ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10

K980031 · Diagnostic Chemicals , Ltd. · LDP · Mar 3, 1998 · Clinical Toxicology

Device Facts

• Record ID: K980031
• Device Name: ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: LDP · Clinical Toxicology
• Decision Date: Mar 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3030
• Device Class: Class 2

Intended Use

For the quantitative determination of acetaminophen in serum. For IN VITRO diagnostic use.

Device Story

The Acetaminophen Assay (ACE) is an in vitro diagnostic reagent kit used for the quantitative measurement of acetaminophen in human serum. It is intended for use in clinical laboratory settings to assist in the management of acetaminophen overdose and the assessment of potential hepatotoxicity or nephrotoxicity. The assay utilizes spectrophotometric principles to detect acetaminophen concentrations in serum samples. By providing rapid and reliable measurements, the device enables clinicians to identify toxic levels (typically >20 mg/dL) and initiate timely therapeutic interventions, such as the administration of N-acetylcysteine, within the critical 8-hour window post-ingestion to prevent severe hepatic damage. The assay is designed for professional use in emergency or clinical laboratory environments.

Clinical Evidence

No clinical data provided; the submission relies on the established performance of spectrophotometric methods for acetaminophen measurement.

Technological Characteristics

Spectrophotometric assay for in vitro diagnostic use. The device is a chemical reagent system designed for use on clinical chemistry analyzers. No specific materials, energy sources, or software algorithms are detailed in the provided documentation.

Indications for Use

Indicated for the quantitative determination of acetaminophen in serum to assist in the management of acetaminophen overdose and monitoring of therapeutic levels.

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

MAR - 3 1998

Karen Callbeck, R.T.B.Sc. Regulatory Affairs Coordinator Diagnostic Chemicals Limited West Royalty Industrial Park Charlottetown, PE Canada C1E, 1B0

Re : K980031 Acetaminophen Assay (ACE), Cataloque Number 503-10 Requlatory Class: ı i Product Code: LDP Dated: December 23, 1997 Received: January 5, 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 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 General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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 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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510(k) Number (if known):

Device Name: Acetaminophen Assay. (ACE)

## Indications for Use:

For the quantitative determination of acetaminophen in serum. For IN VITRO diagnostic use. 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).

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The management of acetaminophen overdose requires early recognition of the drug in the bloodstream. Toxicity is generally reported at concentrations over 20 mg/dL. N-acetylcysteine 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).

The majority of methods for measuring acetaminophen are based on spectrophotometric or chromatographic principles. Chromatographic methods are specific for the parent compound, however, they are not well suited to emergency laboratories. Spectrophotometric methods are simpler and more rapid, but do not always offer the desired specificity.

This spectrophotometric method is rapid, reliable, convenient, and specific for acetaminophen.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K980031

**Prescription Use**
(Per 21 CFR 801.109

OR

Over-The-Counter Use

(Optional Format 1-2-96)