IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT
Device Facts
| Record ID | K964842 |
|---|---|
| Device Name | IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT |
| Applicant | Beckman Instruments, Inc. |
| Product Code | CZW · Immunology |
| Decision Date | Jun 11, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5240 |
| Device Class | Class 2 |
Indications for Use
The IMMAGE Immunochemistry System Complement C3 (C3) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of Complement C3 by rate nephelometry. The IMMAGE Immunochemistry System Complement C4 (C4) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of Complement C4 by rate nephelometry.
Device Story
Reagents for quantitative measurement of Complement C3 and C4 in human serum; used on Beckman IMMAGE Immunochemistry System. System utilizes rate nephelometry; measures light scatter intensity changes over time as antigen-antibody complexes form. Reagents stored in plastic cartridges; assay performed at 37°C. Operated by laboratory personnel in clinical settings. Output provides concentration values (mg/dL) to clinicians for diagnosing immunologic disorders and complement deficiencies. Benefits include automated, precise quantification of complement proteins compared to manual or older methods.
Clinical Evidence
Bench testing only. Method comparison study (n=100 for C3, n=124 for C4) against predicate Array System reagents showed high correlation (r=0.994 for C3; r=0.984 for C4). Precision studies (n=80 per level) demonstrated total C.V.s of 3.0-3.6% for C3 and 3.4-5.2% for C4. Stability testing supports 24-month shelf-life and 14-day open-container/calibration stability.
Technological Characteristics
Rate nephelometry assay; 37°C reaction temperature. Reagents supplied in plastic cartridges. Quantitative measurement of C3 and C4 proteins in human serum. System-based automated analysis.
Indications for Use
Indicated for quantitative determination of human Complement C3 and C4 in serum via rate nephelometry to aid in the diagnosis of immunologic disorders 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
- Immunochemistry Systems Complement C3 Reagent (K771603)
- Immunochemistry Systems Complement C4 Reagent (K780913)
Submission Summary (Full Text)
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200 South Kraemer Boulevard, Box 8000, Brea, CA 92822-8000 • (714) 993-5321
K964842
# BECKMAN
Summary of Safety & Effectiveness
IMMAGE™ Immunochemistry System Complement C3 (C3) and Complement C4 (C4) Reagents
# 1.0 Submitted By:
Margie George
Project Manager
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-343
Brea, California 92822-8000
Telephone: (714) 961-3765
FAX: (714) 961-3759
# 2.0 Date Submitted:
26 November 1996
# 3.0 Device Name(s):
# 3.1 Proprietary Names
IMMAGE™ Immunochemistry System Complement C3 (C3) Reagent
IMMAGE™ Immunochemistry System Complement C4 (C4) Reagent
# 3.2 Classification Name
Complement components) immunological test system (21 CFR § 866.5240)
# 4.0 Predicate Device(s):
| IMMAGE System Reagent | Predicate | Manufacturer | Docket Number |
| --- | --- | --- | --- |
| Complement C3 (C3) Reagent | Immunochemistry Systems Complement C3 Reagent | Beckman Instruments Inc. * | K771603 |
| Complement C4 (C4) Reagent | Immunochemistry Systems Complement C4 Reagent | Beckman Instruments Inc.* | K780913 |
Beckman Instruments, Inc.
twx: 910-592-1260 • telex: 06-78413
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Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Complement C3 (C3) and Complement C4 (C4) Reagents
Summary of Safety & Effectiveness
2
# 5.0 Description:
The IMMAGE Immunochemistry System C3 and C4 Reagents in conjunction with Beckman Calibrator 1, are intended for use in the quantitative determination of Complement C3 and Complement C4 concentrations respectively in human serum samples on Beckman's IMMAGE Immunochemistry System.
# 6.0 Intended Use:
The IMMAGE Immunochemistry System Complement C3 (C3) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of Complement C3 by rate nephelometry.
The IMMAGE Immunochemistry System Complement C4 (C4) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of Complement C4 by rate nephelometry.
file: c3-4510k.sse
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Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Complement C3 (C3) and Complement C4 (C4) Reagents
Summary of Safety & Effectiveness
3
# 7.0 Comparison to Predicate(s):
The following tables show similarities and differences between the predicates identified in Section 4.0 of this summary.
C3 Similarities With The Predicate
| Reagent | Aspect/Characteristic | Comments |
| --- | --- | --- |
| IMMAGE System C3 Reagent | Assay method - rate nephelometry | Same as Beckman's Immunochemistry Systems Complement C3 reagent on the Array System |
| | Sample / reagent ratios | |
| | Antibody | |
C4 Similarities With The Predicate
| Reagent | Aspect/Characteristic | Comments |
| --- | --- | --- |
| IMMAGE System C4 Reagent | Assay method - rate nephelometry | Same as Beckman's Immunochemistry Systems Complement C4 reagent on the Array System |
| | Sample / reagent ratios | |
| | Measuring Range: Initial 10 - 130 mg/dL Extended 10 - 4,680 mg/dL | |
| | Antibody | |
C3 Differences From The Predicate
| Reagent | Aspect/Characteristic | Comments |
| --- | --- | --- |
| IMMAGE System C3 Reagent | Reaction Temperature | IMMAGE System C3 assays run at 37°C and the predicate runs at 26.7°C. |
| IMMAGE System C3 Reagent | Reagent Container | IMMAGE reagent is stored in a plastic cartridge and predicate reagent is stored in glass vials. |
C4 Differences From The Predicate
| Reagent | Aspect/Characteristic | Comments |
| --- | --- | --- |
| IMMAGE System C4 Reagent | Reaction Temperature | IMMAGE System C4 assays run at 37°C and the predicate runs at 26.7°C. |
| IMMAGE System C4 Reagent | Reagent Container | IMMAGE reagent is stored in a plastic cartridge and predicate reagent is stored in glass vials. |
file: c3-4510k.sse
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Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Complement C3 (C3) and Complement C4 (C4) Reagents
Summary of Safety & Effectiveness
4
### 8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the Beckman Reagents to the IMMAGE System Reagents.
Method Comparison Study Results
IMMAGE Complement C3 (C3) and Complement C4 (C4) Reagents
| Analyte | Sample Type | Slope | Intercept | r | n | Predicate Method |
| --- | --- | --- | --- | --- | --- | --- |
| Complement C3 | serum | 0.969 | 6.18 | 0.994 | 100 | Complement C3 Reagent on the Array |
| Complement C4 | serum | 0.983 | -1.48 | 0.984 | 124 | Complement C4 Reagent on the Array |
Stability Study Results
| Reagent | Product Claim |
| --- | --- |
| IMMAGE C3 & C4 | 24 month shelf-life 14 day open container stability 14 day calibration stability |
file: c3-4510k.sse
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Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Complement C3 (C3) and Complement C4 (C4) Reagents
Summary of Safety & Effectiveness
5
### Estimated Imprecision
IMMAGE System C3 Reagent Precision Study Results
| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Within-Run Imprecision | | | | |
| Level 1 | 70.3 | 1.79 | 2.5 | 80 |
| Level 2 | 106 | 3.1 | 2.9 | 80 |
| Total Precision | | | | |
| Level 1 | 70.3 | 2.09 | 3.0 | 80 |
| Level 2 | 106 | 3.9 | 3.6 | 80 |
IMMAGE System C4 Reagent Precision Study Results
| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Within-Run Imprecision | | | | |
| Level 1 | 18.8 | 0.60 | 3.2 | 80 |
| Level 2 | 42.9 | 1.45 | 3.4 | 80 |
| Level 3 | 65.5 | 1.65 | 2.5 | 80 |
| Total Precision | | | | |
| Level 1 | 18.8 | 0.65 | 3.4 | 80 |
| Level 2 | 42.9 | 2.21 | 5.2 | 80 |
| Level 3 | 65.5 | 2.46 | 3.7 | 80 |
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
file: c3-4510k.sse
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[LOGO]
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850
JUN 11 1997
Ms. Margie George
Project Manager
Beckman Instruments, Inc.
200 S. Kraemer Boulevard, W-343
Brea, California 92822-8000
Re: K964842/S1
* Trade Name: IMMAGE™ Immunochemistry System Complement C3 and C4 Reagents
Regulatory Class: II
Product Code: CZW
II
DBI
Dated: March 27, 1997
Received: March 28, 1997
Dear Ms. George:
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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug 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 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.
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Gutman
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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page __ of __
510(k) Number (if known): K964842
Device Name: IMMAGE™ Immunochemistry System
Complement C4 (C4) Reagent
Indications for Use:
The IMMAGE Immunochemistry System Complement C4 (C4) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human complement C4 by rate nephelometry.
21 CFR 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).
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ☑
(per 21 CFR 801.109)
OR
Over-the-Counter Use ____
Optional Format 1-2-96
