VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4

K023875 · Ortho-Clinical Diagnostics, Inc. · CIX · Dec 10, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023875
• Device Name: VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: CIX · Clinical Chemistry
• Decision Date: Dec 10, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1035
• Device Class: Class 2

Intended Use

VITROS Chemistry Products ALB Slides For in vitro diagnostic use only. VITROS ALB Slides quantitatively measure albumin (AL concentration in serum and plasma. VITROS Calibrator Kit 4 For in vitro diagnostic use only. VITROS Calibrator Kit 4 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.

Device Story

VITROS Chemistry Products ALB Slides are multi-layered analytical elements used with VITROS Chemistry System instrumentation to perform quantitative albumin measurements. The system accepts serum or plasma samples; reactions occur within the slide's multi-layered element. The device utilizes reflectance spectrophotometry to measure albumin concentration. The system is intended for in vitro diagnostic use in clinical laboratory settings. Healthcare providers use the quantitative albumin results to assess patient health, including conditions like dehydration, malnutrition, liver disease, and renal protein loss. The modified slide reduces sample volume requirements and reactive ingredient quantities compared to the predicate, while maintaining the same basic principle, reportable range, and instrumentation compatibility.

Clinical Evidence

Bench testing only. Performance was demonstrated using manufactured slides tested with patient and quality control samples spanning the assay range to confirm substantial equivalence to the predicate device.

Technological Characteristics

Dry, multilayered analytical slide; reflectance spectrophotometry sensing principle; serum/plasma sample type; 5.5 µL sample volume; 125.4 µg bromcresol green dye per slide; 37°C incubation at ~5 minutes; compatible with VITROS 250, 500, 750, and 950 Series Analyzers.

Indications for Use

Indicated for the quantitative measurement of albumin concentration in human serum and plasma for diagnostic purposes.

Regulatory Classification

Identification

An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Predicate Devices

• VITROS Chemistry Products ALB Slides (K812030)
• VITROS Chemistry Products Calibrator Kit 4 (K922072)

Submission Summary (Full Text)

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### 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: KOQ 3875

- 1. Submitter Ortho-Clinical Diagnostics, Inc. name, 100 Indigo Creek Drive address, Rochester, New York 14626-5101 contact [phone]
Contact Person: Marlene A. Hanna

- Date Special 510(k) prepared: November 20, 2002 2. Preparation date
- 3. Device Trade or Proprietary Name: name VITROS Chemistry Products ALB Slides VITROS Chemistry Products Calibrator Kit 4 Common Name Classification Name: Albumin test system ( 21 CFR 862.1035).
- 4. Predicate The VITROS Chemistry Products ALB Slides (modified) and VITROS device Chemistry Products Calibrator Kit 4 are substantially equivalent to the VITROS Chemistry Products ALB Slides (current slide) and VITROS Chemistry Products Calibrator Kit 4.

Continued on next page

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### 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 ALB Slides, VITROS Chemistry Products Calibrator Kit 4, which are combined by the VITROS Chemistry System to perform the VITROS ALB 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 ALB Slides intended For in vitro diagnostic use only. use VITROS ALB Slides quantitatively measure albumin (ALB) concentration in serum and plasma.
VITROS Calibrator Kit 4 For in vitro diagnostic use only. VITROS Calibrator Kit 4 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.

Continued on next page

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## 510(k) Summary, Continued

The VITROS Chemistry Products ALB Slide (modified) and VITROS 7. Comparison to predicate Chemistry Products Calibrator Kit 4 are substantially equivalent to VITROS Chemistry Products ALB Slide and VITROS Chemistry Products Calibrator device Kit 4 which were cleared by the FDA for in vitro diagnostic use. ALB Slide: (K812030, Cleared August 3, 1981) Calibrator Kit 4: (K922072, July 19, 1992).

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

### Table 1 List of Slide Characteristics: Comparison to Predicate Device

| Device<br>Characteristic | New Device<br>VITROS ALB Slide | Predicate Device<br>VITROS ALB Slide |
|----------------------------------------------------------------------|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| | (Modified) | (Current) |
| Sample volume | 5.5 µL | 10 µL |
| Quantity of<br>Reactive<br>Ingredients per<br>slide (test) | Bromcresol green dye: 125.4 µg | Bromcresol green dye: 250 µg |
| Concentrations of<br>Slide Reactive<br>Ingredients per<br>cm-squared | No Change. | Bromcresol green: 139.4 µg /cm² |
| Intended Use | No change. | For in vitro diagnostic use only.<br>VITROS ALB Slides quantitatively measure<br>albumin concentration in serum and plasma. |
| Basic principle | No Change. | Dry, multilayered slide utilizing reflectance<br>spectrophotometry |
| Sample type | No Change. | Serum , plasma |
| Reportable Range<br>Serum, Plasma | No Change. | 1.0 - 6.00 g/ dL (Conv. Units)<br>10.0 - 60.0 g/L (SI Units)<br>152 - 912 µmol/L (Alternate Units) |
| Instrumentation | No Change. | VITROS 250, 500, 750 and 950 Series Analyzers |
| Incubation time<br>and temperature | No Change. | Approximately ,5 minutes at 37°C |

Continued on next page

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# 510(k) Summary, Continued

The information presented in the pre-market notification demonstrates that the 8. Conclusions performance of the VITROS ALB 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 albumin values spanning the assay range.

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

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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 and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the caduceus symbol.

Food and Drug Administratio 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

Re: . k023875

> Trade/Device Name: VITROS Chemistry Products ALB Slides/ VITROS Chemistry Products Calibrator Kit 4

Regulation Number: 21 CFR § 862.1035 Regulation Name: Albumin test system Regulatory Class: II Product Code: CIX: JIX 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.

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#### 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 (QS) 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Statement of Intended Use

**Page 1 of 1**

510(k) Number (if known):

Summary and Explanation of

Test:

Device Name:

Intended Use:

K023875

VITROS Chemistry Products ALB Slides VITROS Chemistry Products Calibrator Kit 4

VITROS Chemistry Products ALB Slides For in vitro diagnostic use only. VITROS ALB Slides quantitatively measure albumin (AL concentration in serum and plasma.

VITROS Calibrator Kit 4 For in vitro diagnostic use only. VITROS Calibrator Kit 4 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.

Of all serum proteins, albumin is present in the highest concentration. It maintains the plasma oncotic pressure and the transport of many substances. Increased serum albumin may indicate dehydration or hyperinfusion with albumin; a decrease is found in rapid hydration, overhydration, severe malnutrition and malabsorbtion, severe diffuse liver necrosis, chronic active hepatitis, and neoplasia. Albumin is commonly reduced in chronic alcoholism, pregnancy, renal protein loss, thyroid dysfunction, peptic ulcer disease, and chronic inflammatory disease. '

(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 B Jean Cooper
(Division Sign-Off)
Division: Common Laboratory Devices

| 510(k) Number: | K023875 |
|----------------|---------|
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| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
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(Optional Format 1-2-96)