(18 days)
Not Found
No
The document describes calibrators and controls for an in vitro diagnostic system, which are reagents used for quality control and calibration, not a device that processes data or images using AI/ML. There is no mention of AI, ML, or related concepts.
No
This device is an in vitro diagnostic product used for calibration and quality control of laboratory tests, not for direct treatment or diagnosis of a disease or condition in a patient.
No.
The device is a calibrator and control product used for the calibration and quality control of diagnostic methods, not a diagnostic device itself.
No
The device description clearly states the products are "liquid human serum based products," indicating they are physical reagents, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "Protein 1 Calibrator is an in vitro diagnostic product..."
- "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 Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin / Transthyretin (PREALB) on the Dimension Vista™ System."
These statements clearly indicate that the products are intended for use in vitro (outside the body) for diagnostic purposes, specifically for calibrating and controlling tests for certain proteins on a laboratory system. This aligns directly with the definition of an In Vitro Diagnostic device.
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 Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin / Transthyretin (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 Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin / Transthyretin (PREALB) on the Dimension Vista™ System.
Product codes
JIX, JJY
Device Description
Dimension Vista™ Protein 1 Calibrator
Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing Immunoqlobulin A. Immunoglobulin G 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 Immunoglobulin A, Immunoglobulin G and Prealbumin.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary for Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L, M and H
AUG - 7 2006
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.
is: K062055
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 | |
| D-35001 | |
| 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: July 18, 2006 -
- Device Name: Dimension Vista™ Protein 1 Calibrator Dimension Vista™ Protein 1 Control L Dimension Vista™ Protein 1 Control M Dimension Vista™ Protein 1 Control H
| Classification: | Class II; Class I |
|---|---|
| Product Code: | JIX; JJY |
| Panel: | Clinical Chemistry (75) |
3. ldentification of the Legally Marketed Device:
Dimension Vista™ Protein 1 Calibrator - K061338 Dimension Vista™ Protein 1 Control L- K061338 Dimension Vista™ Protein 1 Control M - K061338 Dimension Vista™ Protein 1 Control H - K061338
1
Dade Behring Inc. Dimension Vista™ Protein 1 Calibrator and Control 510(k) Notification
4. Device Description:
Dimension Vista™ Protein 1 Calibrator
Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing Immunoqlobulin A. Immunoglobulin G 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 Immunoglobulin A, Immunoglobulin G and Prealbumin.
5. Device Intended Use:
Dimension Vista™ Protein 1 Calibrator
Protein Calibrator is an in vitro diagnostic product for the calibration of the Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin / Transthyretin (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 Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin / Transthyretin (PREALB) on the Dimension Vista™ Šystem.
6. Medical device to which equivalence is claimed and comparison information:
The Dimension Vista™ Protein 1 Calibrator and Dimension Vista™ Protein 1 Control L, M and H (modified to include prealbumin) are substantially equivalent in intended use to the Dimension Vista™ Protein 1 Calibrator and Dimension Vista™ Protein 1 Control L, M and H (K061338).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kathleen Dray-Lyons Manager, Regulatory Affairs and Compliance Dade Behring, Inc. Glasgow Site PO Box 6101, M/S 514 Newark, DE 19714-6101
AUG - 7 2006
K062055 Re:
Trade/Device Name: 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§862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX, JJY Dated: July 18, 2006
Received: July 20, 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 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).
3
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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto G
Alberto Guticarez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Dade Behring Inc. Dimension Vista™ Protein 1 Calibrator and Control 510(k) Notification
Indications Statement
Device Name:
Dimension Vista™ Protein 1 Calibrator 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 Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin / Transthyretin (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 Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin / Transthyretin (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)
Page 1 of
CA.C.V.
Division Sign-Off Division Big
Office of in Vitmo Diagnostic Device Office tion and Safety
10(k) K 062055
Image /page/4/Picture/18 description: The image shows a sequence of numbers. The numbers are 000037. The numbers are in a bold, sans-serif font.