(51 days)
AEROSET™ System, Hitachi 717 Analyzer
No
The device description and performance studies focus on a standard in vitro diagnostic assay based on turbidity measurement, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
This device is an in vitro diagnostic assay used for the quantitative determination of immunoglobulin G in human serum or plasma to aid in diagnosis, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" explicitly states that the assay "aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents," which is a diagnostic purpose. The "Device Description" also labels it an "in vitro diagnostic assay."
No
The device description clearly states it is an "in vitro diagnostic assay" that measures turbidity at 700 nm, indicating it involves physical reagents and a measurement system, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly stated in the "Device Description": The description clearly states, "Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum or plasma."
- Intended Use: The intended use is to quantify immunoglobulin G in human serum or plasma, which are biological samples taken from the body. This is a hallmark of IVD devices.
- Mechanism of Action: The device works by detecting and measuring a substance (immunoglobulin G) in a sample outside of the body (in vitro).
- Clinical Purpose: The measurement of immunoglobulin G is used to aid in the diagnosis of abnormal protein metabolism and the body's ability to resist infectious agents, which is a diagnostic purpose.
N/A
Intended Use / Indications for Use
The Immunoglobulin G assay is used for the quantitation of immunoglobulin G in human serum or plasma.
Measurement of immunoglobulin G aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Product codes
DEW
Device Description
Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin G in the sample.
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)
Comparative performance studies were conducted using the AEROSET™ System. The Immunoglobulin G assay method comparison yielded acceptable correlation with the Boehringer Mannheim Immunoglobulin G assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9966, slope = 0.957, and the Y-intercept = 40.555 mg/dL. Precision studies were conducted using the Immunoglobulin G assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 401 is 2.1% and Level 2/Panel 402 is 1.7%. The Immunoglobulin G assay range is 21.0 to 6.147.43 mg/dL. The limit of quantitation (sensitivity) of the Immunoglobulin G assay is 21.0 mg/dL. These data demonstrate that the performance of the Immunoglobulin G assay is substantially equivalent to the performance of the Boehringer Mannheim Immunoglobulin G assay on the Hitachi 717 Analyzer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The correlation coefficient = 0.9966, slope = 0.957, and the Y-intercept = 40.555 mg/dL. The total %CV for Level 1/Panel 401 is 2.1% and Level 2/Panel 402 is 1.7%. The Immunoglobulin G assay range is 21.0 to 6.147.43 mg/dL. The limit of quantitation (sensitivity) of the Immunoglobulin G assay is 21.0 mg/dL.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Summary
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Contact Person
Linda Morris Senior Regulatory Specialist MS 1-8 Regulatory Affairs (972) 518-6711 Fax (972) 753-3367
| Date of Preparation of this Summary: | September 11, 1998 |
|---|---|
| Device Trade or Proprietary Name: | IgG |
| Device Common/Usual Name or Classification Name: | Immunoglobulin G |
| Classification Number/Class: | Class II |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: 198332 | .
Test Description:
Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin G in the sample.
Substantial Equivalence:
The Immunoglobulin G assay is substantially equivalent to the Boehringer Mannheim® Immunoglobulin G assay (K862764) on the Hitachi® 717 Analyzer.
Immunoglobulin G 510(k) September 11, 1998 IgG 5 VI lwp
Section II Page 1
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Both assays yield similar Performance Characteristics. Similarities:
- . Both assays are in vitro immunoassays.
- . Both assavs can be used for the quantitative determination of immunoglobulin G.
- Both assays yield similar clinical results. .
- Both assays are based on the light scattering properties of antigen-antibody . complexes.
Differences:
- There is a difference between the assay range. .
Intended Use:
The Immunoglobulin G assay is used for the quantitation of immunoglobulin G in human serum or plasma.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ System. The Immunoglobulin G assay method comparison vielded acceptable correlation with the Boehringer Mannheim Immunoglobulin G assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9966, slope = 0.957, and the Y-intercept = 40.555 mg/dL. Precision studies were conducted using the Immunoglobulin G assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 401 is 2.1% and Level 2/Panel 402 is 1.7%. The Immunoglobulin G assay range is 21.0 to 6.147.43 mg/dL. The limit of quantitation (sensitivity) of the Immunoglobulin G assay is 21.0 mg/dL. These data demonstrate that the performance of the Immunoglobulin G assay is substantially equivalent to the performance of the Boehringer Mannheim Immunoglobulin G assay on the Hitachi 717 Analyzer.
lmmunoglobulin G 510(k) September 11, 1998 lgG 5 V1 lwp
Section II Page 2
2
Conclusion:
The Immunoglobulin G assay is substantially equivalent to the Boehringer Mannheim Immunoglobulin G assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
lmmunoglobulin G 510(k) September 11, 1998 IgG_5_VI.lwp
Section II Page 3
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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4 1998 NOV
Ms. Linda Morris Senior Requlatory Specialist MS 1-8 Requlatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Re: K983221 Trade Name: IgG Requlatory Class: II Product Code: DEW Dated: September 11, 1998 Received: September 14, 1998
Dear Ms. Morris:
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, qood 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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
5
510(k) Number (if known): 1983021 Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Immunoglobulin G assay is used for the quantitation of immunoglobulin G in human serum or plasma. Measurement of immunoglobulin G aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Peter E. Maken
(Division Sign-Off)
Division of Clinical Laboratory Devices/
510(k) Number [instruction] I want you to create a JSON object based on the following schema: {
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Concyrrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ V Prescription Use OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Immunoglobulin G 510(k) September 11, 1998 lgG_5_VI lwp