(71 days)
Not Found
No
The summary describes a turbidimetric assay for measuring complement C4, which is a standard laboratory technique and does not mention any AI or ML components.
No.
The device is described as an "in vitro diagnostic test intended to quantitatively measure complement C4 (C4) in serum as an aid in the diagnosis of immunologic disorders." It is used for diagnosis, not treatment.
Yes
The C4 Flex® reagent cartridge is explicitly stated as an "in vitro diagnostic test intended to quantitatively measure complement C4 (C4) in serum as an aid in the diagnosis of immunologic disorders." This clearly indicates its purpose in diagnosing medical conditions.
No
The device is a reagent cartridge, which is a physical component used in a clinical chemistry system, not a software-only device.
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 device is an "in vitro diagnostic test intended to quantitatively measure complement C4 (C4) in serum". This is the primary characteristic of an IVD.
- Device Description: The description details a "quantitative, turbidimetric assay using endpoint detection, based on the precipitation of complement C4 by its polyclonal antibody." This describes a laboratory test performed on a biological sample (serum) outside of the body, which is consistent with an in vitro diagnostic.
- Predicate Devices: The listing of predicate devices (K780913 and K922273, which are also likely IVDs) further supports its classification as an IVD.
The information provided clearly indicates that this device is designed to be used in a laboratory setting to analyze a biological sample (serum) to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The C4 Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure complement C4 (C4) in serum as an aid in the diagnosis of immunologic disorders associated with complement C4 protein.
Product codes (comma separated list FDA assigned to the subject device)
DBI
Device Description
The C4 Flex® reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay using endpoint detection, based on the precipitation of complement C4 by its polyclonal antibody.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Split sample comparison between the Dimension® C4 Flex® reagent cartridge method and the Beckman Array® Complement C4 method gave a correlation coefficient of 0.980, slope of 1.01, and an intercept of 6.7 mg/dL when tested with 94 clinical patient samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
994293
DADE BEHRING
DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
Summary of Safety and Effectiveness Information
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.
| Submitter's Name: | Richard M. Vaught
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|--------------------------|----------------------------------------------------------------------------------|
| Date of Preparation: | February 17, 2000 |
| Name of Product: | C4 Flex® Reagent Cartridge |
| FDA Classification Name: | Complement C4, Antigen, Antiserum, Control; 82CZW |
| Predicate Device: | Beckman Array® Complement C4 Assay (K780913; K922273) |
Device Description: The C4 Flex® reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay using endpoint detection, based on the precipitation of complement C4 by its polyclonal antibody.
Intended Use: The C4 Flex® reagent cartridge for the Dimenstry system is an in vitro diagnostic test intended to quantitatively measure complement C4 (C4) in serum as an aid in the diagnosis of immunologic disorders associated with complement C4 protein.
Comparison to Predicate Device:
| Item | Dimension® C4 Flex®
Reagent Cartridge | Beckman
Complement C4 |
|-------------|------------------------------------------------------------|--------------------------|
| Sample Type | Serum | Serum |
| Methodology | Immunoprecipitation | Immunoprecipitation |
| Antibody | Rabbit polyclonal | Goat polyclonal |
| Detection | Bichromatic endpoint
(340 and 700 nm)
(turbidimetry) | Nephelometry
(405 nm) |
Comments on Substantial Equivalence: Split sample comparison between the Dimension® C4 Flex® reagent cartridge method and the Beckman Array® Complement C4 method gave a correlation coefficient of 0.980, slope of 1.01, and an intercept of 6.7 mg/dL when tested with 94 clinical patient samples.
Conclusion: The C4 Flex® reagent cartridge method is substantially equivalent in principle and performance to the Beckman Array® Complement C4 method based on the split sample comparison discussed above.
Rim Vaught
Richard M. Vaught
Regulatory Affairs and Compliance Manager Date: February 17, 2000
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.
MAR - 1 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, Delaware 19714-6101
K994293 Re:
Trade Name: C4 Flex® Reagent Cartridge Regulatory Class: II Product Code: DBI Dated: December 20, 1999 Received: December 21, 1999
Dear Mr. Vaught:
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 Regulations, 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 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.
2
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" (21CFR 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 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
3
Indications For Use Statement
Device Name:
Dimension® C4 Flex® Reagent Cartridge
Indications for Use:
The C4 Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure complement (C4 (C4) in serum as an aid in the diagnosis of immunologic disorders associated with complement C4 protein.
Richard M. Vaught Regulatory Affairs and Compliance Manager
February 28, 2000
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Maker-
Prescription Use_ -(Per 21 CFR 801.109)
OR
Over-the-counter Use
(Optional format 1-2-96)