(60 days)
No
The description focuses on a standard immunochemical reaction and light scattering measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an in vitro diagnostic test used for the quantitative measurement of C1 inhibitor to aid in diagnosis, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the C1IN method is an "in vitro diagnostic test" and aids in the "diagnosis" of certain conditions.
No
The device description clearly outlines physical components (reagent cartridge, calibrator, control) which are used in an immunochemical reaction and measured by light scattering. This indicates a hardware-based in vitro diagnostic system, not a software-only device.
Yes, all three devices described are explicitly stated to be IVDs (In Vitro Diagnostics) in their "Intended Use / Indications for Use" sections:
- Dimension Vista® C1IN Flex® reagent cartridge: "The C1IN method is an in vitro diagnostic test..."
- Dimension Vista® C1IN CAL: "The C1IN CAL is an in vitro diagnostic product..."
- Dimension Vista® C1IN CON: "C1 Inhibitor Control is an assayed, mid level, intralaboratory quality control..." (While not explicitly saying "in vitro diagnostic product," quality controls for IVD tests are considered part of the IVD system).
Furthermore, the descriptions and intended uses align with the definition of an IVD, which is a medical device used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment. These devices are used to measure C1 inhibitor in human serum and plasma to aid in the diagnosis of specific conditions.
N/A
Intended Use / Indications for Use
The C1IN method is an in vitro diagnostic test for the quantitative measurement of C1 inhibitor in human serum and plasma on the Dimension Vista® System. Measurements of C1 Inhibitor aid in the diagnosis of hereditary angioneurotic edema (increase blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).
The C1IN CAL is an in vitro diagnostic product for the calibration of the C1 Inhibitor (C1IN) method on the Dimension Vista® System.
C1 Inhibitor Control is an assayed, mid level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of C1 Inhibitor (C1IN).
Product codes
DBA, JIT, JJX
Device Description
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
C1 Calibrator is a lyophilized, human plasma based product containing C1 Inhibitor (C1IN).
C1 Control is a lyophilized, mid-level, human plasma based products containing C1 Inhibitor (C1IN).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum and plasma
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
The Dimension Vista® C1IN assay was compared to the Dade Behring N Antisera to Human C1 Inhibitor assay on the BN ProSpec® System by evaluating serum and plasma samples with concentrations ranging from 0.03 to 0.39 g/L. Regression analysis of these results yielded the following equation.
Comparative Method: N Antisera to C1Inhibitor on the BN ProSpec® System; n: 196; Slope: 0.915; Intercept g/L: 0.006; Correlation Coefficient: 0.993
Conclusion: These studies demonstrate correlation and equivalent performance between the Dade Behring N Antisera to Human C1 Inhibitor assay and the Dimension Vista® C1IN assay.
Key Metrics
Correlation Coefficient: 0.993
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5250 Complement C
1 inhibitor (inactivator) immunological test system.(a)
Identification. A complement C1 inhibitor (inactivator) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C1 inhibitor (a plasma protein) in serum. Complement C1 inhibitor occurs normally in plasma and blocks the action of the C1 component of complement (a group of serum proteins which destroy infectious agents). Measurement of complement C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).(b)
Classification. Class II (performance standards).
0
510(k) Summary for Dimension Vista® C1IN Flex® reagent cartridge Dimension Vista® C1IN CAL Dimension Vista® C1IN CON
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: _______________________________________________________________________________________________________________________________________________
-
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
| Manufacturer: | Dade Behring Marburg GmbH
Emil-von-Behring Str. 76
35041 Marburg, Germany |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Dade Behring Inc.
P.O. Box 6101
Newark, Delaware 19714-6101
Attn: Kathleen Dray-Lyons
Tel: 781-826-4551
Fax: 781-826-2497 |
| Preparation date: | October 19, 2007 |
| Device Name: | Dimension Vista ® C1IN Flex ® reagent cartridge
Dimension Vista ® C1IN CAL
Dimension Vista ® C1IN CON |
Classification: Class II; Class II; Class I Product Code: DBA; JIS; JJX Panel: Immunology (82) and Clinical Chemistry (75)
DEC 2 1 2007
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4. Device Descriptions:
Dimension Vista® C1IN Flex® reagent cartridge
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista® C1IN CAL
C1 Calibrator is a lyophilized, human plasma based product containing C1 Inhibitor (C1IN).
Dimension Vista® C1IN CON
C1 Control is a lyophilized, mid-level, human plasma based products containing C1 Inhibitor (C1IN).
5. Device Intended Uses:
Dimension Vista® C1IN Flex® reagent cartridge:
The C1IN method is an in vitro diagnostic test for the quantitative measurement of C1 inhibitor in human serum and plasma on the Dimension Vista" System. Measurements of C1 Inhibitor aid in the diagnosis of hereditary agioneuroffic edema (increase blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).
Dimension Vista® C1IN CAL:
The C1IN CAL is an in vitro diagnostic product for the calibration of the C1 Inhibitor (C1IN) method on the Dimension Vista® System.
Dimension Vista® C1IN CON:
C1 Inhibitor Control is an assayed, mid level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of C1 Inhibitor (C1IN).
6. Medical device to which equivalence is claimed and comparison information:
The Dimension Vista® C1N Flex® reagent cartridge, Dimension Vista® C1IN CAL and Dimension Vista® C1 CON are substantially equivalent to the Dade Behring N Antisera to Human C1 Inhibitor assay (K960257), N Protein Standard PY (K962410), and N/T Protein Control PY (K962407), respectively. The Dimension Vista® C1IN assay, like Dade Behring N Antisera to Human C1 Inhibitor is an in vitro diagnostic test for the quantitative measurement of C1 Inhibitor in human serum and plasma.
2
Device Performance Characteristics: 7.
The Dimension Vista® C1IN assay was compared to the Dade Behring N Antisera to Human C1 Inhibitor assay on the BN ProSpec® System by evaluating serum and plasma
samples with concentrations ranging from 0.03 to 0.39 g/L. Regression analysis of these results yielded the following equation.
| Comparative Method | n | Slope | Intercept g/L | Correlation Coefficient |
|---|---|---|---|---|
| N Antisera to | ||||
| C1Inhibitor on the BN | ||||
| ProSpec® System | 196 | 0.915 | 0.006 | 0.993 |
Method Comparison Study
8. Conclusion:
These studies demonstrate correlation and equivalent performance between the Dade Behring N Antisera to Human C1 Inhibitor assay and the Dimension Vista® C1IN assay
000091
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure. The bird is composed of three curved lines that suggest wings and a head.
Public Health Service
DEC 2 1 2007
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dade Behring, Inc. c/o Ms. Kathleen Dray-Lyons Manager, Regulatory Affairs and Compliance Glasgow Site P.O. Box 6101 Newark, DE 19714-6101
Re: K072965
Trade/Device Name: Dimension Vista C1IN Flex reagent cartridge Dimension Vista C1IN CAL Dimension Vista C1IN CON Regulation Number: 21 CFR 866.5250 Regulation Name: Complement C1 inhibitor (inactivator) immunological test system
Regulatory Class: Class II Product Code: DBA, JIT, JJX Dated: October 19, 2007 Received: October 29, 2007
Dear Ms. Dray-Lyons:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
4
Page 2 -
forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert M. Becker, f
Robert L. Becker, Jr., M.D., PH.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): Ko 729 6J
Device Name:
Dimension Vista® C1IN Flex® reagent cartridge Dimension Vista® C1IN CAL Dimension Vista® C1IN CON
Indications For Use:
Dimension Vista® C1IN Flex® reagent cartridge:
The C1IN method is an in vitro diagnostic test for the quantitative measurement of C1 inhibitor in human serum and plasma on the Dimension Vista® System. Measurements of C1 Inhibitor aid in the diagnosis of hereditary angioneurotic edema (increase blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).
Dimension Vista® C1IN CAL:
The C1IN CAL is an in vitro diagnostic product for the calibration of the C1 Inhibitor (C1IN) method on the Dimension Vista® System.
Dimension Vista® C1IN CON:
C1 Inhibitor Control is an assayed, mid level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of C1 Inhibitor (C1IN).
AND/OR
Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Page 1 of
Maria M Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
5101k) Ko72965