(190 days)
Unknown
No
The summary describes a reagent for a standard immunochemistry system using rate nephelometry, with no mention of AI or ML.
No
This device is for the quantitative determination of Complement C3 and C4, which is a diagnostic function, not a therapeutic one.
Yes
The device is intended for the quantitative determination of Complement C3 and C4, which are biomarkers used in diagnosing and monitoring conditions related to the immune system.
No
The device described is a reagent kit used in conjunction with a specific immunochemistry system (Beckman IMMAGE™). Reagents are physical components used in a chemical reaction, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The text explicitly states the device is "intended for the quantitative determination of Complement C3" and "intended for the quantitative determination of Complement C4" in human serum samples. This is a diagnostic purpose, measuring specific substances in a biological sample.
- Device Description: It further clarifies that the reagents are for "quantitative determination of Complement C3 and Complement C4 concentrations respectively in human serum samples". This reinforces the diagnostic nature of the device.
- Sample Type: The device is used with "human serum samples," which are biological specimens.
- Method: The method used is "rate nephelometry," which is a common technique in clinical chemistry for measuring the concentration of substances in biological fluids.
- Performance Studies: The document includes performance studies like "Method Comparison Study Results," "Stability Study Results," and "Estimated Imprecision," which are typical evaluations for IVD devices to demonstrate their accuracy, reliability, and consistency.
- Predicate Device(s): The mention of predicate devices (K771603 and K780913) which are also described as "Immunochemistry Systems Complement C3 Reagent" and "Immunochemistry Systems Complement C4 Reagent" further indicates that this device falls within the category of IVDs.
All these elements strongly indicate that the device is designed to be used outside of the body to examine specimens from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
The IMMAGE Immunochemistry System Complement C4 (C4) Reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1. is intended for the quantitative determination of human complement C4 by rate nephelometry.
Product codes
CZW, DBI
Device 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Method Comparison Study Results:
- Analyte: Complement C3, Sample Type: serum, Slope: 0.969, Intercept: 6.18, r: 0.994, n: 100, Predicate Method: Complement C3 Reagent on the Array
- Analyte: Complement C4, Sample Type: serum, Slope: 0.983, Intercept: -1.48, r: 0.984, n: 124, Predicate Method: Complement C4 Reagent on the Array
Stability Study Results:
- Reagent: IMMAGE C3 & C4, Product Claim: 24 month shelf-life, 14 day open container stability, 14 day calibration stability
Estimated Imprecision:
IMMAGE System C3 Reagent Precision Study Results
- Sample: Level 1, Mean: 70.3 mg/dL, SD (Within-Run): 1.79 mg/dL, %CV (Within-Run): 2.5, SD (Total): 2.09 mg/dL, %CV (Total): 3.0, N: 80
- Sample: Level 2, Mean: 106 mg/dL, SD (Within-Run): 3.1 mg/dL, %CV (Within-Run): 2.9, SD (Total): 3.9 mg/dL, %CV (Total): 3.6, N: 80
IMMAGE System C4 Reagent Precision Study Results
- Sample: Level 1, Mean: 18.8 mg/dL, SD (Within-Run): 0.60 mg/dL, %CV (Within-Run): 3.2, SD (Total): 0.65 mg/dL, %CV (Total): 3.4, N: 80
- Sample: Level 2, Mean: 42.9 mg/dL, SD (Within-Run): 1.45 mg/dL, %CV (Within-Run): 3.4, SD (Total): 2.21 mg/dL, %CV (Total): 5.2, N: 80
- Sample: Level 3, Mean: 65.5 mg/dL, SD (Within-Run): 1.65 mg/dL, %CV (Within-Run): 2.5, SD (Total): 2.46 mg/dL, %CV (Total): 3.7, N: 80
Key Metrics
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Predicate Device(s)
Reference Device(s)
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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
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.
1
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Complement C3 (C3) and Complement C4 (C4) Reagents Summary of Safety & Effectiveness
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.
2
Beckman Instruments, Inc., Section 510(k) Notification Beckman mstranients, mc., Geclon 3 ro(x) Netwould.
IMMAGE™ Immunochemistry System Complement C3 (C3) and Complement C4 (C4) Reagents Summary of Safety & Effectiveness
7.0 Comparison to Predicate(s):
The following tables show similarities and differences between the predicates identified in Section 4.0 of this summary.
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| IMMAGE System C3 | ||
| Reagent | Assay method - rate nephelometry | Same as Beckman's |
| Immunochemistry Systems | ||
| Sample / reagent ratios | Complement C3 reagent on the | |
| Array System | ||
| Antibody |
C3 Similarities With The Predicate
C4 Similarities With The Predicate
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| IMMAGE System C4 | ||
| Reagent | Assay method - rate nephelometry | Same as Beckman's |
| Immunochemistry Systems | ||
| Sample / reagent ratios | Complement C4 reagent on the | |
| Array System | ||
| 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. |
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Summary of Performance Data: 8.0
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 companson, stability, and imprecision experiments that relate results obtained from the Beckman Reagents to the IMMAGE System 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 |
Method Comparison Study Results IMMAGE Complement C3 (C3) and Complement C4 (C4) Reagents
Stability Study Results
| Reagent | Product Claim |
|---|---|
| IMMAGE C3 & C4 | 24 month shelf-life |
| 14 day open container stability | |
| 14 day calibration stability |
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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.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle with a caduceus, a symbol associated with medicine and healthcare, superimposed on its body.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
1997 IIN III
Ms. Margie George Project Manager Beckman Instruments, Inc. 200 S. Kraemer Boulevard, W-343 Brea, California 92822-8000
Re: K964842/S1
华 Trade Name: IMMAGE™ Immunochemistry System Complement C3 and C4 Reagents Regulatory Class: II Product Code: CZW DBI II 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 vou might have under sections 531 through 542 of the Act for devices under the Flectronic 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 Butman
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 _
K964842 510(k) Number (if known):
Device Name: IMMAGE™ Immunochemistry System Complement C4 (C4) Reagent
Indications for Use:
The IMMAGE Immunochemistry System Complement C4 (C4) Reagent, when used in coniunction 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 G1g. G1, G15, G2 C3, C4, C5, Cg, and Cg in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy Measurements of these proteins aids in the diagnosis of infectious agents. immunologic disorders, especially those associated with deficiencies of complement components.
(b) Classification. Class II (performance standards).
Patrick Maher
(Division Sign-Off Division of Clinical Laborato (PLEASE DO NOT WRITE BELOW THIS LINE ! OU ANOTHER PAGE
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﺎ Prescription Use (per 21 CFR 801.109)
NEEDED)
OR
Over-the-Counter Use Optional Format 1-2-96