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).

Device Description

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).

AI/ML Overview

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

Acceptance Criteria	Reported Device Performance (Method Comparison Study)
Correlation	Correlation Coefficient: 0.993 (indicating very strong linear correlation)
Slope	Slope of Regression: 0.915 (ideally close to 1 for perfect agreement)
Intercept	Intercept of Regression: 0.006 g/L (ideally close to 0 for no systematic bias)
Equivalence	The study "demonstrates correlation and equivalent performance" between the new and predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 196 (serum and plasma samples)
Data Provenance: The text does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "human serum and plasma samples."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not describe the use of experts to establish a "ground truth" for the test set in the conventional sense of clinical interpretation. This is a comparison study between two assays, not a diagnostic study where human readers are making interpretations.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this study compares the performance of two analytical assays, not diagnostic interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This study is an analytical method comparison between a new device (Dimension Vista® C1IN assay) and a legally marketed predicate device (Dade Behring N Antisera to Human C1 Inhibitor assay) on two different laboratory platforms. It does not involve human readers evaluating cases or the effect of AI assistance.

6. Standalone Performance Study

Yes, a standalone study was done in the sense that the performance of the Dimension Vista® C1IN assay was evaluated on its own by comparing its results to results from a predicate device. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices. It's not "algorithm only" in the context of AI, but "device only" performance in the context of analytical measurement.

7. Type of Ground Truth Used

The "ground truth" in this context is the results obtained from the legally marketed predicate device, the Dade Behring N Antisera to Human C1 Inhibitor assay on the BN ProSpec® System. The study aims to show that the new device produces results that are comparable or equivalent to the established method.

8. Sample Size for the Training Set

Not applicable. This is an in vitro diagnostic assay, not an AI/ML device that requires a training set in the machine learning sense. The "training" for such a device typically involves method development and optimization, but not with a distinct "training set" of patient data as understood in AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

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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: _______________________________________________________________________________________________________________________________________________

1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:

Manufacturer:	Dade Behring Marburg GmbHEmil-von-Behring Str. 7635041 Marburg, Germany
Contact Information:	Dade Behring Inc.P.O. Box 6101Newark, Delaware 19714-6101Attn: Kathleen Dray-LyonsTel: 781-826-4551Fax: 781-826-2497
Preparation date:	October 19, 2007
Device Name:	Dimension Vista ® C1IN Flex ® reagent cartridgeDimension Vista ® C1IN CALDimension Vista ® C1IN CON

Classification: Class II; Class II; Class I Product Code: DBA; JIS; JJX Panel: Immunology (82) and Clinical Chemistry (75)

1. Identification of the Legally Marketed Devices:
  Dade Behring N Antisera to Human C1 Inhibitor- K960257 Dade Behring N Protein Standard PY - K962410 Dade Behring N/T Protein Control PY - K962407

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.

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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 toC1Inhibitor on the BNProSpec® 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

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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

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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

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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:

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

Regulation Number and Section

§ 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).