(23 days)
No
The device is a calibrator set for an in vitro diagnostic assay and does not describe any computational or analytical functions that would involve AI/ML. The description focuses on the chemical composition and stability of the calibrator materials.
No
The device is an in vitro diagnostic calibrator set intended for calibrating an assay, not for treating a disease or condition in a patient.
No
The provided text explicitly states that this device is a "Calibrator Set," intended for "calibration of the ST AIA-PACK PROG III assay." Calibrators are used to establish a reference point for measurement, not to directly diagnose a condition.
No
The device description clearly indicates it is a set of liquid calibrators (chemical substances) intended for use with a specific hardware analyzer system. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states: "The ST AIA-PACK PROG III Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK PROG III assay." This is the most direct indicator.
- Device Description: The description details the components of the calibrator set, which are used in a laboratory setting to calibrate an assay.
- Intended User / Care Setting: This section also states "In Vitro Diagnostic Use Only."
- Predicate Device: The mention of a predicate device (K933269 ST AIA-PACK PROG (Calibrator Set)) which is also a calibrator set, further supports its classification as an IVD. Calibrators are essential components of many in vitro diagnostic tests.
The information provided clearly indicates that this device is designed and intended to be used outside of the body to perform diagnostic testing, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ST AIA-PACK PROG III Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK PROG III assay.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
- 2 x 1 mL ST AIA-PACK PROG III Calibrator (1) 0 nq/mL Bovine protein matrix containing no detectable concentration of progesterone with sodium azide as a preservative (Liquid).
- 2 x 1 mL ST AIA-PACK PROG III Calibrator (2) 0.5 ng/mL (approx.)
- ST AIA-PACK PROG III Calibrator (3) 1.5 ng/mL (approx.)
- ST AIA-PACK PROG III Calibrator (4) 5.0 ng/mL (approx.)
- ST AIA-PACK PROG III Calibrator (5) 15 ng/mL (approx.)
- ST AIA-PACK PROG III Calibrator (6) 45 ng/mL (approx.)
Bovine protein matrix containing the assigned concentration of progesterone (described on each vial) with sodium azide as a preservative.
The ST AIA-PACK PROG III 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 III Calibrator Set is designed for use with ST AIA-PACK PROG III and ST AIA-PACK PROG III 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 Progesterone III Calibrator Set were stored at refrigerated temperatures and assayed at 3, 6 and 9 months after the day of the first assay.
The acceptance criteria for recovery was within 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
TOSOH BIOSCIENCE, INC. ROBERT WICK REGULATORY SPECIALIST 6000 SHORELINE COURT, SUITE 101 SOUTH SAN FRANCISCO, CA 94080
December 18, 2015
Re: K153417
Trade/Device Name: ST AIA-PACK PROG III Calibrator Set Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: November 24, 2015 Received: November 25, 2015
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 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.
1
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 (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" (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 (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) K153417
Device Name ST AIA-PACK PROG III Calibrator Set
Indications for Use (Describe) The ST AIA-PACK PROG III Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK PROG III assay.
Type of Use (Select one or both, as applicable)
| For activities that do NOT disturb State-owned submerged lands |
|---|
| For Construction (that disturb State-owned submerged lands) |
|× | 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 PROG III 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:
November 23, 2015 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 PROG III Calibrator Set New Product Calibrator, Secondary Progesterone Test System Class II JIT Clinical Chemistry 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 III Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK PROG III 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 PROG III Calibrator (1) 0 nq/mL
Bovine protein matrix containing no detectable concentration of progesterone with sodium azide as a preservative (Liquid).
| 2 x 1 mL ST AIA-PACK PROG III Calibrator (2) | 0.5 | ng/mL (approx.) | |
|---|---|---|---|
| ST AIA-PACK PROG III Calibrator (3) | 1.5 | ng/mL (approx.) | |
| ST AIA-PACK PROG III Calibrator (4) | 5.0 | ng/mL (approx.) | |
| ST AIA-PACK PROG III Calibrator (5) | 15 | ng/mL (approx.) | |
| ST AIA-PACK PROG III Calibrator (6) | 45 | ng/mL (approx.) |
Bovine protein matrix containing the assigned concentration of progesterone (described on each vial) with sodium azide as a preservative.
ST AIA-PACK PROG III Calibrator Set
P/N # 025340
The ST AIA-PACK PROG III 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 III Calibrator Set is designed for use with ST AIA-PACK PROG III and ST AIA-PACK PROG III Sample Diluting Solution.
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PREDICATE COMPARISON TABLE 7.
Substantial Equivalence:
Comparison between the Tosoh ST AIA-PACK PROG III Calibrator Set and the Tosoh ST AIA-PACK PROG Calibrator Set
Similarities
| Characteristic | Predicate | |
|---|---|---|
| Tosoh AIA-PACK PROG III | ||
| Calibrator Set | Tosoh AIA-PACK PROG | |
| Calibrator Set (K933269) | ||
| Intended Use | The ST AIA-PACK PROG III | |
| Calibrator Set is intended for In Vitro | ||
| Diagnostic Use Only for the | ||
| calibration of the ST AIA-PACK | ||
| PROG III assay. | The AIA-PACK PROG Calibrator Set is intended for In Vitro | |
| Diagnostic Use Only for the | ||
| calibration of the ST AIA-PACK | ||
| PROG Assays. | ||
| Indications for Use (same | ||
| as Intended Use) | The ST AIA-PACK PROG III | |
| Calibrator Set is intended for In Vitro | ||
| Diagnostic Use Only for the | ||
| calibration of the ST AIA-PACK | ||
| PROG III assay. | The AIA-PACK PROG Calibrator Set is intended for In Vitro | |
| Diagnostic Use Only for the | ||
| calibration of the ST AIA-PACK | ||
| PROG Assays. | ||
| Analyte | Progesterone | 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 |
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| Characteristic | Predicate | |
|---|---|---|
| Tosoh AIA-PACK PROG III | ||
| Calibrator Set | Tosoh AIA-PACK PROG | |
| Calibrator Set (K933269) | ||
| Shelf-life | 8 months when stored unopened | |
| and refrigerated at 2-8°C | 12 months when stored unopened | |
| and refrigerated at 2-8°C | ||
| Traceability | USP (United States Pharmacopeia) | |
| Standard (Lot #11J239). | Internal reference standards. | |
| Base | Bovine serum | Human serum |
| Levels | Six | |
| (0, 0.5, 1.5, 5.0, 15, 45 | ||
| ng/mL approximately) | Six | |
| (0, 0.5, 1.5, 5.0, 20, 60 | ||
| ng/mL approximately) | ||
| Analyzer | Tosoh AIA-2000 | Tosoh AIA-1200 |
Differences
8. SUMMARY OF STABILITY STUDIES
Summary of Stability Studies
Real Time Testing
ST AIA-PACK Progesterone III Calibrator Set were stored at refrigerated temperatures and assayed at 3, 6 and 9 months after the day of the first assay.
The acceptance criteria for recovery was within 100 +/- 10%.
The criterion for reproducibility (CV %) was