C3

K983441 · Abbott Laboratories · CZW · Nov 4, 1998 · Immunology

Device Facts

• Record ID: K983441
• Device Name: C3
• Applicant: Abbott Laboratories
• Product Code: CZW · Immunology
• Decision Date: Nov 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5240
• Device Class: Class 2

Intended 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.

Device Story

The C3 assay is an in vitro diagnostic test used to measure Complement 3 (C3) levels in human serum or plasma. The device operates by mixing patient samples with antibodies to C3, which form insoluble immune complexes. This reaction increases sample turbidity, which is measured via light scattering at 604 nm. The resulting turbidity is directly proportional to the C3 concentration in the sample. The assay is intended for use in clinical laboratory settings by trained personnel. Results are used by clinicians to assist in the diagnosis of immunologic disorders related to complement deficiencies. The device provides quantitative data that supports clinical decision-making regarding patient immune status.

Clinical Evidence

Bench testing only. Method comparison study performed on the AEROSET System against the K-ASSAY C3 on the Hitachi 717 Analyzer. Results: correlation coefficient = 0.9937, slope = 1.026, Y-intercept = 7.727 mg/dL. Precision studies (within-run, between-run, between-day) showed total %CV of 2.8% (Level 1) and 3.2% (Level 2). Assay range up to 364.98 mg/dL; limit of quantitation (sensitivity) is 0.505 mg/dL.

Technological Characteristics

In vitro diagnostic turbidimetric immunoassay. Measures light scattering at 604 nm. Quantitative determination of C3 in human serum or plasma. Designed for use on automated clinical chemistry analyzers (e.g., AEROSET System).

Indications for Use

Indicated for the quantitative determination of C3 in human serum or plasma to aid in the diagnosis of immunologic disorders, particularly those associated with complement component deficiencies.

Regulatory Classification

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.

Predicate Devices

• K-ASSAY® C3 (K964298/S3)

Submission Summary (Full Text)

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NOV 4 1998

K983441

# 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 [phone] Fax [phone]

| 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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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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