The UCFP CAL is an in vitro diagnostic product for the calibration of Urinary/Cerebrospinal Fluid Protein (UCFP) method on the Dimension Vista" System.

Device Description

UCFP CAL is an aqueous product containing dilute human serum. The kit consists of three vials of Calibrator A. The volume per vial is 1.5 mL. UCFP CAL is ready for use, where no preparation is required. System water is used as the UCFP zero calibrator (Level 1) for the Dimension VistaTM System.

AI/ML Overview

The provided text describes the acceptance criteria and performance of the Dimension Vista™ System Urinary/Cerebrospinal Fluid Protein Calibrator (UCFP CAL - KC260).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Shelf-life Stability	Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc.	Target: 12 months. Testing Method: Comparing results of product stored at 4°C with control stored at -20°C. The 4°C material values are recovered versus the calibration, and percent change over time is monitored. Acceptance Threshold: Percent change should be less than or equal to 3%. Result: The document states that "Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc." This implies the 12-month target was met based on real-time data that exhibited the percent change within the 3% criteria.
On-board Stability (Instrument Punctured Vial)	Stability of a vial punctured by the instrument and stored on board.	Result: Stable for seven days.
Open Vial Stability (Recapped, Refrigerated)	Stability of an open vial not stored on board of the instrument, but recapped and stored in a refrigerator.	Result: Stable for 31 days. Testing Method: Vials are opened/punctured on day zero. A quantity sufficient for multiple calibrations is removed, and the vials are recapped and stored at 2 - 8 °C. Opened/punctured vials are tested on days 8, 15, 22, and 32 versus freshly opened vials. (The acceptance criteria for this testing, likely related to recovery or percent change, is implied to be met for the reported stability duration, but the specific numerical criteria are not explicitly stated in the provided text beyond the 3% for shelf-life, which likely applies here too).
Traceability	The assigned values of the Urinary/Cerebrospinal Fluid Protein Calibrator must be traceable to a recognized standard.	Result: Traceable to the National Institute of Standards and Technology - Standard Reference Material 927 (NIST SRM 927).
Value Assignment	Verification of assigned values for the commercial lot calibrator.	Testing Method: The final bottle assignment for the test calibrator level of the commercial lot is tested with N = 90 replicates, using multiple reagent lots on multiple instruments. Result/Process: Purified human IgG and human serum albumin are weighed into an aqueous solution to form a stock solution, assayed, and further diluted. Master Pool values are verified using an instrument calibrated with a previously approved Master Lot as a control. The control Master Pool values were assigned with an instrument calibrated with the standard reference material. Purified human IgG and human serum albumin are gravimetrically added to stock solution at target concentrations and verified using an instrument calibrated with Master Pool assigned values. Calculated quantities of human serum stock solution are added to a base matrix to form the calibrator level, which is then verified using an instrument calibrated with the Master Pool assigned values. The 90 replicates with multiple reagent lots on multiple instruments confirm the robustness and consistency of the value assignment process. (Explicit acceptance criteria for this specific N=90 test, such as CV% or bias, are not provided but are implied to be met by the described verification process).

2. Sample Size Used for the Test Set and the Data Provenance

Shelf-life Stability: The text mentions "real-time data on file at Dade Behring, Inc." This indicates the data is prospective (generated over time as the product ages). The specific number of samples or vials tested for the 12-month shelf-life is not explicitly stated.
Open Vial Stability (On-board & Recapped): "Vials are opened /punctured on day zero. A quantity sufficient for multiple calibrations is removed and the vials are recapped and stored at 2 - 8 °C. Opened/punctured vials are tested on days 8, 15, 22, and 32 versus freshly opened vials." The exact number of "vials" is not given, but it implies a cohort of vials was tracked prospectively over time.
Value Assignment: N = 90 replicates are used for final bottle assignment of the commercial lot. The data provenance is internal to Dade Behring, Inc., as it's part of their manufacturing and quality control process. It is prospective for each commercial lot manufactured.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to this device. This device is a calibrator, which inherently has a "ground truth" derived from its chemical composition and traceability to a recognized standard (NIST SRM 927), rather than requiring expert interpretation of medical images or clinical data. Expertise in metrology and analytical chemistry is implicit in calibrator development and value assignment, but not in the format of "experts used to establish ground truth" as would be seen in diagnostic imaging studies.

4. Adjudication Method for the Test Set

This is not applicable to this device. Adjudication methods (like 2+1, 3+1) are typically used when subjective expert opinion is involved in establishing ground truth for diagnostic decisions. For a calibrator, the "truth" is based on objective measurements and traceability to a primary standard.

5. 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

This is not applicable to this device. This device is an in vitro diagnostic calibrator, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to its evaluation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable to this device. The device is a calibrator, a physical reagent used to set the measurement scale of an instrument. It does not involve an algorithm or "standalone" performance in the sense of an AI system. Its performance is measured by its chemical stability and its ability to correctly assign values based on its composition and traceability.

7. The Type of Ground Truth Used

The ground truth for the calibrator's values and performance is based on:

Chemical Composition/Gravimetric Addition: Purified human IgG and human serum albumin are "weighed into an aqueous solution" and "added gravimetrically to stock solution at target concentrations." This established a primary, known concentration.
Traceability to NIST SRM 927: The assigned values are explicitly stated to be "traceable to the National Institute of Standards and Technology- Standard Reference Material 927." This is the ultimate ground truth for the concentration of the analytes.
Reference Instrument/Master Pool: The Master Pool values are verified using an instrument calibrated with a "previously approved Master Lot" and ultimately with "the standard reference material." This hierarchical traceability ensures the accuracy of assigned values.

8. The Sample Size for the Training Set

This is not applicable in the conventional sense of an AI model's training set. Calibrators are developed and manufactured based on established chemical and analytical principles. Their "training" is in the form of R&D, formulation, and manufacturing process controls, rather than data fed to an algorithm. The "90 replicates" mentioned are for the final verification (test set) of each commercial lot, not a training set.

9. How the Ground Truth for the Training Set Was Established

As above, this is not applicable in the context of an AI model's training set. The "ground truth" for developing and manufacturing the calibrator is the known, precisely measured chemical concentrations of its components, directly traceable to recognized
standards like NIST SRM 927. The manufacturing process aims to produce a product that consistently meets these known, objective chemical specifications.

Summary

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510(k) Summary for the Dimension Vista™ System Urinary/Cerebrospinal Fluid Protein Calibrator (UCFP CAL - KC260)

JUL 1 3 2005

A. 510(k) Number: K061751

B. Analyte: Urinary/Cerebrospinal Fluid Protein (UCFP)

C. Type of Test: Calibrator Material
D. Applicant: Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101 Victor M. Carrio, Regulatory Affairs and Compliance Manager Office: (302) 631-0376 Fax: (302) 631-6299

E. Proprietary and Established Names:

Dimension VistaTM System Urinary/Cerebrospinal Fluid Protein Calibrator (UCFP CAL - KC260)

F. Regulatory Information:

1. Regulation section: 21 CFR § 862-1150 Calibrator
1. Classification: Class II
1. Product Code: JIT Calibrator, Secondary
1. Panel: Clinical Chemistry
G. Intended Use: The UCFP CAL is an in vitro diagnostic product for the calibration of Urinary/Cerebrospinal Fluid Protein (UCFP) method on the Dimension Vista" System.

H. Device Description:

I. Substantial Equivalence Information:

1. Predicate Device: K934843 Dimension® Urinary/Cerebrospinal Fluid Protein Calibrator.

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1. Comparison with Predicate:

	Device	Predicate
Item	Dimension Vista™System UCFP Calibrator	Dimension®UCFP Calibrator
Intended Use	The UCFP CAL is an in vitrodiagnostic product for thecalibration ofUrinary/Cerebrospinal FluidProtein (UCFP) method on theDimension Vista™ System.	The Dimension®Urinary/Cerebrospinal Fluid Proteinis an in vitro diagnostic product to beused to calibrate the Dimension®clinical chemistry system for theUrinary/Cerebrospinal Fluid Protein(UCFP) method.
Analytes	Urinary/Cerebrospinal FluidProtein	Urinary/Cerebrospinal Fluid Protein
Form	Liquid	Liquid
Traceability	NIST SRM 927(1)	NIST SRM 927(1)
Matrix	Aqueous product containingdilute human serum.	Saline solution containing humanserum albumin and IgG.
Levels	One level (Level 2).Level 1 is system water.	Five levels.

National Institute of Standards and Technology, Standard Reference Material

J. Standard/Guidance Document Referenced:

1. Guidance: Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final, 02/22/1999 Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use, 11/30/2004
1. Standards: CEN 13640 Stability testing of In-Vitro Diagnostic Devices ISO 14971:2000 Medical devices -Application of risk management to medical devices

K. Performance Characteristics:

1. Stability: Target shelf life for the Dimension Vista™ System Urinary/Cerebrospinal Fluid Protein Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at 4°C with control stored at -20°C. The method is calibrated from this stored material. The 4°C material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined. Percent change should be less than or equal to 3%. Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc. A vial punctured by the instrument and stored on board is stable for seven days.

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An open vial not stored on board of the instrument, but recapped and stored in a refrigerator is stable for 31 days.

For testing, vials are opened /punctured on day zero. A quantity sufficient for multiple calibrations is removed and the vials are recapped and stored at 2 - 8 °C. Opened/punctured vials are tested on days 8, 15, 22, and 32 versus freshly opened vials.

1. Traceability: The assigned values of the Urinary/Cerebrospinal Fluid Protein Calibrator are traceable to the National Institute of Standards and Technology- Standard Reference Material 927.
1. Value Assignment:

Purified human IgG and human serum albumin are weighed into an aqueous solution to form a stock solution which is assayed and further diluted to create four more levels. The Master Pool is stored at 2 - 8 °C. The Master Pool recovered values are verified using an instrument calibrated with a previously approved Master Lot as a control. The control Master Pool values were assigned with an instrument calibrated with the standard reference material. The purified human IgG and human serum albumin are added gravimetrically to stock solution at target concentrations and verified using an instrument calibrated with Master Pool assigned values. Calculated quantities of human serum stock solution are added to base matrix (aqueous solution) in appropriate concentrations for one calibrator level. The test calibrator level is verified using an instrument calibrated with the Master Pool assigned values. The final bottle assignment for test calibrator level of the commercial lot is tested N = 90 replicates, with multiple reagent lots on multiple instruments.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with stylized wings and tail feathers.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Victor M. Carrio RA/QS Compliance Manager Dade Behring, Inc. 500 GBC Drive, PO Box 6101, M/S 514 Newark DE 19714-6101

JUL 13 2006

Re: K061751

Trade/Device Name: Dimension Vista™ UCFP Calibrator (KC260) Regulation Number: 21 CFR$862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: June 20, 2006 Received: June 21, 2006

Dear Mr. Carrio:

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) 276-0484. 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 Gutierrez, 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 Statement

510(k) Number (if known): K06175

Device Name:

Dimension Vista™ UCFP Calibrator (KC260)

Indications for Use:

The UCFP CAL is an in vitro diagnostic product for the calibration of Urinary/Cerebrospinal Fluid Protein (UCFP) method on the Dimension Vista" System.

Prescription Use x (Per 21 CFR 801 Subpart D)

19.00 - 11

AND/OR

Over-the-counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of -In Vitro Diagnostic Devices (OIVD)

Carol S. Benam

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.