(105 days)
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No
The summary describes a reagent and calibrator for a standard immunochemistry system using rate nephelometry, a well-established analytical technique. There is no mention of AI, ML, image processing, or any data analysis methods beyond standard statistical calculations for performance evaluation.
No.
The device is an in vitro diagnostic (IVD) reagent intended for quantitative determination of immunoglobulin M, which is used for diagnostic purposes, not for treating or preventing a disease.
Yes
The device is intended for the "quantitative determination of human immunoglobulin M in serum and cerebrospinal fluid," which is a measurement used for diagnostic purposes.
No
The device is a reagent and calibrator intended for use with a specific immunochemistry system, indicating it is a physical component of a larger diagnostic system, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "intended for the quantitative determination of human immunoglobulin M in serum and cerebrospinal fluid by rate nephelometry." This describes a test performed on samples taken from the human body (serum and CSF) to provide information about a person's health status (immunoglobulin M levels).
- Device Description: The description reinforces this by stating it's for the "quantitative determination of immunoglobulin M in serum and cerebrospinal fluid."
- Performance Studies: The performance studies involve testing the device with human samples (serum and CSF) and comparing the results to a predicate device, which is typical for IVD submissions.
- Predicate Device: The predicate devices listed are also IVD reagents used for similar diagnostic purposes.
The core function of the device is to analyze biological samples in vitro (outside the body) to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMMAGE® Immunochemistry System Low Concentration Immunoglobulin M (IGMLC) Reagent, when used in coniunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for the quantitative determination of human immunoglobulin M in serum and cerebrospinal fluid by rate nephelometry.
Product codes
CFN
Device Description
The IMMAGE® Low Concentration Immunoglobulin M (IGMLC) Reagent and Cerebrospinal Fluid Calibrator are designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of immunoglobulin M in serum and cerebrospinal fluid.
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.
Serum Study Results: N=55, Slope=0.977, Intercept=9.12, Mean (IGMLC) mg/L=1039, Mean (predicate) mg/L=1054, Correlation Coefficient=0.988
CSF Study Results: N=51 (Test Positive), 51 (Test Negative), Test Positive=45, Test Negative=6, False Positives=0, False Negative=0, Sensitivity%=100%, Specificity%=100%
Estimated IMMAGE System IGMLC Reagent Imprecision (Serum):
Within-Run: Low: N=80, Mean=173 mg/L, SD=5.4 mg/L, %CV=3.2; Mid: N=80, Mean=869 mg/L, SD=14.6 mg/L, %CV=1.7; High: N=80, Mean=1779 mg/L, SD=31.8 mg/L, %CV=1.8
Total: Low: N=80, Mean=173 mg/L, SD=6.1 mg/L, %CV=3.5; Mid: N=80, Mean=869 mg/L, SD=21.8 mg/L, %CV=2.5; High: N=80, Mean=1779 mg/L, SD=35.5 mg/L, %CV=2.0
Estimated IMMAGE System IGALC Reagent Imprecision (CSF):
Within-Run: Low: N=80, Mean=0.536 mg/L, SD=0.0279 mg/L, %CV=5.2; Mid: N=80, Mean=4.77 mg/L, SD=0.096 mg/L, %CV=2.0; High: N=80, Mean=8.61 mg/L, SD=0.182 mg/L, %CV=2.1
Total: Low: N=80, Mean=0.536 mg/L, SD=0.0320 mg/L, %CV=6.0; Mid: N=80, Mean=4.77 mg/L, SD=0.197 mg/L, %CV=4.1; High: N=80, Mean=8.61 mg/L, SD=0.299 mg/L, %CV=3.5
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Serum Study Results: Slope=0.977, Intercept=9.12, Correlation Coefficient=0.988
CSF Study Results: Sensitivity%=100, Specificity%=100
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a stylized image of two curved lines within a circle. The text "BECKMAN COULTER" is written in bold, sans-serif font.
Summary of Safety & Effectiveness Beckman Coulter IMMAGE® Immunochemistry System Low Concentration Immunoglobulin M (IGMLC) Reagent Beckman Coulter™ Cerebrospinal Fluid Protein Calibrator (CSF CAL)
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: 01 October 1999
3.0 Device Name(s):
3.1 Proprietary Names
Beckman Coulter IMMAGE® Immunochemistry System Low Concentration Immunoglobulin M (IGMLC) Reagent Beckman Coulter™ Cerebrospinal Fluid Protein Calibrator (CSF CAL)
3.2 Classification Name
Method, Nephelometric, Immunoglobulins (G, A, M) (21 CFR §866.5510)
4.0 Predicate Device(s):
| IMMAGE System | Serum Predicate | Manufacturer | Docket Number |
|---|---|---|---|
| IMMAGE System | |||
| Low Concentration | |||
| Immunoglobulin M | |||
| (IGMLC) Reagent | |||
| Cerebrospinal Fluid | |||
| Protein Calibrator | IMMAGE | ||
| Immunochemistry | |||
| Systems | |||
| Immunoglobulin M | |||
| (IGM) Reagent | Beckman | ||
| Instruments, Inc. | K963868 | ||
| CSF Predicate | Manufacturer | Docket Number | |
| Paragon® | |||
| Immunofixation | |||
| Electrophoresis Reagent | Beckman | ||
| Instruments, Inc. | K823884 |
5.0 Description:
The IMMAGE® Low Concentration Immunoglobulin M (IGMLC) Reagent and Cerebrospinal Fluid Calibrator are designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of immunoglobulin M in serum and cerebrospinal fluid.
6.0 Intended Use:
The IMMAGE® Immunochemistry System Low Concentration Immunoglobulin M (IGMLC) Reagent, when used in coniunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for the quantitative determination of human immunoglobulin M in serum and cerebrospinal fluid by rate nephelometry.
Mailing Address: 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000
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7.0 Comparison to Predicate(s):
The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary.
SIMILARITIES to the SERUM PREDICATE
| IMMAGE System | Aspect/Characteristic | Comments |
|---|---|---|
| IMMAGE System IGMLC Reagent | Intended use | Same as |
| Predicate | ||
| device | ||
| Rate nephelometry method | ||
| Antibody is goat antihuman IgM | ||
| Cerebrospinal Fluid Protein Calibrator | Single level calibrator | |
| SIMILARITIES to the CSF PREDICATE | ||
| IMMAGE System | Aspect/Characteristic | Comments |
| IMMAGE System IGMLC | Intended use | Same as predicate device |
| Reagent | Serum and CSF are acceptable sample types | |
| Antibody is goat antihuman IgM | ||
| Cerebrospinal Fluid Protein | ||
| Calibrator | Single level calibrator | N/A |
| Protein is of human serum origin | ||
| added to human urine base | Predicate has | |
| no calibrator |
DIFFERENCES from the SERUM PREDICATE
| IMMAGE System | Aspect/Characteristic | Comments |
|---|---|---|
| IMMAGE System | ||
| IGMLC Reagent | Serum or CSF as sample type | Predicate cleared for serum only |
| CSF CAL | CSF CAL Cerebrospinal Fluid | |
| Calibrator is a single level, | ||
| human urine base, azide | ||
| preserved liquid | Predicate calibrator is a single | |
| level, human serum based, azide | ||
| preserved liquid |
DIFFERENCES from the CSF PREDICATE
| IMMAGE System | Aspect/Characteristic | Comments |
|---|---|---|
| IMMAGE System | ||
| IGMLC Reagent | IMMAGE System IGMLC is | |
| a rate nephelometric reaction | ||
| at a controlled 37°C | Predicate is a gel immunofixation | |
| electrophoresis at room | ||
| temperature | ||
| IMMAGE System | ||
| IGMLC Reagent | IMMAGE System provides | |
| quantitative result based on | ||
| calibration curve | Qualitative result based on visual | |
| comparison to known controls | ||
| IMMAGE System | ||
| IGMLC Reagent | Sample may be loaded | |
| and/or run neat without pre- | ||
| analysis concentration | Sample concentration typically | |
| required prior to IFE analysis | ||
| CSF CAL | Single level calibrator | Predicate has no calibrator |
Beckman Coulter, Inc. IMMAGE® Low Concentration Immunoglobulin M (IGMLC) Reagent Filename: igmlcSSE2.doc
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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 comparison and imprecision experiments.
| Serum Study Results | CSF Study Results | ||
|---|---|---|---|
| N | 55 | N | 51 51 |
| Slope | 0.977 | Test Positive | 51 45 |
| Intercept | 9.12 | Test Negative | 0 6 |
| Mean (IGMLC) mg/L | 1039 | False Positives | 6 0 |
| Mean (predicate) mg/L | 1054 | False Negative | 0 0 |
| Correlation Coefficient | 0.988 | Sensitivity % | 100 100 |
| Specificity % | 89.5 100 | ||
| % sensitivity = (N/(N + false negative))*100 | |||
| % specificity = (N/(N + false positive))*100 |
Method Comparisons
Estimated IMMAGE System IGMLC Reagent Imprecision (Serum)
| PRECISION | SAMPLE | N | MEAN (mg/L) | SD (mg/L) | % CV |
|---|---|---|---|---|---|
| Within-Run | Low | 80 | 173 | 5.4 | 3.2 |
| Within-Run | Mid | 80 | 869 | 14.6 | 1.7 |
| Within-Run | High | 80 | 1779 | 31.8 | 1.8 |
| Total | Low | 80 | 173 | 6.1 | 3.5 |
| Total | Mid | 80 | 869 | 21.8 | 2.5 |
| Total | High | 80 | 1779 | 35.5 | 2.0 |
Estimated IMMAGE System IGALC Reagent Imprecision (CSF)
| PRECISION | SAMPLE | N | MEAN (mg/L) | SD (mg/L) | % CV |
|---|---|---|---|---|---|
| Within-Run | Low | 80 | 0.536 | 0.0279 | 5.2 |
| Within-Run | Mid | 80 | 4.77 | 0.096 | 2.0 |
| Within-Run | High | 80 | 8.61 | 0.182 | 2.1 |
| Total | Low | 80 | 0.536 | 0.0320 | 6.0 |
| Total | Mid | 80 | 4.77 | 0.197 | 4.1 |
| Total | High | 80 | 8.61 | 0.299 | 3.5 |
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.
Beckman Coulter, Inc. IMMAGE® Low Concentration Immunoglobulin M (IGMLC) Reagent Filename: igmlcSSE.doc
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
FEB 1 2000 Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Richard T. Ross Staff Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard, W-104 P.O. Box 8000 Brea, California 92622-8000
Re: K993547
Trade Name: IMMAGE® Immunochemistry System Low Concentration Immunoglobulin M (IGMLC) Reagent Beckman Coulter™ Cerebrospinal Fluid Protein Calibrator (CSF CAL) Regulatory Class: II Product Code: CFN Dated: December 20, 1999 Received: December 21, 1999
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 Regulations, 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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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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" (21CFR 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 _ of _
510(k) Number (if known): Not yot assigned
Device Name:
IMMAGE® Immunochemistry System
Low Concentration Immunoglobulin M (IGMLC) Reagent
Beckman Coulter™ Cerebrospinal Fluid Protein Calibrator (CSF CAL)
Indications for Use:
The IMMAGE® Immunochemistry System Low Concentration Immunoglobulin M (IGMLC) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for the quantitative determination of human immunoglobulin M in serum and cerebrospinal fluid by rate nephelometry.
Clinical Significance:
The concentration ratio of immunoglobulins in CSF and serum detects increased permeability of the blood-CSF barrier and intrathecal synthesis of immunoglobulins.
The permeability of the blood-CSF barrier to plasma increases due to brain tumor, intracerebral hemorrhage, meningitis, encephalitis, and bacterial infections. The intrathecal synthesis of immunoglobulins is important in the diagnosis of diseases of the Central Nervous Systems (CNS).
Method, Nephelometric, Immunoglobulins (G, A, M) (21 CFR §866.5510)
(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
| 510(k) Number | K993547 |
|---|---|
| --------------- | --------- |
| Prescription Use (per 21 CFR 801.109) | ✓ | OR | Over-the-Counter Use |
|---|---|---|---|
| Optional Format 1-2-96 |