VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III

K060940 · Ortho-Clinical Diagnostics, Inc. · JIX · Apr 24, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060940
• Device Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Apr 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5, 1 FS Chemistry systems for the quantitative measurement of proteins in body fluids. VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, III are assayed controls used to monitor performance of protein measurements in body fluids with VITROS 5, 1 FS Chemistry systems.

Device Story

VITROS Chemistry Products Calibrator Kit 99 and AAT/HPT Performance Verifiers are processed human serum-based products containing inorganic salts, buffers, and preservatives. Calibrator Kit 99 provides a five-level set for system calibration; Performance Verifiers provide a three-level set for monitoring measurement performance. Used exclusively with VITROS 5, 1 FS Chemistry systems, these products support the quantitative immunoturbidimetric assay of alpha-1 antitrypsin and haptoglobin. The system uses these materials to establish and verify the accuracy of protein measurements in clinical laboratory settings. By ensuring proper calibration and control, the device enables healthcare providers to obtain reliable quantitative results for patient protein levels, facilitating clinical assessment of associated disease states.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Processed human serum matrix with added inorganic salts, buffers, and preservatives. Liquid, ready-to-use format. Five-level calibrator set; three-level control set. Standardized to BAM-IRMM-LGC ERM-DA 470 reference material. Designed for use with VITROS 5, 1 FS Chemistry systems (random access, fully automated clinical chemistry analyzer).

Indications for Use

Indicated for use as calibrators and assayed controls for the quantitative measurement of alpha-1 antitrypsin (AAT) and haptoglobin (HPT) in body fluids using VITROS 5, 1 FS Chemistry systems.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

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 the limitations in § 862.9.

Predicate Devices

• VITROS Chemistry Products Calibrator Kit 99 (K052819)
• VITROS Chemistry Products AAT Performance Verifiers I, II, and III (K052819)

Submission Summary (Full Text)

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### 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: 1000000

### Submitter name, address, contact 5.1

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester. New York 14626-5101 Telephone: [phone] Facsimile: [phone] Contact Person: Marlene Hanna

### Date of Preparation: April 5, 2006 5.2

#### Device Proprietary Names: 5.3

VITROS Chemistry Products Calibrator Kit 99 Trade Names:

VITROS Chemistry Products AAT/HPT Performance Verifier I, II, and III

Common Name: 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

### Predicate devices 5.5

The VITROS Chemistry Products Calibrator Kit 99 (new intended use), and VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 99 (current product), and VITROS Chemistry Products AAT Performance Verifiers I, II, and III respectively. The predicate devices were both previously cleared by the FDA (K052819) for IVD use.

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### 5.6 Device description

### VITROS Chemistry Products Calibrator Kit 99

VITROS Chemistry Products Calibrator Kit 99 is a five level set of fluids used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of 0,1-antitrypsin (AAT), and haptoglobin (HPT) using VITROS Chemistry Products AAT and HPT Reagents. VITROS Chemistry Products Calibrator Kit 99 is prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added.

## VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III

VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III is a three level set of assayed liquid controls used to monitor the performance of cx1-antitrypsin (AAT), and haptoglobin (HPT) measurements, using VITROS Chemistry Products AAT and HPT Reagents, respectively, with the VITROS 5,1 FS Chemistry Systems. The VITROS AAT/HPT Performance Verifiers are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added.

### 5.7 Device intended use

### VITROS Chemistry Products Calibrator Kit 99

For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of proteins in body fluids.

## VITROS Chemistry Products AAT/HPT Performance Verifier I, II, and III For in vitro diagnostic use only. VITROS Chemistry Products AAT/HPT Performance Verifiers are assayed controls used to monitor the performance of protein measurements in body fluids on VITROS 5,1 FS Chemistry Systems.

Continued on next page

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#### Comparison to predicate device 5.8

The VITROS Chemistry Products Calibrator Kit 99 (new intended use), and VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 99 (current product), and VITROS Chemistry Products AAT Performance Verifiers I, II and III, respectively. The predicate devices were both previously cleared by the FDA (K052819) for IVD use.

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

Table 1 lists the similarities and differences of the device characteristics between new device VITROS Chemistry Products Calibrator Kit 99 (new intended use) and predicate device, VITROS Chemistry Products Calibrator Kit 99 (current Product).

### TABLE 1

| Device | VITROS Calibrator Kit 99 | VITROS Calibrator Kit 99 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | (New intended use)<br>New Device#1 | (Current Product)<br>Predicate Device#1 |
| Intended Use<br>Statement | For in vitro diagnostic use only.<br>VITROS Chemistry Products<br>Calibrator Kit 99 is used to<br>calibrate VITROS 5,1 FS<br>Chemistry Systems for the<br>quantitative measurement of<br>proteins in body fluids. | For in vitro diagnostic use only.<br>VITROS Chemistry Products<br>Calibrator Kit 99 is used to<br>calibrate VITROS 5,1 FS<br>Chemistry Systems for the<br>quantitative measurement of α1-<br>antitrypsin (AAT). |
| Analytes | α₁-Antitrypsin(AAT),<br>Haptoglobin (HPT) | α₁-Antitrypsin (AAT) |
| Traceability | BAM-IRMM-LGC<br>(Bundesanstalt für<br>Materialforschung und -prüfung /<br>Institute for Reference Methods<br>and Materials / Laboratory of the<br>Government Chemist) ERM-<br>DA470 Reference Material¹ | BAM-IRMM-LGC<br>(Bundesanstalt für<br>Materialforschung und -prüfung /<br>Institute for Reference Methods<br>and Materials / Laboratory of the<br>Government Chemist) ERM-<br>DA470 Reference Material¹ |
| Number of levels | Five | Five |
| Format | Liquid ready to use | Liquid ready to use |
| Fluid Matrix | Processed human serum | Processed human serum |

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Table 2 lists the similarities and differences of the device characteristics between new device VITROS AAT/HPT Performance Verifiers and predicate device, VITROS AAT Performance Verifiers.

| Device<br>Characteristic | VITROS AAT/HPT Performance<br>Verifiers I, II and III<br>New device #2 | VITROS AAT Performance<br>Verifiers I, II, and III<br>Predicate device #2 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>Statement | For in vitro diagnostic use only.<br>VITROS Chemistry Products<br>AAT/HPT Performance Verifiers<br>are assayed controls used to<br>monitor performance of protein<br>measurements in body fluids with<br>VITROS 5,1 FS Chemistry<br>Systems. | For in vitro diagnostic use only.<br>VITROS Chemistry Products<br>AAT Performance Verifiers are<br>assayed controls used to<br>monitor performance of<br>VITROS AAT Reagents on<br>VITROS 5,1 FS Chemistry<br>Systems. |
| Analytes | α₁-Antitrypsin(AAT), Haptoglobin<br>(HPT) | α₁-Antitrypsin (AAT) |
| Number of<br>levels | Three | Three |
| Format | Liquid ready to use | Liquid ready to use |
| Fluid Matrix | Prepared from processed human<br>serum to which inorganic salts,<br>buffers, and preservatives have<br>been added. | Prepared from processed human<br>serum to which inorganic salts,<br>buffers, and preservatives have<br>been added. |

### ર . 9 Conclusions

The information presented in this premarket notification provide a reasonable assurance that the VITROS Chemistry Products Calibrator Kit 99 and the VITROS Chemistry Products AAT/HPT Performance Verifiers I, II and III are safe and effective for the stated intended uses.

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Ortho-Clinical Diagnostics, Inc. believes that the VITROS Chemistry Products Calibrator Kit 99 (new intended use), and VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 99 (current product), and VITROS Chemistry Products AAT Performance Verifiers I, II, and III respectively. The predicate devices were both previously cleared by the FDA (K052819) for IVD use.

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Image /page/4/Picture/1 description: The image shows a black and white logo. The logo is a circular seal with text around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 4 2006

Ortho-Clinical Diagnostics, Inc. c/o Ms. Marlenc Hanna Regulatory Affairs Manager 100 Indigo Creek Dr. Rochester, NY 14626-5101

Rc: k060940

Trade/Device Name: VITROS Chemistry Products Calibrator Kit 99 VITROS Chemistry Products AAT/HPT Performance Verifier I, II and III Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX, JJX Dated: April 5, 2006 Received: April 6, 2006

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) requlation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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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 FI>A 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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,

Zohut H. Becker/

Robert I .. Becker, Jr., M.D/, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# 4.0 Indications for Use Statement

_ . . . . . . ________________________________________________________________________________________________________________________________________________________________

| 510(k) Number<br>(if known): | K060940 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | VITROS Chemistry Products Calibrator Kit 99<br>VITROS Chemistry Products AAT/HPT Performance Verifier I, II, and III |
| Indications for Use: | For <i>in vitro</i> diagnostic use only.<br>VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS<br>5,1 FS Chemistry Systems for the quantitative measurement of proteins<br>in body fluids.<br><br>For <i>in vitro</i> diagnostic use only.<br>VITROS Chemistry Products AAT/HPT Performance Verifiers are assayed<br>controls used to monitor the performance of protein measurements in<br>body fluids on VITROS 5,1 FS Chemistry Systems. |

Over-The-Counter Use AND/OR Prescription Use ど (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

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

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Office of In Vitro Diagnostic Device Evaluction and Safety

Ks 60745

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