(43 days)
Not Found
No
The device description is for a calibrator set used in an in vitro diagnostic assay, which are standard laboratory reagents and do not involve AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No
This device is for in vitro diagnostic use, specifically for calibration of an assay, not for treating a disease or condition.
No
Explanation: This device is a calibrator set, which means it is used to ensure the accuracy of a diagnostic assay, rather than performing a diagnostic test itself. The "Intended Use" clearly states it is "FOR IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK DHEA-S assay."
No
The device description clearly states it contains human sera and is a physical calibrator set, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "ST AIA-PACK DHEA-S Calibrator Set is designed for IN VITRO DIAGNOSTIC USE ONLY".
This statement clearly indicates that the device is intended to be used outside of the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The ST AIA-PACK DHEA-S CALIBRATOR SET is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK DHEA-S assay.
ST AIA-PACK DHEA-S Calibrator Set is designed for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK DHEA-S assay on Tosoh AIA System Analyzers.
Product codes
JIT
Device Description
The ST AIA-PACK DHEA-S CALIBRATOR SET contains human sera with assigned levels of DHEA-S. Calibration should be performed according to the schedule indicated in the TOSOH AIA System Operator's Manual.
2 x 1 mL 0 ug/dL ST AIA-PACK DHEA-S CALIBRATOR (1) Human serum containing no detectable concentration of DHEA-S with sodium azide as a preservative.
2 x 1 mL ST AIA-PACK DHEA-S CALIBRATOR (2) 5.0 µg/dL (approx.)
ST AIA-PACK DHEA-S CALIBRATOR (3) 12 µg/dL (approx.)
ST AIA-PACK DHEA-S CALIBRATOR (4) 60 µg/dL (approx.)
ST AIA-PACK DHEA-S CALIBRATOR (5) 300 µg/dL (approx.)
ST AIA-PACK DHEA-S CALIBRATOR (6) 1200 µg/dL (approx.)
Human serum containing the assigned concentration of DHEA-S (described on each vial) with sodium azide as a preservative.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Tosoh Bioscience, Inc.
:
Abbreviated 510(k) Summary
ST AIA-PACK ACTH
| Date: | June 17, 2011 |
|---|---|
| Submitter: | Tosoh Bioscience, Inc |
| 3600 Gantz Road | |
| Grove City, OH 43123 | |
| Contact Person: | Judith K. Ogden |
| Director, New Business & Technical Development | |
| 6000 Shoreline Ct., Ste. 101 | |
| South San Francisco, CA 94080 | |
| Phone: 650-636-8112 | |
| Fax: 650-636-8113 | |
| Email: Judy.Ogden@tosoh.com | |
| Device Name: | ST AIA-PACK DHEA-S Calibrator Set |
| Classification | Class II |
| JIT | |
| Clinical Chemistry | |
| 21 CFR 862.1150 | |
| Predicate Device: | K040181 |
| Access DHEA-S Calibrators |
ST AIA-PACK DHEA-S Calibrator Set
1
Abbreviated 510(k) Summary
ST AIA-PACK ACTH
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:
The ST AIA-PACK DHEA-S CALIBRATOR SET contains human sera with assigned levels of DHEA-S. Calibration should be performed according to the schedule indicated in the TOSOH AIA System Operator's Manual.
2 x 1 mL 0 ug/dL ST AIA-PACK DHEA-S CALIBRATOR (1) Human serum containing no detectable concentration of DHEA-S with sodium azide as a preservative.
| 2 x 1 mL | ||
|---|---|---|
| ST AIA-PACK DHEA-S CALIBRATOR (2) | 5.0 | µg/dL |
| (approx.) | ||
| ST AIA-PACK DHEA-S CALIBRATOR (3) | 12 | µg/dL |
| (approx.) | ||
| ST AIA-PACK DHEA-S CALIBRATOR (4) | 60 | µg/dL |
| (approx.) | ||
| ST AIA-PACK DHEA-S CALIBRATOR (5) | 300 | µg/dL |
| (approx.) | ||
| ST AIA-PACK DHEA-S CALIBRATOR (6) | 1200 | µg/dL |
| (approx.) |
Human serum containing the assigned concentration of DHEA-S (described on each vial) with sodium azide as a preservative.
ST AIA-PACK ACTH Calibrator Set
P/N 025322
Device Intended Use:
The ST AIA-PACK DHEA-S CALIBRATOR SET is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK DHEA-S assay.
2
Substantial Equivalence:
Comparison between the Tosoh ST AIA-PACK DHEA-S Calibrator Set and the Access DHEA-S Calibrators
| Characteristic | Predicate
Access® DHEA-S
Calibrators
(K040181) | Tosoh ST AIA-PACK
DHEA-S Calibrator Set |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Access DHEA-S
Calibrators are intended to
calibrate the Access DHEA-S
assay for the quantitative
determination of
Dehydroepiandrosterone
sulphate levels in human
serum and plasma using the
Access Immunoassay Systems | The ST AIA-PACK DHEA-S
CALIBRATOR SET is
intended for IN VITRO
DIAGNOSTIC USE ONLY
for the calibration of the ST
AIA-PACK DHEA-S assay. |
| Analyte | DHEA-S | DHEA-S |
| Analyzer | Beckman Coulter Access
Immunoassay System | Tosoh AIA Systems |
| Levels | Six
(0, 20, 50, 200, 500 and 1000
µg/mL approximately) | Six
(0, 5, 12, 60, 300 and 1200
µg/mL, approximately) |
| Format | Ready to use liquid calibrators;
Six two-mL bottles, one for
each of the six calibrator
levels. | Ready to use liquid calibrators;
Six one-mL bottles, one for
each of the six calibrator
levels. |
| Assay Protocol | Competitive
immunoenzymatic | Same |
| Chemistry | Bovine serum / buffer base
with surfactant and
preservative | Human serum base with
sodium azide preservative |
| Traceability | Traceable to the
manufacturer's working
calibrators. | Same |
| Matrix | Serum
Plasma | Serum
Heparinized plasma
EDTA plasma
Citrated plasma cannot be used |
| Storage | Store in upright and refrigerate
at 2 to 10°C. | Store in upright position at 2-
8°C when not in use. |
| Stability
(un-opened vial) | Stable until the expiration date
stated on the label when stored
at 2 to10°C. | When stored unopened and
refrigerated at 2-8°C, the
calibrator set is stable until the
expiration date on the label. |
| Stability
(opened vial) | Vial is stable at 2 to10°C for
28 days after initial use. | The calibrator materials should
be used within 1 day of
opening, provided the vials are
kept tightly sealed and
refrigerated at 2-8°C. |
| Shelf-life | 12 months when stored
unopened and refrigerated at 2-
8°C | 12 months when stored
unopened and refrigerated at 2-
8°C |
| Calibration Stability | Assay calibration data are
valid up to 28 days | Stable up to 90 days |
3
:
.
4
Conclusion:
The Tosoh Bioscience, Inc. ST AIA-PACK DHEA-S Calibrator Set is substantially equivalent to the Access DHEA-S Calibrators K040181 for the in vitro diagnostic use only for the calibration the ST AIA-PACK DHEA-S assay.
5
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Tosoh Bioscience, Inc c/o Ms. Judith K. Ogden 6000 Shoreline Ct., Ste. 101 South San Francisco, CA 94080
AUG 0 5 2011
K111762 Re:
Trade Name: ST AIA-PACK DHEA-S Calibrator Set Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIT Dated: June 22, 2011 Received: June 23, 2011
Dear Ms. Ogden:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
6
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
C.C.
Courmey Harper. Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
: 上一:
Enclosure
7
Indications for Use
| 510(k) Number (if known): | k 111762 |
|---|---|
| Device Name: | ST AIA-PACK DHEA-S Calibrator Set |
| Indication For Use: | ST AIA-PACK DHEA-S Calibrator Set is designed for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK DHEA-S assay on Tosoh AIA System Analyzers |
Prescription Use ___ √ -(21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Qute chulu K111762
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety