(44 days)
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No
The summary describes a reagent for a standard immunochemistry system using rate nephelometry, with no mention of AI or ML terms or functionalities.
No.
The device is for the quantitative determination of human beta-2-microglobulin, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is intended for the quantitative determination of human beta-2-microglobulin, which is a measurement used in diagnosis, and its intended use is to determine concentrations in human serum samples. The performance studies also compare this device to a predicate device that is a "chemistry test system," implying a diagnostic purpose.
No
The device description clearly states it is a "Reagent" intended for use with a specific "Immunochemistry System," indicating it is a chemical substance used in a laboratory instrument, not a software-only device.
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" using human serum samples. This is a diagnostic test performed in vitro (outside the body) on a biological sample.
- Device Description: The description reinforces that it's used for "quantitative determination of beta-2-microglobulin concentrations in human serum samples."
- Method: The method used is "rate nephelometry," which is a common technique for analyzing components in biological fluids.
- Context: The document is a Premarket Notification, which is a regulatory submission for medical devices, including IVDs. The comparison to a predicate device (K940353; Array Systems Beta-2-Microglobulin(B2M)) further indicates its nature as a diagnostic device.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMMAGE Immunochemistry System Beta-2-Microglobulin (B2M) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human beta-2-microglobulin by rate nephelometry.
Product codes
JZG
Device Description
The IMMAGE Immunochemistry System B2M Reagent in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of beta-2-microglobulin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System.
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
Not Found
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
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, stability, and imprecision experiments that relate results obtained from the Beckman Reagent on the Array® 360 System to the IMMAGE System Reagent.
Stability Study Results:
IMMAGE B2M reagent has a 24 month shelf-life, 14 day open container stability, and 14 day calibration stability.
Estimated Imprecision:
Sample: Level 1, Mean (mg/dL): 0.34, S.D. (mg/dL): 0.029, %C.V.: 8.5, N: 80
Sample: Level 2, Mean (mg/dL): 1.65, S.D. (mg/dL): 0.045, %C.V.: 2.7, N: 80
Sample: Level 3, Mean (mg/dL): 3.43, S.D. (mg/dL): 0.099, %C.V.: 2.9, N: 80
Key Metrics
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Predicate Device(s)
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.
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BECKMAN
Image /page/0/Picture/2 description: The image shows a handwritten alphanumeric string. The string is "K973813". The characters are written in a simple, slightly irregular style, typical of handwriting.
Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Beta-2-Microglobulin (B2M) Reagent
NOV 20 1997
Submitted By: 1.0
Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4457
2.0 Date Submitted:
October 6, 1997
3.0 Device Name(s):
3.1 Proprietary Names
IMMAGE™ Immunochemistry System Beta-2-Microglobulin (B2M) Reagent
3.2 Classification Name
Beta-2-microglobulin immunological test system (21 CFR § 866.5630)
4.0 Predicate Device(s):
| IMMAGE System
Reagent | Predicate | Manufacturer | Docket
Number |
|----------------------------------------------|---------------------------------------------|------------------------------|------------------|
| IMMAGE System Beta-
2-Microglobulin (B2M) | Array Systems Beta-2-
Microglobulin(B2M) | Beckman Instruments,
Inc. | K940353 |
5.0 Description:
The IMMAGE Immunochemistry System B2M Reagent in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of beta-2-microglobulin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System.
6.0 Intended Use:
The IMMAGE Immunochemistry System Beta-2-Microglobulin (B2M) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human beta-2-microglobulin by rate nephelometry.
Beckman Instruments, Inc.
1
2017 11:22 PM IST 11:20 PM IST 1
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Beta-2-Microglobulin (B2M) Reagent Summary of Safety & Effectiveness
Comparison to Predicate(s): 7.0
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SIMILARITIES | ||
| IMMAGE System | ||
| B2M Reagent | Analytic Range | Same as Array System Beta-2- |
| Microglobulin reagent | ||
| Off-line sample dilution | ||
| Nephelometric methodology | ||
| Antibody source (goat) | ||
| DIFFERENCES | ||
| IMMAGE System | ||
| B2M Reagent | Buffer/Reagent volumes | IMMAGE System uses half of the |
| volumes than are utilized by the Array | ||
| System for B2M. | ||
| Coreagent concentration | IMMAGE B2M has a higher coreagent | |
| concentration than the Array Beta-2- | ||
| Microglobulin reagent |
8.0 Summary of Performance Data:
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 companson, stability, and imprecision experiments that relate results obtained from the Beckman Reagent on the Array® 360 System to the IMMAGE System Reagent.
Method Comparison Study Results
IMMAGE Beta-2-Microglobulin (B2M) Reagent
|
. I E E A S E R E R B R B E S B E B E B B B E B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B B |
|
.
| ANSEPER'
|
STANTAL PARKET THE COLLECTION CONTENTION THE COLLECTION COLLEGIAL COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION CONTENTION CONTENTIONAL CONTENTIONAL CONTENTIONA
|
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | |
Stability Study Results
| Reagent | Product Claim |
|---|---|
| IMMAGE B2M | 24 month shelf-life |
| 14 day open container stability | |
| 14 day calibration stability |
Estimated Imprecision
| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Level 1 | 0.34 | 0.029 | 8.5 | 80 |
| Level 2 | 1.65 | 0.045 | 2.7 | 80 |
| Level 3 | 3.43 | 0.099 | 2.9 | 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.
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Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly separated. The overall impression is clean and straightforward, suggesting an official or institutional context.
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the top and bottom of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Annette Hellie Senior Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Boulevard, W-337 Brea, California 92822-8000
NOV 20 1997
Re: K973813 IMMAGE™ Immunochemistry System Beta-2-Microglobulin Trade Name: (B2M) Reagent Regulatory Class: II Product Code: JZG Dated: October 6, 1997 Received: October 7, 1997
Dear Ms. Hellie:
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, labelinq, 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 requirement, 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 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.
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Page 2
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.
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 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
4
510(k) Number (if known): K973813
Device Name: IMMAGE™ Immunochemistry System Beta-2-Microglobulin (B2M) Reagent
Indications for Use:
The IMMAGE Immunochemistry System Beta-2-Microglobulin (B2M) Reagent, when THE IMMAGE Inimanoonemisay Oyenni MMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human beta-2microglobulin in serum by rate nephelometry.
(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 | ||
| 510(k) Number ____________________________ |
| Prescription Use | ✓ | OR | Over-the-Counter Use _________ |
|---|---|---|---|
| (per 21 CFR 801.109) | Optional Format 1-2-96 |