(49 days)
AIA-PACK TSH 3rd-Gen is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of thyroid stimulating hormone (thyrotrophin) in human serum on TOSOH AIA System analyzers. Measurements obtained by human serum on TOSOH AIA Syste numan serum on 100017 M : System any of thyroid or pituitary disorders.
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It appears you've provided snippets from an FDA 510(k) clearance letter for the "AIA-PACK TSH 3rd-Gen Assay". This document is an FDA clearance letter, which confirms the device is substantially equivalent to a predicate device and can be marketed. It does not contain the detailed study information, acceptance criteria, or performance data that you've requested.
The FDA clearance letter primarily focuses on:
- Confirming the device's classification (Class II).
- Stating that it's substantially equivalent to a predicate device.
- Listing general controls and regulatory requirements.
- Providing contact information for various FDA offices.
To answer your specific questions (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.), you would typically need to refer to:
- The 510(k) summary document submitted by the manufacturer to the FDA, which often includes a summary of performance data.
- The full 510(k) submission, if publicly available or requested from the manufacturer, which would contain the detailed study protocols and results.
- Peer-reviewed publications related to the device.
Therefore, based only on the provided text, I cannot answer most of your detailed questions about the study design and acceptance criteria.
However, I can extract the following limited information:
- Device Name: AIA-PACK TSH 3rd-Gen Assay
- Intended Use: For IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of thyroid stimulating hormone (thyrotrophin) in human serum on TOSOH AIA System analyzers. Measurements obtained by human serum on TOSOH AIA Syste numan serum on 100017 M : System any of thyroid or pituitary disorders. (There appears to be a transcription error in the last part of this sentence in the provided document).
- Regulatory Class: II
- Product Code: JLW, JIS
To illustrate what you're asking for, if this were a document that did contain the information, here's how a hypothetical answer might appear, with placeholders for the actual data that is missing from your provided text:
Based on the typical structure of device clearance documentation, the following information would be found in the 510(k) summary or full submission. The provided FDA clearance letter does not contain these details directly.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|---|
| Analytical Sensitivity (Limit of Detection) | ≤ 0.01 mIU/L | 0.005 mIU/L |
| Functional Sensitivity | ≤ 0.02 mIU/L | 0.015 mIU/L |
| Intra-assay Precision (CV%) | < 5% at 0.1 mIU/L; < 3% at 10 mIU/L | 3.2% at 0.1 mIU/L; 1.8% at 10 mIU/L |
| Inter-assay Precision (CV%) | < 10% at 0.1 mIU/L; < 5% at 10 mIU/L | 6.5% at 0.1 mIU/L; 3.1% at 10 mIU/L |
| Linearity/Recovery | Recovery within 90-110% | Average recovery 98.5% |
| Method Comparison (Correlation to Predicate) | R > 0.98, Slope 0.95-1.05, Intercept near 0 | R = 0.992, Slope = 1.01, Intercept = 0.002 |
| Interference (Hemolysis, Lipemia, Bilirubin) | < 10% bias at tested concentrations | No significant interference observed |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: [Information not available in the provided document. Hypothetically: 200 patient samples]
- Data Provenance: [Information not available in the provided document. Hypothetically: Retrospective clinical samples from multiple hospitals in the USA and Europe]
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- [Information not available in the provided document. Hypothetically: Ground truth for quantitative assays like TSH is typically based on reference method assays, not expert consensus on individual cases. For clinical interpretation studies, if applicable, it might be 3 board-certified endocrinologists with 15+ years of experience.]
4. Adjudication method for the test set
- [Information not available in the provided document. Not typically applicable for quantitative IVD performance studies, where ground truth is analytical.)
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
- [Information not available in the provided document. This type of study (MRMC for AI assistance) is not generally relevant for a standalone in vitro diagnostic assay like a TSH test, which produces a quantitative result and does not involve human "readers" interpreting images or complex data in the same way an AI diagnostic imaging tool would. Performance is typically compared against a reference method or predicate device.]
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, for an in vitro diagnostic assay, the performance metrics (sensitivity, precision, accuracy, linearity) evaluate the "algorithm only" or assay's performance in generating a quantitative result. The provided document indicates the device "AIA-PACK TSH 3rd-Gen is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement..." implying standalone performance testing. Specific details, however, are not in the provided text.
7. The type of ground truth used
- [Information not available in the provided document. For quantitative assays like TSH, ground truth is typically established by:
- Reference method/gold standard assays: Using highly accurate and validated laboratory methods.
- Validated calibrators: Traceable to international reference materials (e.g., WHO standards).
- Clinical diagnosis/outcome correlation (for clinical utility studies): Though less direct for the assay's analytical ground truth.]
8. The sample size for the training set
- [Information not available in the provided document. In vitro diagnostic assays like this typically involve reagent and method development, calibration curve generation, and rigorous validation rather than a "training set" in the machine learning sense. However, if there were adaptable algorithms within the system, this information would be found in assay development details.]
9. How the ground truth for the training set was established
- [Information not available in the provided document. Refer to point 8 for context. Calibration and standardization are key for IVDs.]
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AUG 2 9 100:
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Lori Robinson Manager, Quality Assurance Tosoh Medics, Jnc. 373 D Vintage Park Drive Foster City, California 94404
K972586 Re : AIA-PACK TSH 3rd-Gen Assay Requlatory Class: II Product Code: JLW, JIS Dated: August 12, 1997 Received: August 13, 1997
Dear Ms. Robinson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows a chemical structure, specifically the hydroxyl group. The structure consists of an oxygen atom bonded to a hydrogen atom, represented by the symbols 'O' and 'H' respectively. The 'OH' is positioned at the bottom of the image. There is also a shape above the 'OH' that is dark and abstract.
TOSOH MEDICS, INC.
PREMARKET NOTIFICATION
INDICATION FOR USE STATEMENT
AIA-PACK TSH 3rd-Gen Assay
AIA-PACK TSH 3rd-Gen is intended for IN VITRO DIAGNOSTIC USE ONLY for AIA-PACK TSH Stu-Gen is interiod of thyroid stimulating hormone (thyrotrophin) in
the quantitative measurement of thyroid stimulating horners obtained by the quantitative measurement of thyrou valimans. Measurements obtained by
human serum on TOSOH AIA System analyzers. Measurements obtained by
human serum on TOSOH AIA Syste numan serum on 100017 M : System any of thyroid or pituitary disorders.
A
(Division Sign-Off)
Division of Clinical Laboratarevices
510(k) Number. 0912586
\✓ Prescription Use
§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.