(35 days)
K964298/S3
K964298/S3
No
The description details a standard in vitro diagnostic assay based on turbidity measurements, with no mention of AI or ML technologies.
No
This device is an in vitro diagnostic assay used for the quantitation of C3 in human serum or plasma to aid in the diagnosis of immunologic disorders, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the C3 assay "aids in the diagnosis of immunologic disorders." This indicates its role in identifying or characterizing a disease or health condition.
No
The device description clearly states it is an "in vitro diagnostic assay" that uses antibodies and measures light scattering (turbidity) to determine the concentration of C3. This indicates a chemical and physical process involving reagents and a measurement system, not solely software.
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 C3 assay is used for the quantitation of C3 in human serum or plasma and that measurements of these proteins aid in the diagnosis of immunologic disorders. This clearly indicates that the device is intended for use in the diagnosis of disease.
- Device Description: The "Device Description" further clarifies that it is an "in vitro diagnostic assay" for the quantitative determination of C3 in human serum or plasma.
- Mechanism: The description of how the assay works (combining antibodies with C3 in the sample to form immune complexes and measuring turbidity) is consistent with an in vitro diagnostic test performed on a biological sample outside of the body.
Therefore, based on the provided information, the C3 assay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The C3 assay is used for the quantitation of C3 in human serum or plasma. 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.
Product codes
CZW
Device Description
C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3 combine with C3 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of C3 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
Comparative performance studies were conducted using the AEROSET™ System. The C3 assay method comparison yielded acceptable correlation with the K-ASSAY C3 on the Hitachi 717 Analyzer. Precision studies were conducted using the C3 assay. Within-run, between-run, and between-day studies were performed using two levels of control material.
Key Metrics
The correlation coefficient = 0.9937, slope = 1.026, and Y-intercept = 7.727 mg/dL. The total %CV for Level 1/Panel 401 is 2.8% and Level 2/Panel 402 is 3.2%. The C3 assay range is up to 364.98 mg/dL. The limit of quantitation (sensitivity) for the C3 assay is 0.505 mg/dL.
Predicate Device(s)
K964298/S3
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
NOV 4 1998
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 29, 1998 |
|---|---|
| Device Trade or Proprietary Name: | C3 |
| Device Common/Usual Name or Classification Name: | Complement 3 |
| 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: K98344) -
Test Description:
C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3 combine with C3 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of C3 in the sample.
C3 510(k) September 29, 1998 C3 V1.lwp
Section II Page 1
Image /page/0/Picture/12 description: The image shows a sequence of numbers. The numbers are all zeros except for the last two digits. The last two digits are ones. The sequence of numbers is 0000011.
1
Substantial Equivalence:
The C3 assay is substantially equivalent to the K-ASSAY® C3 (K964298/S3) on the Hitachi® 717 Analyzer.
Both assays vield similar Performance Characteristics. Similarities:
- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of C3. .
- Both assays vield similar clinical results. .
- . Both assays are based on the formation of immune complexes.
Differences:
- There is a difference between the assay range. .
Intended Use:
The C3 assay is used for the quantitation of C3 in human serum or plasma.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ System. The C3 assay method comparison yielded acceptable correlation with the K-ASSAY C3 on the Hitachi 717 Analyzer. The correlation coefficient = 0.9937, slope = 1.026, and Y-intercept = 7.727 mg/dL. Precision studies were conducted using the C3 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 2.8% and Level 2/Panel 402 is 3.2%. The C3 assay range is up to 364.98 mg/dL. The limit of quantitation (sensitivity) for the C3 assay is 0.505 mg/dL. These data demonstrate that the performance of the C3 assay is substantially equivalent to the performance of the K-ASSAY C3 on the Hitachi 717 Analyzer.
Section II Page 2
0000012
2
Conclusion:
The C3 assay is substantially equivalent to the K-ASSAY C3 on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
C3 510(k) September 29, 1998
C3_VI Iwp Section II Page 3
Image /page/2/Picture/4 description: The image shows the number 0000013 in a bold, sans-serif font. The numbers are black against a white background. The numbers are evenly spaced and aligned horizontally.
3
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures, one behind the other. The figures are facing to the right.
NOV
Ms. Linda Morris Senior Regulatory Specialist MS 1-8 Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
K983441 Re: Trade Name: G3 Requlatory Class: II Product Code: CZW Dated: September 29, 1998 Received: September 30, 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, 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 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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 obliqation 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
4
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 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 (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): K98344 /
Device Name: C3
Indications For Use:
The C3 assay is used for the quantitation of C3 in human serum or plasma. 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.
Peter E. Malcom
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ﻪ ﺳﻨﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V OR Over-The-Counter Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
00000006