(77 days)
AIA-PACK IGE II is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of immunoglobulin E (IgE) in human serum on TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of atopic disorders, allergic conditions and the body's inability to resist infectious agents.
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Here's a breakdown of the acceptance criteria and study information based on the provided text for the AIA-PACK IqE II Assay:
Device Name: AIA-PACK IqE II Assay
Indications For Use: The AIA-PACK IGE II is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of immunoglobulin E (IgE) in human serum on TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of atopic disorders, allergic conditions and the body's inability to resist infectious agents.
1. Acceptance Criteria and Reported Device Performance
The provided 510(k) submission summary (K972697) does not explicitly list a table of acceptance criteria or detailed reported device performance metrics in the format normally associated with clinical studies for AI/ML devices (e.g., sensitivity, specificity, AUC). This document is primarily an FDA clearance letter and an "Indications For Use" statement.
For in-vitro diagnostic (IVD) assays like the AIA-PACK IqE II, typical acceptance criteria often relate to:
- Precision/Reproducibility: Within-run, between-run, and total precision (e.g., %CV < a certain threshold).
- Accuracy/Correlation: Comparison to a reference method or predicate device (e.g., correlation coefficient R > x, bias within y%).
- Analytical Sensitivity: Limit of Detection (LoD), Limit of Quantitation (LoQ).
- Analytical Specificity: Interference studies (e.g., no significant interference from common substances).
- Linearity/Measuring Range: Demonstrate accurate results across the reportable range.
- Reference Range: Establishment of normal values.
Since these specific details are not present in the provided text, a table cannot be generated. The document only confirms the device's substantial equivalence to a predicate device, implying that the performance was deemed acceptable for its intended use by the FDA.
2. Sample Size Used for the Test Set and Data Provenance
The provided document (an FDA 510(k) clearance letter and Indications for Use) does not contain any information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature) of any studies. This type of detail would typically be found in the full 510(k) submission's performance data section, which is not included here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding the number of experts used, their qualifications, or how ground truth was established for a test set. Given this is an in-vitro diagnostic assay for quantitative measurement, the "ground truth" would likely be established through a primary reference method or a highly accurate predicate device, rather than expert consensus on images.
4. Adjudication Method for the Test Set
The document does not provide any information regarding an adjudication method for a test set. For quantitative IVD assays, adjudication methods like 2+1 or 3+1 (common for image-based diagnostics) are generally not applicable. Instead, discrepancy analysis between the investigational device and a reference method would be performed if there were significant differences.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, nor would it be applicable for this type of in-vitro diagnostic device. MRMC studies are typically performed for imaging diagnostics where human readers interpret medical images, often with and without AI assistance, to measure the impact of AI on reader performance. The AIA-PACK IqE II Assay is an automated quantitative measurement system that doesn't involve human interpretation of complex visual data in the same way.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device, being an "AIA-PACK IGE II Assay" on "TOSOH AIA System analyzers," inherently operates as a standalone algorithm/system (without human-in-the-loop for result generation). The system performs the quantitative measurement of IgE in serum. Human involvement would be in sample preparation, loading, and interpretation of the numerical output, but not in the analytical measurement itself, thus it is a standalone performance by nature. The provided text doesn't explicitly state "standalone study" but the nature of the device implies its core function is standalone.
7. The Type of Ground Truth Used
For an in-vitro diagnostic quantitative assay, the ground truth is typically established by:
- A "gold standard" reference method: A highly accurate and well-established method for measuring IgE.
- A legally marketed predicate device: The performance of the new device is compared to a previously cleared device that measures the same analyte.
The provided document does not explicitly state which type of ground truth was used, but given the substantial equivalence determination, it strongly implies comparison to one or more predicate devices. Pathology or outcomes data are generally not used as direct ground truth for analytical performance of such a quantitative assay (though outcomes data might be used in broader clinical utility studies).
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size for a training set. For in-vitro diagnostic assays, the concept of a "training set" (as understood in AI/ML model development) may not be directly applicable in the same way. Instead, developmental studies involve analytical validation (precision, accuracy, linearity, etc.) and potentially small clinical studies for method comparison and reference range establishment.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information regarding how ground truth was established for a training set, nor does it mention a training set in the context of AI/ML. For IVD development, "ground truth" during development (if applicable) would be established by the reference method or predicate device against which the assay's performance is optimized and validated.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lori Robinson Manager, Quality Assurance TOSOH Medics, Inc. 373 D Vintage Park Drive Foster City, California 94404
OCT = 3 1997
Re: K972697 Trade Name: AIA-PACK IqE II Assay Regulatory Class: II Product Code: DGC Dated: July 17, 1997 Received: July 18, 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 of the Act. The qeneral 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 at (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html"
Sincerely yours,
Steven Dutman
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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Page _ of _
510(k) Number (if known): $973697
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
AIA-PACK IGE II Assay
AIA-PACK IGE II is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of immunoglobulin E (IgE) in human serum on TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of atopic disorders, allergic conditions and the body's inability to resist infectious agents.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Madessi
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number _
Prescription Use
(Per 21 CFR 801.109)
2008 A
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).