(22 days)
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No
The summary describes a reagent for a quantitative immunoassay system based on rate nephelometry, with no mention of AI or ML. The performance studies focus on method comparison and imprecision, typical for a laboratory diagnostic reagent.
No
This device is for the quantitative determination of beta-2-microglobulin in serum or plasma, which is a diagnostic function, not a therapeutic one.
Yes
The device is intended for the "quantitative determination of human Beta-2-Microglobulin in serum or plasma," which is a measurement used for diagnostic purposes in healthcare.
No
The device is a reagent (chemical substance) used with a specific hardware system (IMMAGE® Immunochemistry System) for quantitative determination, not a standalone software product.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of human Beta-2-Microglobulin in serum or plasma." This involves testing biological samples (serum or plasma) outside of the body.
- Device Description: The description reinforces that it's for the "quantitative determination of beta-2-microglobulin in serum or plasma."
- Performance Studies: The performance studies involve method comparison and imprecision experiments using serum samples, which are typical for evaluating IVD performance.
- Predicate Device: The predicate device listed is the "Beckman Array® Beta-2-Microglobulin (B2M)", which is also an IVD for measuring beta-2-microglobulin in biological samples.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Calibrator 2, is intended for the quantitative determination of human Beta-2-Microglobulin in serum or plasma by rate nephelometry.
Product codes
JZG
Device Description
The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent is designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of beta-2-microglobulin in serum or plasma.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison and imprecision experiments.
Method Comparison Study Results:
Analyte: IMMAGE B2MX Reagent
Sample Type: serum
Slope: 0.979
Intercept (mg/dL): -0.017
r: 0.996
n: 111
Predicate Method: Array 360 Beta-2-Microglobulin
IMMAGE® System Beta-2-Microglobulin (B2MX) Imprecision:
Within-Run Imprecision:
Sample Level 1: Mean (mg/dL) 0.10, S.D. (mg/dL) 0.010, %C.V. 10.0, N 80
Sample Level 2: Mean (mg/dL) 1.84, S.D. (mg/dL) 0.042, %C.V. 2.3, N 80
Sample Level 3: Mean (mg/dL) 3.19, S.D. (mg/dL) 0.062, %C.V. 1.9, N 80
Total Imprecision:
Sample Level 1: Mean (mg/dL) 0.10, S.D. (mg/dL) 0.010, %C.V. 10.0, N 80
Sample Level 2: Mean (mg/dL) 1.84, S.D. (mg/dL) 0.048, %C.V. 2.6, N 80
Sample Level 3: Mean (mg/dL) 3.19, S.D. (mg/dL) 0.069, %C.V. 2.2, N 80
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '983895'. The numbers are written in a cursive style, with some connections between the digits.
Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle with two curved lines inside, followed by the words "BECKMAN" on the top line and "COULTER" on the bottom line, both in a bold, sans-serif font. To the left of the circle is a smaller, solid black circle.
Summary of Safety & Effectiveness
Beckman Coulter IMMAGE® Immunochemistry System Beta-2-Microglobulin Reagent
1.0 Submitted By:
Richard T. Ross Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 South Kraemer Blvd., W-104 Brea. California 92822-8000 Telephone: (714) 961-4912 FAX: (714) 961-4123
2.0 Date Submitted:
02 November 1998
3.0 Device Name(s):
Proprietary Names 3.1
IMMAGE® Immunochemistry System Beta-2-Microglobulin Reagent
3.2 Classification Name
(21 CFR §866.5630) Beta-2-Microglobulin immunological test system
4.0 Predicate Device(s):
| IMMAGE Reagent | Predicate | Manufacturer | Docket
Number |
|-------------------------------------------------|-----------------------------------------------|------------------------------|------------------|
| IMMAGE System
Beta-2-Microglobulin
(B2MX) | Beckman Array® Beta-
2-Microglobulin (B2M) | Beckman
Instruments, Inc. | K940353 |
5.0 Description:
The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent is designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of beta-2-microglobulin in serum or plasma.
6.0 Intended Use:
The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Calibrator 2, is intended for the quantitative determination of human beta-2-microglobulin in serum or plasma by rate nephelometry.
1
7.0 Comparison to Predicate(s):
The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary.
| IMMAGE
| System | Aspect/Characteristic | Comments |
|---|---|---|
| IMMAGE | ||
| System | Intended use | Same as Array Beta-2- |
| Microglobulin | ||
| B2MX | ||
| Reagent | Reaction temperature of 37° C | |
| Detection methodology of rate nephelometry |
SIMILARITIES to the PREDICATE
DIFFERENCES from the PREDICATE
| IMMAGE
| System | Aspect/Characteristic | Comments |
|---|---|---|
| IMMAGE | ||
| System | Sample dilution | IMMAGE has on line sample dilution. |
| Array requires off line sample dilution. | ||
| B2MX | ||
| Reagent | Antibody source | IMMAGE is rabbit (polyclonal). Array is |
| goat (polyclonal). | ||
| Reagent | Antibody reagent | |
| composition | IMMAGE is latex particle bound antibody. | |
| Array is soluble antibody. |
Summary of Performance Data: 8.0
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison and imprecision experiments.
Method Comparison Study Results
IMMAGE® System Beta-2-Microglobulin (B2MX) Reagent
| Analyte | Sample
Type | Slope | Intercept
(mg/dL) | r | n | Predicate Method |
|---------------------------|----------------|-------|----------------------|-------|-----|---------------------------------------|
| IMMAGE
B2MX
Reagent | serum | 0.979 | -0.017 | 0.996 | 111 | Array 360
Beta-2-
Microglobulin |
IMMAGE® System Beta-2-Microglobulin (B2MX) Imprecision
| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Level 1 | 0.10 | 0.010 | 10.0 | 80 |
| Level 2 | 1.84 | 0.042 | 2.3 | 80 |
| Level 3 | 3.19 | 0.062 | 1.9 | 80 |
| Total Imprecision | ||||
| Level 1 | 0.10 | 0.010 | 10.0 | 80 |
| Level 2 | 1.84 | 0.048 | 2.6 | 80 |
| Level 3 | 3.19 | 0.069 | 2.2 | 80 |
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
Image /page/1/Picture/14 description: The image shows a black and white close-up of a circular object. The object is mostly black, with a small white highlight on the upper left side. The object appears to be smooth and featureless, with no visible texture or details.
2
Public Health Service
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird-like figure. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Richard T. Ross Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 South Kraemer Boulevard, W-104 Brea, California 92822-8000
Re: K983895 IMMAGE® Immunochemistry System Beta-2 Microglobulin Trade Name: Reagent Regulatory Class: II Product Code: JZG November 2, 1998 Dated: Received: November 3, 1998
Dear Mr. Ross:
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 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 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 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 regulations.
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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 leqally 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 requlation (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.gov/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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page 1 of 1
K983895 510(k) Number (if known): Not vet assigned-
Device Name:
IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent
Indications for Use:
The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Calibrator 2, is intended for the quantitative determination of human Beta-2-Microglobulin in serum or plasma by rate nephelometry.
Clinical Significance:
An increase in the concentration of serum beta-2-microglobulin can result from an overproduction of the protein by nucleated cells and/or decreased clearance by the kidneys. Under normal conditions, beta-2-microglobulin passes readily through the glomerular membrane. Levels of beta-2microglobulin in serum, therefore, are inversely proportional to glomerular filtration rate (GFR). Measurement of Beta-2-Microglobulin in serum or plasma assists in the diagnosis and management of patients with active rheumatoid arthritis and renal disease.
(21 CFR §866.5630) Beta-2-Microglobulin immunological test system
(b) Classification. Class II.
(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 | K983895 |
| 510(k) Number |
| Prescription Use (per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | ----------------------------------------------- |
OR
| Over-the-Counter Use | |
|---|---|
| Optional Format 1-2-96 |