(90 days)
The Quantikine™ IVD™ sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.
The product is a microtiter-plate-based sandwich enzyme immunoassay for soluble transferrin receptor.
Acceptance Criteria and Study for Quantikine™ IVD™ sTfR ELISA kit
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria in a dedicated table format. However, it outlines performance characteristics that were tested. I will infer the implied acceptance criteria based on the descriptions provided.
| Performance Characteristic | Implied Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Precision | Demonstrate reliable and reproducible measurements. (Specific CV% or SD not stated) | Testing performed. Implied acceptable as device was cleared. |
| Linearity | Show consistent response across the expected range of sTfR concentrations. (Specific range or R² not stated) | Testing performed. Implied acceptable as device was cleared. |
| Specificity | Accurately detect sTfR without significant interference from other substances. (Specific cross-reactivity limits not stated) | Testing performed. Implied acceptable as device was cleared. |
| Sensitivity | Detect low concentrations of sTfR. (Specific limit of detection not stated) | Testing performed. Implied acceptable as device was cleared. |
| Stability (Kit) | Maintain performance for at least 13 weeks when stored at 2-8°C. | Established at 13 weeks when stored at 2-8℃ and handled according to instructions. |
| Stability (Opened/Diluted Reagents) | Maintain performance for up to 4 weeks when stored at 2-8°C (within kit expiration). | Good for up to 4 weeks when stored at 2-8℃, provided it's within expiration date. |
| Stability (Reconstituted Controls) | Maintain performance for a minimum of 4 weeks. | Stable for a minimum of 4 weeks. |
| Intended Use | Aid in the diagnosis of iron deficiency anemia and differential diagnosis. | Stated as intended use, implying performance supports this claim. |
| Substantial Equivalence | Performance characteristics similar to predicate Sanofi Diagnostics ferritin assay. | Performance testing "centered on the attributes of precision, linearity, specificity, sensitivity and stability." Technologies are similar. |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not specify the sample sizes used for the test set for precision, linearity, specificity, sensitivity, or stability studies.
The data provenance (e.g., country of origin, retrospective or prospective) is also not mentioned in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention using experts to establish ground truth for the test set. The performance characteristics (precision, linearity, specificity, sensitivity) typically rely on laboratory-based analytical validation, not expert consensus on clinical cases.
4. Adjudication Method for the Test Set:
Since the ground truth for the test set, in terms of clinical cases or diagnoses, is not mentioned as being established by experts, there is no adjudication method described for the test set. The evaluation seems to be based on analytical performance metrics.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or is not mentioned in this 510(k) summary. This type of study is more common for imaging devices where human interpretation plays a significant role. The Quantikine™ IVD™ sTfR ELISA kit is an in vitro diagnostic assay, which typically focuses on analytical performance characteristics rather than human reader improvement with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
The device described is an in vitro diagnostic (IVD) ELISA kit, which is inherently a "standalone" device in the sense that its output is a quantitative measurement of sTfR concentration. There isn't an "algorithm" in the typical AI sense, nor is there a "human-in-the-loop" interaction during the assay's execution. The result is generated by the biochemical reaction, and then a human interprets that numerical result in a clinical context.
7. Type of Ground Truth Used:
For the performance characteristics described:
- Precision: Likely assessed by repeated measurements of control samples or patient samples.
- Linearity: Assessed by diluting samples with known concentrations or by spiking samples.
- Specificity: Assessed by testing for interference from various substances or cross-reactivity with related molecules.
- Sensitivity: Assessed by determining the lowest detectable concentration of sTfR.
- Stability: Assessed by testing reagents and kits over time under specified storage conditions.
In these contexts, the "ground truth" is typically established by:
- Reference materials/standards: For accuracy and calibration.
- Pre-established analytical methods: For defining what constitutes a "true" concentration or a valid measurement.
- Spiking experiments: Where a known amount of analyte is added to a sample.
Pathology, expert consensus, or outcomes data are not mentioned as directly being used to establish the ground truth for the performance characteristics reported in this 510(k) summary. Given its nature as an IVD, the ground truth relates to the analytical performance of the assay itself.
8. Sample Size for the Training Set:
The document does not mention a "training set" in the context of machine learning or AI algorithms. This is an IVD kit, which typically does not involve machine learning models that require training data. The development of such an assay involves optimization of reagents and protocols, which is an iterative process but not typically referred to as "training" in this context.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set in the context of an AI/ML algorithm, the question of how its ground truth was established is not applicable based on the provided text. The development of an ELISA assay involves extensive R&D to define optimal antibody pairs, reagent concentrations, incubation times, etc., but this is a different paradigm from AI model training.
{0}------------------------------------------------
MAY 27 1997
510(k) Summary Quantikine™ IVD™ sTfR ELISA kit
Date of Summary: Company Name:
Contact name:
February 14, 1997 R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413 Kenneth T. Edds, Ph.D. 612-379-2956, FAX 612-379-6580
Classification name: Product name: Device Class:
sTfR immunological test system Quantikine IVD sTfR immunoassay Class II
Device to which substantial equivalence is claimed: Sanofi Diagnostics ferritin assay, Chaska, MN, K926221
The product is a microtiter-plate-based sandwich enzyme immunoassay for soluble transferrin receptor.
The Quantikine™ IVD™ sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.
R&D Systems' Quantikine IVD sTfR ELISA kit has an intended use that is similar to the predicate device. The technologies of the two devices are similar in that both are immunoassays involving the solid phase binding of an antibody-analyte-antibody* complex. They differ in the "reporter" moiety (*) attached to the complex. R&D System's assay is based on a colorimetric reaction and Sanofi's is chemiluminescent.
Testing of performance characteristics centered on the attributes of precision, linearity, specificity, sensitivity and stability. The assay is run at room temperature on the bench top.
Expiration dating for the kit has been established at 13 weeks when stored at 2-8℃ and handled according to instructions for use. Opened or diluted reagents are good for up to 4 weeks when stored at 2-8℃ provided that this is within the expiration date. The controls provided with the kit are lyophilized; once they are reconstituted they are stable for a minimum of 4 weeks.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 27 1997
Kenneth T. Edds, Ph.D. Regulatory Affairs R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, Minnesota 55413
K970718 Re: Trade Name: Quantikine IVD sTfR Immunoassay Regulatory Class: II Product Code: JNM Dated: February 26, 1997 Received: February 26, 1997
Dear Dr. Edds:
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, 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Register.
Please note: this response is 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.
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.
{2}------------------------------------------------
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 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.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
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
{3}------------------------------------------------
510(k) Number:
Device Name: The Quantikine™ IVD™ sTFR Enzyme linked immunosorbent assay
Indications for Use: The Quantikine™ IVD™ sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.
Gita E. Makeri
(Division Jun. 097 Laboratory D ""ines Divi : Dit . . . . .
510(k) Number __ and, and I am sorry for the inconvenience.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-CounterUse
(Optional Format 1-2-96)
$k=3^{k}
§ 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).