(183 days)
The Quantikine IVD β,-microglobulin EIA kit is intended for the quantitative determination of β, microglobulin concentration in human serum and urine as an aid in the diagnosis of active rheumatoid arthritis and kidney diseases.
The product is a competitive binding enzyme immunoassay (EIA) for ß2 microglobulin.
The provided text describes the acceptance criteria and performance of the Quantikine™ IVD™ ß2 microglobulin enzyme immunoassay.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Signal generated by standard 0 to be greater than 1.5 absorbance units | Not explicitly stated, but implied to be met for device approval. |
| Signal generated by standard 5 to be less than 0.35 absorbance units | Not explicitly stated, but implied to be met for device approval. |
| Curve fitting individual replicates of Standard 1 to fit within ±15% of nominal value and the Mean value of Standard 1 to fit within ±10% of nominal value. Individual replicates and Mean values of Standards 2-5 to fit within ± 10% of nominal value. | Not explicitly stated, but implied to be met for device approval. |
| In-house control and kit control values to be within the ranges quoted on the appropriate control data sheets. | Not explicitly stated, but implied to be met for device approval. |
| Sensitivity to be less than 0.2 µg/mL. | < 0.2 µg/mL |
| Precision (based on 10 replicates of three in-house controls) to be typically less than 8%. | Typically < 8% |
| Additional Performance Attributes: | |
| Accuracy | Demonstrated acceptable performance (no specific values provided) |
| Precision (general) | Demonstrated acceptable performance (specific precision above) |
| Stability (Expiration dating) | 26 weeks when stored at 2-8°C |
| Stability (Opened/diluted reagents) | Up to 4 weeks when stored at 2-8°C (within expiration date) |
| Other performance parameters | Similar to the predicate device (Pharmacia's B2 Micro RIA) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The nonclinical testing "centered on the performance attributes of accuracy, precision and stability." For precision, "10 replicates of three in-house controls" were used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is an immunoassay device, not an imaging or diagnostic device that typically relies on expert interpretation for ground truth. Therefore, the concept of "experts" establishing ground truth in the context of radiologists for imaging is not applicable here. The ground truth for this type of device would be based on established analytical methods and reference standards for calibrating the assay and determining analyte concentrations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable for an immunoassay device. Adjudication methods are typically used in studies where human readers or interpreters are involved in determining ground truth or evaluating performance, such as in clinical trials or diagnostic imaging studies.
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
No, this is not applicable. The device is an immunoassay, a laboratory test for directly measuring a biomarker (β2 microglobulin). It does not involve human readers interpreting images or data that would be augmented by AI, nor is it an AI-powered diagnostic tool itself.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance described is a standalone performance of the immunoassay kit itself. As an in vitro diagnostic (IVD) device, its performance characteristics (accuracy, precision, sensitivity, stability) are determined by testing the kit's ability to measure β2 microglobulin concentrations directly, without human interpretation as part of its primary function beyond following the assay protocol. The "algorithm" here refers to the biochemical reactions and detection mechanism of the EIA.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For an immunoassay, the "ground truth" for analytical performance (accuracy, precision, sensitivity) would typically be established using:
- Reference materials/standards: Known concentrations of β2 microglobulin used for calibration and validation.
- Spiked samples: Samples with a known, added amount of analyte to assess recovery.
- Established analytical methods: Comparison against a gold standard or a well-validated reference method.
The document does not explicitly detail the ground truth method but implies the use of "standards" (Standard 0 to 5) and "in-house controls," which are fundamental to establishing ground truth in immunoassay validation.
8. The sample size for the training set
The concept of a "training set" in the machine learning sense is not applicable to this traditional immunoassay. These devices are developed based on established biochemical principles (competitive binding immunoassay) rather than being "trained" on a dataset like an AI algorithm. Their performance is validated through analytical studies.
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 model for this traditional immunoassay.
{0}------------------------------------------------
K 964767
510(k) Summary Quantikine™ IVD™ ß2 microglobulin enzyme immunoassay
| Date of Summary: | November 27, 1996 |
|---|---|
| Company Name: | R&D Systems, Inc.614 McKinley Place N.E.Minneapolis, MN 55413 |
| Contact name: | Kenneth T. Edds, Ph.D.612-379-2956, FAX 612-379-6580 |
| Classification name: | β₂ microglobulin immunological test system |
| Product name: | Quantikine IVD β₂ microglobulin enzymeimmunoassay |
| CFR section: | 866.5630 |
| Device Class: | Class II |
Device to which substantial equivalence is claimed:
Pharmacia's B2 Micro RIA currently being marketed by Pharmacia Diagnostics, Fairfield, N.J. 07006.
The product is a competitive binding enzyme immunoassay (EIA) for ß2 microglobulin.
It is intended for the quantitative determination of ß2 microglobulin concentration in human serum and urine as an aid in the diagnosis of active rheumatoid arthritis and kidney diseases.
R&D Systems' Quantikine IVD ß2-microglobulin enzyme immunoassay has an intended use that is similar to the predicate device. The technologies of the two devices are similar in that both are competitive binding based assays. They differ in the "reporter" moeity attached to assayed molecule. R&D System's assay is colorimetric and Pharmacia's is radiometric.
Nonclinical testing centered on the performance attributes of accuracy, precision and stability. In addition to demonstrating acceptable performance for the above attributes Quantikine IVD ß-microglobulin enzyme immunoassay passed the additional acceptance criteria that all parameters met their individual specifications. Those criteria are:
- Signal generated by standard 0 to be greater than 1.5 absorbance units 1)
- Signal generated by standard 5 to be less than 0.35 absorbance units 2)
- Curve fitting individual replicates of Standard 1 to fit within ±15% of 3) nominal value and the Mean value of Standard 1 to fit within ±10% of nominal value. Individual replicates and Mean values of Standards 2 -5 to fit within ± 10% of nominal value.
- In house control and kit control values to be within the ranges quoted on the 4) appropriate control data sheets.
8
{1}------------------------------------------------
-
Sensitivity to be less than 0.2 µg/mL. ર)
1 -
Precision based on 10 replicates of three in-house controls, to be typically 6) less than 8%.
All other performance parameters were similar to the predicate device. Expiration dating has been established as 26 weeks when stored at 2-8°C and handled according to instructions for use. Opened or diluted reagents are good for up to 4 weeks when stored at 2-8°C provided that this is within the expiration date.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. In the center of the seal is an eagle with its wings spread. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 9 1997
Kenneth T. Edds, Ph.D. Regulatory Affairs R&D Systems, Inc ... ......... 614 McKinley Place N.E. . . . . . . . . Minneapolis, Minnesota 55413
Re: K964767/S1
Trade Name: B, Microglobulin Immunological Test System Regulatory Class: II Product Code: JZG Dated: March 24, 1997 Received: March 25, 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 to your premarket notification submission does not affect any obligation you might have under sections 331 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.
{3}------------------------------------------------
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
{4}------------------------------------------------
510(k) Number: K964767
Device Name: Quantikine™ IVD™ ß, Microglobulin Enzyme Immunoassay Kit
Indications for Use: The Quantikine IVD β,-microglobulin EIA kit is intended for the quantitative determination of β, microglobulin concentration in human serum and urine as an aid in the diagnosis of active rheumatoid arthritis and kidney diseases.
Cutter E. Musser
Division Sign-Off Division of Clinical L 510(k) Number
(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)
§ 866.5630
Beta -2-microglobulin immunological test system.(a)
Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.(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 § 866.9.