(234 days)
Not Found
No
The device description details a standard turbidimetric immunoassay based on chemical reactions and optical density measurements, with no mention of AI or ML components. The performance studies focus on traditional analytical metrics like precision, linearity, and method comparison.
No.
The device is an in vitro diagnostic test for the quantitative determination of a specific biomarker, ß2-microglobulin, in human serum and plasma to aid in diagnosis, not to treat a condition.
Yes
The "Intended Use / Indications for Use" states that the measurement "aids in the diagnosis of active rheumatoid arthritis and kidney disease."
No
The device description clearly outlines a laboratory-based in vitro diagnostic test using reagents and a turbidimetric measurement method, indicating a hardware component (likely an analyzer or spectrophotometer) is required.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "Immunological latex agglutination test for the in vitro quantitative determination of ß 2microglobulin in human serum and plasma." The phrase "in vitro" is a key indicator of an IVD. It also states the measurement "aids in the diagnosis of active rheumatoid arthritis and kidney disease," which is a diagnostic purpose.
- Device Description: The description details a test performed on a biological sample (serum or plasma) outside of the body, using reagents to measure a substance within the sample. This is the core function of an IVD.
- Performance Studies: The inclusion of performance characteristics like precision, detection limit, linearity, and method comparison are typical for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a predicate device (Abbott IMx® ß 2-microglobulin assay) which is also an IVD, further supports the classification of this device as an IVD.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunoturbidometric assay for the quantitative in-vitro determination of ß 2-microglobulin.
Immunological latex agglutination test for the in vitro quantitative determination of ß 2-microglobulin in human serum and plasma.
Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.
Product codes
JZG
Device Description
The ß 2-microglobulin determination is based upon turbidimetric immunoinhibition (TINIA) using a serum or plasma blood sample. The sample containing B 2-microglobulin is transferred into a TRIS buffer solution (R1 reagent). In the second step, an aliquot of solution of polyclonal antirabbit ß 2-microglobulin antibodies (R2 reagent) is added to mixture of the first step. The antibody will bind to the ß 2-microglobulin in the sample to form "aggregates" such that the amount of aggregate formed is proportionate to the amount of B 2-microglobulin present in the sample. The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of ß 2-microglobulin in the sample is directly proportional to the amount of turbidity formed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics:
Precision:
Tina-quant® β 2-microglobulin
Intra-Assay (mg/l): Low N=21 Mean=0.57 %CV=4.4; Mid N=21 Mean=2.26 %CV=1.9; High N=21 Mean=7.75 %CV=1.0
Inter-Assay (mg/l): Sample 1 N=21 Mean=1.16 %CV=2.6; Sample 2 N=21 Mean=4.70 %CV=2.7
Abbott IMx® β 2-microglobulin
Intra-Assay (mg/L): Low N=12 Mean=1.7 %CV=6.0; Mid N=12 Mean=3.9 %CV=4.4; High N=12 Mean=9.7 %CV=4.9
Inter-Assay (mg/L): Low N=90 Mean=1.7 %CV=9.2; Mid N=90 Mean=3.9 %CV=6.8; High N=90 Mean=9.7 %CV=7.3
Lower Detection Limit: Tina-quant® β 2-microglobulin: 0.05 mg/L; Abbott IMx® β 2-microglobulin: 0.5 µg/L
Linearity: Tina-quant® β 2-microglobulin: 0.20 - 8.0 mg/L
Method Comparison: Vs Abbott IMx® β 2-microglobulin
Deming's: y = 1.26x - 0.15, r = 0.983, SEE = 0.23, N = 36
Least Squares: y = 1.24x - 0.11, r = 0.983, SEE = 0.32, N = 36
Interfering substances: No interference at (≤ 10% error) with Bilirubin 20 mg/dL, Hemoglobin 500 mg/dL, Lipemia 1500 mg/dL, Rheumatoid Factor 200 IU/mL
Specificity: Specific for β 2-microglobulin for both devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Abbott IMx® ß 2-microglobulin assay.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
OCT 16 1998
510(k) Summary
Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
| 1. Submitter name, address, contact | Boehringer Mannheim Corporation
P.O. Box 9002
Pleasanton, CA 94566-0900
(510) 730-8240
FAX (510) 225-0654
Contact Person: Betsy Soares-Maddox
Date Prepared: February 11, 1998 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Device name | Proprietary name: Tina-quant® ẞ 2-microglobulin Assay
Common name: Immunoturbidometric assay for the determination of ẞ 2-microglobulin.
Classification name: ẞ 2-microglobulin immunological test system |
| 3. Predicate device | The Boehringer Mannheim Tina-quant® ẞ 2-microglobulin is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Abbott IMx® ẞ 2-microglobulin assay. |
Continued on next page
1
510(k) Summary, Continued
The ß 2-microglobulin determination is based upon turbidimetric 4. Device immunoinhibition (TINIA) using a serum or plasma blood sample. The Description sample containing B 2-microglobulin is transferred into a TRIS buffer solution (R1 reagent). In the second step, an aliquot of solution of polyclonal antirabbit ß 2-microglobulin antibodies (R2 reagent) is added to mixture of the first step. The antibody will bind to the ß 2-microglobulin in the sample to form "aggregates" such that the amount of aggregate formed is proportionate to the amount of B 2-microglobulin present in the sample. The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of ß 2-microglobulin in the sample is directly proportional to the amount of turbidity formed. Immunoturbidometric assay for the quantitative in-vitro determination of ß 2-ಳು Intended use microglobulin. The Boehringer Mannheim Tina-quant® ß 2-microglobulin is substantially 6. Comparison equivalent to other products in commercial distribution intended for similar to predicate use. Most notably it is substantially equivalent to the currently marketed device Abbott IMx® ß 2-microglobulin assay. Continued on next page
2
510(k) Summary, Continued
Comparison to predicate device cont.
The following table compares the Tina-quant® ß 2-microglobulin with the predicate device, Abbott IMx ® ß 2-microglobulin assay. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device in provided in attachment 6.
Similarities:
•Intended Use: Immunoassay for the in vitro quantitative determination of ß 2-microglobulin
Differences:
| Feature | Tina-quant® ß 2-
microglobulin | Abbott IMx® ß 2-
microglobulin |
|----------------------------|-----------------------------------|-----------------------------------|
| Sample Type | Serum and Plasma | Serum, Plasma, and Urine |
| Reaction test
principle | Immunoturbidimetric | Microparticle |
| Instrument
required | Hitachi | Abbott IMx |
Performance Characteristics:
| Feature | | Tina-quant® β 2-
microglobulin | | Abbott IMx® β 2-
microglobulin | | | |
|--------------------------|------------------------------|-----------------------------------|------------------------------|-----------------------------------|----------|-----|------|
| Precision | Intra and InterAssay (mg/l): | | Intra and InterAssay (mg/L): | | | | |
| | Level | Low | Mid | High | Low | Mid | High |
| | N | 21 | 21 | 21 | 12 | 12 | 12 |
| Intra-Assay | Mean | 0.57 | 2.26 | 7.75 | 1.7 | 3.9 | 9.7 |
| | %CV | 4.4 | 1.9 | 1.0 | 6.0 | 4.4 | 4.9 |
| | Level | Sample 1 | Sample 2 | | Low | Mid | High |
| | N | 21 | 21 | | 90 | 90 | 90 |
| Inter-Assay | Mean | 1.16 | 4.70 | | 1.7 | 3.9 | 9.7 |
| | %CV | 2.6 | 2.7 | | 9.2 | 6.8 | 7.3 |
| Lower Detection
Limit | | 0.05 mg/L | | | 0.5 µg/L | | |
Continued on next page
3
510(k) Summary, Continued
Performance Characteristics:
Comparison to predicate device, (cont.)
| Feature | Tina-quant® β 2-
microglobulin | Abbott IMx® β 2-
microglobulin |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Linearity | 0.20 - 8.0 mg/L | --- |
| Method
Comparison | Vs Abbott IMx® β 2-
microglobulin
Deming's
$y=1.26 x - 0.15$
r=0.983
SEE =0.23
N=36
Least Squares:
$y = 1.24x - 0.11$
r = 0.983
SEE = 0.32
N = 36 | --- |
| Interfering
substances | No interference at:
(≤ 10% error)
Bilirubin 20 mg/dL
Hemoglobin 500 mg/dL
Lipemia 1500 mg/dL
Rheumatoid
Factor 200 IU/mL | --- |
| Specificity | Specific for β 2-
microglobulin | Specific for β 2-
microglobulin |
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top and left side of the logo in a circular fashion.
OCT 16 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Betsy Soares-Maddox Manager, Regulatory Affairs and Quality Assurance Boehringer Mannheim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900
K980724/S1 Re: Trade Name: Tina-quant® ß 2-microglobulin Assay Requlatory Class: II Product Code: JZG Dated: August 31, 1998 Received: September 1, 1998
Dear Ms. Soares-Maddox:
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, listinq 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 Requlations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance 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 obliqation 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.
5
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 requlation 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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
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
6
510(k) Number (if known): N/A
Device Name: Tina-quant® ß 2-microglobulin Assay
Indications For Use:
Intended use
Immunological latex agglutination test for the in vitro quantitative determination of ß 2microglobulin in human serum and plasma.
Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number
. ............................................................................................................................................................................