(71 days)
The C3 Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure complement C3 (C3) in serum as an aid in the diagnosis of immunologic disorders associated with complement C3 protein.
The C3 Flex® reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay using endpoint detection, based on the precipitation of complement CJ by its polyclonal antibody.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the C3 Flex® Reagent Cartridge are implicitly defined by its substantial equivalence to the predicate device, the Beckman Array® Complement C3 Assay. The key performance metric used to demonstrate this equivalence is the correlation between the two methods when testing patient samples.
| Acceptance Criteria (Implied) | Reported Device Performance | Met? |
|---|---|---|
| Correlation coefficient (r) indicative of strong agreement with predicate device | 0.980 | Yes |
| Slope of regression analysis close to 1.00 | 1.01 | Yes |
| Intercept of regression analysis close to 0 | 6.7 mg/dL | Yes (within reasonable range for clinical assays) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 94 clinical patient samples.
- Data Provenance: The text does not explicitly state the country of origin. The samples are referred to as "clinical patient samples," implying they were collected from human patients and are likely retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study relies on a comparative method (split sample comparison) where the predicate device's results are considered the reference, rather than independent expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document, as the ground truth was established by comparison to a predicate device rather than expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) reagent cartridge for a clinical chemistry system, not an AI-powered diagnostic imaging or decision support system that involves human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of the device itself (the C3 Flex® reagent cartridge on the Dimension® system), which is intrinsically "standalone" in the context of an IVD assay. The performance data presented (correlation, slope, intercept) represents the standalone performance of the device compared to the predicate.
7. The Type of Ground Truth Used
The "ground truth" for the test set was established by comparison to a legally marketed predicate device (Beckman Array® Complement C3 Assay). The results from the predicate device served as the reference standard against which the new device was evaluated.
8. The Sample Size for the Training Set
The document does not explicitly mention a training set in the context of this 510(k) submission. This is common for traditional IVD assays like a reagent cartridge, where development involves optimization and validation rather than machine learning model training based on a distinct dataset. The "94 clinical patient samples" were used for the comparative testing of the device's performance against the predicate.
9. How the Ground Truth for the Training Set was Established
As no training set is explicitly mentioned or defined in the context of machine learning, this question is not applicable based on the provided text. The development process for such a device would likely involve internal validation and optimization against reference materials and known samples, but not "ground truth" derived from expert consensus or pathology on a distinct training set in the way AI models are trained.
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DADE BEHRING
MAR - 1 2000
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. VaughtDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101 |
|---|---|
| Date of Preparation: | February 17, 2000 |
| Name of Product: | C3 Flex® Reagent Cartridge |
| FDA Classification Name: | Complement C3, Antigen, Antiserum, Control; 82CZW |
| Predicate Device: | Beckman Array® Complement C3 Assay (K780913; K922273) |
Device Description: The C3 Flex® reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay using endpoint detection, based on the precipitation of complement CJ by its polyclonal antibody.
Intended Use: The C3 Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure complement C3 (C3) in serum as an aid in the diagnosis of immunologic disorders associated with complement C3 protein.
| Comparison to Predicate Device:Dimension® C3 Flex®Reagent Cartridge | BeckmanComplement C3 | |
|---|---|---|
| Item | ||
| 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® C3 Flex® reagent cartridge method and the Beckman Array® Complement C3 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.
The C3 Flex® reagent cartridge method is substantially equivalent in principle and performance to Conclusion: the Beckman Array® Complement C3 method based on the split sample comparison discussed above.
KmVaught
Richard M. Vaught
Richard M. Vaught Regulatory Affairs and Compliance Manager Date: February 17, 2000
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, composed of three curved lines that suggest the bird's head, body, and tail 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
Re: K994296 Trade Name: C3 Flex® Reagent Cartridge Regulatory Class: II Product Code: CZW 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.
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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 (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
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Indications For Use Statement
Device Name:
Dimension® C3 Flex® Reagent Cartridge
Indications for Use:
The C3 Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure complement C3 (C3) in serum as an aid in the diagnosis of immunologic disorders associated with complement C3 protein.
Rm Vaught
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)
Petu E. Mefin
(Division Sign-Off, Division of Clinical Laboratory Der 510(k) Number
Prescription Use V (Per 21 CFR 801.109) '
OR
Over-the-counter Use
(Optional format 1-2-96)
§ 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).