(183 days)
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No
The summary describes a standard enzyme immunoassay (EIA) kit and does not mention any AI or ML components. The performance studies focus on traditional analytical performance metrics.
No
The device is an in vitro diagnostic (IVD) kit intended for quantitative determination of β2 microglobulin, which aids in diagnosis rather than directly treating or mitigating a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the kit is intended "as an aid in the diagnosis of active rheumatoid arthritis and kidney diseases."
No
The device description explicitly states it is a "competitive binding enzyme immunoassay (EIA) for ß2 microglobulin," which is a laboratory test kit involving reagents and physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the 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." This clearly indicates that the device is used to examine specimens derived from the human body (serum and urine) to provide information for diagnostic purposes.
- Device Description: The "Device Description" mentions it's a "competitive binding enzyme immunoassay (EIA) for ß2 microglobulin." Immunoassays are a common type of in vitro diagnostic test.
These points directly align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures.
N/A
Intended Use / 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.
Product codes
JZG
Device Description
The product is a competitive binding enzyme immunoassay (EIA) for ß2 microglobulin.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
- Sensitivity to be less than 0.2 µg/mL.
- Precision based on 10 replicates of three in-house controls, to be typically less than 8%.
Key Metrics
- Sensitivity to be less than 0.2 µg/mL.
- Precision based on 10 replicates of three in-house controls, to be typically less than 8%.
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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 enzyme |
| immunoassay | |
| 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.
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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.
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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.
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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)