(41 days)
K-ASSAY C4 assay on the Hitachi 717 Analyzer
No
The device description and performance studies focus on a standard in vitro diagnostic assay measuring light scattering (turbidity) to quantify C4. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text.
No.
This device is an in vitro diagnostic assay used for the quantitative determination of C4 in human serum or plasma to aid in the diagnosis of immunologic disorders, not for treating or preventing a disease or condition.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the "Measurement of these proteins aids in the diagnosis of immunologic disorders." This indicates the device is used to help diagnose conditions.
No
The device is an in vitro diagnostic assay that measures light scattering from an immune complex formed in a sample of human serum or plasma. This involves physical reagents and a measurement system (reading turbidity at 604 nm), indicating it is a hardware-based device with associated software, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the C4 assay is used for the quantitation of C4 in human serum or plasma and that measurement of these proteins aids in the diagnosis of immunologic disorders. This clearly indicates a diagnostic purpose performed in vitro (outside the body) using biological samples.
- Device Description: The "Device Description" further clarifies that it is an "in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma." It describes the mechanism of action, which involves analyzing a sample (serum or plasma) to measure a specific analyte (C4).
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K964297/S3) is a strong indicator that this device is being compared to a previously cleared IVD by a regulatory body like the FDA.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The C4 assay is used for the quantitation of C4 in human serum or plasma. Complement is a group of serum proteins which destroy infectious agents. Measurement of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
Product codes
DBI
Device Description
C4 is an in vitro diagnostic assay for the quantitative determination of C4 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 604 nm, which correlates with the concentration of C4 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 C4 assay method comparison yielded acceptable correlation with the K-ASSAY C4 assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9956, slope = 1.003, and Y-intercept = 0.018 mg/dL. Precision studies were conducted using the C4 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 1.6% and Level 2/Panel 402 is 2.5%. The C4 assay range is up to 82.23 mg/dL. The limit of quantitation (sensitivity) for the C4 assay is 0.471 mg/dL. These data demonstrate that the performance of the C4 assay is substantially equivalent to the performance of the K-ASSAY C4 assay on the Hitachi 717 Analyzer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The limit of quantitation (sensitivity) for the C4 assay is 0.471 mg/dL.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(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 23, 1998 |
|---|---|
| Device Trade or Proprietary Name: | C4 |
| Device Common/Usual Name or Classification Name: | Complement 4 |
| 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: { 983335 0 .
Test Description:
C4 is an in vitro diagnostic assay for the quantitative determination of C4 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 604 nm, which correlates with the concentration of C4 in the sample.
Substantial Equivalence:
The C4 assay is substantially equivalent to the K-ASSAY C4 assay (K964297/S3) on the Hitachi® 717 Analyzer.
C4 510(k) September 23, 1998 C4 5 vl
Section II Page 1
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1
Both assays vield similar Performance Characteristics.
Similarities:
- Both assays are in vitro immunoassay methods. •
- Both assays can be used for the quantitative determination of C4. .
- Both assays vield 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 C4 assay is used for the quantitation of C4 in human serum or plasma.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ System. The C4 assay method comparison vielded acceptable correlation with the K-ASSAY C4 assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9956, slope = 1.003, and Y-intercept = 0.018 mg/dL. Precision studies were conducted using the C4 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 1.6% and Level 2/Panel 402 is 2.5%. The C4 assay range is up to 82.23 mg/dL. The limit of quantitation (sensitivity) for the C4 assay is 0.471 mg/dL. These data demonstrate that the performance of the C4 assay is substantially equivalent to the performance of the K-ASSAY C4 assay on the Hitachi 717 Analyzer.
Section II Page 2
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2
Conclusion:
The C4 assay is substantially equivalent to the K-ASSAY C4 assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
C4 510(k) September 23, 1998
C4_s_v1 Section II Page 3
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Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked one above the other.
NOV 4 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Linda Morris Senior Requlatory Specialist MS 1-8 Requlatory Affairs Abbott Laboratories 1920 Hurd Drive Irvinq, Texas 75038
Re: K983356 Trade Name: ্রের Requlatory Class: II Product Code: DBI Dated: September 23, 1998 Received: September 24, 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 qeneral controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 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 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
This letter will allow you to beqin 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 qeneral 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
5
510(k) Number (if known):
C4 Device Name:
Indications For Use:
The C4 assay is used for the quantitation of C4 in human serum or plasma. Complement is a group of serum proteins which destroy infectious agents. Measurement of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
Peter E. Mahon
(Division Sign-Off)
Division of Clinical Laboratory Devices 1983356
510(k) Number
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______________________________________________________________________________________________________________________________________________________________________________ Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use v Over-The-Counter Use OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)