(46 days)
FOR IN VITRO DIAGNOSTIC USE.
The Transferrin SPQ™ III ANTIBODY REAGENT SET is designed for the quantitative determination of transferrin in human serum by immunoprecipitin analysis.
Transferrin (TRF) Immunological Test Kit
The provided document is a 510(k) summary for the Transferrin SPQ™ III Antibody Reagent Set, which is a modification of an existing device. It discusses the substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and detailed performance metrics. Therefore, many of the requested details about acceptance criteria, specific performance numbers, sample sizes, ground truth establishment, and expert involvement are not explicitly stated in the provided text.
Based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with numerical targets. Instead, it states that the modified device was compared to a predicate device (Transferrin SPQ™ II Antibody Reagent Set) and found to be "substantially equivalent."
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Nonclinical Testing | Performance characteristics are substantially equivalent to the predicate device. | "Nonclinical testing demonstrated that the performance characteristics of the modified device were substantially equivalent to those of the predicate device." |
| Clinical Testing | Performance characteristics are substantially equivalent to the predicate device. | "Clinical testing demonstrated that the performance characteristics of the modified device were substantially equivalent to those of the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. It is not mentioned whether the data was retrospective or prospective, nor the country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document describes an in vitro diagnostic device for quantitative determination of transferrin, not an imaging or diagnostic device that typically involves expert interpretation for ground truth establishment in a study of this nature. The "ground truth" for such a device would typically be established by a reference method or validated assays, not expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. This is an in vitro diagnostic device, and its performance is evaluated against chemical/biological measurements, not human consensus on visual findings.
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
Not applicable. An MRMC study is relevant for AI systems assisting human readers, typically in medical imaging. This document describes an in vitro diagnostic reagent set for chemical analysis, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is an in vitro diagnostic reagent set. Performance refers to the assay's ability to accurately measure transferrin levels. The "algorithm only" concept does not directly apply in the way it would for AI/software devices. The "standalone" performance would be the analytical performance of the assay itself (e.g., precision, accuracy, linearity, limit of detection), which is what "Nonclinical Testing" and "Clinical Testing" generally refer to for such devices. The document states that both nonclinical and clinical testing demonstrated substantial equivalence to the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used. For an in vitro diagnostic quantitative assay like this, "ground truth" would typically be established by:
- Reference method/assay: Comparing results to a recognized, highly accurate, and precise reference method for transferrin measurement.
- Calibrators and controls: Using materials with known transferrin concentrations.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set in that context. It is an in vitro diagnostic reagent set. The development involved modification of an existing reagent set, not training an algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this type of device.
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DEC 18 1998
11983880
Special 510(k): Device Modification: Transferrin SPQ™ III Antibody Reagent Set
10 510(k) Summary
October 30, 1998
. .
| Submitted By: | Judith J. SmithDiaSorin, Inc.9175 Guilford Rd. Suite 100Columbia, MD 21046 |
|---|---|
| Name Of Device:Trade Name: | Transferrin SPQ™ III Antibody Reagent Set |
| Common Name: | Transferrin (TRF) Immunological Test Kit |
| Classification Name: | Transferrin, antigen, antiserum, Control (82 DDG) |
| Device Classification | Class II |
| Predicate Device: | SPQ™ Antibody Reagent Set II for Transferrin |
| Device Description: | Transferrin (TRF) Immunological Test Kit |
| Intended Use: | FOR IN VITRO DIAGNOSTIC USE.The Transferrin SPQ™ III ANTIBODY REAGENT SET is designedfor the quantitative determination of transferrin in human serum byimmunoprecipitin analysis. |
| TechnologicalComparison: | The modified device has the same technological basis as thepredicate device. |
| Labeling Comparison: | The labeling of the modified assay is substantially equivalent to thatof the predicate device. Changes in labeling directly reflect thedevice modification (higher titer primary antibody, elimination ofpatient sample diluent). |
| Nonclinical Testing: | Nonclinical testing demonstrated that the performancecharacteristics of the modified device were substantially equivalentto those of the predicate device. |
| Clinical Testing: | Clinical testing demonstrated that the performance characteristicsof the modified device were substantially equivalent to those of thepredicate device. |
| Conclusions fromTesting: | The modified device is substantially equivalent to the predicatedevice. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/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 a stylized symbol of three human profiles facing right, stacked on top of each other.
DEC 1 8 1998 Ms. Judith J. Smith Corporate Director Worldwide Requlatory Affairs And Ouality Systems DiaSorin, Inc. 9175 Guilford Road, Suite 100 Columbia, Maryland 21046
Re: K983880 Trade Name: Transferrin SPQ™ III Antibody Reagent Set Requlatory Class: II Product Code: DDG Dated: October 30, 1998 November 2, 1998 Received:
Dear Ms. Smith:
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 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). 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 aqainst 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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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 requlatory 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 regulations.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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Page 2
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 diaqnostic 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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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Indications for Use 3
510(k) Number: _ K 983880
Device Name: Transferrin SPQ™ III Antibody Reagent Set
Indications For Use:
FOR IN VITRO DIAGNOSTIC USE.
The Transferrin SPQTM III ANTIBODY REAGENT SET is designed for the quantitative determination of transferrin in human serum by immunoprecipitin analysis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | f983880 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)
§ 866.5880 Transferrin immunological test system.
(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).