VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905

K082099 · Ortho-Clinical Diagnostics, Inc. · CGZ · Aug 21, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082099
• Device Name: VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: CGZ · Clinical Chemistry
• Decision Date: Aug 21, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1170
• Device Class: Class 2

Intended Use

For in vitro diagnostic use only. VITROS Cl- DT 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. 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 , NH2, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

Device Story

VITROS Chemistry Products Cl- DT Slides are multilayered analytical elements for direct potentiometric measurement of chloride ions in serum/plasma. Input: 10 uL each of reference fluid and sample fluid deposited on separate halves of the slide. Operation: Reference and indicator electrodes connected by a paper bridge form a stable liquid junction; chloride ions migrate to silver/silver chloride layers to establish equilibrium; potential difference between electrodes is proportional to chloride concentration. Output: Chloride concentration in mmol/L. Used in clinical laboratory settings on VITROS DT Chemistry Systems; operated by laboratory technicians. Results assist healthcare providers in diagnosing/treating metabolic and electrolyte disorders. Benefits: Rapid, quantitative electrolyte assessment.

Clinical Evidence

Bench testing only; design control activities and risk analysis performed to validate manufacturing and formulation changes.

Technological Characteristics

Ion-Selective Electrode (ISE) baseweb; modification to manufacturing process and component formulation. Fundamental scientific technology unchanged.

Indications for Use

Indicated for in vitro diagnostic quantitative measurement of chloride (Cl-) in human serum and plasma to aid in diagnosis and treatment of electrolyte and metabolic disorders, including cystic fibrosis and diabetic acidosis.

Regulatory Classification

Identification

A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Predicate Devices

• VITROS Chemistry Products CI DT Slides (K912844)
• VITROS Chemistry Products DT Calibrator Kit (K072443)

Submission Summary (Full Text)

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## 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.

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The assigned 510(k) number is: _082099

| 1. | Submitter<br>name,<br>address,<br>contact | Ortho-Clinical Diagnostics, Inc.<br>100 Indigo Creek Drive<br>Rochester, New York 14626-5101<br>[phone]<br><br>Contact Person: Marlene A. Hanna |
|----|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Preparation<br>date | Date Special 510(k) prepared: July 24, 2008 |
| 3. | Device<br>name | Trade or Proprietary Name:<br>VITROS Chemistry Products CI DT Slides<br>Common Name: chloride test<br>Classification Name: Chloride test system (21 CFR 862.1170)<br><br>VITROS Chemistry Products DT Calibrator Kit<br>Common Name: calibrator<br>Classification Name: Calibrator (21 CFR 862.1150) |
| 4. | Predicate<br>device | The VITROS Chemistry Products CI DT Slides (modified) and VITROS Chemistry<br>Products DT Calibrator Kit are substantially equivalent to the VITROS Chemistry<br>Products CI DT Slides (current slide: K912844, cleared September 4, 1991) and<br>VITROS Chemistry Products DT Calibrator Kit (Current Kit: K072443, cleared<br>September 24, 2007). |

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## 510(k) Summary, Continued

The VITROS Chemistry Products CI Slide assay is performed using the VITROS 5. Device Description Chemistry Products Cl DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT Chemistry Systems. The VITROS CI DT 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 CI DT Slide. The slide consists of two ionselective electrodes, each containing a protective laver, a silver laver 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 DT 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 CT DT 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. The chloride ions in the tested reference and sample fluids migrate to the silver/ silver chloride layers and establish equilibrium. Each electrode produces an electrical potential in response to the activity of chloride ions applied to it. The potential difference poised between the two electrodes is proportional to the chloride concentration in the sample. The test result is reported in 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 boyine 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 DT Systems and reagents are designed specifically for use with the VITROS Chemistry Products range of products. 6. Device VITROS Chemistry Products Cli DT Slides intended For in vitro diagnostic use only. VITROS CI Slides quantitatively measure chloride use (CI) 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 , NH2, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

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### 510(k) Summary, Continued

The VITROS Chemistry Products CI DT Slide (modified) and VITROS Chemistry 7. Comparison to predicate Products DT Calibrator Kit are substantially equivalent to VITROS Chemistry device Products CI DT Slide and VITROS Chemistry Products DT Calibrator Kit, which were Cleared by the FDA for in vitro diagnostic use.

> VITROS Chemistry Products CI DT Slide: (K912844, cleared September 4, 1991). VITROS Chemistry Products DT Calibrator Kit: (K072443, cleared September 24, 2007).

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

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

| Device<br>Characteristic | New Device<br>VITROS Chemistry Products CI DT Slide<br>(Modified) | Predicate Device<br>VITROS Chemistry Products CI DT Slide<br>(Current) |
|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | No Change. | For <i>in vitro</i> diagnostic use only.<br>VITROS CI DT Slides quantitatively measure<br>chloride (Cl⁻) concentration in serum and plasma. |
| Fundamental<br>scientific<br>technology | No Change. | Dry, multilayered slide utilizing direct<br>potentiometry |
| Reactive<br>Ingredients per<br>cm² | No Change. | Silver 0.4 mg and silver chloride 0.2 mg |
| Other Ingredients | Polymer, plasticizer, surfactant, and nickel-<br>chromium. | Polymer, plasticizer, surfactant, and nickel. |
| Sample type | No Change. | Serum, plasma |
| Instrumentation | No Change. | VITROS DT Chemistry Systems. |
| Manufacturing<br>Process of the ISE<br>baseweb*<br>(Ag/AgCl and<br>Support Layers of<br>the Cl⁻ DT Slide) | Magnetic sputter deposition | Electron beam evaporation |
| Composition of<br>ISE baseweb<br>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) |

*|SE (Ion-Sclective Electrode) basewcb= Polyethylene tercphthalate film (substrate used for metallized film) oaated 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 CIT DT Slide.

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

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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 CI 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 chloride values spanning the assay range.

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

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ortho-Clinical Diagnostics, Inc. c/o Ms. Marlene A. Hanna Regulatory Affairs Manager 100 Indigo Creek Dr. Rochester, NY 14626

AUG 2 1 2008

Re: k082099

Trade/Device Name: VITROS Chemistry Products Cl- DT Slides, VITROS Chemistry Products DT Calibrator Kit Regulation Number: 21 CFR 862.1170 Regulation Name: Chloride test system Regulatory Class: Class II Product Code: CGZ, JIX Dated: July 24, 2008 Received: July 25, 2008

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.

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 mumber [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.

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): K082099

1. Device Name: VITROS Chemistry Products Cl- DT Slides

Indication For Use: For in vitro diagnostic use only. VITROS Cl- DT Slides quantitatively measure chloride (CI-) concentration in serum and plasma. Chloride measurements are used in the diagnosis and treatment of clectrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

2. 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 the quantitative measurement of ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, 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 (OVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K082099

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