(38 days)
Dimension Vista™ A1AT Flex® reagent cartridge:
The A1AT method is an in vitro diagnostic test for the quantitative determination of a - antitrypsin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of a-antitrypsin aid in the diagnosis of cirrhosis of the liver and pulmonary emphysema.
Dimension Vista™ Protein 1 Calibrator
PROT1 CAL is an in vitro diagnostic product for the calibration of the a1antitrypsin (A1AT), C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System.
Dimension Vista™ Protein 1 Control L. M and H
PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of α1-antitrypsin (A1AT), C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin (PREALB) on the Dimension Vista® System.
Dimension Vista" A1AT 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™ Protein 1 Calibrator
Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing a1antitrypsin (A1AT). C3 complement, C4 complement, immunoglobulin A (IGA). immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
Dimension Vista" Protein 1 Control L. M and H
Protein 1 Control L, M and H are multi-analyte, liguid, human serum based products containing a1-antitrypsin (A1AT), C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista" A1AT Flex® reagent cartridge:
Acceptance Criteria and Device Performance Study
The submission focuses on establishing substantial equivalence for the Dimension Vista™ A1AT Flex® reagent cartridge by comparing its performance to a legally marketed predicate device, the Dade Behring N Antisera to Human α1-Antitrypsin assay on the BN ProSpec® System. The primary method used to demonstrate this is a method comparison study.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence in this context are typically demonstrated through strong correlation and agreement between the new device and the predicate device. While explicit numerical acceptance criteria (e.g., minimum correlation coefficient, maximum allowable bias) are not directly stated as "acceptance criteria" in the provided document, they are implied by the reported results and the conclusion of equivalence.
For the purpose of this analysis, I will infer the performance metrics from the Method Comparison Study as the "reported device performance," which implicitly met the internal or regulatory acceptance thresholds for demonstrating equivalence.
| Performance Metric | Implied Acceptance Criteria (Typically Good Correlation) | Reported Device Performance |
|---|---|---|
| Sample Size (n) | Sufficient for statistical significance | 139 |
| Slope | Close to 1.0 | 1.000 |
| Intercept (g/L) | Close to 0.0 | 0.070 |
| Correlation Coefficient (r) | Close to 1.0 (ideally > 0.97 for method comparison in analytical assays) | 0.996 |
| Concentration Range | Representative of clinical use | 0.23 g/L to 4.71 g/L (for α1-antitrypsin in human serum and plasma) |
Conclusion from document: "These studies demonstrate correlation and equivalent performance between the Dade Behring N Antisera to Human α-Antitrypsin assay and the Dimension Vista™ A1AT assay."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 139 samples.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "evaluating serum and plasma samples." Given the nature of a 510(k) submission for an in vitro diagnostic, these samples would typically come from human subjects, either collected retrospectively or prospectively for the purpose of the study. Without further information, we cannot definitively classify the provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of submission for an in vitro diagnostic (IVD) assay typically relies on a "predicate device" as the gold standard or reference for comparison, rather than expert consensus on individual cases. The "ground truth" for the test set is established by the results obtained from the predicate device (Dade Behring N Antisera to Human α1-Antitrypsin assay on the BN ProSpec® System). Therefore, there were no human "experts" establishing a ground truth in the traditional sense of clinical diagnosis or interpretation for this specific method comparison.
4. Adjudication Method
As the "ground truth" or reference method is another automated IVD assay, there is no adjudication method described or necessary in the sense of resolving discrepancies between human readers or interpretations. The comparison is between two quantitative analytical measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is relevant for diagnostic imaging devices or other tests that involve human interpretation and reader variability. For an automated in vitro diagnostic assay like the Dimension Vista™ A1AT Flex® reagent cartridge, the performance is assessed by analytical comparison to a predicate method, not by comparing human reader performance with and without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was implicitly done. The "Method Comparison Study" directly evaluates the performance of the Dimension Vista™ A1AT assay (the new device, effectively "standalone" in its measurement capability) against a predicate device. The reported slope, intercept, and correlation coefficient are standard metrics for evaluating the analytical performance of an IVD assay by itself when compared to a reference method, without human intervention in the measurement process itself.
7. Type of Ground Truth Used
The ground truth used for the comparison was the results obtained from a legally marketed predicate in vitro diagnostic assay (Dade Behring N Antisera to Human α1-Antitrypsin assay on the BN ProSpec® System). This is a common and accepted method for establishing equivalence for new IVD assays.
8. Sample Size for the Training Set
This information is not provided. The document describes a "Method Comparison Study" for the new device against a predicate. For IVD assays, there wasn't a separate "training set" in the context of machine learning, and the study doesn't mention how the assay itself (e.g., reagent formulation, instrument parameters) was developed or optimized. The 139 samples were used for the performance evaluation, not to "train" an algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" or a machine learning component for this traditional IVD reagent cartridge, this question is not applicable in the context of the provided document. The assay's analytical principles are based on known immunochemical reactions, and its calibration would be established using calibrators with known concentrations (as mentioned for the Dimension Vista™ Protein 1 Calibrator), not through a "training set" and ground truth in the AI sense.
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510(k) Summary for Dimension Vista" A1AT Flex® reagent cartridge
Dimension Vista™ Protein 1 Control L, M and H
JAN 1 1 2007
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 ofPreparation: | |
|---|---|---|
| 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: | December 20, 2006 | |
| 2. | Device Name: | Dimension Vista™ A1AT Flex® reagent cartridgeDimension Vista™ Protein 1 CalibratorDimension Vista™ Protein 1 Control LDimension Vista™ Protein 1 Control MDimension Vista™ Protein 1 Control H |
| Classification:Product Code:Panel: | Class II; Class II; Class IDEM; JIX; JJYImmunology (82) and Clinical Chemistry (75) |
3. ldentification of the Legally Marketed Devices:
Dade Behring N Antisera to Human α1-Antitrypsin– Κ053072 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468
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Device Descriptions: 4.
Dimension Vista" A1AT 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™ Protein 1 Calibrator
Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing a1antitrypsin (A1AT). C3 complement, C4 complement, immunoglobulin A (IGA). immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
Dimension Vista" Protein 1 Control L. M and H
Protein 1 Control L, M and H are multi-analyte, liguid, human serum based products containing a1-antitrypsin (A1AT), C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
Device Intended Uses: 5.
Dimension Vista™ A1AT Flex® reagent cartridge:
The A1AT method is an in vitro diagnostic test for the quantitative determination of aantitrypsin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of q-antitrypsin aid in the diagnosis of cirrhosis of the liver and pulmonary emphysema.
Dimension Vista™ Protein 1 Calibrator:
PROT1 CAL is an in vitro diagnostic product for the calibration of the a - antitrypsin (A1AT), C3 complement (C3), C4 complement (C4), Immunoglobulin A (IGA), lmmunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin (PREALB) methods
on the Dimension Vista System.
Dimension Vista " Protein 1 Control L. M and H:
PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of a1-antitrypsin (A1AT), C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vista System.
6. Medical device to which equivalence is claimed and comparison information:
The Dimension Vista" A1AT assay, like Dade Behring N Antisera to Human a1-Antitrypsin is an in vitro diagnostic test for the quantitative measurement of a1-antitrypsin in human serum and plasma.
7. Device Performance Characteristics:
The Dimension Vista™ A1AT assay was compared to the Dade Behring N Antisera to Human a1-antitrypsin assay on the BN ProSpec® System by evaluating serum and plasma samples with concentrations ranging from 0.23 g/L to 4.71 g/L. Regression analysis of these results yielded the following equation.
CUNF II-NTIAL
0000020
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Method Comparison Study
| Comparative Method | n | Slope | Interceptg/L | CorrelationCoefficient |
|---|---|---|---|---|
| N Antisera to Humanα₁-Antitrypsin BNProSpec® | 139 | 1.000 | 0.070 | 0.996 |
8. Conclusion:
These studies demonstrate correlation and equivalent performance between the Dade
Behring N Antisera to Human α-Antitrypsin assay and the Dimension Vista" A1AT assay.
Image /page/2/Picture/4 description: The image is a black and white photograph that appears to be of a document with some markings on it. The markings are mostly vertical lines and some scattered dots. The document itself is not clearly visible, and the markings are the most prominent feature of the image. The overall impression is that of a document that has been marked or annotated in some way.
·
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dade Behring, Inc. JAN 1 1 2007 c/o Ms. Kathleen Dray-Lyons Manager, Regulatory Affairs and Compliance Glasgow Site P.O. Box 6101 Newark, DE 19714
Re: K063610
Trade/Device Name: Dimension Vista™ A1AT Flex® Reagent Cartridge Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L Dimension Vista™ Protein 1 Control M Dimension Vista™ Protein 1 Control H Regulation Number: 21 CFR 866.5130
Regulation Name: Alpha-1-Antitrypsin Immunological Test System Regulatory Class: Class II Product Code: DEM, JIX, JJY Dated: December 1, 2006 Received: December 4, 2006
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);
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labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on vour 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,
ia Chan for
Dr. Robert Becker
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 Statement
· K063610
Dimension Vista" A1AT Flex® reagent cartridge
Dimension Vista" Protein 1 Calibrator
Dimension Vista" Protein 1 Calibrator
Dimension Vista" Protein 1 Control Mar
Dimension Vis Device Name:
Indications for Use:
Dimension Vista™ A1AT Flex® reagent cartridge:
The A1AT method is an in vitro diagnostic test for the quantitative determination of a - antitrypsin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of a-antitrypsin aid in the diagnosis of cirrhosis of the liver and pulmonary emphysema.
Dimension Vista™ Protein 1 Calibrator
PROT1 CAL is an in vitro diagnostic product for the calibration of the a1antitrypsin (A1AT), C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista® System.
Dimension Vista™ Protein 1 Control L. M and H
PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of α1-antitrypsin (A1AT), C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin (PREALB) on the Dimension Vista® System.
Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use ___________ (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
m chan
Page 1 of
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K063610
CONFIDENTIAL
บบบบบบ
§ 866.5130
Alpha -1-antitrypsin immunological test system.(a)
Identification. Analpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition,alpha -1-antitrypsin deficiency has been associated with pulmonary emphysema.(b)
Classification. Class II (performance standards).