COBAS INTEGRA ACETAMINOPHEN

K991598 · Roche Diagnostics Corp. · LDP · Jul 22, 1999 · Clinical Toxicology

Device Facts

• Record ID: K991598
• Device Name: COBAS INTEGRA ACETAMINOPHEN
• Applicant: Roche Diagnostics Corp.
• Product Code: LDP · Clinical Toxicology
• Decision Date: Jul 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3030
• Device Class: Class 2

Intended Use

The cassette COBAS INTEGRA Acetaminophen contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the quantitative determination of toxic levels of acetaminophen in human serum or heparinized plasma.

Device Story

The COBAS INTEGRA Acetaminophen assay is an in vitro diagnostic reagent system used on the COBAS INTEGRA 700 analyzer. It measures acetaminophen levels in human serum or heparinized plasma. The assay uses an enzymatic reaction where acetaminophen is hydrolyzed by arylacylamidase to produce p-aminophenol and acetate. p-aminophenol is then converted to indophenol using o-cresol and a periodate catalyst. The analyzer measures the resulting colorimetric change in absorbance. The system calculates the change in absorbance units (ΔΑ/min) and uses a linear least squares regression analysis on calibrators to determine drug concentration. Results are used by clinicians to assess acetaminophen toxicity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Enzymatic colorimetric assay; utilizes arylacylamidase, o-cresol, and periodate catalyst. Operates on COBAS INTEGRA 700 analyzer. Measures absorbance change (ΔΑ/min).

Indications for Use

Indicated for the quantitative determination of toxic levels of acetaminophen in human serum or heparinized plasma for clinical diagnostic use.

Regulatory Classification

Identification

An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

Predicate Devices

• COBAS INTEGRA Acetaminophen (K954992)

Submission Summary (Full Text)

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JUL 222 1999

1991598

## 510(k) Summary

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter name, address, contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis, IN 46250<br>[phone]<br>Contact person: Lisa M. Gerard<br>Date prepared May 7, 1999 |
| 2) Device name | Proprietary name: COBAS INTEGRA Acetaminophen<br>Common name: Enzymatic assay for the determination of acetaminophen<br>Classification name: Acetaminophen test system |
| 3) Predicate device | We claim substantial equivalence to the COBAS INTEGRA Acetaminophen (K954992). |

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## 510(k) Summary, Continued

4) Device The Roche COBAS INTEGRA Acetaminophen assay contains an in vitro description diagnostic reagent system intended for use on the COBAS INTEGRA 700 analyzer for the quantitative determination of toxic levels of acetaminophen in human serum or heparinized plasma.

> The COBAS INTEGRA Acetaminophen assay determinations are made on the COBAS INTEGRA 700 analyzer using an enzymatic reaction. Acetaminophen is hydrolyzed by an arylacylamidase to yield p-aminophenol and acetate. Subsequently the p-aminophenol is converted to an indophenol in the presence of o-cresol and a periodate catalyst. The production of indophenol is followed colorimetrically.

The change in absorbance is directly proportional to the quantitative drug concentration in serum.

The COBAS INTEGRA 700 analyzer calculates the change in absorbance units (ΔΑ/min). After ΔΑ/min values have been calculated for the calibrators, the system calculates a best-fit curve for the calibrators using a linear least squares regression analysis. The concentration of drug in each sample is then interpolated from this curve using its measured AA/min value.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 222 1999

Ms. Lisa M. Gerard Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 50457

Re: Kodi 200

> Trade Name: Roche COBAS INTEGRA Acetaminophen Regulatory Class: II Product Code: LDP Dated: May 7, 1999 Received: May 10, 1999

Dear Ms. Gerard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Autman

Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

| 510(k) Number (if known): | K991598 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | COBAS INTEGRA Acetaminophen |
| Indications for Use: | The cassette COBAS INTEGRA Acetaminophen contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the quantitative determination of toxic levels of acetaminophen in human serum or heparinized plasma. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use <span style="text-decoration: overline;">/</span> (Per 21 CFR 801.109) | OR Over-the-Counter Use ______ |
|-----------------------------------------------------------------------------------------|--------------------------------|
| (Optional format 1-2-96) | |

(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number: K991598

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