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).

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, liquid 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.

AI/ML Overview

Here's an analysis of the provided information, focusing on the acceptance criteria and the study that proves the device meets those criteria:

The provided document is a 510(k) summary for the Dimension Vista® CDT CAL, Dimension Vista® CDT CON L, and Dimension Vista® CDT CON H devices, which are calibrators and controls for carbohydrate-deficient transferrin (CDT) measurements. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results with explicit acceptance criteria for novel diagnostic performance.

Therefore, the nature of the acceptance criteria and the "study" that proves the device meets them will differ significantly from what one might expect for a new diagnostic assay or an AI-powered medical device. In this context, the "acceptance criteria" revolve around demonstrating that the new devices perform similarly to the predicate devices for their intended use (calibration and quality control).

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of "substantial equivalence" to the predicate devices. The study conducted is a comparison study against the legally marketed predicate devices.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Comparison to Predicate: Siemens N Latex CDT Test Kit)
Intended Use: Match the predicate device's intended use for calibration and quality control.	Matched. The Intended Uses for Dimension Vista® CDT CAL, CON L, and CON H are described as calibration and quality control for CDT on the Dimension Vista® System, mirroring the function of the predicate's components.
Fundamental Scientific Technology: Similar scientific principle of operation.	Similar. Both the new devices and the predicate are used for CDT determination, implicitly relying on similar underlying principles (e.g., immunochemical methods for transferrin analysis).
Performance Characteristics: Comparable composition, storage, and shelf-life. (For calibrators/controls, this is key to ensuring they can fulfill their role in analytical performance).	Matched/Similar: - Contents: The new calibrator has 4 vials (2.0 mL each) versus the predicate's 3 x 1mL. The new controls have 4 vials (2.0 mL each) versus the predicate's 3 x 1mL. This is a difference in packaging/volume, not core function. - Storage Temperature: Both are 2 - 8 °C. - Shelf life: Both are 24 months. - Composition: Both are liquid human serum-based products containing carbohydrate-deficient transferrin.

Details of the "Study" (Comparison for Substantial Equivalence)

Given the nature of the device (calibrators and controls) and the 510(k) submission, the "study" is primarily a comparative analysis of the device's characteristics against the predicate device to establish substantial equivalence. It's not a clinical trial in the traditional sense with patient outcomes.

1. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a "test set" in the context of diagnostic accuracy for patient samples. Instead, the comparison focuses on the characteristics of the calibrators and controls themselves (e.g., composition, storage, shelf life, intended use). There might have been internal analytical verification studies (e.g., lot-to-lot consistency, stability) for the new devices, but these details are not provided in this 510(k) summary.
- Data Provenance: Not applicable in the same way as clinical data. The data originates from the manufacturer's characterization of their new products and the known specifications of the predicate device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in this context would typically refer to a gold standard for a diagnostic condition. For calibrators and controls, the "ground truth" is their defined concentration or stability characteristics, which are established by the manufacturer through rigorous analytical methods, not by expert consensus in the clinical sense.
3. Adjudication method for the test set:
- Not applicable. There's no adjudication process described for this type of comparison.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI-powered diagnostic device, nor is it a diagnostic device where human "readers" interpret results. Therefore, an MRMC study is not relevant or performed.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm or AI device. It's a laboratory reagent (calibrator/control).
6. The type of ground truth used:
- For the calibrators and controls, the "ground truth" (or reference standard) is their defined analytical characteristics (e.g., concentration of CDT, stability over time). This is established through internal analytical testing and certification processes by the manufacturer, ensuring traceability to reference materials where appropriate.
7. The sample size for the training set:
- Not applicable. There is no training set for an algorithm as this is not an AI/ML device.
8. How the ground truth for the training set was established:
- Not applicable for the same reason as above.

Summary

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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 GmbHEmil von Behring Str. 76Marburg, 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.

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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	PredicateN 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 serumbased product containingcarbohydrate-deficient transferrin.	Same

Similarities and Differences

ltem	Device (K110169)Dimension Vista® CDTCON L and H	PredicateN CDT Con Land H
Contents	4 vials, (4Low and 4 High, 2.0 mLper vial)	3 X 1mL
Storage Temp	2 - 8 °C.	Same
Shelf life	24 months	Same
Composition	CDT CON L and H are liquidhuman serum based productscontaining human carbohydrate-deficient transferrin.	Same

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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

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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

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

Regulation Number and Section

§ 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.