VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659
Device Facts
| Record ID | K071801 |
|---|---|
| Device Name | VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659 |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Product Code | JIX · Clinical Chemistry |
| Decision Date | Jul 20, 2007 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 862.1150 |
| Device Class | Class 2 |
Indications for Use
For in vitro diagnostic use only. VITROS CI Slides quantitatively measure chloride (CI) concentration in serum and plasma. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. For in vitro diagnostic use only. VITROS Calibrator Kit 2 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of CHOL, CI, ECO2, HDLC, K+, Na+, and TRIG.
Device Story
VITROS Chemistry Products CI Slides are multilayered analytical elements for direct potentiometric measurement of chloride ions in serum or plasma. Device inputs: 10 uL reference fluid and 10 uL sample fluid deposited on separate halves of the slide. Operation: fluids connect via paper bridge; chloride ions migrate to silver/silver chloride layers to establish equilibrium; electrometer measures potential difference between reference and indicator electrodes after 2-3 minute incubation. Output: chloride concentration in mmol/L. Used in clinical laboratory settings on VITROS Chemistry Systems; operated by laboratory technicians. System microcomputer uses stored calibration parameters to calculate results. Output assists clinicians in diagnosing/treating electrolyte and metabolic disorders.
Clinical Evidence
Bench testing only. Performance demonstrated using manufactured slides with patient and quality control samples spanning the assay range to confirm substantial equivalence to the predicate device.
Technological Characteristics
Dry, multilayered slide on polyester support. Sensing principle: direct potentiometry via ion-selective electrodes (silver/silver chloride). ISE baseweb includes polyethylene terephthalate film, silver/silver chloride layers, and NiCr (80% Ni, 20% Cr) stripes. Manufacturing process: magnetic sputter deposition. Connectivity: integrated with VITROS Chemistry Systems.
Indications for Use
Indicated for the quantitative measurement of chloride in human serum and plasma to aid in the diagnosis and treatment of electrolyte and metabolic disorders, including cystic fibrosis and diabetic acidosis.
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
Submission Summary (Full Text)
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## Summary Information
## 510(k) Summary
JUL 2 0 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: Ko7180
- Ortho-Clinical Diagnostics, Inc. 1. Submitter name, 100 Indigo Creek Drive address, Rochester. New York 14626-5101 contact (585) 453-4041
Contact Person: Marlene A. Hanna
- Date Special 510(k) prepared: June 29, 2007 2. Preparation date
- Trade or Proprietary Name: 3. Device VITROS Chemistry Products Cl Slides name Common Name: chloride test Classification Name: Chloride test system (21 CFR 862.1170)
VITROS Chemistry Products Calibrator Kit 2 Common Name: calibrator Classification Name: Calibrator (21 CFR 862.1150)
- The VITROS Chemistry Products CI Slides (modified) and VITROS Chemistry 4. Predicate Products Calibrator Kit 2 are substantially equivalent to the VITROS Chemistry device Products CI Slides (current slide) and VITROS Chemistry Products Calibrator Kit 2.
Continued on next page
Ortho-Clinical Diagnostics VITROS Chemistry Products Cl Slides VITROS Chemistry Products Calibrator Kit 2
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## 510(k) Summary, Continued
The VITROS Chemistry Products Cli Slide assay is performed using the VITROS 5. Device Chemistry Products Cli Slide and the VITROS Chemistry Products Calibrator Kit 2 on Description the VITROS Chemistry Systems. The VITROS CI Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry' for measurement of chloride ions. All reactions necessary for a single quantitative measurement of chloride take place within the multi-layered analytical element of a VITROS Chemistry Products Cli slide. The slide consists of two ion-selective electrodes, each containing a protective layer, a silver layer and a silver chloride layer coated on a polyester support. The protective layer inhibits interference from normal levels of bromide and uric acid
> VITROS Chemistry Products CI Slides use ion-selective electrodes for potentiometric measurements of ionic chloride. Ionic chloride determinations are made by simultaneously depositing 10 uL each of a reference fluid and a sample fluid on separate halves of the VITROS Chemistry Products CI slide. The electrode receiving the reference fluid is identified as the reference electrode. A paper bridge connects the reference electrode and the indicator electrode, which receives the sample fluid. A stable liquid junction between the two fluids is formed in the paper bridge in approximately 20 seconds. The chloride ions in the tested reference and sample fluids migrate to the silver/ silver chloride layers and establish equilibrium.
After a 2 or 3-minute (depends on the VITROS Chemistry System used) incubation period, the electrometer in the VITROS Chemistry System measures the potential difference between the reference and indicator electrodes. Each electrode responds to the activity of chloride ions in the respective fluids to produce a potential for the concentration cell. The VITROS Chemistry System's microcomputer uses this measurement and the stored calibration parameters to determine the concentration value of the chloride ion in the sample fluid. The test result is reported in millimoles per liter (mmol/ L).
VITROS Chemistry Products Calibrator Kit 2 contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from processed bovine serum to which bovine cholesterol, chicken egg yolk, inorganic salts, electrolytes, buffers, stabilizers, and preservatives have been added. The companion diluents are prepared from processed water to which inorganic salts have been added. In addition, Calibrator 4 Diluent contains 0.5 M diethylaminoethanol and 0.01 M (ethylenedinitrilo) tetraacetic acid.
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
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- VITROS Chemistry Products CI Slides 6. Device For in vitro diagnostic use only. VITROS CT Slides quantitatively measure chloride intended (CI) concentration in serum and plasma. use
VITROS Chemistry Products Calibrator Kit 2 For in vitro diagnostic use only. VITROS Calibrator Kit 2 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of CHOL, CI, ECO2, HDLC, K*, Na*, and TRIG.
Continued on next page
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## 510(k) Summary, Continued
### The VITROS Chemistry Products Cli Slide (modified) and VITROS Chemistry 7. Comparison Products Calibrator Kit 2 are substantially equivalent to VITROS Chemistry to predicate Products Cl Slide and VITROS Chemistry Products Calibrator Kit 2, which were device Cleared by the FDA for in vitro diagnostic use.
VITROS Chemistry Products Cli Slide: (K800054, cleared February 5, 1980) VITROS Chemistry Products Calibrator Kit 2: (K012593, cleared August 30, 2001).
Table 1 lists the characteristics of the tests performed using the VITROS Cl Slide (modified) and the VITROS CI Slide (current).
| Device<br>Characteristic | New Device<br>VITROS Chemistry Products CI Slide<br>(Modified) | Predicate Device<br>VITROS Chemistry Products CI Slide<br>(Current) |
|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | No Change. | For in vitro diagnostic use only.<br>VITROS CI Slides quantitatively measure chloride<br>(CI) concentration in serum and plasma. |
| Fundamental scientific<br>technology | No Change. | Dry, multilayered slide utilizing direct<br>potentiometry |
| Reactive Ingredients<br>per cm2 | No Change. | Silver 0.4 mg and silver chloride 0.2 mg |
| Sample type | No Change. | Serum , plasma |
| Instrumentation | No Change. | VITROS 250, 550, 750, 950 and 5, 1FS Series<br>Analyzers |
| Manufacturing<br>Process of the ISE<br>baseweb* (Ag/AgCl<br>and Support Layers of<br>the CI Slide) | Magnetic sputter deposition | Electron beam evaporation |
| Composition of ISE<br>baseweb component | Ag/AgCl concentration: No change<br>Nickel Stripes: NiCr (80% Nickel, 20% Chromium) | Ag/AgCl concentration: Silver 0.4 mg and silver<br>chloride 0.2 mg<br>Nickel Stripes: Ni (99+% Nickel) |
## Table 1. List of VITROS Chemistry Products Cl Slide Characteristics: Comparison to Predicate Device
*ISE (Ion-Selective Electrode) baseweb= Polyethylene terephthalate film (substrate used for metallized film) coated with silver (Ag)/ silver chloride (Ag/Cl) and striped with nominal nickel (Ni) stripes. The "ISE baseweb" refers to the Ag/ AgCl with nickel stripes layer and support layer of the VITROS Chemistry Products CT Slide.
No modifications were made to VITROS Chemistry Products Calibrator Kit 2.
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 CI 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 chloride values spanning the assay range.
The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products CT Slides (modified) for use with human serum and plasma is safe and effective for the stated intended use.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 3 2007
Ortho-Clinical Diagnostics, Inc. c\o Ms. Marlene A. Hanna Regulatory Affairs Manager 100 Indigo Creek Drive Rochester. New York 14626-5101
Re: k071801
> Trade Name: Vitros Chemistry Products CI Slides Vitros Chemistry Products Calibrator Kit 2 Regulation Number: 21 CFR 862.1170 Regulation Name: Chloride test system Regulatory Class: Class II Product Code: CGZ, JIX Dated: June 29, 2007 Received: July 02, 2007
Dear Ms. Hanna:
This letter corrects our substantially equivalent letter of July 20, 2007.
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. Ilsting 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 (240) 276-0490. 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 (240) 276-3150 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.
Yean 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): K071801
Device Name: VITROS Chemistry Products CI Slides
Indication For Use: For in vitro diagnostic use only. VITROS CI Slides quantitatively measure chloride (CI) concentration in serum and plasma. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
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)
Patricia Bernhardt for Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K 071801
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## Indication for Use
510(k) Number (if known):K071801
Device Name: VITROS Chemistry Products Calibrator Kit 2
Indication For Use: For in vitro diagnostic use only. VITROS Calibrator Kit 2 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of CHOL, CI', ECO2, HDLC, K+, Na*, and TRIG.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Patricia Bernhart for Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K07/80/
