VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III

K043386 · Ortho-Clinical Diagnostics, Inc. · LEH · Feb 7, 2005 · Clinical Toxicology

Device Facts

• Record ID: K043386
• Device Name: VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: LEH · Clinical Toxicology
• Decision Date: Feb 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3950
• Device Class: Class 2

Intended Use

VITROS Chemistry Products VANC Reagent: For in vitro diagnostic use only. VITROS Chemistry Products VANC Reagent is used on the VITROS 5.1 FS Chemistry System to quantitatively measure vancomycin (VANC) concentration in human serum and plasma. Serum or plasma vancomycin measurements are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy. VITROS Chemistry Products Calibrator Kit 11: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 11 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of vancomycin (VANC). VITROS Chemistry Products TDM Performance Verifier I, II and III: For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and VANC on VITROS Chemistry Systems.

Device Story

VITROS Chemistry Products Vancomycin (VANC) Reagent is a quantitative homogeneous enzyme immunoassay for use on the VITROS 5,1 FS Chemistry System. The system processes human serum or EDTA plasma samples; reagent 1 (vancomycin labeled with glucose-6-phosphate dehydrogenase) and reagent 2 (NAD, glucose-6-phosphate, and anti-vancomycin antibodies) are added to the sample. The assay principle relies on competition between sample vancomycin and labeled vancomycin for antibody binding sites; enzyme activity is measured spectrophotometrically at 340 nm. The system uses a stored calibration curve to determine sample concentration. The device is intended for clinical laboratory use to monitor therapeutic drug levels and manage potential overdose. Results are provided to healthcare providers to guide dosing decisions and ensure therapeutic efficacy.

Clinical Evidence

Bench testing only. Performance was validated through method comparison studies against the predicate device using patient samples, yielding a correlation coefficient of 0.996 (slope 1.00, intercept 0.00 µg/mL). Additional bench studies confirmed precision, linearity, and specificity within the reportable range of 5.0–50 µg/mL.

Technological Characteristics

Quantitative homogeneous enzyme immunoassay. Reagents: vancomycin-labeled glucose-6-phosphate dehydrogenase, NAD, glucose-6-phosphate, murine monoclonal antibodies. Form factor: liquid reagents for automated chemistry analyzer (VITROS 5,1 FS). Detection: spectrophotometric (340 nm). Calibration: USP-traceable aqueous calibrators. Controls: bovine serum-based performance verifiers. Connectivity: integrated with VITROS 5,1 FS system.

Indications for Use

Indicated for the quantitative measurement of vancomycin in human serum and plasma to aid in the diagnosis and treatment of vancomycin overdose and therapeutic drug monitoring.

Regulatory Classification

Identification

A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Predicate Devices

• Syva® EMIT® 2000 Vancomycin Assay and calibrators (k020692, k020845)
• VITROS Chemistry Products Performance Verifiers (k042476)

Submission Summary (Full Text)

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# 1.0 510(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: KOH 3386

# 1.1 Submitter name, address, contact

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 Phone: [phone] Fax: [phone]

Contact Person: Carey A. Mayo, M.S., RAC

# 1.2 Date of Preparation: December 8, 2004

## 1.3 Device Proprietary Name(s)

- Trade Name(s):
VITROS Chemistry Products VANC Reagent VITROS Chemistry Products Calibrator Kit 11 VITROS Chemistry Products TDM Performance Verifier I, II, and III Common Name(s): Vancomycin assay and controls

### 1.4 Classification Name(s)

Vancomycin Test System: Class II (21 CFR 862.3950) Calibrators: Class II (21 CFR 862.3200) Assayed Controls: Class I (21 CFR 862. 3280)

### 1.5 Predicate device

The VITROS Chemistry Products VANC reagent and calibrators are substantially equivalent to the SYVA® Emit® 2000 Vancomycin Assay and Calibrators (Dade Behring, Inc.).

The VITROS Chemistry Products TDM Performance Verifiers are substantially equivalent to the previously cleared VITROS Chemistry Products TDM Performance Verifiers.

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# 1.6 Device description

The VITROS Chemistry Products VANC Reagent, VITROS Chemistry Products Calibrator Kit 11, and the VITROS Chemistry Products TDM Performance Verifiers are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS VANC assay. VITROS Chemistry Products VANC Reagent is a dual chambered package containing ready-to-use liquid reagents that are used in a two-step reaction to quantitatively measure vancomycin.

VITROS Chemistry Products Calibrator Kit 11 and TDM Performance Verifiers are packaged and sold separately.

VITROS Chemistry Products Calibrator Kit 11 is a liquid ready to use calibrator set for vancomycin. Each kit contains one bottle each of six (6) levels. The level 1 bottle (zero level) contains 5 milliliters. The level 2 through 6 bottles each contain 2 milliliters.

VITROS Chemistry Products TDM Performance Verifier I, II and III are liguid ready to use controls with assayed values published for each lot. The controls are prepared from bovine serum with therapeutic drugs and preservatives added. The product is sold in separate kits of Level I, II and III. Each kit contains 6 vials (2 mL each).

#### 1.7 Device intended use(s)

VITROS Chemistry Products VANC Reagent: For in vitro diagnostic use only. VITROS Chemistry Products VANC Reagent is used on the VITROS 5.1 FS Chemistry System to quantitatively measure vancomycin (VANC) concentration in human serum and plasma. Serum or plasma vancomycin measurements are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.

VITROS Chemistry Products Calibrator Kit 11: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 11 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of vancomycin (VANC).

VITROS Chemistry Products TDM Performance Verifier I, II and III: For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and VANC on VITROS Chemistry Systems.

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#### 1.8 Comparison to predicate device: Reagent and Calibrators

The VITROS Chemistry Products VANC Reagent and VITROS Chemistry Products Calibrator Kit 11 are substantially equivalent to the SYVA Emit 2000 Vancomycin Assay and the SYVA Emit 2000 Vancomycin Calibrators, which were cleared by FDA (K020692 and K020845) for IVD use.

The relationship between the VITROS VANC assay and the predicate device. determined by least squares linear regression, is:

VITROS VANC assay = 1.00 X + 0.00 µg/mL, with a correlation coefficient of 0.996, where X is the predicate device.

In addition to the correlation studies, studies were performed to determine the precision, expected values, linearity, and specificity of the VITROS VANC assay, (refer to the VITROS Chemistry Products VANC Reagent Instructions for Use for summaries of the results of these studies).

The table below lists the characteristics of the VITROS Chemistry Products VANC assay and the predicate device.

| Device<br>Characteristic | VITROS VANC Assay<br>(New device) | SYVA Emit 2000 Vancomycin Assay<br>(Predicate device) |
|--------------------------|-------------------------------------------|-------------------------------------------------------|
| Intended Use | Quantitative measurement of<br>vancomycin | Quantitative measurement of<br>vancomycin |
| Basic principle | Homogeneous enzyme<br>immunoassay | Homogeneous enzyme immunoassay |
| Reportable<br>Range | 5.0 - 50 µg/mL | 5.0 - 50 µg/mL |
| Reagents | Liquid ready to use | Liquid ready to use |
| Instrumentation | VITROS 5,1 FS Chemistry<br>System | SYVA-30R Biochemical System |
| Sample type | Serum and plasma | Serum and plasma |

#### 1.9 Comparison to predicate device: Performance Verifiers

The VITROS Chemistry Products TDM Performance Verifiers are identical in intended use, base matrix, storage and handling and instructions for use as the previously cleared VITROS Chemistry Products TDM Performance Verifiers (K042476). The labeling will be updated to add assigned values for yancomycin so that the TDM Performance Verifiers may be used with the VITROS Chemistry Products VANC assay.

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#### 1.10 Conclusions

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The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products VANC reagent, VITROS Chemistry Products Calibrator Kits 11, and the VITROS Chemistry Products TDM Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices. Equivalence to the predicates was demonstrated using a commercially available assay along with patient samples.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Carey A. Mayo, MS., RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. Regulatory Affairs MC00881 100 Indigo Creek Drive Rochester, NY 14626

Re: k043386

> Trade/Device Name: VITROS Chemistry Products VANC Reagent VITROS Chemistry Products Calibrator Kit 11 VITROS Chemistry Products TDM Performance Verifiers I, II, and III

FEB - 7 2005

Regulation Number: 21 CFR 862.3950 Regulation Name: Vancomycin test system Regulatory Class: Class II Product Code: LEH, DLJ, DIF Dated: December 8, 2004 Received: December 9, 2004

Dear Ms. Mayo:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices 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 devices, 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 devices are 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 devices 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 http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sean M. Cooper MS, DUM

Jean M. Cooper, MS. 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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### 2.0 Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

- 1. VITROS Chemistry Products VANC Reagent
Koy3386

- 2. VITROS Chemistry Products Calibrator Kit 11
- 3. VITROS Chemistry Products TDM Performance Verifiers I, II, and III

1. For in vitro diagnostic use only. VITROS Chemistry Products VANC Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure vancomycin (VANC) concentration in human serum and plasma. Serum or plasma vancomycin measurements are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.

- 2. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 11 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of vancomycin (VANC).
- For in vitro diagnostic use only. VITROS TDM Performance 3. Verifier is an assaved control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and VANC on VITROS Chemistry Systems.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C Benson
Division Sign-Off

Office of In Vitro Diagnostic

510(k) K043386

VITROS Chemistry Products VANC assay and Controls Ortho-Clinical Diagnostics, Inc.

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Prescription Use
(Part 21 CFR 801 Subpart D)

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