(38 days)
Not Found
No
The description focuses on standard immunochemical reaction principles and comparison to known standards, with no mention of AI/ML algorithms for data analysis or interpretation.
No
The device is described as an in vitro diagnostic test for quantitative determination of substances in human serum/plasma, aiding in diagnosis, not for treating or preventing a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "A1AT method is an in vitro diagnostic test" and that "Measurements of a-antitrypsin aid in the diagnosis of cirrhosis of the liver and pulmonary emphysema."
No
The device description clearly indicates that the device is a reagent cartridge, calibrator, and control, which are physical components used in an in vitro diagnostic test on a specific system (Dimension Vista® System). These are not software-only components.
Yes, all three devices described are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use / Indications for Use: Each description explicitly states that the device is an "in vitro diagnostic test" or "in vitro diagnostic product." This is the most direct indicator.
- Purpose: The intended use of each device is to analyze biological samples (human serum, heparinized plasma, or EDTA plasma) outside of the body to provide information about a patient's health status (e.g., quantitative determination of alpha-1 antitrypsin, calibration for diagnostic tests, quality control for diagnostic tests). This aligns with the definition of an IVD.
- Device Description: The descriptions detail how the devices interact with biological samples to produce a result (immunochemical reaction, scattering of light, containing specific proteins). This further supports their role in in vitro testing.
Therefore, based on the provided information, all three devices clearly fall under the category of In Vitro Diagnostics.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DEM, JIX, JJY
Device Description
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).
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)
Method Comparison Study. 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. Sample size (n) = 139. Regression analysis of these results yielded the following equation: Slope = 1.000, Intercept = 0.070 g/L, Correlation Coefficient = 0.996.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient = 0.996
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
§ 866.5130
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).
0
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 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: | December 20, 2006 |
| 2. | 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 |
| | Classification:
Product Code:
Panel: | Class II; Class II; Class I
DEM; JIX; JJY
Immunology (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
1
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
2
Method Comparison Study
| Comparative Method | n | Slope | Intercept
g/L | Correlation
Coefficient |
|------------------------------------------------------|-----|-------|------------------|----------------------------|
| N Antisera to Human
α₁-Antitrypsin BN
ProSpec® | 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
5
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
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