VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II

K042643 · Ortho-Clinical Diagnostics, Inc. · DCF · Nov 18, 2004 · Immunology

Device Facts

• Record ID: K042643
• Device Name: VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: DCF · Immunology
• Decision Date: Nov 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5040
• Device Class: Class 2

Intended Use

VITROS Chemistry Products mALB Reagent: For in vitro diagnostic use only. VITROS Chemistry Products mALB Reagent is used to quantitatively measure albumin concentration in human urine (mALB). VITROS Chemistry Products Calibrator Kit 24: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 24 is used to calibrate VITROS 5, 1 FS Chemistry Systems for the quantitative measurement of albumin in urine (mALB). VITROS Chemistry Products mALB Performance Verifiers I and II: For in vitro diagnostic use only. VITROS Chemistry Products mALB Performance Verifiers are assayed controls used to monitor the performance of mALB Reagent on VITROS 5, 1 FS Chemistry Systems.

Device Story

VITROS Chemistry Products mALB Reagent, Calibrator Kit 24, and Performance Verifiers I and II are used on the VITROS 5,1 FS Chemistry System; a fully automated clinical chemistry analyzer. The system processes human urine samples using immunoturbidimetry to determine albumin concentration. The analyzer combines liquid reagents with samples to perform the assay. Results are provided to clinicians to assist in diagnosing diabetic nephropathy, hypertension, and cardiovascular disease. The system is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Precision evaluated per NCCLS EP5-A (within-lab CV 0.73-3.28%). Linearity confirmed across 0.6-19.0 mg/dL per NCCLS EP6-A. Specificity tested per NCCLS EP7-A against 20+ endogenous/exogenous substances; minor bias noted for furosemide and sulfamethoxazole. Method comparison (n=61) against predicate showed y = 0.93x + 0.03, r=0.977. Reference range established per NCCLS C28 using 129 healthy subjects.

Technological Characteristics

Liquid, dual-chambered reagent kit. Principle: immunoturbidimetric assay. Energy: spectrophotometric (340 nm). Instrumentation: VITROS 5, 1 FS Chemistry System. Traceability: IRMM/IFCC CRM 470. Reagents contain goat anti-sera to human albumin, polymers, and surfactants. Software: embedded in VITROS 5, 1 FS system for automated analysis and calibration curve storage.

Indications for Use

Indicated for quantitative measurement of human urine albumin (mALB) to aid in the diagnosis of diabetic nephropathy, hypertension, and cardiovascular disease. For prescription use on VITROS 5, 1 FS Chemistry Systems.

Regulatory Classification

Identification

An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

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 § 866.9.

Predicate Devices

• N Antiserum to Human Albumin assayed on the Dade Behring BN ProSpec System (K972929)
• VITROS Chemistry Products Performance Verifiers I and II (K041720)

Submission Summary (Full Text)

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# NOV 1 8 2004

### 3.0 510(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: _ KO 2 2 4 3

#### 3.1 Submitter name, address, contact

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

Contact Person: Darlene J. Phillips

#### 3.2 Date of Preparation:

September 24, 2004

#### 3.3 Device Proprietary Names:

VITROS Chemistry Products mALB Reagent Trade Names VITROS Chemistry Products Calibrator Kit 24 VITROS Chemistry Products mALB Performance Verifiers I and II Common Name Microalbumin assay

#### 3.4 Classification Names

Classification Name: Albumin immunological test system (866.5040): Class: II (Special controls)

Classification Name: Calibrator (862.1150): Class II The Clinical Chemistry and Toxicology Panel of the FDA has placed calibrators in Class II.

Classification Name: Quality Control material (assayed and unassayed) (862.1660): Class I: The Clinical Chemistry and Toxicology Panel of the FDA has placed Quality Control material (assayed and unassayed) for clinical chemistry in Class I. Since this device is an assayed control, it meets the reserved criteria under Section 510(1) of the Food, Drug, and Cosmetic Act.

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#### 3.5 Predicate device

- 3.5.1 The VITROS Chemistry Products mALB Reagent and VITROS Chemistry Products Calibrator Kit 24 are substantially equivalent to the N Antiserum to Human Albumin assayed on the Dade Behring BN System.
- 3.5.2 The VITROS Chemistry Products mALB Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Performance Verifiers I and II.

#### 3.6 Device description

The VITROS 5,1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS System is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.

The system is comprised of four main elements:

- The VITROS 5,1 FS Chemistry System instrumentation, which provides automated 1 use of the chemistry reagents. The VITROS 5,1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
- 2 The VITROS Chemistry Products MicroTip range of fiquid reagent products (in this case VITROS Chemistry Products mALB Reagent, VITROS Chemistry Products Calibrator Kit 24 and VITROS Chemistry Products mALB Performance Verifiers I and II), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS mALB assay.
- The VITROS Chemistry Products Thin Film range of dry products, which are dry, 3 multilayered, analytical elements, coated on polyester supports. The thin film products each have their own 510(k) clearance numbers and were cleared for market for use on the VITROS 5,1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers''. The required information was provided in the VITROS 5,1 FS Chemistry System premarket notification (K031924).
- 4. Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2).

The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

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#### 3.7 Device intended use

#### 3.7.1 VITROS Chemistry Products mALB Reagent

For in vitro diagnostic use only. VITROS Chemistry Products mALB Reagent is used to quantitatively measure albumin concentration in human urine (mALB).

#### 3.7.2 VITROS Chemistry Products Calibrator Kit 24

For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 24 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of albumin.

#### 3.7.3 VITROS Chemistry Products mALB Performance Verifiers I and II

For in vitro diagnostic use only. VITROS Chemistry Products mALB Performance Verifiers are assayed controls used to monitor the performance of mALB Reagent on VITROS 5,1 FS Chemistry Systems.

#### 3.8 Comparison to predicate device

- 3.8.1 The VITROS Chemistry Products mALB Reagent and VITROS Chemistry Products Calibrator Kit 24 are substantially equivalent to the N Antiserum to Human Albumin assay on the Dade Behring BN ProSpec System (predicate device) which was cleared by the FDA (K972929) for IVD use.
The relationship between the VITROS mALB assay and the predicate device, determined by the Passing & Bablock linear regression is:

VITROS mALB assay = 0.93x + 0.03

with a correlation coefficient of 0.977,

where X is the result for the N Antiserum to Human Albumin assay on the Dade Behring BN ProSpec System.

In addition to the above mentioned correlation studies were performed to determine the precision, analytical sensitivity, specificity and expected values of the VITROS mALB assay, (refer to VITROS mALB Reagent Instructions For Use in Section 8 for summaries of the results of these studies).

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| Table 1 | Table 1 lists the characteristics of the VITROS mALB assay (new device) and the Dade N |
|---------|----------------------------------------------------------------------------------------|
| | Antiserum to Human Albumin assay (predicate device). |

| Device<br>Characteristic | VITROS mALB assay<br>(New Device) | Dade Albumin assay<br>(Predicate Device) |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only.<br>VITROS Chemistry Products mALB<br>Reagent is used to quantitatively<br>measure albumin concentration in<br>human urine (mALB). | In vitro diagnostic reagents for the<br>quantitative determination of albumin<br>in human urine using the BN<br>Systems. |
| Method | Immunoturbidimetry | Rate nephelometry |
| Reportable Range | 0.6 to 19.0 mg/dL | 0.0 to 34.0 mg/dL |
| Instrumentation | VITROS 5,1 FS Chemistry Systems | Dade Behring BN ProSpec Systems |
| Sample type | Urine | Urine |
| Reactive Ingredient | Goat anti-sera to human albumin | Rabbit antiserum to human albumin |

3.8.2 The VITROS Chemistry Products mALB Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Performance Verifiers (predicate device) which were cleared by the FDA (K041720) for IVD use.

- Table 2 lists the similarities and differences of the device characteristics between the VITROS Table 2 mALB Performance Verifiers with the predicate device, VITROS Performance Verifiers I and II.

| Device<br>Characteristic | New device | Predicate device |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only.<br>VITROS Chemistry Products mALB<br>Performance Verifiers are assayed<br>controls used to monitor the<br>performance of mALB Reagents on<br>VITROS 5,1 FS Chemistry Systems. | For in vitro diagnostic use only.<br>VITROS Performance Verifier is<br>an assayed control used to<br>monitor performance on VITROS<br>Chemistry Systems. |
| Fluid Matrix | A base matrix of processed human<br>serum to which inorganic salt,<br>buffers, protein, surfactant and<br>preservative have been added. | A base matrix of freeze-dried<br>human serum to which enzymes,<br>electrolytes, stabilizers,<br>preservatives and other organic<br>analytes have been added. |
| Analyte Levels | Low and High | Low and High |

#### 3.9 Conclusions

The data presented in the premarket notification provide a reasonable assurance that the VITROS mALB assay and the VITROS Chemistry Products mALB 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 commercially available reagents along with patient samples.

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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 & Human Services. The logo consists of a stylized eagle or bird-like symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged in a circular fashion around the left side of the emblem.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 18 2004

Ms. Darlene J. Phillips, RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626-5101

Re: k042643

> Trade/Device Name: VITROS Chemistry Products mALB Reagent VITROS Chemistry Products Calibrator Kit 24 VITROS Chemistry Products mALB Performance Verifiers I and II Regulation Number: 21 CFR 866.5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Code: DCF, JJX, JIT Dated: September 24, 2004 Received: September 27, 2004

Dear Ms. Phillips:

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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### Page 2

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/dsma/dsmamain.html.

Sincerely yours.

Jean M. Cooper US. Div.

Tean 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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# 1.0 Indications for Use

| 510(k) Number (if known): | K042643 |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | VITROS Chemistry Products mALB Reagent<br>VITROS Chemistry Products Calibrator Kit 24<br>VITROS Chemistry Products mALB Performance Verifiers I and II |
| Indications for Use: | For <i>in vitro</i> diagnostic use only.<br>VITROS Chemistry Products mALB Reagent is used to quantitatively measure albumin concentration in human urine (mALB). Measurement of urinary albumin aids in the diagnosis of diabetic nephropathy, hypertension and cardiovascular disease.<br><br>For <i>in vitro</i> diagnostic use.<br>VITROS Chemistry Products Calibrator Kit 24 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of albumin in urine (mALB).<br><br>For <i>in vitro</i> diagnostic use only.<br>VITROS Chemistry Products mALB Performance Verifiers are assayed controls used to monitor the performance of mALB Reagent on VITROS 5,1 FS Chemistry Systems. |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | ✓ AND/OR Over-The-Counter Use<br>(21 CFR 807 Subpart C) |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

and the comments of the comments of the country of the country of the country of the country of the country of the country of the country of the country of the country of the

Carol Benam

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

210(K) Koy2663

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