(30 days)
No
The device is a calibrator set for an in vitro diagnostic assay and does not describe any computational or algorithmic functions that would involve AI or ML.
No
This device is an In Vitro Diagnostic (IVD) calibrator set used for assay calibration, not for treating or preventing disease.
No
The device is a calibrator set, intended for calibrating an assay. It is used to ensure the accuracy of a diagnostic test, but it is not the diagnostic test itself.
No
The device description clearly states it is a "Calibrator Set" consisting of liquid solutions containing specific concentrations of progesterone in human serum, intended for calibrating an in vitro diagnostic assay. This is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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."
This statement clearly indicates that the device is intended to be used outside of the body to examine specimens for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
The ST AIA-PACK PROG II Calibrator Set contains:
2 x 1 mL ST AIA-PACK PROG II Calibrator (1) (0 ng/mL) - Protein matrix containing no detectable concentration of PROG with sodium 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.)
These five calibrators (2-6) are human serum containing the assigned concentration of progesterone (described on each vial) with sodium azide as a preservative.
The ST AIA-PACK PROG II Calibrator Set (P/N # 025339) 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.
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.
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)
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
§ 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a stacked formation. The profiles are connected and form a single, abstract shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
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.
1
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 (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
2
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: 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.: | 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 |
4
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 | ||
| 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.
5
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 | ||
| Calibrator Set | Tosoh AIA-PACK PROG | |
| Calibrator Set (K933269) | ||
| 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. | 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 II | |
| Calibrator Set is intended for In Vitro | ||
| Diagnostic Use Only for the | ||
| calibration of the ST AIA-PACK | ||
| PROG II 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 |
6
| Characteristic | Tosoh AIA-PACK PROG II
Calibrator Set | Predicate
Tosoh AIA-PACK PROG
Calibrator Set (K951848) |
|----------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Shelf-life | 6 months when stored unopened
and refrigerated at 2-8°C | 12 months when stored unopened
and refrigerated at 2-8°C |
| Traceability | The calibrators for use with the ST
AIA-PACK PROG II were referred to
USP (United States Pharmacopeia)
Standard. | The calibrators in this set are
prepared gravimetrically and are
compared to internal reference
standards. |
| 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
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