DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)

K061818 · Dade Behring, Inc. · JIT · Jul 18, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061818
• Device Name: DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)
• Applicant: Dade Behring, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jul 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

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

Device Story

Dimension Vista ALP Calibrator (KC330) is a liquid, bovine protein-based product containing porcine kidney-derived alkaline phosphatase; used for calibrating ALP assays on Dimension Vista clinical chemistry systems. Kit consists of three ready-to-use vials (1.0 mL each); system water serves as the zero calibrator. Device is used by laboratory professionals in clinical settings to ensure accurate quantitative measurement of ALP. Calibration process involves instrument-based analysis of calibrator levels to establish assay performance parameters. Proper calibration enables clinicians to obtain reliable ALP measurements for patient diagnostic assessment.

Clinical Evidence

No clinical data. Bench testing only. Stability testing performed per ISO 13640; shelf-life stability validated via comparison of -70°C vs -20°C storage (percent change ≤ 6%). Open vial stability established at 7 days on-instrument and 30 days refrigerated. Value assignment verified via N=45 replicates on multiple instruments.

Technological Characteristics

Liquid bovine protein-based matrix containing porcine kidney-derived alkaline phosphatase. Ready-to-use. Traceable to Master Pool, Dimension clinical chemistry system values. Stability tested per CEN 13640. Risk management per ISO 14971:2000.

Indications for Use

Indicated for the calibration of the Alkaline Phosphatase (ALP) assay on the Dimension Vista System in a clinical laboratory setting.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• Dimension® Enzyme Verifier (k860021)
• VITROS Chemistry Products Calibrator Kit 3

Submission Summary (Full Text)

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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: [phone] Fax: [phone]
### 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
- 2. Classification: Class II
- 3. Product Code: JIT Calibrator, Secondary
- 4. 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:

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.

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# I. Substantial Equivalence Information:

- 1. Predicate Device: Dimension® Enzyme Verifier (DC19) and VITROS Chemistry Products Calibrator Kit 3.
- 2. 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™<br>System ALP<br>Calibrator | Dimension®<br>Enzyme Verifier | Otho-Clinical<br>Diagnostics<br>VITROS<br>Calibrator Kit 3 |
| Intended Use | The ALP Calibrator is an<br>in vitro diagnostic product<br>for the calibration of<br>alkaline phosphatase<br>(ALP) on the Dimension<br>Vista™ System. | Enzyme Verifier is an in<br>vitro diagnostic product to<br>be used to verify alkaline<br>phosphatase (ALP),<br>amylase (AMY), g-<br>glutamyl transferase<br>(GGT), aspartame<br>aminotransferase (AST),<br>alanine aminotransferase<br>(ALT) and lactic<br>dehydrogenase (LDH)<br>method performance on<br>the Dimension® clinical<br>chemistry system. | For in vitro diagnostic use<br>only.<br>VITROS Calibrator Kit 3 is<br>intended for use in<br>calibration of the VITROS<br>Chemistry Systems for the<br>quantitative measurement<br>of AcP, ALKP, ALT, AST,<br>CK, GGT, LDH and LIPA. |
| Analytes | Alkaline phosphatase<br>(ALP). | Alkaline phosphatase<br>(ALP), Amylase (AMY)<br>g-glutamyl transferase<br>(GGT), Aspartame<br>aminotransferase (AST),<br>Alanine aminotransferase<br>(ALT), Lactic<br>dehydrogenase (LDH). | Acid Phosphatase (AcP),<br>alanine aminotransferase<br>(ALT), alkaline<br>phosphatase (ALKP),<br>amylase (AMYL), aspartate<br>aminotransferase (AST),<br>creatine kinase (CK),<br>gamma glutamyltransferase<br>(GGT), lactate<br>dehydrogenase (LDH) and<br>lipase (LIPA). |
| Form | Liquid. | Lyophilized | Lyophilized |
| Traceability | Master Pool, Dimension®<br>clinical chemistry system<br>values. | Master Pool, Dimension®<br>clinical chemistry system<br>values. | Values assigned to<br>VITROS Chemistry<br>Product Calibrator Kit 3 are<br>traceable to high quality<br>materials. |
| Matrix | Bovine protein, porcine<br>kidney based product. | Human serum, bovine<br>kidney based product. | Bovine serum, porcine<br>kidney based product. |
| Calibration /<br>Verification<br>Levels | One level. | Three levels. | Three levels. |

- 3. 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 Phosphatase<br>Calibrator is 12 months. Calibrator shelf life is determined by<br>comparing results of the product stored at 4°C with control stored<br>at -70°C. The method is calibrated from this stored material. The<br>4°C material values are recovered versus the calibration. Recovery<br>versus time is monitored and percent change over time is<br>determined where the allowable shelf life percent change should be<br>$\leq$ 6 %. Shelf-life stability (expiration) dating assignment at<br>commercialization reflects the real-time data on file at Dade<br>Behring, Inc.<br>A vial punctured by the instrument and stored on board is stable<br>for seven days.<br>An open vial not on instrument, but recapped and stored in a<br>refrigerator is stable for 30 days.<br>For testing, vials are opened /punctured on day zero. A quantity<br>sufficient for multiple calibrations is removed and the vials are<br>recapped and stored at 2 – 8 °C. Opened/punctured vials are tested<br>on days 0, 8, 15, 22, and 32 versus freshly opened vials. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Traceability: | The assigned values of the Alkaline Phosphatase Calibrator are<br>traceable 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 [phone]. 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 [phone] or [phone] 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