ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30

K081938 · Genzyme Diagnostics P.E.I., Inc. · LDP · May 1, 2009 · Clinical Toxicology

Device Facts

• Record ID: K081938
• Device Name: ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
• Applicant: Genzyme Diagnostics P.E.I., Inc.
• Product Code: LDP · Clinical Toxicology
• Decision Date: May 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3030
• Device Class: Class 2

Intended Use

For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity. Excessive amounts of acetaminophen leads to hepatotoxicity and nephrotoxicity. In acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated.

Device Story

The Acetaminophen L3K® Assay is an in vitro diagnostic reagent kit for the quantitative measurement of acetaminophen in human serum and plasma. The device utilizes an enzymatic colorimetric method involving aryl acylamidase to hydrolyze acetaminophen, followed by an oxidative coupling reaction with 2,5-dimethylphenol to produce a measurable color change. The intensity of the color is proportional to the concentration of acetaminophen in the sample. The assay is intended for use in clinical laboratory settings by trained personnel. Healthcare providers use the resulting quantitative values to assess the severity of acetaminophen overdose, monitor for potential hepatotoxicity and nephrotoxicity, and guide clinical treatment decisions. The assay provides a rapid diagnostic tool to identify patients at risk of severe hepatic damage or failure, facilitating timely medical intervention.

Clinical Evidence

No clinical data. Performance established via bench testing on the Hitachi 717 analyzer. Precision studies (n=40 runs) showed total CV% between 0.6% and 2.9%. Linearity evaluated across 11 concentrations (slope 0.993). Method comparison against predicate (n=88 samples) yielded a correlation coefficient of 0.9998, slope 1.063, and y-intercept 7.0 μmol/L. Matrix comparison (n=25 matched serum/plasma sets) showed high correlation (r=0.9999). Analytical specificity testing confirmed no significant interference from common endogenous substances or therapeutic drugs.

Technological Characteristics

Two-part liquid reagent system. R1: buffer (pH 8.6), MnCl2, aryl acylamidase, surfactant, preservatives. R2: sodium carbonate buffer (pH 12.2), 2,5-dimethylphenol, surfactant, preservatives. Principle: enzymatic hydrolysis followed by oxidative coupling colorimetry. Standalone diagnostic assay for use on clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative measurement of acetaminophen in serum and plasma to aid in the diagnosis and treatment of acetaminophen overdose toxicity in patients suspected of acetaminophen ingestion.

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

• Genzyme Diagnostics P.E.I. Inc. (K042330)

Submission Summary (Full Text)

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K081938

**MAY**

- 1 2009

Acetaminophen L3K® Assay

# Product Cat. No. 506-10 & 506-30

# 510(K) SUMMARY

Introduction: 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.

Genzyme Diagnostics P.E.I. Inc. Submitter: 70 Watts Avenue Charlottetown, P.E.I. Canada C1E 2B9 (Tel:) [phone] (Fax:) [phone]

Contact Person: Penny White

Date Prepared: June 1, 2008

Acetaminophen L3K® Assay Device Name: Tradename: FDA Regulation Name: 862.3030 Colorimetry, Acetaminophen FDA Product Code: LDP

Predicate Device: Genzyme Diagnostics P.E.I. Inc. (K042330)

Device Description: For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity. Excessive amounts of acetaminophen leads to hepatotoxicity and nephrotoxicity. In acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated.

> Reagent is a two-part liquid in plastic bottles packaged in the appropriate box.

Intended Use For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acctaminophen is used in the diagnosis and treatment of scycre liver damage caused by overdose toxicity. Excessive amounts of acetaminophen leads to hepatotoxicity and nephrotoxicity. In acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated. For IN VITRO diagnostic use.

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## Comparison to Predicate Device:

## Description of the Item Being Compared:

For the In Vitro quantitative measurement

Acetaminophen Enzyme Reagent (R1): buffer (pH 8.6 at 25 ℃ ) 0.2 mmol/L MnCl2 . 4H2O, ≥ 0.9 KU/L Acyl Amidohydrolase, surfactant, preservatives.

Acetaminophen Color Reagent (R2): 0.1 mol/L sodium carbonate buffer (pH 12.2 at 25 ℃ ), 30 mmol/L 8-hydroxyquinolinc-5-sulfonic acid, surfactant, preservatives.

Acetaminophen Standard: buffer (pH 5.0 at 25 ℃ ), 1000μmol/L (15.1 mg/dL) acetaminophen, preservatives.

#### Similaries:

The submission device and the predicate device have the same intended use.

The submission device and the predicate device both use Aryl Acylamidase enzyme method in acetaminophen measurement.

The submission device and the predicate device have the same oxidative coupling method.

# Differences:

The predicate device uses a different chromophore in the oxidative coupling reaction during color development.

The predicate devices uses 8 hydroxyquinoline and the submission device uses 2,5 dimethylphenol.

Comments on Substantial Equivalence:

Testing results demonstrate that the Acetaminophen L3K® Assay is equivalent to the predicate device. Method comparison results provided the following:

#### Serum

Deming regression using NCCLS EP9-A2.

A comparison was made between this method and a similar acetaminophen method using 100 samples in serum ranging from 26 to 2361 @mol/L. The correlation coefficient was 0.9999. Deming regression analysis gave the following equation:

This method = 1.060(reference method) + 4.6 @mol/L

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Confidence interval is 95%. Correlation coefficient is 0.9999. The amount of scatter around the estimate regression line is 8.9. The approach is not different from the predicate device.

# Plasma

A comparison was made between serum and plasma using 25 samples ranging from 30 to 2441 umol/L. The correlation coefficient was 0.9999. Linear regression analysis gave the following equation:

This method (plasma) = 0.999 [This method (serum)] -2.2 umol/L

Genzyme Diagnostics P.E.I. Inc. Acetaminophen L3K® Assay is Conclusion: substantially cquivalent in principle and performance to the predicate product.

> Penny White Regulatory Affairs Coordinator Genzyme Diagnostics P.E.I. Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

MAY - 1 2009

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Genzyme Diagnostics P.E.I. Inc. c/o Ms. Penny J. White Regulatory Affairs Coordinate 70 Watts Avenue Charlottetown, Prince Edward Island Canada C1E 2B9

Re: k081938

> Trade/Device Name: Acetaminophen L3K Assay Regulation Number: 21 CFR 862.3030 Regulation Name: Acetaminophen test system Regulatory Class: Class II Product Code: LDP Dated: April 8, 2009 Received: April 27, 2009

Dear Ms. White:

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 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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Page - 2

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial cquivalence 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), 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 device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/industry/support/index.html.

Sincerely yours,

A.C.H

Courtney C. Harper, Ph.D. 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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# Indication for Use

510(k) Number (if known): k081938

Device Name: Acetaminophen L3K Assay

Indication For Use:

For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Lucy Phillips

Office of In Vitro Diagnostic Device Evaluation and Safety

4081938 510(k)