The ALP CAL is an in vitro diagnostic product for the calibration of Alkaline Phosphatase (ALP) method on the Dimension Vista System.
The ALP CAL is an in vitro diagnostic product for the calibration of Alkaline Phosphatase (ALP) method on the Dimension Vista™ System.

Device Description

ALP CAL is liquid bovine protein based product containing alkaline phosphatase from porcine kidney. The kit consists of three vials (Calibrator A, Level 2) which are ready for use (no preparation is required). The volume per vial is 1.0 mL. System water is used as the ALP zero calibrator (Level 1) for the Dimension VistaTM System.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Dimension Vista™ System Alkaline Phosphatase Calibrator (ALP CAL - KC330), based on the provided text:

Important Note: The provided document is a 510(k) summary for a calibrator, which is a reference material used to ensure the accuracy of a diagnostic test. Therefore, the "device performance" and "acceptance criteria" discussed here relate to the calibrator's stability and value assignment, not the performance of a diagnostic test for a patient condition. This type of device does not involve expert readers, comparative effectiveness studies (MRMC), or a ground truth established from pathology/outcomes data in the same way as an imaging or diagnostic algorithm would.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Shelf-life Stability	Allowable shelf life percent change should be $\leq$ 6% (comparing 4°C stored product to -70°C control). Target shelf life is 12 months.	"Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc." (This implies the real-time data supported the 12-month shelf life and met the ≤ 6% change criterion, though the specific data is not explicitly shown in this summary.)
On-board Stability	A vial punctured by the instrument and stored on board is stable for seven days.	The summary states this is the reported stability, implying that testing confirmed stability for this duration. (Specific data not provided in summary).
Opened Vial Stability (Recapped, Refrigerated)	An open vial not on instrument, but recapped and stored in a refrigerator is stable for 30 days.	The summary states this is the reported stability, implying that testing confirmed stability for this duration. (Specific data not provided in summary).
Value Assignment (New Master Pool)	Concentrations are verified "using a previously approved Master Pool lot as a control." (Implicitly, the new Master Pool must agree with the control within acceptable limits). The final bottle value is assigned after N=45 replicates on multiple instruments.	The new calibrator Master Pool concentrations are verified using a previously approved Master Pool lot. The final bottle value is assigned for each level by testing N=45 replicates on multiple instruments. (Performance is that this process was followed and values were assigned).
Value Assignment (Commercial Lot)	The stock solution concentration is verified by comparing the Master Pool assigned bottle values. The commercial lot's concentration is verified to be "within acceptable range" using an instrument calibrated with Master Pools. The final bottle value is assigned and verified using a previously released commercial lot on multiple instruments for N=45 total replicates.	The stock solution concentration for the new commercial calibrator lot is verified by comparing Master Pool assigned bottle values. The commercial lot concentration is verified to be within acceptable range. The final bottle value is assigned and verified using a previously released commercial lot on multiple instruments for N=45 total replicates. (Performance is that this process was followed and values were assigned within acceptable limits).

Study Details:

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

Test Set for Shelf-life Stability: The summary mentions comparing the product stored at 4°C with a control stored at -70°C. The sample size for this real-time stability study is not explicitly stated as a number of vials or batches, but implies ongoing monitoring.
Test Set for Opened Vial Stability: Vials are opened/punctured on day zero and re-tested on days 0, 8, 15, 22, and 32. The number of vials or replicates for this testing is not specified.
Test Set for Value Assignment: N = 45 replicates were used on multiple instruments for both the Master Pool and commercial lot value assignments.
Data Provenance: The studies were conducted by Dade Behring, Inc. (Newark, DE, USA). The data is from prospective stability studies and internal value assignment processes.

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

Not applicable in the typical sense. This device is a calibrator, not a diagnostic test for a patient condition. The "ground truth" here is the assigned value of the calibrator, which is established through a rigorous, traceable protocol (gravimetric additions, comparison to approved Master Pools, multiple replicates on instruments) rather than expert interpretation of patient data.

4. Adjudication Method for the Test Set:

Not applicable. See point 3. The "adjudication" is inherent in the robust statistical process of value assignment involving N=45 replicates and comparison to established references.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, not specified. This type of study is typically for evaluating the performance of diagnostic algorithms or imaging interpretations where human readers are involved. As a calibrator, it doesn't fit this paradigm.

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

Yes, effectively. The performance of the calibrator and its assigned values are determined analytically and statistically, independent of human interpretation or assistance in the final "performance" measure. The "device performance" refers to the calibrator's stability and accuracy of its assigned value, which is intrinsic to the material itself and how accurately its concentration can be determined by instruments.

7. The Type of Ground Truth Used:

The "ground truth" for the calibrator's assigned value is established through:
- Gravimetric addition: Precisely weighing the alkaline phosphatase component to create target concentrations.
- Traceability to Master Pool, Dimension® clinical chemistry system values: The values are linked to a primary reference standard.
- Comparison to previously approved reference lots: Both Master Pool and commercial lot assays refer back to established, validated materials.

8. The Sample Size for the Training Set:

Not applicable in the typical sense. Calibrators do not have a "training set" in the way a machine learning algorithm would. The process involves creating material with a known concentration, then verifying that concentration. The "training" aspects are the established protocols and reference materials used in the manufacturing and value assignment processes.

9. How the Ground Truth for the Training Set was Established:

Not applicable. See point 8. The "ground truth" for the calibrator's value is established through gravimetric preparation (precisely measured ingredients) and analytical verification against established, traceable reference materials and protocols.

Summary

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510(k) Summary for the Dimension Vista™ System Alkaline Phosphatase Calibrator (ALP CAL - KC330)

A. 510(k) Number: K061818

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

E. Proprietary and Established Names:

Dimension Vista™ System Alkaline Phosphatase Calibrator (ALP CAL-KC330)

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 ALP CAL is an in vitro diagnostic product for the calibration of Alkaline Phosphatase (ALP) method on the Dimension Vista System.

H. Device Description:

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I. Substantial Equivalence Information:

1. Predicate Device: Dimension® Enzyme Verifier (DC19) and VITROS Chemistry Products Calibrator Kit 3.
1. Predicate K Number(s): K860021 for Dimension® clinical chemistry system. For the Ortho-Diagnostics VITROS Calibrator Kit 3, a 510(k) number was not available.

Comparison
Item	Dimension Vista™System ALPCalibrator	Dimension®Enzyme Verifier	Otho-ClinicalDiagnosticsVITROSCalibrator Kit 3
Intended Use	The ALP Calibrator is anin vitro diagnostic productfor the calibration ofalkaline phosphatase(ALP) on the DimensionVista™ System.	Enzyme Verifier is an invitro diagnostic product tobe used to verify alkalinephosphatase (ALP),amylase (AMY), g-glutamyl transferase(GGT), aspartameaminotransferase (AST),alanine aminotransferase(ALT) and lacticdehydrogenase (LDH)method performance onthe Dimension® clinicalchemistry system.	For in vitro diagnostic useonly.VITROS Calibrator Kit 3 isintended for use incalibration of the VITROSChemistry Systems for thequantitative measurementof AcP, ALKP, ALT, AST,CK, GGT, LDH and LIPA.
Analytes	Alkaline phosphatase(ALP).	Alkaline phosphatase(ALP), Amylase (AMY)g-glutamyl transferase(GGT), Aspartameaminotransferase (AST),Alanine aminotransferase(ALT), Lacticdehydrogenase (LDH).	Acid Phosphatase (AcP),alanine aminotransferase(ALT), alkalinephosphatase (ALKP),amylase (AMYL), aspartateaminotransferase (AST),creatine kinase (CK),gamma glutamyltransferase(GGT), lactatedehydrogenase (LDH) andlipase (LIPA).
Form	Liquid.	Lyophilized	Lyophilized
Traceability	Master Pool, Dimension®clinical chemistry systemvalues.	Master Pool, Dimension®clinical chemistry systemvalues.	Values assigned toVITROS ChemistryProduct Calibrator Kit 3 aretraceable to high qualitymaterials.
Matrix	Bovine protein, porcinekidney based product.	Human serum, bovinekidney based product.	Bovine serum, porcinekidney based product.
Calibration /VerificationLevels	One level.	Three levels.	Three levels.

1. Comparison with Predicate:

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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
CEN 13640 Stability testing of In-Vitro Diagnostic Devices 2. Standards: ISO 14971:2000 Medical devices -Application of risk management to medical devices

K. Performance Characteristics:

1. Stability:	Target shelf life for the Dimension Vista™ Alkaline PhosphataseCalibrator is 12 months. Calibrator shelf life is determined bycomparing results of the product stored at 4°C with control storedat -70°C. The method is calibrated from this stored material. The4°C material values are recovered versus the calibration. Recoveryversus time is monitored and percent change over time isdetermined where the allowable shelf life percent change should be$\leq$ 6 %. Shelf-life stability (expiration) dating assignment atcommercialization reflects the real-time data on file at DadeBehring, Inc.A vial punctured by the instrument and stored on board is stablefor seven days.An open vial not on instrument, but recapped and stored in arefrigerator is stable for 30 days.For testing, vials are opened /punctured on day zero. A quantitysufficient for multiple calibrations is removed and the vials arerecapped and stored at 2 – 8 °C. Opened/punctured vials are testedon days 0, 8, 15, 22, and 32 versus freshly opened vials.
2. Traceability:	The assigned values of the Alkaline Phosphatase Calibrator aretraceable to Master Pool, Dimension® clinical chemistry system.
3. Value Assignment:

1. Stability:

Target shelf life for the Dimension Vista™ Alkaline PhosphataseCalibrator is 12 months. Calibrator shelf life is determined bycomparing results of the product stored at 4°C with control storedat -70°C. The method is calibrated from this stored material. The4°C material values are recovered versus the calibration. Recoveryversus time is monitored and percent change over time isdetermined where the allowable shelf life percent change should be$\leq$ 6 %. Shelf-life stability (expiration) dating assignment atcommercialization reflects the real-time data on file at DadeBehring, Inc.A vial punctured by the instrument and stored on board is stablefor seven days.An open vial not on instrument, but recapped and stored in arefrigerator is stable for 30 days.For testing, vials are opened /punctured on day zero. A quantitysufficient for multiple calibrations is removed and the vials arerecapped and stored at 2 – 8 °C. Opened/punctured vials are testedon days 0, 8, 15, 22, and 32 versus freshly opened vials.

2. Traceability:

The assigned values of the Alkaline Phosphatase Calibrator aretraceable to Master Pool, Dimension® clinical chemistry system.

3. Value Assignment:

The new calibrator Master Pool is made by gravimetrically adding quantities of alkaline phosphatase to StabilZyme® AP to target concentrations. Three levels of Master Pool are prepared and stored at -70° C. The concentrations are verified using a previously approved Master Pool lot as a control. The final bottle

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value for the Master Pool is assigned for each level by testing N = 45 replicates on multiple instruments.

A stock solution is prepared for the new commercial calibrator lot by gravimetrically adding alkaline phosphatase to StabilZyme® AP to target concentration. The stock solution concentration is verified by comparing the Master Pool assigned bottle values. For the commercial calibrator lot, calculated quantity of the stock solution is added to StabilZyme® AP to target concentrations. The concentration of the commercial lot is verified to be within acceptable range by using an instrument calibrated with Master Pools. The final bottle value is assigned to the commercial lot level and verified using a previously released commercial lot of calibrator on multiple instruments for N = 45 total replicates.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming a flowing, abstract design.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 8 2006

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

Re: K061818

Trade/Device Name: Dimension Vista™ ALP Calibrator (KC330) Regulation Number: 21 CFR$862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: June 27, 2006 Received: June 28, 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, Trug, 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 Gutt

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):

Device Name: Kd6|818

Dimension Vista™ ALP Calibrator (KC330)

Indications for Use:

The ALP CAL is an in vitro diagnostic product for the calibration of Alkaline Phosphatase (ALP) method on the Dimension Vista™ System.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

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

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

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

Carl Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Sufety

(K) K06/8/8

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.