VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY

K072443 · Ortho-Clinical Diagnostics, Inc. · CJY · Sep 24, 2007 · Clinical Chemistry

Device Facts

• Record ID: K072443
• Device Name: VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: CJY · Clinical Chemistry
• Decision Date: Sep 24, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Intended Use

For in vitro diagnostic use only. VITROS Ca DT Slides quantitatively measure calcium (Ca) concentration in serum and plasma. 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).

Device Story

VITROS Chemistry Products Ca DT slide; in vitro diagnostic device for calcium measurement. Modification involves change in manufacturing process and formulation of spreading layer component. Device operates via chemical reaction on slide; used in clinical laboratory settings by trained personnel. Output provides quantitative calcium concentration to assist clinicians in diagnosis and monitoring of calcium metabolism disorders. Modification verified via FMECA risk analysis and design control activities to ensure performance equivalence to previously cleared version.

Clinical Evidence

Bench testing only; no clinical data provided. Verification and validation activities performed per design control requirements to confirm modification impact.

Technological Characteristics

In vitro diagnostic slide for calcium measurement. Modification to spreading layer formulation. Fundamental scientific technology unchanged from predicate. Design controls per 21 CFR 820.30 applied.

Indications for Use

Indicated for in vitro diagnostic measurement of calcium in serum and plasma to aid in 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 DT slide (k870035)

Submission Summary (Full Text)

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# Summary Information

# 510(k) Summary

SEP 2 4 2007

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: K072443

- Ortho-Clinical Diagnostics, Inc. 1. Submitter 100 Indigo Creek Drive name, address, Rochester, New York 14626-5101 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 DT Slides Common Name: calcium test Classification Name: Calcium test system (21 CFR 862.1145)

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

- 4. Predicate The VITROS Chemistry Products Ca DT Slides (modified) and VITROS Chemistry Products DT Calibrator Kit are substantially equivalent to the VITROS Chemistry device Products Ca DT Slides (current slide) and VITROS Chemistry Products DT Calibrator Kit. The FDA cleared the VITROS Chemistry Products Ca DT Slides on May 12, 1987 (K870035) under the product name KODAK EKTACHEM DT SLIDES (Ca). With the purchase of KODAK Clinical Products Division by Johnson and Johnson in 1994, the product branding was revised to VITROS Chemistry Products Ca DT Slides The most recent FDA clearance for the VITROS Chemistry Products DT Calibrator Kit was May 25, 2007 (K071216).
Continued on next page

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## 510(k) Summary, Continued

The VITROS Chemistry Products Ca DT Slide assay is performed using the VITROS 5. Device Description Chemistry Products Ca DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT60/ DT60 II Chemistry Systems. The VITROS Ca DT 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 DT slide. A drop of patient sample is deposited on the VITROS Ca DT Slide and is evenly distributed by the spreading layer to the underlying lavers. 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. 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 DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from bovine serum albumin and processed bovine serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added. The companion diluents are prepared from processed water to which inorganic salts have been added. The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products. 6. Device VITROS Chemistry Products Ca DT Slides intended For in vitro diagnostic use only. VITROS Ca DT Slides quantitatively measure use calcium (Ca) concentration in serum and plasma. VITROS Chemistry Products DT Calibrator Kit For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMY, AST, TBIL, NBIL, BUN/CREA, Ca, CHOL, CK, CI, CO2 CREA, CRSC, Fe, GGT, GLU, HDLC, K*, LAC, LDH, LIPA, Mg, Na*, NHz, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

Continued on next page

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## 510(k) Summary, Continued

- 7. Comparison The VITROS Chemistry Products Ca DT Slide (modified) and VITROS Chemistry Products DT Calibrator Kit are substantially equivalent to VITROS Chemistry Products to predicate Ca DT Slide and VITROS Chemistry Products DT Calibrator Kit, which were Cleared device by the FDA for in vitro diagnostic use.
VITROS Chemistry Products Ca DT Slide: (K870035, cleared May 12, 1987) VITROS Chemistry Products DT Calibrator Kit: (K071216, cleared May 25, 2007).

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

#### Table 1. List of VITROS Chemistry Products Ca DT Slide Characteristics: Comparison to Predicate Device

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

*The "Spreading Layer" refers to the spreading layer component of the VITROS Chemistry Products Ca DT Slide (Refer to Page 2 of the Instructions For Use for VITROS Chemistry Products Ca DT Slides). The Spreading Layer evenly distributes sample fluid to the underlying layers of the VITROS Ca DT Slide.

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

Continued on next page

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### 510(k) Summary, Continued

The information presented in the premarket notification demonstrates that the 8. Conclusions performance of the VITROS Chemistry Products Ca DT Slides (modified) for use with human serum and plasma 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 assay range.

The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products Ca DT Slides (modified) for use with human serum and plasma 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 and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The bird is positioned above three wavy lines, which could represent water or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 4 2007

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

Re: k072443

Trade/Device Name: VITROS Chemistry Products Ca DT Slides VITROS Chemistry Products DT Calibrator Kit 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:

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. Iisting 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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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 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): K072443

Device Name: VITROS Chemistry Products Ca DT Slides

Indication For Use: For in vitro diagnostic use only. VITROS Ca DT Slides quantitatively measure calcium (Ca) concentration in serum and plasma. 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) k072443

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### Indication for Use

510(k) Number (if known):

K072443

Device Name: VITROS Chemistry Products DT Calibrator Kit

Indication For Use: For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMY, AST, TBIL, NBIL, BUN/CREA, Ca, CHOL, CK, CI, CO2 CREA, CRSC, Fe, GGT, GLU, HDLC, K*, LAC, LDH, LIPA, Mg, Na*, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

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)

Carol C. Benson

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

510(k) k072443

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Ortho-Clinical Diagnostics VITROS Chemistry Products Ca DT Slides VITROS Chemistry Products DT Calibrator Kit

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