VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II

K042838 · Ortho-Clinical Diagnostics, Inc. · JIT · Dec 9, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042838
• Device Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Dec 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 23 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of prealbumin. For in vitro diagnostic use only. VITROS Chemistry Products PALB Performance Verifiers are assayed controls used to monitor the performance of PALB Reagent on VITROS 5,1 FS Chemistry Systems.

Device Story

VITROS Chemistry Products Calibrator Kit 23 and PALB Performance Verifiers are liquid, ready-to-use reagents for clinical chemistry analyzers. Calibrator Kit 23 provides five levels of processed human serum with added inorganic salts, buffers, and preservatives to calibrate prealbumin measurements. PALB Performance Verifiers provide two levels of assayed controls to monitor reagent performance. Used in clinical laboratory settings by trained technicians. Output is used by the VITROS 5,1 FS system to ensure accurate quantitative measurement of prealbumin, aiding clinicians in assessing patient nutritional status or inflammatory states.

Clinical Evidence

No clinical data. Bench testing only. Stability established via real-time data; traceability established to CRM 470 (RPPHS).

Technological Characteristics

Liquid, ready-to-use processed human serum matrix with inorganic salts, buffers, and preservatives. Calibrator Kit 23: 5 levels. PALB Performance Verifiers: 2 levels (Low/High). Traceability: CRM470. Designed for use on VITROS 5,1 FS Chemistry Systems.

Indications for Use

Indicated for use as a calibrator and quality control material for the quantitative measurement of prealbumin on VITROS 5, 1 FS Chemistry Systems in a clinical laboratory setting.

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 17 (hsCRP) and VITROS hsCRP Performance Verifiers (k041799)

Submission Summary (Full Text)

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# DEC - 9 2004

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## 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.

and the comments of the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the con

The assigned 510(k) number is:

#### Submitter name, address, contact 3.1

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:

October 13, 2004

### 3.3 Device Proprietary Names:

| Trade Names | VITROS Chemistry Products Calibrator Kit 23<br>VITROS Chemistry Products PALB Performance Verifier I and II |
|-------------|-------------------------------------------------------------------------------------------------------------|
| Common Name | Prealbumin calibrator and controls |

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#### 3.4 Classification Names

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.

### 3.5 Predicate devices

The VITROS Chemistry Products Calibrator Kit 23 and VITROS Chemistry Products PALB Performance Verifiers are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 17 and VITROS Chemistry Products hsCRP Performance Verifiers, respectively. The predicate devices were cleared by FDA (K041799) for IVD use.

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#### 3.6 Device description

### VITROS Chemistry Products Calibrator Kit 23

VITROS Chemistry Products Calibrator Kit 23 is a liquid ready use kit containing five levels for the calibration of VITROS 5,1 FS Chemistry Systems for the quantitative measurement of prealbumin.

These calibrators are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added.

### VITROS Chemistry Products PALB Performance Verifiers I and II

VITROS Chemistry Products PALB Performance Verifiers contain two levels of liquid ready to use assayed controls for use in monitoring performance of PALB Reagents on VITROS 5,1 FS Chemistry Systems.

These controls are prepared from processed human serum to which inorganic salt, buffers and preservative have been added.

### 3.7 Device intended use

### VITROS Chemistry Products Calibrator Kit 23

For in vitro diagnostic use only

VITROS Chemistry Products Calibrator Kit 23 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of prealbumin.

### VITROS Chemistry Products PALB Performance Verifiers I and II

For in vitro diagnostic use only

VITROS Chemistry Products PALB Performance Verifiers are assayed controls used to monitor the performance of PALB Reagent on VITROS 5,1 FS Chemistry Systems.

### 3.8 Comparison to predicate device

The VITROS Chemistry Products Calibrator Kit 23 and VITROS Chemistry Products PALB Performance Verifiers are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 17 and VITROS Chemistry Products hsCRP Performance Verifiers, respectively. The predicate devices were cleared by the FDA (K041799) for IVD use,

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

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- Table 1 lists the similarities and differences of the device characteristics between new device, Table 1 VITROS Chemistry Products Calibrator Kit 23 and predicate device, VITROS Chemistry Products Calibrator Kit 17.

| Device<br>Characteristic | VITROS Calibrator Kit 23<br>New device | VITROS Calibrator Kit 17<br>Predicate device |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only.<br>VITROS Chemistry Products<br>Calibrator Kit 23 is used to calibrate<br>VITROS 5,1 FS Chemistry Systems<br>for the quantitative measurement of<br>prealbumin (PALB). | For in vitro diagnostic use only.<br>VITROS Chemistry Products Calibrator<br>Kit 17 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 C-reactive protein (CRP<br>using VITROS hsCRP Reagent. |
| Fluid Matrix | A base matrix of processed human<br>serum to which inorganic salts,<br>buffers, and preservatives have been<br>added. | A base matrix of stabilized human serum<br>to which analytes and preservatives have<br>been added |
| Analyte Levels | Five levels | Single level |
| Analyte | Prealbumin (transthyretin) | C-reactive protein |
| Traceability | CRM470 | Same |
| Format | Liquid ready to use | Same |

Table 2 Table 2 lists the similarities and differences of the device characteristics between new device, VITROS PALB Performance Verifiers and predicate device, VITROS hsCRP Performance Verifiers

| Device<br>Characteristic | VITROS PALB Performance<br>Verifiers<br>New device#2 | VITROS hsCRP Performance<br>Verifiers<br>Predicate device#2 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only.<br>VITROS Chemistry Products PALB<br>Performance Verifiers are assayed<br>controls used to monitor the<br>performance of PALB Reagent on<br>VITROS 5,1 FS Chemistry Systems. | For in vitro diagnostic use only. VITROS<br>Chemistry Products hsCRP Performance<br>Verifiers are assayed controls used to<br>monitor performance of hsCRP Reagent<br>on VITROS 5,1 FS Chemistry Systems. |
| Fluid Matrix | A base matrix of processed human<br>serum to which inorganic salt,<br>buffers and preservative have been<br>added. | A base matrix of human plasma and<br>plasma proteins to which stabilizers and<br>preservative have been added. |
| Analyte Levels | Low and High | Low, Medium and High |
| Analyte | Prealbumin (transthyretin) | C-reactive protein |
| Format | Liquid ready to use | Same |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 9 2004

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

k042838 Re:

Trade/Device Name: VITROS Chemistry Products Calibrator Kit 23 · VITROS Chemistry Products PALB Performance Verifiers I and II Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, JJX Dated: October 13, 2004 Received: October 14, 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. Iisting 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 (OS) 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/dsma/dsmamain.html.

Sincerely yours,

Cornelia B. Lorks

Cornelia B. Rooks, MA Acting 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<br>(if known): | K042838 | | |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|----------------------|
| Device Name: | VITROS Chemistry Products Calibrator Kit 23<br>VITROS Chemistry Products PALB Performance Verifiers I and II | | |
| Indications for Use: | For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit<br>23 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative<br>measurement of prealbumin.<br><br>For in vitro diagnostic use only. VITROS Chemistry Products PALB<br>Performance Verifiers are assayed controls used to monitor the performance<br>of PALB Reagent on VITROS 5,1 FS Chemistry Systems. | | |
| Prescription Use | X | AND/OR | Over-The-Counter Use |
| (Part 21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) | |

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

:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042838

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