(77 days)
Not Found
No
The document describes calibration and control materials for a diagnostic test, not a device that processes data or makes decisions using AI/ML.
No.
The devices are in vitro diagnostic products used for the calibration and quality control of a diagnostic method, not for treating or preventing a disease or condition.
No
Explanation: The provided text describes products for calibration and quality control of a CDT method, and not a device that directly diagnoses a disease or condition in a patient. They are used to ensure the accuracy of a diagnostic method/system.
No
The device description clearly states that the products are liquid human serum based, indicating they are physical reagents, not software.
Yes, based on the provided information, these devices are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use/Indications for Use: The descriptions explicitly state that these products are for "in vitro diagnostic product" and are used for the "calibration" and "quality control" of a method for determining carbohydrate-deficient transferrin (CDT) on a diagnostic system (Dimension Vista® System). This clearly indicates their use in testing samples outside of the body to provide information for diagnostic purposes.
- Device Description: The descriptions mention they are "liquid human serum based products containing carbohydrate-deficient transferrin." This aligns with the nature of reagents and controls used in in vitro diagnostic tests.
- Predicate Device: The mention of a "Predicate Device" with a K number (K060677) and the name "Siemens N Latex CDT Test Kit" strongly suggests that this submission is related to a regulatory process for IVDs, where a new device is compared to a previously cleared device.
The fact that they are used for calibration and quality control within a laboratory setting further supports their role as components of an in vitro diagnostic testing system.
N/A
Intended Use / Indications for Use
Dimension Vista® CDT CAL
CDT CAL is an in vitro diagnostic product for the calibration of the carbohydrate-deficient transferrin (CDT) method on the Dimension Vista® System.
Dimension Vista® CDT CON L
CDT CON L is an assayed, low level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of carbohydrate-deficient transferrin (CDT).
Dimension Vista® CDT CON H
CDT CON H is an assayed, high level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of carbohydrate-deficient transferrin (CDT).
Product codes (comma separated list FDA assigned to the subject device)
JIT, JJX
Device Description
Dimension Vista® CDT CAL
CDT CAL is a liquid human serum based product containing carbohydrate-deficient transferrin.
Dimension Vista® CDT CON L
CDT CON L is a low level, liguid human serum based product containing human carbohydrate-deficient transferrin.
Dimension Vista® CDT CON H
CDT CON H is a high level, liquid human serum based product containing human carbohydrate-deficient transferrin.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
2011 - /
510(k) Summary for Dimension Vista® CDT CAL Dimension Vista® CDT CON L and H
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:
er is: K116169
Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation: 1.
| Manufacturer: | Siemens Healthcare Diagnostics Products GmbH
Emil von Behring Str. 76
Marburg, 35041 Germany |
| --------------- | ---------------------------------------------------------------------------------------------------- |
|---|
Siemens Healthcare Diagnostics Contact Information: P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497
March 30, 2011 Preparation date:
2. Device Name:
Dimension Vista® CDT CAL Dimension Vista® CDT CON L and H
Classification:
Calibrator, Secondary, Class II Single-Analyte Controls, Class I
JIT: JJX Product Code: Chemistry Panel:
- ldentification of the Legally Marketed Device: 3.
Siemens N Latex CDT Test Kit
Device Description: 4.
Dimension Vista® CDT CAL
CDT CAL is a liquid human serum based product containing carbohydrate-deficient transferrin.
Dimension Vista® CDT CON L
CDT CON L is a low level, liguid human serum based product containing human carbohydratedeficient transferrin.
1
Dimension Vista® CDT CON H
CDT CON H is a high level, liquid human serum based product containing human carbohydratedeficient transferrin.
5. Device Intended Use:
Dimension Vista® CDT CAL
CDT CAL is an in vitro diagnostic product for the calibration of the carbohydrate-deficient transferrin (CDT) method on the Dimension Vista® System.
Dimension Vista® CDT CON L
CDT CON L is an assayed, low level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of carbohydrate-deficient transferrin (CDT).
Dimension Vista® CDT CON H
CDT CON H is an assaved, high level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of carbohydrate-deficient transferrin (CDT).
Medical device to which equivalence is claimed and comparison information: 6.
The Dimension Vista® CDT CAL and CON L and CON H are substantially equivalent to the Siemens N Latex CDT Test Kit (K060677), which contains N CDT Standard, N CDT Control 1 and N CDT Control 2 respectively.
| Item | Device (K110169)
Dimension Vista® CDT CAL | Predicate
N CDT Standard |
|--------------|----------------------------------------------------------------------------------------------------|-----------------------------|
| Contents | 4 vials, (4A, 2.0 mL per vial) | 3 X 1mL |
| Storage Temp | 2 - 8 °C. | Same |
| Shelf life | 24 months | Same |
| Composition | CDT CAL is a liquid human serum
based product containing
carbohydrate-deficient transferrin. | Same |
Similarities and Differences
Similarities and Differences
| ltem | Device (K110169)
Dimension Vista® CDT
CON L and H | Predicate
N CDT Con L
and H |
|--------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Contents | 4 vials, (4Low and 4 High, 2.0 mL
per vial) | 3 X 1mL |
| Storage Temp | 2 - 8 °C. | Same |
| Shelf life | 24 months | Same |
| Composition | CDT CON L and H are liquid
human serum based products
containing human carbohydrate-
deficient transferrin. | Same |
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.
Siemens Healthcare Diagnostics c/o Kathleen Dray-Lyons
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Image /page/2/Picture/5 description: The image shows the date "APR 7 2011" in a bold, sans-serif font. The letters and numbers are closely spaced, giving the date a compact appearance. The text is likely part of a document or label where the date is relevant.
Re: K110169
500 GBC Drive
Newark, Delaware 19714
PO Box 6101
Trade Name: Dimension Vista CDT Calibrator Dimension Vista CDT Control L, Dimension Vista CDT Control H Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIT, JJX Dated: January 19, 2011 Received: January 20, 2011
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (011) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to paremarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
G.C.
Courmey Harper, 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
Indications for Use Form
510(k) Number (if known): | ||0169
Device Name: Dimension Vista® CDT CAL Dimension Vista® CDT CON L Dimension Vista®CDT CON H
Indications For Use:
Dimension Vista® CDT CAL
CDT CAL is an in vitro diagnostic product for the calibration of the carbohydrate-deficient transferrin (CDT) method on the Dimension Vista® System.
Dimension Vista® CDT CON L
CDT CON L is an assayed, low level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of carbohydrate-deficient transferrin (CDT).
Dimension Vista® CDT CON H
CDT CON H is an assayed, high level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of carbohydrate-deficient transferrin (CDT).
Prescription Use X (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)
AND/OR
Concurrence of CDRH, Office of In vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety