(29 days)
No
The document describes a calibrator set for an in vitro diagnostic assay and its performance characteristics. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is an In Vitro Diagnostic (IVD) device used for calibrating an assay, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The ST AIA-PACK hsE2 Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK hsE2 assay." The term "In Vitro Diagnostic Use" indicates that the device is intended for diagnostic purposes outside of a living organism.
No
The device description clearly indicates it is a set of physical calibrators (human serum with specific concentrations of estradiol) intended for use with a specific hardware analyzer system. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ST AIA-PACK hsE2 Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK hsE2 assay."
This statement clearly indicates that the device is intended to be used in vitro (outside of the body) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The ST AIA-PACK hsE2 Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK hsE2 assay.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
- 2 x 1 mL ST AIA-PACK hsE2 Calibrator (1) 0 pg/mL Human serum containing no detectable concentration of estradiol with sodium azide as a preservative.
- 2 x 1 mL ST AIA-PACK hsE2 Calibrator (2) 25 pg/mL (approx.)
- ST AIA-PACK hsE2 Calibrator (3) 50 pg/mL (approx.)
- ST AIA-PACK hsE2 Calibrator (4) 100 pg/mL (approx.)
- ST AIA-PACK hsE2 Calibrator (5) 500 pg/mL (approx.)
- ST AIA-PACK hsE2 Calibrator (6) 1,100 pg/mL (approx.)
Human serum containing the assigned concentration of estradiol (described on each vial) with sodium azide as a preservative.
ST AIA-PACK hsE2 Calibrator Set P/N # 025325
The ST AIA-PACK hsE2 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 hsE2 Calibrator Set is designed for use with ST AIA-PACK hsE2 and ST AIA-PACK hsE2 Sample Diluting Solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Stability Studies
- Real Time Testing: ST AIA-PACK hsE2 Calibrator Set were stored at refrigerated temperatures and assayed at 6, 12 and 13 months after the day of the first assay.
The acceptance criteria for recovery was 100% +/- 10%.
The criterion for reproducibility (CV %) was
§ 862.1150 Calibrator.
(a)
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.)(b)
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.
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Image /page/0/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 circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 17, 2016
TOSOH BIOSCIENCES, INC. ROBERT L. WICK REGULATORY SPECIALIST 6000 SHORELINE COURT, STE. 101 SOUTH SAN FRANCISCO, CA, 94080, US
Re: K160113
Trade/Device Name: ST AIA-PACK hsE2 Calibrator Set Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator, Secondary Regulatory Class: Class II Product Code: JIT Dated: January 18, 2016 Received: January 19, 2016
Dear 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
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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" (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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) K160113
Device Name ST AIA-PACK hsE2 Calibrator Set
Indications for Use (Describe)
The ST AIA-PACK hsE2 Calibrator Set is intended for In Vitro Diagnostic Use Only for the calbration of the ST AIA-PACK hsE2 assay.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary ST AIA-PACK hsE2 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.
2. SUBMITTER NAME AND ADDRESS
Date of Summary Preparation: Submitter:
January 18, 2016 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: 650-636-8117 Fax: 650-636-8121 Email: Robert.Wick@Tosoh.com
510K NUMBER, DEVICE PROPRIETARY NAME, 3. COMMON NAME, PURPOSE FOR THE SUBMISSION, REGULATORY CLASSIFICATION, PANEL, PRODUCT CODE, AND 21 CFR NUMBER.
510k No.: Device Proprietary Name: Purpose of Submission: Regulatory Classification Common Name: Classification: Product Code: Panel: 21 CFR Number:
ST AIA-PACK hsE2 Calibrator Set New Product Calibrator, Secondary Estradiol Test System Class II JIT Clinical Chemistry 21 CFR 862.1260
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PREDICATE DEVICE PROPRIETARY NAMES AND 4. 510 (K) NUMBERS
Predicate Device Number: Predicate: Manufacturer:
K932084 ST AIA-PACK E2 (Calibrator Set) Tosoh Bioscience, Inc. (previously known as Tosoh Medics, Inc.)
INTENDED USE 5.
The ST AIA-PACK hsE2 Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK hsE2 assay.
6. DEVICE DESCRIPTION
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 hsE2 Calibrator (1) 0 pg/mL
Human serum containing no detectable concentration of estradiol with sodium azide as a preservative.
| 2 x 1 mL ST AIA-PACK hsE2 Calibrator (2) | 25 pg/mL (approx.) |
|---|---|
| ST AIA-PACK hsE2 Calibrator (3) | 50 pg/mL (approx.) |
| ST AIA-PACK hsE2 Calibrator (4) | 100 pg/mL (approx.) |
| ST AIA-PACK hsE2 Calibrator (5) | 500 pg/mL (approx.) |
| ST AIA-PACK hsE2 Calibrator (6) | 1,100 pg/mL (approx.) |
Human serum containing the assigned concentration of estradiol (described on each vial) with sodium azide as a preservative.
ST AIA-PACK hsE2 Calibrator Set
P/N # 025325
The ST AIA-PACK hsE2 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 hsE2 Calibrator Set is designed for use with ST AIA-PACK hsE2 and ST AIA-PACK hsE2 Sample Diluting Solution.
5
Tosoh Bioscience, Inc.
PREDICATE COMPARISON TABLE 7.
Substantial Equivalence:
Comparison between the Tosoh ST AIA-PACK hsE2 Calibrator Set and the Tosoh ST AIA-PACK E2 Calibrator Set
Similarities
| Characteristic | Tosoh ST AIA-PACK hsE2
Calibrator Set | Predicate | Tosoh AIA-PACK E2 Calibrator
Set (K932084) |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------|----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ST AIA-PACK hsE2 Calibrator
Set is intended for In Vitro
Diagnostic Use Only for the
calibration of the ST AIA-PACK
hsE2 assay. | | The AIA-PACK E2 Calibrator Set is
intended for In Vitro Diagnostic Use
Only for the calibration of the ST
AIA-PACK E2 Assays. |
| Indications for Use (same
as Intended Use) | The ST AIA-PACK hsE2 Calibrator
Set is intended for In Vitro
Diagnostic Use Only for the
calibration of the ST AIA-PACK
hsE2 assay. | | The AIA-PACK E2 Calibrator Set is
intended for In Vitro Diagnostic Use
Only for the calibration of the ST
AIA-PACK E2 Assay. |
| Analyte | Estradiol | | Same |
| Format | Liquid
Six bottles, one for
each of the six calibrator
levels. | | Same |
| Matrix | Serum and heparinized plasma | | Same |
| Storage | Store upright and refrigerate at 2 to
8°C. | | Same |
| Stability
(unopened vial) | Stable until the expiration date
stated on the label when stored at 2
- 8°C. | | Same |
| Calibration Stability | Stable up to 90 days | | Same |
| Stability
(opened vial) | 24 hours (1 day) | | Same |
| Shelf-life | 12 months when stored unopened
and refrigerated at 2-8°C | | 12 months when stored unopened
and refrigerated at 2-8°C |
| Base | Human Serum | | Human serum |
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| Characteristic | Predicate | |
|---|---|---|
| Tosoh AIA-PACK hsE2 Calibrator Set | Tosoh AIA-PACK E2 Calibrator Set (K932084) | |
| Traceability | IRMM (Institute for Reference | |
| Materials and Measurements) | ||
| CRM577 | Internal reference standards. | |
| Levels | Six | |
| (Approximately 0, 25, 50, 100, 500 | ||
| and 1100 pg/mL - lot specific) | Six | |
| (Approximately 0, 40, 100, 500, | ||
| 1000 and 3250 – lot specific) |
Differences
8. SUMMARY OF STABILITY STUDIES
Summary of Stability Studies
Real Time Testing
ST AIA-PACK hsE2 Calibrator Set were stored at refrigerated temperatures and assayed at 6, 12 and 13 months after the day of the first assay.
The acceptance criteria for recovery was 100% +/- 10%.
The criterion for reproducibility (CV %) was