VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;

K052645 · Ortho-Clinical Diagnostics · GTQ · Dec 14, 2005 · Microbiology

Device Facts

• Record ID: K052645
• Device Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873
• Applicant: Ortho-Clinical Diagnostics
• Product Code: GTQ · Microbiology
• Decision Date: Dec 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3720
• Device Class: Class 1

Intended Use

VITROS Chemistry Products Calibrator Kit 28: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 28 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of antistreptolysin O (ASO). VITROS Chemistry Products FS Calibrator 1: For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits 16, 17, 18, 19, and 28 to calibrate VITROS 5,1 FS Chemistry Systems. VITROS Chemistry Products ASO/RF Performance Verifier I and II: For in vitro diagnostic use only. VITROS Chemistry Products ASO/RF Performance Verifiers are assayed quality controls used to monitor the performance of VITROS ASO and RF Reagent on VITROS 5,1 FS Chemistry Systems.

Device Story

System comprises calibrators and assayed controls for VITROS 5,1 FS Chemistry Systems; used by laboratory professionals to ensure accurate quantitative measurement of antistreptolysin O (ASO) and Rheumatoid Factor (RF). Calibrator Kit 28 (aqueous solution with human serum, protein, salt) and FS Calibrator 1 (saline/water) calibrate system response. ASO/RF Performance Verifiers (lyophilized human serum-based controls) monitor reagent performance. Output used by clinicians to assess patient streptococcal infection status or rheumatoid conditions. Benefits include standardized, reliable diagnostic testing within clinical laboratory workflows.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Calibrator Kit 28: Aqueous solution, processed human serum, protein, inorganic salt, preservative. FS Calibrator 1: Processed water, 0.9% w/v sodium chloride. Performance Verifiers: Lyophilized processed human serum, purified human proteins, bovine serum albumin, preservative. Traceability: NIBSC 97/662. System: VITROS 5,1 FS Chemistry Systems.

Indications for Use

Indicated for in vitro diagnostic use to calibrate VITROS 5,1 FS Chemistry Systems for quantitative measurement of antistreptolysin O (ASO) and to monitor performance of ASO and Rheumatoid Factor (RF) reagents. Intended for professional clinical laboratory use.

Regulatory Classification

Identification

Streptococcus spp. exoenzyme reagents are devices used to identify antibodies to Streptococcus spp. exoenzyme in serum. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Streptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.

Predicate Devices

• VITROS Chemistry Products Calibrator Kit 16 (K041863)
• VITROS Chemistry Products FS Calibrator 1 (K041863)
• VITROS Chemistry Products RF Performance Verifiers I and II (K041863)

Submission Summary (Full Text)

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DEC 1 4 2005

## 5.0 510(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: 1052045

### 5.1 Submitter name, address, contact

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

#### 5.2 Date of Preparation:

9/23/05

### Device Proprietary Names: 5.3

| Trade Names | VITROS Chemistry Products Calibrator Kit 28 |
|-------------|----------------------------------------------------------------|
| | VITROS Chemistry Products FS Calibrator 1 |
| | VITROS Chemistry Products ASO/RF Performance Verifier I and II |
| Common Name | Antistreptolysin O calibrators and controls |

#### 5.4 Classification Names

Classification Name: Calibrator (21 CFR 862.1150): Class II

Classification Name: Quality Control material (assayed and unassayed) (21 CFR 862.1660): Class I: Reserved

#### ર્સ્ડ Predicate devices

The VITROS Chemistry Products Calibrator Kit 28, VITROS Chemistry Products FS Calibrator 1 and VITROS Chemistry Products ASO/RF Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 16, VITROS Chemistry Products FS Calibrator 1 and VITROS Chemistry Products RF Performance Verifiers I and II, respectively. The predicate devices were cleared by the FDA (K041863) for IVD use.

Ortho-Clinical Diagnostics, Inc. VITROS Calibrator Kit 28, VITROS FS Calibrator 1, and VITROS ASORF Performance Verificas Page 6 of 32

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#### 5.6 Device description

The quantitative measurement of antistreptolysin O is performed using the VITROS Chemistry Products ASO Reagent in conjunction with the VITROS Chemistry Products Calibrator Kit 28 and VITROS Chemistry Products FS Calibrator 1 on VITROS 5,1 FS Chemistry Systems. The FDA has classified Streptococcus spp. exoenzyme reagents (Sec. 866.3720) in Class I (general controls), therefore, the VITROS Chemistry Products ASO Reagent is exempt from premarket notification procedures in 21 CFR Part 807 Subpart E.

### VITROS Chemistry Products Calibrator Kit 28

VITROS Chemistry Products Calibrator Kit 28 is an aqueous solution containing processed human serum, protein, inorganic salt, and preservative.

### VITROS Chemistry Products FS Calibrator 1

VITROS Chemistry Products FS Calibrator 1 is composed of processed water and 0.9% w/v sodium chloride (Saline).

### VITROS Chemistry Products ASO/RF Performance Verifier I and II

VITROS Chemistry Products ASO/RF Performance Verifiers contain two levels of lyophilized assayed controls for use in monitoring performance of VITROS ASO and RF Reagents on VITROS 5,1 FS Chemistry Systems.

These controls are prepared from processed human serum to which purified human proteins, bovine serum albumin and preservative have been added. These controls are reconstituted with VITROS Chemistry Products FS Reconstitution Diluent that contains processed water.

#### 5.7 Device intended use

### VITROS Chemistry Products Calibrator Kit 28

For in vitro diagnostic use only.

VITROS Chemistry Products Calibrator Kit 28 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of antistreptolysin O (ASO).

### VITROS Chemistry Products FS Calibrator 1

For in vitro diagnostic use only.

VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits 16, 17, 18, 19, and 28 to calibrate VITROS 5,1 FS Chemistry Systems. continued on next page

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### VITROS Chemistry Products ASO/RF Performance Verifier I and II

For in vitro diagnostic use only

VITROS Chemistry Products ASO/RF Performance Verifiers are assayed quality controls used to monitor the performance of VITROS ASO and RF Reagent on VITROS 5,1 FS Chemistry Systems.

#### 5.8 Comparison to predicate device

The VITROS Chemistry Products Calibrator Kit 28, VITROS Chemistry Products FS Calibrator 1, and VITROS Chemistry Products ASO/RF Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 16, VITROS Chemistry Products FS Calibrator 1, and VITROS Chemistry Products RF Performance Verifiers I and II, respectively. These predicate devices were cleared by the FDA (K041863) for IVD use.

Tables 1, 2, and 3 provide similarities and differences between the new devices and predicate devices.

- Table 1 Table 1 lists the similarities and differences of the device characteristics between new device, VITROS Chemistry Products Calibrator Kit 28 and predicate device, VITROS Chemistry Products Calibrator Kit 16.

| Device<br>Characteristic | VITROS Calibrator Kit 28<br>New device #1 | VITROS Calibrator Kit 16<br>Predicate device #1 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only.<br>VITROS Chemistry Products<br>Calibrator Kit 28 is used in<br>conjunction with VITROS Chemistry<br>Products FS Calibrator 1 to calibrate<br>VITROS 5,1 FS Chemistry Systems<br>for the quantitative measurement of<br>antistreptolysin O (ASO). | For in vitro diagnostic use only.<br>VITROS Chemistry Products Calibrator<br>Kit 16 is used in conjunction with<br>VITROS Chemistry Products FS<br>Calibrator 1 to calibrate VITROS 5,1 FS<br>Chemistry Systems for the quantitative<br>measurement of rheumatoid factor (RF). |
| Fluid Matrix | Same | An aqueous solution |
| Analyte Levels | One level | Five levels |
| Analyte | Antistreptolysin O (ASO) | Rheumatoid factor (RF) |
| Traceability | NIBSC 97/6621 | NIBSC 64/22 |
| Format | Same | Liquid ready to use |

Continued on next page

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- Table 2 Table 2 lists the similarities and differences of the device characteristics between new device, VITROS Chemistry Products FS Calibrator Kit 1 and predicate device, VITROS Chemistry Products FS Calibrator Kit 1.

| Device<br>Characteristic | VITROS FS Calibrator Kit 1<br>New device #2 | VITROS FS Calibrator Kit 1<br>Predicate device #2 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For <i>in vitro</i> diagnostic use only<br>VITROS Chemistry Products FS<br>Calibrator 1 is used in conjunction<br>with VITROS Calibrator Kits 16, 17,<br>18, 19 and 28 to calibrate VITROS<br>5,1 FS Chemistry Systems. | For <i>in vitro</i> diagnostic use only<br>VITROS Chemistry Products FS<br>Calibrator 1 is used in conjunction with<br>VITROS Calibrator Kits 16, 17, 18 and<br>19 to calibrate VITROS 5,1 FS<br>Chemistry Systems. |
| Fluid Matrix | Same | Saline and processed water |
| Analyte Levels | Same | One level |
| Analyte | Antistreptolysin O (ASO) | Rheumatoid factor (RF) |
| Traceability | NIBSC 97/6621 | NIBSC 64/22 |
| Format | Same | Liquid ready to use |

- Table 3 Table 3 lists the similarities and differences of the device characteristics between new device, VITROS ASO/RF Performance Verifiers and predicate device, VITROS RF Performance Verifiers.

| Device<br>Characteristic | VITROS ASO/RF Performance<br>Verifiers I and II<br>New device #3 | VITROS RF Performance Verifiers I<br>and II<br>Predicate device #3 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only. VITROS<br>Chemistry Products ASO/RF Performance<br>Verifiers are assayed controls used to<br>monitor the performance of VITROS ASO<br>and RF Reagents on VITROS 5,1 FS<br>Chemistry Systems. | For in vitro diagnostic use only. VITROS<br>Chemistry Products RF Performance<br>Verifiers are assayed controls used to<br>monitor performance of VITROS RF<br>Reagent on VITROS 5,1 FS Chemistry<br>Systems. |
| Fluid Matrix | Same | A base matrix of processed human serum<br>to which purified human proteins, bovine<br>serum albumin and preservative have<br>been added. |
| Analyte Levels | Same | Low and High |
| Analyte | Antistreptolysin O and Rheumatoid factor | Rheumatoid factor |
| Format | Same | Lyophilized |

### ર. 9 Conclusions

The information presented in this premarket notification provide a reasonable assurance that the VITROS Chemistry Products Calibrator Kit 28 when used in conjunction with VITROS Chemistry Systems FS Calibrator 1 and the VITROS Chemistry Products ASO/RF Performance Verifiers I and II are safe and effective for the stated intended uses.

Continued on next page

Ortho-Clinical Diagnostics, Inc. VITROS Calibrator Kit 28, VITROS FS Calibrator 1, and VITROS ASO/RF Performance Verifiers Page 9 of 32

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Ortho-Clinical Diagnostics, Inc. believes that the VITROS Chemistry Products Calibrator Kit 28, VITROS Chemistry Products FS Calibrator 1, and VITROS Chemistry Products ASO/RF Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 16, VITROS Chemistry Products FS Calibrator 1, and VITROS Chemistry Products RF Performance Verifiers I and II, respectively. These predicate devices were cleared by the FDA (K041863) for IVD 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 stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

DEC 1 4 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Michael M. Byrne Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626-5101

Re: k052645

Trade/Device Name: VITROS Chemistry Products Calibrator Kit 28 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products ASO/RF Performance Verifier I and II Regulation Number: 21 CFR 862.1150

Regulation Name: Calibrator Regulatory Class: Class II Product Code: GTQ Dated: November 21, 2005 Received: November 22, 2005

Dear Mr. Byrne:

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/industry/support/index.html

Sincerely yours,

Sally a story

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K052645

VITROS Chemistry Products Calibrator Kit 28 Device Name: VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products ASO/RF Performance Verifiers I and

Indications For Use: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 28 is used in coniunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of antistreptolysin O (ASO).

For in vitro diagnostic use only.

VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits 16, 17, 18, 19, and 28 to calibrate VITROS 5,1 FS Chemistry Systems.

For in vitro diagnostic use only. VITROS Chemistry Products ASO/RF Performance Verifiers are assayed controls used to monitor the performance of VITROS ASO and RF Reagent on VITROS 5,1 FS 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)

Ney Catan
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) k052645