ACETAMINOPHEN-SL ASSAY

K042330 · Diagnostic Chemicals , Ltd. · LDP · Jan 7, 2005 · Clinical Toxicology

Device Facts

• Record ID: K042330
• Device Name: ACETAMINOPHEN-SL ASSAY
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: LDP · Clinical Toxicology
• Decision Date: Jan 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3030
• Device Class: Class 2

Intended Use

The Diagnostic Chemicals Limited’s Acetaminophen-SL Assay is an in vitro diagnostic device intended to measure acetaminophen levels in human serum or plasma (lithium heparin). Such measurements are used in the diagnosis of acetaminophen toxicity and overdose. This assay consists of two reagents and a calibrator. This assay is for prescription use only.

Device Story

In vitro diagnostic assay; measures acetaminophen concentration in human serum or lithium heparin plasma. Principle: acyl amidohydrolase cleaves acetaminophen to p-aminophenol and acetate; p-aminophenol reacts with 8-hydroxyquinoline-5-sulfonic acid and manganese ions to form 5-(4-iminophenol)-8-quinolone. Device produces colorimetric output measured via spectrophotometry at 615 nm; absorbance is directly proportional to acetaminophen concentration. Used in clinical laboratories on automated chemistry analyzers or generic spectrophotometers. Results assist clinicians in diagnosing acetaminophen toxicity and overdose.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Quantitative colorimetric assay. Reagents: acyl amidohydrolase, manganese, 8-hydroxyquinoline-5-sulfonic acid, stabilizers, preservatives. Detection: spectrophotometric absorbance at 615 nm. Compatible with automated chemistry analyzers or generic spectrophotometers. No specific materials of construction or software algorithms described.

Indications for Use

Indicated for the quantitative measurement of acetaminophen in human serum or plasma (Lithium heparin) to aid in the diagnosis of acetaminophen toxicity and 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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN - 7 2005

Ms. Marlene Walker Director of Quality Systems Diagnostic Chemicals Limited West Royalty Industrial Park 16 McCarville Street Charlottetown, PE Canada C1E 2A6

k042330 Re:

Trade/Device Name: Acetaminophen-Sl Assay, Cat. No. 505-10, 505-30 Regulation Number: 21 CFR 862.3030 Regulation Name: Acetaminophen test system Regulatory Class: Class II Product Code: LDP Dated: December 17, 2004 Received: December 22, 2004

Dear Ms. Walker;

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ills letter will anow you to oegin marketing of substantial equivalence of your device to a legally prematics notification: "The PDT Intentig gour device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, 11 you desire specific morniation assusting of your device, please contact the Office of In of questions on the promotion and Safety at [phone]. Also, please note the v in o Diagnostic Device Devilance and many and to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may other 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,

Camelia B. Rooks

Cornelia B. Rooks, MA 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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## Indications for Use

k042330 510(k) Number (if known):

Device Name: Acetaminophen-SL Assay, Cat. No. 505-10, 505-30

Indications For Use:

The Diagnostic Chemicals Limited's Acetaminophen-SL Assay is an in vitro diagnostic device intended to measure acetaminophen levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of acetaminophen toxicity and overdose. This assay consists of two reagents and a calibrator.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Carol C Ben
Division Sign-off

Offici of in the

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