VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1

{0}------------------------------------------------ # DEC 1 0 2002 ## 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: KC23876 - Ortho-Clinical Diagnostics, Inc. 1. Submitter 100 Indigo Creek Drive name, Rochester, New York 14626-5101 address, contact (585) 453-4041 Contact Person: Marlene A. Hanna - Date Special 510(k) prepared: November 20, 2002 2. Preparatio n date - Trade or Proprietary Name: 3. Device VITROS Chemistry Products Mg Slides name VITROS Chemistry Products Calibrator Kit 1 Common Name Classification Name: Magnesium test system ( 21 CFR 862.1495). - The VITROS Chemistry Products Mg Slides (modified) and VITROS 4. Predicate device Chemistry Products Calibrator Kit 1 are substantially equivalent to the VITROS Chemistry Products Mg Slides (current slide) and VITROS Chemistry Products Calibrator Kit 1. Continued on next page {1}------------------------------------------------ ### 510(k) Summary, Continued - The VITROS Chemistry System uses Vitros Slides to perform discrete 5. Device chemistry tests on body fluid specimens. All reactions necessary for a single description quantitative measurement take place within the multi-layered analytical element of a Vitros Slide. The system is comprised of two main elements: 1. The VITROS Chemistry Products range of chemistry products (in this case VITROS Chemistry Products Mg Slides, VITROS Chemistry Products Calibrator Kit 1, which are combined by the VITROS Chemistry System to perform the VITROS Mg test. 2. The VITROS Chemistry System - instrumentation, which provides automated use of the chemistry slides. Multiple VITROS Chemistry Systems were cleared for market by separate 510(k) pre-market notifications (K890928, K890929, K922072, K946090 and K922072). The VITROS Chemistry System and Calibrators are dedicated specifically for use only with the VITROS Chemistry Products range of products. 6. Device VITROS Mg Slides intended For in vitro diagnostic use only. VITROS Mg Slides quantitatively measure Magnesium (MG) concentration use in serum, plasma, and urine. VITROS Calibrator Kit 1 For in vitro diagnostic use only. VITROS Calibrator Kit 1 is intended for use in calibration of 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 {2}------------------------------------------------ - The VITROS Chemistry Products Mg Slide (modified) and VITROS 7. Comparison Chemistry Products Calibrator Kit 1 are substantially equivalent to VITROS to Chemistry Products Mg Slide and VITROS Chemistry Products Calibrator Kit predicate 1 that were cleared by the FDA for in vitro diagnostic use. device Mg Slide: (K861386, Cleared August 26, 1986) Calibrator Kit 1: (K001885 Cleared July 20, 2000) Table 1 lists the characteristics of the tests performed using the VITROS Mg Slide (modified) and the VITROS Mg Slide (current). | Device<br>Characteristic | New Device<br>VITROS Mg Slide<br>(Modified) | Predicate Device<br>VITROS Mg Slide<br>(Current) | |-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sample volume | 5 µL | 10 µL | | Quantity of<br>Reactive<br>Ingredients per<br>slide (test) | 1,2-bis(o-aminophenoxy)ethane-N,N,N',N'-<br>tetraacetic acid (calcium chelator) 272.1 µg<br>and<br>1,5-bis(2-hydroxy-3,5-dichlorophenyl)-3-<br>cyanoformazan (dye) 46.19 µg | 1,2-bis(o-aminophenoxy)ethane-N,N,N',N'-<br>tetraacetic acid (calcium chelator) 542.3 µg and<br>1,5-bis(2-hydroxy-3,5-dichlorophenyl)-3-<br>cyanoformazan (dye) 92.06 µg | | Concentrations<br>of Slide<br>Reactive<br>Ingredients per<br>cm-squared | No Change. | 1,2-bis(o-aminophenoxy)ethane-N,N,N',N'-<br>tetraacetic acid (calcium chelator) 302.3 µg and<br>1,5-bis(2-hydroxy-3,5-dichlorophenyl)-3-<br>cyanoformazan (dye) 51.32 µg | | Intended Use | No change. | For in vitro diagnostic use only.<br>VITROS Mg Slides quantitatively measure<br>magnesium (Mg) concentration in serum,<br>plasma and urine. | | Basic principle | No Change. | Dry, multilayered slide utilizing reflectance<br>spectrophotometry | | Sample type | No Change. | Serum , plasma , urine | | Reportable<br>Range | | | | Serum,Plasma: | No Change. | 0.20 - 10.00 mg/ dL | | Urine: | No Change. | 1.20 - 60.00 mg/dL (after multiplying by a 6X<br>dilution factor) | | Instrumentation | No Change. | VITROS 250, 500, 750 and 950 Series<br>Analyzers | | Incubation time<br>and temperature | No Change. | Approximately 5 minutes at 37°C | Table 1 List of Slide Characteristics: Comparison to Predicate Device Continued on next page {3}------------------------------------------------ ## 510(k) Summary, Continued #### The information presented in the pre-market notification demonstrates that 8. Conclusions the performance of the VITROS Mg 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 Magnesium values spanning the assay range. The information presented in the premarket notification provides a reasonable assurance that the VITROS Mg Slides (modified) for use with human serum, plasma, and urine is safe and effective for the stated intended use. {4}------------------------------------------------ ## 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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 # DEC 1 0 2002 Ms. Marlene A. Hanna Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 k023876 Re: > Trade/Device Name: VITROS Chemistry Products Mg Slides/ VITROS Chemistry Products Calibrator Kit 1 Regulation Number: 21 CFR § 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIX; JGJ Dated: November 20, 2002 Received: November 21, 2002 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, 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. {5}------------------------------------------------ #### Page 2 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 (OS) regulation (21 CFR Part 820). 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 (301) 594-3084. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html. Sincerely yours, Steven Sutman Steven I. Gutman, M.D., M.B. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ | Statement of Intended Use | | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Page 1 of 1 | | 510(k) Number (if known): | K023876 | | Device Name: | VITROS Chemistry Products Mg Slides<br>VITROS Chemistry Products Calibrator Kit 1 | | Intended Use: | VITROS Chemistry Products Mg Slides<br>For in vitro diagnostic use only.<br>VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine. | | | VITROS Calibrator Kit 1<br>For in vitro diagnostic use only.<br>VITROS Calibrator Kit 1 is intended for use in calibration of the<br>VITROS Chemistry Systems for the quantitative measurement of<br>BUN/ UREA, Ca, CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC. | | Summary and Explanation of Test: | Magnesium is predominantly an intracellular cation and is essential in enzyme reactions. Magnesium deficiency may cause weakness, tremors, tetany, and convulsions. Hypomagnesemia is associated with hypocalcemia, alcoholism, some types of malnutrition, chronic hemodialysis, and pregnancy. Increased serum magnesium concentrations occur in patients with renal failure, dehydration, and Addison's disease. ¹ | ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | | Carol C Benson for Jean Cooper | |---------------------|--------------------------------| | (Division Sign-Off) | | | Division | Clinical Laboratory Devices | | 510(k) Number | K023876 | | Prescription Use | <div style="text-align:center;">X</div> | OR | Over-The-Counter Use | |----------------------|-----------------------------------------|----|--------------------------| | (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |