(74 days)
The IMMAGE Immunochemistry System AlphaMacroglobulin (AMG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human alpha macroglobulin by rate nephelometry. Measurement of alpha_macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.
The IMMAGE Immunochemistry System AMG Reagent, in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of Alpha-Macroglobulin concentrations on Beckman's IMMAGE Immunochemistry System.
This is an in vitro diagnostic device, not an AI/ML device. Therefore, the questions related to AI/ML device studies, such as the use of experts for ground truth, adjudication methods, MRMC studies, and training set information, are not applicable.
Here's a breakdown of the available information:
Acceptance Criteria and Device Performance
The submission primarily focuses on establishing "substantial equivalence" to a predicate device, as opposed to defining explicit performance acceptance criteria with numerical targets. Equivalence is demonstrated through "method comparison, stability, and imprecision experiments."
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document does not explicitly state numerical acceptance criteria. Instead, it refers to the demonstration of "substantial equivalence" through method comparison, stability, and imprecision experiments. Therefore, the "Reported Device Performance" is inferred from the results presented as part of demonstrating this equivalence, rather than direct numerical comparisons to pre-defined thresholds.
| Performance Area | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Comparison | Substantial equivalence to predicate device (Beckman Alpha₂-Macroglobulin (AMG)) | Data presented supports substantial equivalence (detailed results not explicitly provided in extract, but stated as sufficient). |
| Stability | Acceptable stability over time | Stability study results presented (detailed results not explicitly provided in extract, but stated as sufficient). |
| Imprecision | Acceptable level of measurement variability | Imprecision study results presented (detailed results not explicitly provided in extract, but stated as sufficient). |
2. Sample Size and Data Provenance for Test Set
- Sample Size for Test Set: Not explicitly stated in the provided text for method comparison, stability, or imprecision studies. The tables showing "Method Comparison Study Results," "Stability Study Results," and "Estimated Imprecision" are largely corrupted and do not provide clear numerical data on sample sizes.
- Data Provenance: Not explicitly stated. Given that it's a Beckman Instruments submission, it's likely internal company data, but the geographical origin or whether it's retrospective or prospective is not mentioned.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This is an in vitro diagnostic device measuring a quantitative analyte, not an AI/ML device requiring expert interpretation for ground truth establishment. The "ground truth" for such devices typically refers to the true concentration of the analyte, often determined by reference methods or gravimetric preparation of calibrators/controls.
4. Adjudication Method
- Not Applicable. As this is an in vitro diagnostic device measuring a quantitative analyte, an adjudication method (like 2+1 or 3+1 used for expert consensus in image interpretation) is not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This is an in vitro diagnostic device, not an AI/ML system that assists human readers. Therefore, an MRMC study is not relevant.
6. Standalone Performance Study (Algorithm Only)
- Yes, in spirit. The performance data presented (method comparison, stability, imprecision) assesses the "algorithm only" in the sense that it measures the performance of the IMMAGE Immunochemistry System AMG Reagent as a standalone diagnostic assay on the IMMAGE system, without human interpretive input that would be common in AI/ML clinical decision support. The device is intended for quantitative determination by rate nephelometry, which is an automated process.
7. Type of Ground Truth Used
- For Method Comparison: The ground truth is established by the predicate device (Beckman Alpha₂-Macroglobulin (AMG) using the Array System) or another established method against which the new device's results are compared.
- For Stability and Imprecision: The ground truth is typically the known concentration of the analyte in control materials or patient samples, or the expected measurement derived from robust, repetitive testing.
8. Sample Size for Training Set
- Not Applicable. This is an in vitro diagnostic device with reagents and a defined measurement principle (rate nephelometry), not a machine learning algorithm that requires a "training set" in the AI/ML sense. Data is used for characterization, calibration, and validation rather than training a model.
9. How Ground Truth for Training Set Was Established
- Not Applicable. See reasoning for "Sample Size for Training Set."
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BECKMAN
<974564
Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Alpha-Macroglobulin (AMG) Reagent
FEB 1 7 1998
- 1.0 Submitted By:
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:
December 4, 1997
3.0 Device Name(s):
3.1 Proprietary Names
IMMAGE™ Immunochemistry System Alpha-Macroglobulin (AMG) Reagent
Classification Name 3.2
Alpha-Macroglobulin immunological test system (21 CFR § 866.5620)
4.0 Predicate Device(s):
| IMMAGE SystemReagent | Predicate | Manufacturer | DocketNumber |
|---|---|---|---|
| IMMAGE SystemAlpha₂-Macroglobulin(AMG) | Beckman Alpha₂-Macroglobulin (AMG) | Beckman Instruments,Inc. | K791340 |
5.0 Description:
The IMMAGE Immunochemistry System AMG Reagent, in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of Alpha-Macroglobulin concentrations on Beckman's IMMAGE Immunochemistry System.
6.0 Intended Use:
The IMMAGE Immunochemistry System Alpha-Macroglobulin (AMG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human Alpha-Macroglobulin by rate nephelometry.
Beckman Instruments, Inc.
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Beckman Instruments, Inc., Section 510(k) Notification Beckhan instruments, inc., System Alpha-Macroglobulin (AMG) 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 SystemAMG Reagent | Nephelometric methodology | Same asBeckman AMG reagent |
| Antibody source (goat) | ||
| DIFFERENCES | ||
| IMMAGE SystemAMG Reagent | Buffer/Reagent volumes | IMMAGE System uses half of thevolumes than are utilized by the ArraySystem for AMG. |
| Antibody concentration | IMMAGE AMG has a higher antibodyconcentration than the BeckmanAlpha-Macroglobulin reagent |
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 companson, stability, and imprecision experiments that relate results obtained on the IMMAGE System.
Method Comparison Study Results IMMAGE Alpha2Macroglobulin (AMG) Reagent
| Schurch Chican and Child Child Child Comments of Child Child Child Child Child Child Child Child Child Child Child Child Child Child Child Child Child Child Child Child Child. | ALLARI STORES OF LES AND1888973 - A A F A C 4 4 F 4 4 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 | . PART LE CARACERRES . PET . CIRCHERRENMEN POPULAL SEP SEPTEMPER | ||||
|---|---|---|---|---|---|---|
| ------------------------- | 1. 1 1-4 1-8 1-8 1-8 1-8 1-8 1-8 1-8 1-8 1-8 1-4-4-4 | WARRANER | ||||
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Stability Study Results
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|---|---|
Estimated Imprecision
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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 shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Annie Hellie Senior Regulatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, CA 92822-8000
FEB 1 7 1998
Re: K974564 Trade Name: Immage Immunochemistry System Alpha(2)-Macroglobulin (AMG) Reagent Regulatory Class: II Product Code: DEB 82 December 04, 1997 Dated: December 05, 1997 Received:
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, 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 (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 requlations.
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Paqe 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 Butman
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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510(k) Number (if known):
page ⊥ of ⊥
Device Name: IMMAGE™ Immunochemistry System Alphaz-Macroglobulin (AMG) Reagent
Indications for Use:
Intended Use:
The IMMAGE Immunochemistry System AlphaMacroglobulin (AMG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human alpha macroglobulin by rate nephelometry.
Clinical Significance:
. . .
1
Measurement of alpha_macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.
Kittie E. Madson
(Division Sign-Om)
Division of Clinical Laboratory Devices
510(k) Number
K974564
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use (per 21 CFR 801.109)
OR
Over-the-Counter Use Optional Format 1-2-96
§ 866.5620
Alpha -2-macroglobulin immunological test system.(a)
Identification. Analpha -2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -2-macroglobulin (a serum protein) in plasma. Measurement ofalpha -2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.(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.