(35 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study details for the C3 assay, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Measurement | Reported Device Performance (C3 Assay) |
|---|---|---|
| Correlation with Predicate | Correlation Coefficient | 0.9937 |
| Slope | 1.026 | |
| Y-intercept | 7.727 mg/dL | |
| Precision | Total %CV (Level 1/Panel 401) | 2.8% |
| Total %CV (Level 2/Panel 402) | 3.2% | |
| Assay Range | Maximum quantifiable value | Up to 364.98 mg/dL |
| Sensitivity | Limit of quantitation | 0.505 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the comparative performance studies or precision studies. It mentions "two levels of control material" for precision, but not the number of individual runs or samples within each control level. The data provenance is also not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since this is an in vitro diagnostic assay focusing on quantitative measurement and comparison to a predicate device, the concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists for imaging) is not directly applicable. The ground truth for the comparison was the results obtained from the K-ASSAY® C3 on the Hitachi® 717 Analyzer, which is itself an established and legally marketed device. The "expertise" lies in the established performance and accuracy of this predicate device.
4. Adjudication Method for the Test Set
Not applicable. This is a quantitative assay comparison, not a diagnostic interpretation with potential inter-observer variability requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance
Not applicable. This document describes an in vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the study describes the standalone performance of the C3 assay (the algorithm/device itself) in comparison to a predicate device and through precision studies. There is no human-in-the-loop component mentioned.
7. The Type of Ground Truth Used
The primary "ground truth" used for the comparative effectiveness study was the results obtained from the legally marketed predicate device, K-ASSAY® C3 on the Hitachi® 717 Analyzer. For precision, the "ground truth" was established by the known concentrations of the control materials.
8. The Sample Size for the Training Set
Not applicable. This document describes the performance of a chemical assay, not a machine learning or AI model that typically requires a separate training set. The assay's parameters would have been developed and optimized through standard analytical chemistry methods, not a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there's no "training set" in the AI sense for this type of device. The development of the assay would have involved rigorous analytical procedures to establish its performance characteristics against known standards and reference materials.
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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
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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
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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
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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
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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 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
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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)
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§ 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).