ROCHE ACETAMINOPHEN

K013757 · Roche Diagnostics Corp. · LDP · Jan 8, 2002 · Clinical Toxicology

Device Facts

• Record ID: K013757
• Device Name: ROCHE ACETAMINOPHEN
• Applicant: Roche Diagnostics Corp.
• Product Code: LDP · Clinical Toxicology
• Decision Date: Jan 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3030
• Device Class: Class 2

Intended Use

For the quantitative determination of toxic levels of acetaminophen in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

Device Story

In vitro diagnostic reagent system for quantitative measurement of acetaminophen in human serum or plasma. Used on automated clinical chemistry analyzers (Roche/Hitachi 911, 912, 917, and Modular P). Operates via automated clinical chemistry workflow; reagents react with patient sample to produce measurable signal proportional to acetaminophen concentration. Output is concentration value (μg/mL) provided to clinicians for diagnosis and treatment of acetaminophen overdose. Used in clinical laboratory settings by trained laboratory personnel.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (within-run, day-to-day, total CV%) and method comparison against the predicate. Method comparison (N=150) yielded R=0.999, Y = -0.31 + 0.987x, range 1.2 to 160.6 μg/mL. Precision studies showed CVs ranging from 0.5% to 9.9% across three levels.

Technological Characteristics

In vitro diagnostic reagent system for automated clinical chemistry analyzers. Quantitative colorimetric/enzymatic assay principle. Compatible with Roche/Hitachi 911, 912, 917, and Modular P analyzers. No specific materials of construction or software algorithm architecture details provided.

Indications for Use

Indicated for the quantitative determination of toxic levels of acetaminophen in human serum or plasma for patients suspected of acetaminophen overdose. Used on automated clinical chemistry analyzers.

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 Assay

Reference Devices

• Abbott TDx Acetaminophen assay

Submission Summary (Full Text)

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JAN 8 2002

## Roche Acetaminophen Assay

| 510(k) Summary |
|----------------|
|----------------|

**510(k) Summary**

*K013757*

**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.

| <b>1) Submitter name, address, contact</b> | Roche Diagnostics Corporation 9115 Hague Rd. Indianapolis, IN 46250 [phone] |
|--------------------------------------------|------------------------------------------------------------------------------------|
| Contact Person: | Mike Flis |
| Date Prepared: | November 9, 2001 |

| <b>2) Device name</b> | Roche Acetaminophen |
|-----------------------|---------------------|
|-----------------------|---------------------|

| <b>3) Predicate device</b> | We claim substantial equivalence to the COBAS INTEGRA Acetaminophen Assay. |
|----------------------------|----------------------------------------------------------------------------|
|----------------------------|----------------------------------------------------------------------------|

| <b>4) Device Description</b> | The Roche Acetaminophen assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of toxic levels of acetaminophen in human serum or plasma on automated clinical chemistry analyzers. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche Acetaminophen reagent kits. |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Continued on next page

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## 510(k) Summary, Continued

Y = -0.31 + 0.987x

Range = 1.2 to 160.6 ug/mL

Level 1

7.9

5.6

5.7

5.7

R =0.999

Precision:

Mean (μg/mL)

CV% (withinnun)

CV% (day to day)

CV% (total)

)

5) Intended use For the quantitative determination of toxic levels of acetaminophen in human serum or plasma on automated clinical chemistry analyzers.

6) Comparison to predicate device The Roche COBAS INTEGRA Acetaminophen was evaluated for several performance characteristics, including precision, lower detection limit, method comparison, specificity, and interfering substances. All of the evaluation studies gave acceptable results compared to the predicate device. These experiments provide evidence that the Roche Acetaminophen Assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Acetaminophen Assay. The following table presents the precision and method comparison results.

| | Roche Acetaminophen | Roche COBAS INTEGRA Acetaminophen, (Predicate) |
|--|-------------------------------------------------------------------------|------------------------------------------------|
| | Versus Roche COBAS INTEGRA Acetaminophen assay on the COBAS Integra 700 | Versus Abbott TDx Acetaminophen assay |
| | N = 150 | N=87 |
| | | Y=1.047x – 6.689 |

R=0.984

Level 1

9.9

న.8

3.7

7.5

Level 3

102.13

0:5

1.4

1.4

Level 2

34.83

1.2

1.0

ાં .ડ

Range = 0-234.7μg/mL

Level 2

32.9

0.9

4.0

4.4

Level 3

97.4

0.7

4.3

4.9

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Mike Flis Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

JAN 8 2002

Re: k013757

> Trade/Device Name: Roche Acetaminophen Assay Regulation Number: 21 CFR 862.3030 Regulation Name: Acetaminophen test system Regulatory Class: Class II Product Code: LDP Dated: November 9, 2001 Received: November 13, 2001

Dear Mr. Flis:

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) regulation (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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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## Roche Diagnostics Corporation

510(k) Number (if known): K013757 Device Name: Roche Acetaminophen Assay Indications for Use:

For the quantitative determination of toxic levels of acetaminophen in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of acctaminophen overdose.

-Off)
Division. Clinical Laboratory Devices
510(k) Number K013757

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use V (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)