COBAS INTEGRA ALP IFCC GEN.2

K033185 · Roche Diagnostics Corp. · CJE · Oct 14, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033185
• Device Name: COBAS INTEGRA ALP IFCC GEN.2
• Applicant: Roche Diagnostics Corp.
• Product Code: CJE · Clinical Chemistry
• Decision Date: Oct 14, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1050
• Device Class: Class 2

Intended Use

The cassettes COBAS Integra ALP IFCC Gen.2 Small (ALP2S) and COBAS Integra ALP IFCC Gen.2 Large (ALP2L) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the catalytic activity of alkaline phosphatase in human serum and plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Device Story

In vitro diagnostic reagent system for COBAS Integra clinical chemistry analyzers; utilizes colorimetric assay method per IFCC recommendations. Input: human serum or plasma samples. Principle: magnesium and zinc ions facilitate cleavage of p-nitrophenyl phosphate by alkaline phosphatase into phosphate and p-nitro-phenol; p-nitro-phenol concentration is directly proportional to catalytic ALP activity. Output: quantitative measurement of ALP activity (U/L). Used in clinical laboratory settings by trained technicians. Results assist physicians in diagnosing and monitoring liver, bone, parathyroid, and intestinal disorders.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control requirements; results met predetermined acceptance criteria confirming substantial equivalence.

Technological Characteristics

In vitro diagnostic reagent; dual-reagent (R2) format; citrate buffer system. Photometric assay principle. Designed for use on COBAS Integra automated clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of alkaline phosphatase (ALP) activity in human serum and plasma on COBAS Integra systems.

Regulatory Classification

Identification

An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Predicate Devices

• COBAS Integra ALP IFCC Assay (K981897)

Submission Summary (Full Text)

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OCT 1 4 2003

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K033185

## 510(k) Summary - COBAS Integra ALP IFCC Gen.2

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone]<br><br>Contact person: Sherri L. Coenen<br><br>Date prepared: September 29, 2003 |
| Device Name | Proprietary name: Roche Diagnostics COBAS Integra ALP IFCC Gen.2<br><br>Common name: Alkaline phosphatase Assay<br><br>Classification name: Alkaline phosphatase or isoenzymes test system |
| Device<br>description | The COBAS Integra ALP IFCC Gen.2 is a colorimetric assay for the<br>determination of the catalytic activity of alkaline phosphatase in serum or<br>plasma in accordance to the recommended reference method of the<br>International Federation of Clinical Chemists (IFCC). In the presence of<br>magnesium and zinc ions, p-nitrophenyl phosphate is cleaved by<br>phosphatases into phosphate and p-nitro-phenol. The p-nitro-phenol released<br>is directly proportional to the catalytic ALP activity. |
| Intended use | The cassettes COBAS Integra ALP IFCC Gen.2 Small (ALP2S) and COBAS<br>Integra ALP IFCC Gen.2 Large (ALP2L) contains an in vitro diagnostic<br>reagent system intended for use on COBAS Integra systems for the<br>quantitative determination of the catalytic activity of alkaline phosphatase in<br>human serum and plasma. Measurements of alkaline phosphatase or its<br>isoenzymes are used in the diagnosis and treatment of liver, bone,<br>parathyroid, and intestinal diseases. |

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# 510(k) Summary - COBAS Integra ALP IFCC Gen.2, continued

| Predicate<br>Device | We claim substantial equivalence to the currently marketed COBAS Integra<br>ALP IFCC Assay. (K981897). |
|---------------------|--------------------------------------------------------------------------------------------------------|
|---------------------|--------------------------------------------------------------------------------------------------------|

The following table describes the similarities and differences between the Reagent Summary COBAS Integra ALP IFCC Gen.2 and the predicate device.

| Topic | COBAS Integra ALP IFCC<br>(K981897) | COBAS Integra ALP IFCC Gen.2<br>(Modified Device) |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The cassettes COBAS Integra ALP<br>IFCC (ALPL2 and ALPL6) contain<br>an in vitro diagnostic reagent system<br>intended for use on COBAS Integra<br>systems for the quantitative<br>determination of the catalytic activity<br>of alkaline phosphatase in serum and<br>plasma. | The cassettes COBAS Integra ALP<br>IFCC Gen.2 Small (ALP2S) and<br>COBAS Integra ALP IFCC Gen.2<br>Large (ALP2L) contain an in vitro<br>diagnostic reagent system intended<br>for use on COBAS Integra systems<br>for the quantitative determination of<br>the catalytic activity of alkaline<br>phosphatase in serum and plasma. |
| | | |
| Method | colorimetric assay in accordance with<br>the recommended reference method<br>of the International Federation of<br>Clinical Chemistry (IFCC) | Same |
| Sample type | Serum<br>Heparin plasma | Same |
| Measuring<br>range | 2 - 1500 U/L | 2 - 1200 U/L |
| Expected<br>values | Measured at 37° C<br>Adults<br>Females: 35 - 104 U/L<br>Males: 40 - 129 U/L<br>Children<br>1 day: < 250 U/L<br>2 - 5 days: < 231 U/L<br>6 days - 6 months: < 449 U/L<br>7 months - 1 year: < 462 U/L<br>1 - 3 years: < 281 U/L<br>4 - 6 years: < 269 U/L<br>7 - 12 years: < 300 U/L<br>13 - 17 years (f): < 187 U/L<br>13 - 17 years (m): < 390 U/L | Same |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 4 2003

Ms. Sherri L. Coenen Regulatory Affairs Consultant Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

Re: k033185

> Trade/Device Name: COBAS Integra ALP IFCC Gen.2 Regulation Number: 21 CFR 862.1050 Regulation Name: Alkaline phosphatase or isoenzymes test system Regulatory Class: Class II Product Code: CJE Dated: September 29, 2003 Received: October 1, 2003

Dear Ms. Coenen:

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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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,

Steven Putman

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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### Indications for Use Statement

510(k) Number (if known): N/A

K033185

Device Name: COBAS Integra ALP IFCC Gen.2

Indications For Use:

The cassettes COBAS Integra ALP IFCC Gen.2 Small (ALP2S) and COBAS Integra ALP IFCC Gen.2 Large (ALP2L) contain an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the catalytic activity of alkaline phosphatase in human serum and plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Carol C. Benam/R. Jean Cooper. DVM
**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033185

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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)