ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.

K981059 · Diagnostic Chemicals , Ltd. · LDP · May 12, 1998 · Clinical Toxicology

Device Facts

• Record ID: K981059
• Device Name: ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: LDP · Clinical Toxicology
• Decision Date: May 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3030
• Device Class: Class 2

Intended Use

For the determination of acetaminophen in human serum. Acetaminophen (paracetamol) is used as an analgesic in many different formulations (1). While therapeutic doses rarely cause adverse side effects, the effect of long term treatment with acetaminophen is unclear. Cases have been reported where chronic excessive use of acetaminophen has led to hepatotoxicity and nephrotoxicity (2,3). In cases of acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated (4,5,6). The management of acetaminophen overdose requires early recognition of the drug in the bloodstream. Toxicity is generally reported at concentrations over 1324 umol/L (20 mg/dL). Nacetylcysteine has been used as an antidote in conjunction with intensive support care. Early diagnosis of acetaminophen-induced hepatotoxicity is important since initiation of therapy within 8 hours of ingestion lessens the potential for hepatic injury, and decreases the mortality rate (7). For quantitative, in vitro, diagnostic use.

Device Story

Acetaminophen-SL Assay is an in vitro diagnostic reagent system for quantitative measurement of acetaminophen in human serum. Used in clinical laboratory settings by trained personnel to detect drug concentrations; aids in early recognition of overdose and management of potential hepatotoxicity. Input: human serum sample. Principle: chemical assay for acetaminophen quantification. Output: numerical concentration value. Healthcare providers use results to guide clinical decisions regarding administration of antidotes like N-acetylcysteine and intensive supportive care. Benefits: early diagnosis of acetaminophen-induced toxicity, reducing hepatic injury and mortality.

Indications for Use

Indicated for the quantitative determination of acetaminophen in human serum for the management of acetaminophen overdose and monitoring of potential hepatotoxicity/nephrotoxicity.

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.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY | 2 1998

Karen Callbeck, R.T.B.Sc. . Diagnostic Chemicals Limited 16 First Street West Royalty Industrial Park Charlottetown, PE Canada C1E, 1B0

Re : K981059 Acetaminophen-SL Assay Requlatory Class: II Product Code: LDP Dated: March 19, 1998 Received: March 23, 1998

Dear Ms. Callbeck:

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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If vour 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ 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 Adminestration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 requlations.

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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/dsmamain.html".

Sincerely yours,
Steven Litman

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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Device Name: Acetaminophen-SL Assay

## Indications for Use:

For the determination of acetaminophen in human serum. Acetaminophen (paracetamol) is used as an analgesic in many different formulations (1). While therapeutic doses rarely cause adverse side effects, the effect of long term treatment with acetaminophen is unclear. Cases have been reported where chronic excessive use of acetaminophen has led to hepatotoxicity and nephrotoxicity (2,3). In cases of acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated (4,5,6).

The management of acetaminophen overdose requires early recognition of the drug in the bloodstream. Toxicity is generally reported at concentrations over 1324 umol/L (20 mg/dL). Nacetylcysteine has been used as an antidote in conjunction with intensive support care. Early diagnosis of acetaminophen-induced hepatotoxicity is important since initiation of therapy within 8 hours of ingestion lessens the potential for hepatic injury, and decreases the mortality rate (7).

For quantitative, in vitro, diagnostic use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Veronica I. Cairun for a Montgomery
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981059

**Prescription Use**
(Per 21 CFR 801.109

OR

Over-The-Counter Use

(Optional Format 1-2-96)