ROCHE ACETAMINOPHEN ASSAY

K110726 · Roche Diagnostics · LDP · Dec 23, 2011 · Clinical Toxicology

Device Facts

• Record ID: K110726
• Device Name: ROCHE ACETAMINOPHEN ASSAY
• Applicant: Roche Diagnostics
• Product Code: LDP · Clinical Toxicology
• Decision Date: Dec 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3030
• Device Class: Class 2

Intended Use

The Roche Acetaminophen assay is an in vitro test for the quantitative determination of toxic levels of acetaminophen in serum and plasma on Roche Cobas Integra, Roche/Hitachi and cobas c system analyzers. For in vitro diagnostic use only. For prescription use.

Device Story

Roche Acetaminophen assay is an enzymatic, colorimetric, end-point assay for quantitative determination of acetaminophen in serum/plasma. Input: patient serum/plasma samples. Operation: arylacylamidase enzyme cleaves acetaminophen amide bond to produce p-aminophenol and acetate; p-aminophenol reacts with o-cresol and periodate catalyst to form indophenol; colorimetric absorbance change measured on Roche Cobas Integra, Hitachi 917, or cobas c system analyzers. Output: quantitative drug concentration (μg/mL). Used in clinical laboratories by technicians/pathologists. Results used to assess potential toxicity and guide clinical management of overdose. Modification includes updated measuring range (15-500 μg/mL) and specific bilirubin/hemolysis/lipemia interference thresholds requiring mandatory serum index evaluation before result release.

Clinical Evidence

No clinical data. Bench testing only. Interference studies performed per CLSI EP7-A2 to evaluate effects of icterus (bilirubin), hemolysis (hemoglobin), and lipemia (intralipids) on acetaminophen recovery. Results established specific serum index thresholds for each analyzer to ensure <10% interference.

Technological Characteristics

Enzymatic end-point assay. Reagents: arylacylamidase (microbial), o-cresol, sodium periodate. Automated colorimetric detection. Compatible with Roche COBAS Integra, Roche/Hitachi, and cobas c system analyzers. Measuring range 15-500 µg/ml (varies by system).

Indications for Use

Indicated for the quantitative determination of toxic levels of acetaminophen in human serum or plasma for patients suspected of acetaminophen overdose.

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

• Roche Cobas Integra Acetaminophen (k991598)
• Roche Acetaminophen Assay (k013757)
• Cobas 6000 Series System (k060373)

Submission Summary (Full Text)

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K110726

## 510(k) Summary: Roche cobas 8000 Modular Analyzer Series (Revised 12-20-2011)

| Introduction | The information in this 510(k) Summary is being submitted in accordance<br>with the requirements of 21 CFR 807.92. |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>name, address,<br>contact | Roche Diagnostics<br>9115 Hague Rd<br>Indianapolis IN 46250<br><br>Contact person: Angelo Pereira<br>Phone: [phone]<br>Fax: [phone]<br>Email : [e-mail]<br><br>Date prepared: December 20, 2011 |
| Device Name | Proprietary name: Roche Acetaminophen assay<br><br>Common names: Enzymatic assay for the determination of acetaminophen<br><br>Classification names: Acetaminophen test system (21 CFR 862.3030).<br>Product code LDP |
| Predicate<br>Device | We claim substantial equivalence to the following predicate devices: Roche<br>COBAS Integra Acetaminophen assay (K991598), the Roche/Hitachi<br>Acetaminophen assay (K013757) and the cobas c501 Acetaminophen assay<br>(K060373). |
| Intended use /<br>Indications for<br>use | The Roche Acetaminophen assay is an in vitro test for the quantitative<br>determination of toxic levels of acetaminophen in serum and plasma on<br>Roche COBAS Integra, Roche/ Hitachi and cobas c system analyzers. |
| Device<br>Description | The Roche Diagnostics Acetaminophen assays under consideration in this<br>submission are the same assays as were cleared on the COBAS Integra in<br>K991598, Hitachi 917 in K013757 and cobas c501 in K060373 for the<br>quantitative determination of toxic levels of Acetaminophen in human serum<br>and plasma on automated clinical chemistry analyzers. The same reagents are<br>used on all three systems.<br>Acetaminophen is hydrolyzed by an arylacylamidase to yield p-aminophenol |

DEC 2 3 2011

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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 the sample.

The following tables illustrate the similarities and differences between the current Acetaminophen assays and the predicate assays

| Feature | Cobas c501<br>Acetaminophen | Cobas c501<br>Acetaminophen<br>(Predicate K060373) |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Indications for Use | In Vitro test for the<br>quantitative determination<br>of toxic levels of<br>acetaminophen in serum<br>and plasma on Roche/<br>Hitachi and cobas c systems | Same |
| Technology | Enzymatic- end point | Same |
| Sample types | Serum and plasma | Same |
| Calibrators | COBAS Integra calibrators | Same |
| Reagents | R1: Sodium periodote 3.75<br>mmol/L<br>R2: Arlyacylamidase<br>(microbial)≥7000U/L: o-<br>cresol 3.75 mmol/L | Same |
| Analytical Sensitivity | LoB 1.2 µg/ml<br>LoD 2.4 µg/ml<br>LoQ 15 µg/ml | Lower detection level<br>(LDL) 1.2 µg/ml |
| Measuring range | 15-500 µg/ml | 1.2-500 µg/ml |
| Interferences | Bilirubin interference at<br>Acetaminophen level of 15,<br>30 and 50 µg/ml | Bilirubin interference at<br>Acetaminophen level of<br>50µg/ml |

#### Table A- cobas c501

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## Table B- Hitachi 917

1

| Feature | Hitachi 917<br>Acetaminophen | Hitachi 917<br>Acetaminophen<br>(Predicate K060373) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Indications for Use | The Roche Acetaminophen<br>assay is for the quantitative<br>determination of toxic<br>levels of acetaminophen in<br>human serum or plasma on<br>automated clinical<br>chemistry analyzers | Same |
| Technology | Enzymatic- end point | Same |
| Sample types | Serum and plasma | Same |
| Calibrators | COBAS Integra calibrators | Same |
| Reagents | R1: Sodium periodote 3.75<br>mmol/L<br>R2: Arlyacylamidase<br>(microbial)≥7000U/L; o-<br>cresol 3.75 mmol/L | Same |
| Analytical Sensitivity | LoB 1.2 µg/ml<br>LoD 2.4 µg/ml<br>LoQ 15 µg/ml | Lower detection level<br>(LDL) 1.2 µg/ml |
| Measuring range | 15-500 µg/ml | 1.2-600 µg/ml |
| Interferences | Bilirubin interference at<br>Acetaminophen level of 15,<br>30 and 50 µg/ml. | Bilirubin interference at<br>Acetaminophen level of<br>50µg/ml |

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| Feature | COBAS Integra<br>Acetaminophen | COBAS Integra<br>Acetaminophen<br>(Predicate K991598) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Indications for Use | In Vitro test for the<br>quantitative determination<br>of toxic levels of<br>acetaminophen in serum or<br>heparinized plasma on<br>COBAS INTEGRA systems | Same |
| Technology | Enzymatic- end point | Same |
| Sample types | Serum and plasma | Same |
| Calibrators | COBAS Integra calibrators | Same |
| Reagents | R1: Arlyacylamidase<br>(microbial)≥7000U/L; o-<br>cresol 3.75 mmol/L<br>R2: Sodium periodote 3.75<br>mmol/L | Same |
| Analytical Sensitivity | LoB 1.2 µg/ml<br>LoD 2.4 µg/ml<br>LoQ 15.0 µg/ml | Lower detection level<br>(LDL) 0.7 µg/ml |
| Measuring range | 15-300 µg/ml | 0.7-300 µg/ml |
| Interferences | Bilirubin interference at<br>Acetaminophen level of 15,<br>30 and 50 µg/ml. | Bilirubin interference at<br>Acetaminophen level of<br>50µg/ml |

#### Table C – COBAS Integra 800

Conclusion The Acetaminophen assays are substantially equivalence to the following predicate devices: Roche COBAS Integra Acetaminophen assay (K991598), the Roche/Hitachi Acetaminophen assay (K013757) and the cobas c501 Acetaminophen assay (K060373). This submission included additional information on interference caused by bilirubin in order to help improve the safe and effective use of the products.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized representation of a human figure, possibly symbolizing health and well-being.

10903 New Hampshire Avenue Silver Spring, MD 20993

Roche Diagnostics c/o Angelo Pereira 9115 Hague Road Indianapolis, IN 46250-0416

DEC 2 3 2011

Re: k110726

> Trade Name: ROCHE ACETAMINOPHEN ASSAY Regulation Number: 21 CFR §862.3030 Regulation Name: Acetaminophen Test System Regulatory Class: Class II Product Codes: LDP Dated: December 7, 2011 Received: December 8, 2011

Dear Mr. Pereira:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...

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/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours.

\$

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: Roche Acetaminophen Assay

Indications For Use:

The Roche Acetaminophen assay is an in vitro test for the quantitative determination of toxic levels of acetaminophen in serum and plasma on Roche COBAS Integra, Roche/ Hitachi and cobas c system analyzers.

Prescription Use XXX

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 IF NEEDED)

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

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110726

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