VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)

K072440 · Ortho-Clinical Diagnostics, Inc. · CJY · Sep 20, 2007 · Clinical Chemistry

Device Facts

• Record ID: K072440
• Device Name: VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: CJY · Clinical Chemistry
• Decision Date: Sep 20, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Intended Use

VITROS Chemistry Products Ca Slides For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine. VITROS Chemistry Products Calibrator Kit 1 For in vitro diagnostic use only. VITROS Calibrator Kit 1 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of BUN/UREA, Ca, CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC.

Device Story

VITROS Chemistry Products Ca slide; in vitro diagnostic reagent for quantitative measurement of calcium in serum, plasma, or urine. Modification involves change in manufacturing process and formulation of spreading layer component. Device used in clinical laboratory settings by trained personnel. Output provides quantitative calcium concentration to assist in clinical diagnosis and monitoring of calcium metabolism disorders.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures to assess impact of manufacturing and formulation changes. Results demonstrated adherence to predetermined acceptance criteria.

Technological Characteristics

In vitro diagnostic reagent slide for calcium measurement. Modification to spreading layer formulation. Fundamental scientific technology unchanged from predicate. Conformance with 21 CFR 820.30 design controls.

Indications for Use

Indicated for quantitative measurement of calcium in serum, plasma, and urine to aid diagnosis and treatment of parathyroid disease, bone disorders, chronic renal disease, and tetany.

Regulatory Classification

Identification

A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Predicate Devices

• VITROS Chemistry Products Ca slide (K961226)

Submission Summary (Full Text)

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## Summary Information

## 510(k) Summary

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: K072440

- 1. Submitter Ortho-Clinical Diagnostics, Inc. name. 100 Indigo Creek Drive Rochester, New York 14626-5101 address, contact [phone]
Contact Person: Marlene A. Hanna

- 2. Preparation Date Special 510(k) prepared: August 29, 2007 date
- 3. Device Trade or Proprietary Name: name VITROS Chemistry Products Ca Slides Common Name: calcium test Classification Name: Calcium test system (21 CFR 862.1145)

VITROS Chemistry Products Calibrator Kit I Common Name: calibrator Classification Name: Calibrator (21 CFR 862.1150)

- The VITROS Chemistry Products Ca Slides (modified) and VITROS Chemistry 4. Predicate device Products Calibrator Kit 1 are substantially equivalent to the VITROS Chemistry Products Ca Slides (current slide) and VITROS Chemistry Products Calibrator Y it 1.
Continued on next page

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## 510(k) Summary, Continued

The VITROS Chemistry Products Ca Slide assay is performed using the VITROS 5. Device Chemistry Products Ca Slide and the VITROS Chemistry Products Calibrator Kit 1 on Description the VITROS Chemistry Systems. The VITROS Ca Slide is a multilayered, analytical element coated on a polyester support. All reactions necessary for a single quantitative measurement of calcium take place within the multi-layered analytical element of a VITROS Chemistry Products Ca slide.

> A drop of patient sample is deposited on the VITROS Ca Slide and is evenly distributed by the spreading layer to the underlying layers. The bound calcium is dissociated from binding proteins, allowing the calcium to penetrate through the spreading layer into the underlying reagent layer. In the reagent layer, the calcium forms a complex with Arsenazo III dye, causing a shift in the absorption maximum.

After incubation, the reflection density of the colored complex is measured spectrophotometrically by a VITROS Chemistry System. The amount of colored complex formed is proportional to the calcium concentration in the sample fluid. The test result is reported in milligrams per deciliter (mg/dL) or millimoles per liter (mmol/ L).

VITROS Chemistry Products Calibrator Kit 1 contains three levels of lyophilized standards with corresponding diluents. The standards are prepared from processed bovine serum to which organic analytes, electrolytes, stabilizers, and preservatives have been added. The companion diluents are prepared from processed water to which inorganic salts have been added.

The VITROS Chemistry System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

- 6. Device intended use
VITROS Chemistry Products Ca Slides For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine.

VITROS Chemistry Products Calibrator Kit 1

For in vitro diagnostic use only. VITROS Calibrator Kit 1 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of BUN/UREA, Ca, CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC.

Continued on next page

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## 510(k) Summary, Continued

- The VITROS Chemistry Products Ca Slide (modified) and VITROS Chemistry Products 7. Comparison Calibrator Kit 1 are substantially equivalent to VITROS Chemistry Products Ca Slide to predicate and VITROS Chemistry Products Calibrator Kit 1, which were Cleared by the FDA for device in vitro diagnostic use.
VITROS Chemistry Products Ca Slide: (K961226, cleared May 7, 1996) VITROS Chemistry Products Calibrator Kit 1: (K023876, cleared December 10, 2002).

Table 1 lists the characteristics of the tests performed using the VITROS Ca Slide (modified) and the VITROS Ca Slide (current).

Table 1. List of VITROS Chemistry Products CaSlide Characteristics: Comparison to Predicate Device

| Device | New Device | Predicate Device |
|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | VITROS Chemistry Products Ca Slide<br>(Modified) | VITROS Chemistry Products Ca Slide<br>(Current) |
| Intended Use | No Change. | For <i>in vitro</i> diagnostic use only.<br>VITROS Ca Slides quantitatively measure<br>calcium (Ca) concentration in serum, plasma,<br>and urine. |
| Fundamental scientific<br>technology | No Change. | Dry, multilayered slide utilizing<br>spectrophotometrics |
| Test Type | No Change. | Colorimetric |
| Reactive Ingredients per cm2 | No Change. | Arsenazo III dye 60 µg |
| Sample type | No Change. | Serum, plasma, urine. |
| Instrumentation | No Change. | VITROS 250, 550, 750, 950 and 5,1FS<br>Series Analyzers |
| Composition of the<br>Spreading Layer* component<br>of the VITROS Ca Slide | TiO2: New Supplier<br>Cellulose Acetate: New lot<br>Estane: Increased to 1.7 times the current level,<br>i.e. 70% increase. Estane concentration is<br>correlated to manufacturability of the VITROS<br>Ca Slide.<br>Surfactants: No Change. | TiO2, Cellulose Acetate, Estane, Surfactants |
| Manufacturing Process<br>Changes due to the increased<br>Estane level in the Spreading<br>Layer* Component of the<br>VITROS Ca Slide | The increased concentration of Estane raised<br>the viscosity, requiring modifications to the<br>solution delivery system and to the non-solvent<br>flow rate. | Current Manufacturing Process. |

*The "Spreading Layer" refers to the spreading layer component of the VITROS Chemistry Products Ca Slide (Refer to Page 2 of the Instructions For Use for VITROS Chemistry Products Ca Shide (Reights). The Spreading Layer even) y discributes sample fluid to the underlying layers of the VITROS Ca Slide,

No modifications were made to VITROS Chemistry Products Calibrator Kit 1.

Continued on next page

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# 510(k) Summary, Continued

#### 8. Conclusions

The information presented in the premarket notification demonstrates that the performance of the VITROS Chemistry Products Ca Slides (modified) for use with human serum, plasma and urine is substantially equivalent to the cleared predicate device.

Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured calcium values spanning the assarring and

The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products Ca Slides (modified) for use with human serum, plasma, and urine is safe and effective for the stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the top and sides of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 0 2007

Ortho-Clinical Diagnostics, Inc. c/o Marlene A. Hanna 100 Indigo Creek Drive Rochester, New York 14626-5101

> k072440 Trade/Device Name: VITROS® Chemistry Products Ca Slides VITROS® Chemistry Products Calibrator Kit 1 Regulation Number: 21 CFR§ 862.1145 . Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CJY, JIX Dated: August 29, 2007 Received: August 30, 2007

Dear Ms. Hanna:

Re:

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 1egally marketed predicate device results in a classification for your device and this, permite 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 othe the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 80.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolla the [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Sean M. Cooper, M.S., D.V.M. 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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## Indication for Use

510(k) Number (if known):

K072440

Device Name: VITROS Chemistry Products Ca Slides

Indication For Use: For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Prescription Use_ X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072440

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## Indication for Use

510(k) Number (if known):

K012440

Device Name: VITROS Chemistry Products Calibrator Kit 1

Indication For Use: For in vitro diagnostic use only. VITROS Calibrator Kit 1 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of BUN/UREA, Ca, CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carolf. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072440

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