(64 days)
Not Found
No
The document describes calibrators and controls for in vitro diagnostic tests, which are chemical reagents used to ensure the accuracy of laboratory instruments. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No
The device is described as an "in vitro diagnostic product for the calibration" and "intralaboratory quality controls," indicating its use for diagnostic testing, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the products are "in vitro diagnostic product[s] for the calibration" or "for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of..." various substances on the Dimension Vista® System. This indicates their role in the diagnostic process.
No
The device description clearly states that the products are "liquid human serum based products" or "lyophilized, polygeline based product," indicating they are physical substances used for calibration and control, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the products are "in vitro diagnostic products" and are used for the calibration and quality control of various protein methods on the Dimension Vista® System. This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease.
N/A
Intended Use / Indications for Use
Dimension Vista™ Protein 1 Calibrator
Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the a1acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), 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
Protein 1 Control L. M and H are for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of a 1- acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vista® System.
Dimension Vista™ Protein 2 Calibrator
Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the antistreptolysin O (ASL), C-reactive protein (CRP), CardioPhase® high sensitivity CRP (hsCRP), and rheumatoid factors (RF) methods on the Dimension Vista® System.
Dimension Vista™ Protein 2 Control L and H
Protein 1 Control L and H are for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of antistreptolysin O (ASL). C-reactive protein (CRP), and rheumatoid factors (RF) on the Dimension Vista® System.
Dimension Vista™ Protein 3 Calibrator
Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the armicroglobulin (A1MIC) and microalbumin (MALB) methods on the Dimension Vista® System.
Dimension Vista™ Protein 3Control
Protein 3 Control is for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of amicroglobulin (A1MIC) and microalbumin (MALB) on the Dimension Vista® System.
Product codes (comma separated list FDA assigned to the subject device)
JIX, JJY
Device Description
Dimension Vista™ Protein 1 Calibrator
Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing a1acid glycoprotein, C3 complement, C4 complement, haptoglobin, immunoglobulin A, immunoglobulin G, immunoglobulin M and prealbumin.
Dimension Vista™ Protein 1 Control L, M and H
Protein 1 Control L, M and H are multi-analyte, liquid human serum based products containing a1 - acid glycoprotein, C3 complement, C4 complement, haptoglobin, immunoglobulin A, immunoglobulin G, immunoglobulin M and prealbumin.
Dimension Vista™ Protein 2 Calibrator
Protein 2 Calibrator is a multi-analyte, liquid human serum based product containing antistreptolysin O, C-reactive protein, CardioPhase® high sensitivity CRP and rheumatoid factors.
Dimension Vista™ Protein 2 Control L and H
Protein 2 Control L and H are multi-analyte, liquid human serum based products containing antistreptolysin O, C-reactive protein, and rheumatoid factors.
Dimension Vista™ Protein 3 Calibrator
Protein 3 Calibrator is a multi-analyte, lyophilized, polygeline based product, with human source urinary and serum proteins, containing a - microglobulin and microalbumin.
Dimension Vista™ Protein 3Control
Protein 3 Control is a multi-analyte, lyophilized, polygeline, rabbit based albumin product, with human source urinary and serum proteins, containing a-microglobulin and microalbumin.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Dade Behring Inc. Dado Denning me:
Dimension Vista™ Protein 1 Calibrator and Control,
Dimension Vista™ Protein 2 Calibrator and Control, and Dimension Vista™ Protein 3 Calibrator and Control 510{k} Notification
510(k) Summary for Dimension Vista™ Protein 1 Calibrator and Control L, M and H, Dimension Vista™ Protein 2 Calibrator and Control L and H, Dimension Vista™ Protein 3 Calibrator and Control
- 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.
JAN 2 3 2007
ith the requirements of SMDA 1990 and 21 CFR Part 807.
The assigned 510(k) number is: K063508
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. 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: Helen Lee Tel: 302-631-8706 Fax: 302-631-6299
Preparation date: November 17, 2006
- Dimension Vista™ Protein 1 Calibrator 2. Device Name: Dimension Vista™ Protein 1 Control L, M, H Dimension Vista™ Protein 2 Calibrator Dimension Vista™ Protein 2 Control L and H Dimension Vista™ Protein 3 Calibrator Dimension Vista™ Protein 3 Control
Classification: Class II; Class I Product Code: JIX; JJY Panel: Clinical Chemistry (75)
Identification of the Legally Marketed Device: 3.
Dimension Vista ™ Protein 1 Calibrator - K062055 Dimension Vista™ Protein 1 Control L, M, H - K062055
Dimension Vista™ Protein 2 Calibrator - K062035 Dimension Vista™ Protein 2 Control L. H - K062035
Dimension Vista™ Protein 3 Calibrator - K061990 Dimension Vista™ Protein 3 Control - K061990
1
Dade Behring Inc. Dimension Vista™ Protein 1 Calibrator and Control,
Dimension Vista™ Protein 2 Calibrator and Control, and Dimension Vista™ Protein 3 Calibrator and Control 510(k) Notification
4. Device Descriptions:
Dimension Vista™ Protein 1 Calibrator
Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing a1acid glycoprotein, C3 complement, C4 complement, haptoglobin, immunoglobulin A, immunoglobulin G, immunoglobulin M and prealbumin.
Dimension Vista™ Protein 1 Control L, M and H
Protein 1 Control L, M and H are multi-analyte, liquid human serum based products containing a1 - acid glycoprotein, C3 complement, C4 complement, haptoglobin, immunoglobulin A, immunoglobulin G, immunoglobulin M and prealbumin.
Dimension Vista™ Protein 2 Calibrator
Protein 2 Calibrator is a multi-analyte, liquid human serum based product containing antistreptolysin O, C-reactive protein, CardioPhase® high sensitivity CRP and rheumatoid factors.
Dimension Vista™ Protein 2 Control L and H
Protein 2 Control L and H are multi-analyte, liquid human serum based products containing antistreptolysin O, C-reactive protein, and rheumatoid factors.
Dimension Vista™ Protein 3 Calibrator
Protein 3 Calibrator is a multi-analyte, lyophilized, polygeline based product, with human source urinary and serum proteins, containing a - microglobulin and microalbumin.
Dimension Vista™ Protein 3Control
Protein 3 Control is a multi-analyte, lyophilized, polygeline, rabbit based albumin product, with human source urinary and serum proteins, containing a-microglobulin and microalbumin.
5. Device Intended Uses:
Dimension Vista™ Protein 1 Calibrator
Protein Calibrator is an in vitro diagnostic product for the calibration of the a1- acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), 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
Protein 1 Control L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of a1- acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vista® System.
2
Dade Behring Inc. Dimension Vista™ Protein 1 Calibrator and Control, Dimension Vista™ Protein 2 Calibrator and Control, and Dimension Vista™ Protein 3 Calibrator and Control 510(k) Notification
Dimension Vista™ Protein 2 Calibrator
Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the antistreptolysin O (ASL), C-reactive protein (CRP), CardioPhase® high sensitivity CRP (hsCRP) and rheumatoid factors (RF) methods on the Dimension Vista® System.
Dimension Vista™ Protein 2 Control L and H
Protein 2 Control L and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of antistreptolysin O (ASL), C-reactive protein (CRP) and rheumatoid factors (RF) on the Dimension Vista® System.
Dimension Vista™ Protein 3 Calibrator
Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the amicroglobulin (A1MIC) and microalbumin (MALB) methods on the Dimension Vista® System.
Dimension Vista™ Protein 3Control
Protein 3 Control is an assayed intralaboratory quality control for assessment of precision and analytical bias in determination of a1-microglobulin (A1MIC) and microalbumin (MALB) on the Dimension Vista® System.
Medical device to which equivalence is claimed and comparison information: 6.
The Dimension Vista™ Protein 1 Calibrator and Dimension Vista™ Protein 1 Control L, M and H (modified to include 1- acid glycoprotein and haptoglobin) are substantially equivalent in intended use to the Dimension Vista™ Protein 1 Calibrator and Dimension Vista™ Protein 1 Control L, M and H (K062055).
The Dimension Vista™ Protein 2 Calibrator and Dimension Vista™ Protein 2 Control L and H (modified to include antistreptolysin O) are substantially equivalent in intended use to the Dimension Vista™ Protein 2 Calibrator and Dimension Vista™ Protein 2 Control L and H (K062035).
The Dimension Vista™ Protein 3 Calibrator and Dimension Vista™ Protein 3 Control (modified to include a - microglobulin) are substantially equivalent in intended use to the Dimension Vista™ Protein 2 Calibrator and Dimension Vista™ Protein 2 Control L and H (K061990).
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Helen M. Lee. Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, DE 19714
Re:
JAN 2 3 2007
K063508 Trade/Device Name: Dimension Vista™ Protein 1 Calibrator, Dimension Vista™ Protein 1 Control L, M, H, Dimension Vista™ Protein 2 Calibrator, Dimension Vista™ Protein 2 Control L and H, Dimension Vista™ 3 Calibrator, Dimension Vista™ Protein 3 Control Regulation Number: 21 CFR § 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX, JJY Dated: November 17, 2006 Received: November 20, 2006
Dear Ms. Lee:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
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) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Dade Behring Inc. Dimension Vista™ Protein 1 Calibrator and Control, Dimension Vista™ Protein 2 Calibrator and Control. and Dimension Vista ™ Protein 3 Calibrator and Control S10(k) Notification
K06 3508
Indications Statement
Dimension Vista™ Protein 1 Calibrator Device Name: Dimension Vista™ Protein 1 Control L Dimension Vista™ Protein 1 Control M Dimension Vista™ Protein 1 Control H
Indications for Use:
Dimension Vista™ Protein 1 Calibrator
Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the a1acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), 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
Protein 1 Control L. M and H are for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of a 1- acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), 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)
DIVISION S
Office of In Vitro Diagnostic Device
Evaluation and Safety
5100(A) K063508
Page 1 of 3
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Indications Statement
Dimension Vista™ Protein 2 Calibrator Device Name: Dimension Vista™ Protein 2 Control L Dimension Vista™ Protein 2 Control H
Indications for Use:
Dimension Vista™ Protein 2 Calibrator
Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the antistreptolysin O (ASL), C-reactive protein (CRP), CardioPhase® high sensitivity CRP (hsCRP), and rheumatoid factors (RF) methods on the Dimension Vista® System.
Dimension Vista™ Protein 2 Control L and H
Protein 1 Control L and H are for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of antistreptolysin O (ASL). C-reactive protein (CRP), and rheumatoid factors (RF) on the Dimension Vista® System.
Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Page 2 of 3
Office of In Vitro Dinquestic Device Fivaluation and Just
7
Dade Behring Inc. Dimension Vista™ Protein 1 Calibrator and Control, Dimension Vista - Protein 1 Calibrator and Control, and Dimension Vista 16 Protein 3 Calibrator and Control 510(k) Notification
Indications Statement
Device Name:
Dimension Vista™ Protein 3 Calibrator Dimension Vista™ Protein 3 Control
Indications for Use:
Dimension Vista™ Protein 3 Calibrator
Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the armicroglobulin (A1MIC) and microalbumin (MALB) methods on the Dimension Vista® System.
Dimension Vista™ Protein 3 Control
Protein 3 Control is for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of amicroglobulin (A1MIC) and microalbumin (MALB) on the Dimension Vista® System.
Prescription Use x (Per 21 CFR 801 Subpart D) Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801)
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Page 3 of 3
Gf
Office of In Vitro Diagnostic Device
K06350Y