| Characteristic | Predicate | |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| | Tosoh AIA-PACK PROG II<br>Calibrator Set | Tosoh AIA-PACK PROG<br>Calibrator Set (K933269) |
| Intended Use | The ST AIA-PACK PROG II<br>Calibrator Set is intended for In Vitro<br>Diagnostic Use Only for the<br>calibration of the ST AIA-PACK<br>PROG II assay. | The AIA-PACK PROG Calibrator<br>Set is intended for In Vitro<br>Diagnostic Use Only for the<br>calibration of the ST AIA-PACK<br>PROG Assays. |
| Indications for Use (same<br>as Intended Use) | The ST AIA-PACK PROG II<br>Calibrator Set is intended for In Vitro<br>Diagnostic Use Only for the<br>calibration of the ST AIA-PACK<br>PROG II assay. | The AIA-PACK PROG Calibrator<br>Set is intended for In Vitro<br>Diagnostic Use Only for the<br>calibration of the ST AIA-PACK<br>PROG Assays. |
| Analyte | Progesterone | Same |
| Format | Liquid<br>Six bottles, one for<br>each of the six calibrator<br>levels. | Same |
| Matrix | Serum and heparinized plasma | Same |
| Storage | Store upright and refrigerate at 2 to<br>8°C. | Same |
| Stability<br>(unopened vial) | Stable until the expiration date<br>stated on the label when stored at 2<br>- 8°C. | Same |
| Calibration Stability | Stable up to 90 days | Same |
| Stability<br>(opened vial) | 24 hours (1 day) | Same |

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| Characteristic | Tosoh AIA-PACK PROG II<br>Calibrator Set | Predicate<br>Tosoh AIA-PACK PROG<br>Calibrator Set (K951848) |
|----------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Shelf-life | 6 months when stored unopened<br>and refrigerated at 2-8°C | 12 months when stored unopened<br>and refrigerated at 2-8°C |
| Traceability | The calibrators for use with the ST<br>AIA-PACK PROG II were referred to<br>USP (United States Pharmacopeia)<br>Standard. | The calibrators in this set are<br>prepared gravimetrically and are<br>compared to internal reference<br>standards. |
| Levels | Six<br>(0, 0.5, 1.5, 5.0, 15, 45<br>ng/mL approximately) | Six<br>(0, 0.5, 1.5, 5.0, 20, 60<br>ng/mL approximately) |
| Analyzer | Tosoh AIA-2000 | Tosoh AIA-1200 |

## Differences

#### SUMMARY OF STABILITY STUDIES 8.

## Summary of Stability Studies

## Real Time Testing

AIA-PACK Progesterone Calibrator Set were stored at refrigerated temperatures and assayed at 1, 2, 3, 4 and 6 months after the day of the first assay.

The acceptance criteria for recovery was within 100 +/- 10%.

The criterion for reproducibility (CV %) was </= 10%.

Current Real Time Studies support a 6 month Shelf life at 2-8°C.

## Open Vial Stability

Open vial stability of the AIA-PACK Progesterone Calibrator Set was assessed by reconstituting the material according to the package insert. Samples were reconstituted and stored at refrigerated temperatures for 2 days and tested for progesterone.

The criterion for recovery was within 100 +/-10%.

The criterion for reproducibility (CV %) was </= 10%.

Current open vial studies support a reconstituted claim of 1 day when stored at 2-8°C.

#### SUMMARY OF VALUE ASSIGNMENT 9.

The ST AIA-PACK PROG II Calibrator Set contains assigned concentrations of progesterone. The assigned value is determined on a lot-by-lot basis and is designed to provide an assay calibration range of 0.1 to 40 ng/mL of progesterone. The calibrators for use with the ST AIA-PACK PROG II were referred to through the USP (United States Pharmacopeia) Standard.

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The primary reference material was using the Tosoh AIA-2000 with the USP Reference as calibrator. The values were verified by comparing measured results with those obtained with the previous lot for control materials.

The value of the secondary reference material was assigned using the Tosoh AIA-2000 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-2000 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.

The value assignment was determined by analyzing 5 replicates of the test calibrator on two Tosoh AIA-2000 instruments and the mean, SD and CV calculated for each lot before release to the user. The acceptance criteria states the precision measured by the CV should be within 10%.

| Progesterone<br>(Calibrator Levels) | N | Reference<br>Value<br>(ng/mL) | Mean<br>(ng/mL) | CV % |
|-------------------------------------|---|-------------------------------|-----------------|------|
| Cal (2) | 5 | 0.5 | .447 | 5.8 |
| Cal (3) | 5 | 1.5 | 1.34 | 3.5 |
| Cal (4) | 5 | 5.0 | 5.16 | 1.9 |
| Cal (5) | 5 | 15 | 15.1 | 2.2 |
| Cal (6) | 5 | 45 | 46.3 | 1.8 |

#### TRACEABILITY 10.

| ANALYTE | SUPPLIER | PRODUCT<br>NUMBER | ORIGIN | SOURCE |
|--------------|----------|-------------------|----------------------------------------------------------|----------------------|
| Progesterone | Sigma | I1J239 | Steroid stripped<br>and lipid<br>stripped human<br>serum | Chemical<br>Compound |

## 11. CONCLUSION

Testing results indicate that the proposed device is substantially equivalent to the predicate device.