(43 days)
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
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.
The provided document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of algorithm performance metrics (e.g., sensitivity, specificity for classification tasks).
This document is an Abbreviated 510(k) Summary for a medical device (ST AIA-PACK DHEA-S Calibrator Set) used as a calibrator for an assay, not an AI/ML powered diagnostic device.
Therefore, many of the requested fields are not applicable in this context. However, I can extract the relevant information from the document regarding the device's characteristics and its comparison to a predicate device for substantial equivalence.
Here's the breakdown of the information available:
Acceptance Criteria and Device Performance Study (as applicable)
This document details a substantial equivalence comparison to a legally marketed predicate device (Access DHEA-S Calibrators, K040181) for the purpose of 510(k) clearance, not a study evaluating specific performance metrics against pre-defined acceptance criteria for a diagnostic algorithm.
The "acceptance criteria" here are implicitly related to demonstrating that the new device's characteristics and performance are sufficiently similar to the predicate device, as confirmed by the FDA's substantial equivalence determination. The "reported device performance" refers to the characteristics of the calibrator set itself.
The study described is a comparative effectiveness study against a predicate device's specifications, rather than a clinical trial or algorithm performance study.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Predicate (Access® DHEA-S Calibrators, K040181) | Reported Device Performance (Tosoh ST AIA-PACK DHEA-S Calibrator Set) | Notes/Acceptance Criteria Implication |
|---|---|---|---|
| Intended Use | Calibrate the Access DHEA-S assay for quantitative determination of DHEA-S levels in human serum and plasma. | Intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK DHEA-S assay. | Demonstrated to be similar, for the calibration of a DHEA-S assay. |
| Analyte | DHEA-S | DHEA-S | Identical. |
| Analyzer | Beckman Coulter Access Immunoassay System | Tosoh AIA Systems | Different, but expected for a new calibrator system designed for a specific manufacturer's assay. This is a characteristic, not a performance metric for the calibrator directly. |
| Levels (approx.) | Six: 0, 20, 50, 200, 500, 1000 µg/mL | Six: 0, 5, 12, 60, 300, 1200 µg/mL | Different concentration ranges, but both provide six levels for calibration. This difference is accepted as part of product specificity. |
| Format | Ready to use liquid calibrators; Six two-mL bottles. | Ready to use liquid calibrators; Six one-mL bottles. | Similar format, volume difference is noted. |
| Assay Protocol | Competitive immunoenzymatic | Same (Competitive immunoenzymatic) | Identical. |
| Chemistry | Bovine serum / buffer base with surfactant and preservative | Human serum base with sodium azide preservative | Different base matrix (bovine vs. human) and preservative. This difference required evaluation but was deemed acceptable for substantial equivalence. |
| Traceability | Traceable to the manufacturer's working calibrators. | Same (Traceable to the manufacturer's working calibrators). | Identical. |
| Matrix | Serum, Plasma | Serum, Heparinized plasma, EDTA plasma (Citrated plasma cannot be used) | Broader matrix compatibility for the new device compared to the predicate, with a specific exclusion. This is a characteristic difference. |
| Storage | Store in upright and refrigerate at 2 to 10°C. | Store in upright position at 2-8°C when not in use. | Similar storage requirements. |
| Stability (un-opened) | Stable until expiration date on label when stored at 2-10°C. | Stable until expiration date on label when stored unopened and refrigerated at 2-8°C. | Similar. |
| Stability (opened) | Vial is stable at 2-10°C for 28 days after initial use. | Calibrator materials should be used within 1 day of opening, provided vials are kept tightly sealed and refrigerated at 2-8°C. | A significant difference in opened vial stability (28 days vs. 1 day). This difference was accepted, likely due to differences in formulation or stability profile, and addressed via labeling. |
| Shelf-life | 12 months when stored unopened and refrigerated at 2-8°C. | 12 months when stored unopened and refrigerated at 2-8°C. | Identical. |
| Calibration Stability | Assay calibration data are valid up to 28 days. | Stable up to 90 days. | The new device offers significantly longer calibration stability (90 days vs. 28 days), which is an improvement and thus acceptable. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in terms of a "test set" for performance evaluation, as this is a calibrator, not a diagnostic test with patient samples. The information covers the characteristics of the calibrator itself and its intended use.
- Data Provenance: Not applicable in the context of patient data. The summary describes the physical characteristics and stability profiles of the calibrator set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts/Qualifications: Not applicable. This is not a study involving human interpretation or ground truth establishment by experts for a diagnostic algorithm. The "ground truth" for a calibrator would be its assigned concentration values, which are typically established by the manufacturer through rigorous analytical methods traceable to primary standards, not expert consensus in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. There is no "test set" requiring adjudication by human experts in this context.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study / AI Assistance: Not applicable. This product is a calibrator, not an AI-powered diagnostic device, and therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithm, so "standalone performance" of an algorithm is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: For a calibrator, the "ground truth" would be the assigned concentration values for DHEA-S in each calibrator vial. These values are established by the manufacturer, traceable to primary reference materials, and validated through analytical methods. It's not based on expert consensus, pathology, or outcomes data in the diagnostic sense.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not applicable, as there is no "training set."
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Tosoh Bioscience, Inc.
:
Abbreviated 510(k) Summary
ST AIA-PACK ACTH
| Date: | June 17, 2011 |
|---|---|
| Submitter: | Tosoh Bioscience, Inc3600 Gantz RoadGrove City, OH 43123 |
| Contact Person: | Judith K. OgdenDirector, New Business & Technical Development6000 Shoreline Ct., Ste. 101South San Francisco, CA 94080Phone: 650-636-8112Fax: 650-636-8113Email: Judy.Ogden@tosoh.com |
| Device Name: | ST AIA-PACK DHEA-S Calibrator Set |
| Classification | Class IIJITClinical Chemistry21 CFR 862.1150 |
| Predicate Device: | K040181Access DHEA-S Calibrators |
ST AIA-PACK DHEA-S Calibrator Set
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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.
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Substantial Equivalence:
Comparison between the Tosoh ST AIA-PACK DHEA-S Calibrator Set and the Access DHEA-S Calibrators
| Characteristic | PredicateAccess® DHEA-SCalibrators(K040181) | Tosoh ST AIA-PACKDHEA-S Calibrator Set |
|---|---|---|
| Intended Use | The Access DHEA-SCalibrators are intended tocalibrate the Access DHEA-Sassay for the quantitativedetermination ofDehydroepiandrosteronesulphate levels in humanserum and plasma using theAccess Immunoassay Systems | The ST AIA-PACK DHEA-SCALIBRATOR SET isintended for IN VITRODIAGNOSTIC USE ONLYfor the calibration of the STAIA-PACK DHEA-S assay. |
| Analyte | DHEA-S | DHEA-S |
| Analyzer | Beckman Coulter AccessImmunoassay System | Tosoh AIA Systems |
| Levels | Six(0, 20, 50, 200, 500 and 1000µg/mL approximately) | Six(0, 5, 12, 60, 300 and 1200µg/mL, approximately) |
| Format | Ready to use liquid calibrators;Six two-mL bottles, one foreach of the six calibratorlevels. | Ready to use liquid calibrators;Six one-mL bottles, one foreach of the six calibratorlevels. |
| Assay Protocol | Competitiveimmunoenzymatic | Same |
| Chemistry | Bovine serum / buffer basewith surfactant andpreservative | Human serum base withsodium azide preservative |
| Traceability | Traceable to themanufacturer's workingcalibrators. | Same |
| Matrix | SerumPlasma | SerumHeparinized plasmaEDTA plasmaCitrated plasma cannot be used |
| Storage | Store in upright and refrigerateat 2 to 10°C. | Store in upright position at 2-8°C when not in use. |
| Stability(un-opened vial) | Stable until the expiration datestated on the label when storedat 2 to10°C. | When stored unopened andrefrigerated at 2-8°C, thecalibrator set is stable until theexpiration date on the label. |
| Stability(opened vial) | Vial is stable at 2 to10°C for28 days after initial use. | The calibrator materials shouldbe used within 1 day ofopening, provided the vials arekept tightly sealed andrefrigerated at 2-8°C. |
| Shelf-life | 12 months when storedunopened and refrigerated at 2-8°C | 12 months when storedunopened and refrigerated at 2-8°C |
| Calibration Stability | Assay calibration data arevalid up to 28 days | Stable up to 90 days |
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:
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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.
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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).
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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
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Enclosure
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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
§ 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.