SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71

K980032 · Diagnostic Chemicals , Ltd. · DKJ · Mar 2, 1998 · Clinical Toxicology

Device Facts

• Record ID: K980032
• Device Name: SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: DKJ · Clinical Toxicology
• Decision Date: Mar 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3830
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

For the quantitative determination of salicylate in serum. For IN VITRO diagnostic use. Salicylate is a common drug used for its analgesic and anti-inflammatory properties. Its accessability leads to its implication in a large number of accidental ingestions by children and it is a popular choice among adults and adolescents for attempted suicidal poisoning. (1) Salicylate overdose results in disturbances of the central nervous system and the gastrointestinal tract as well as encephalopathy and renal failure. It represents an acute medical emergency and rapid quantitation of the drug is necessary for effective patient management. (2) Salicylate has been traditionally measured by the "Trinder Reaction" which is based on the interaction between salicylate and ferric ions. This test however is not specific and requires extraction or centrifugation which inhibit the automation of the test. This enzymatic Salicylate Assay provides a rapid, specific and simplified method for salicylate determination. It is based on the action of salicylate hydroxylase on salicylate and NADH which results in a decrease in absorbance proportional to the amount of salicylate present. (3) The test can be adapted to automated instruments resulting in rapid, accurate results required by physicians.

Device Story

The Salicylate Assay (ACE) is an in vitro diagnostic reagent kit for the quantitative measurement of salicylate in serum. It is designed for use in clinical laboratories on automated chemistry analyzers. The assay utilizes an enzymatic reaction involving salicylate hydroxylase, which acts on salicylate and NADH. The reaction produces a decrease in absorbance that is directly proportional to the concentration of salicylate in the sample. This enzymatic method replaces the traditional, non-specific 'Trinder Reaction' that required manual extraction or centrifugation. By enabling automation, the assay provides rapid and accurate results to clinicians, facilitating the management of acute salicylate overdose, which can cause CNS disturbances, gastrointestinal issues, encephalopathy, and renal failure. The output is a quantitative salicylate concentration value used by physicians to guide emergency medical treatment.

Clinical Evidence

No clinical data provided. The submission relies on the analytical performance of the enzymatic assay method compared to traditional chemical methods.

Technological Characteristics

Enzymatic assay using salicylate hydroxylase; measures decrease in NADH absorbance; compatible with automated clinical chemistry analyzers; in vitro diagnostic reagent.

Indications for Use

Indicated for the quantitative determination of salicylate in serum for patients suspected of salicylate overdose or toxicity, including children, adolescents, and adults.

Regulatory Classification

Identification

A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR - 2 1998

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

Re: K980032 Salicylate Assay (ACE), Catalogue Number 501-71 Requlatory Class: II Product Code: DKJ December 18, 1997 Dated: 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 Requlations, Title 21, Parts 800 to 895. ਕਿ 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 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 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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Salicylate Assay (ACE)

## Indications for Use:

For the quantitative determination of salicylate in serum. For IN VITRO diagnostic use. Salicylate is a common drug used for its analgesic and anti-inflammatory properties. Its accessability leads to its implication in a large number of accidental ingestions by children and it is a popular choice among adults and adolescents for attempted suicidal poisoning. (1)

Salicylate overdose results in disturbances of the central nervous system and the gastrointestinal tract as well as encephalopathy and renal failure. It represents an acute medical emergency and rapid quantitation of the drug is necessary for effective patient management. (2)

Salicylate has been traditionally measured by the "Trinder Reaction" which is based on the interaction between salicylate and ferric ions. This test however is not specific and requires extraction or centrifugation which inhibit the automation of the test.

This enzymatic Salicylate Assay provides a rapid, specific and simplified method for salicylate determination. It is based on the action of salicylate hydroxylase on salicylate and NADH which results in a decrease in absorbance proportional to the amount of salicylate present. (3) The test can be adapted to automated instruments resulting in rapid, accurate results required by physicians.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical oxiratory E.
510(k) Number: K980032

Prescription Use (Per 21 CFR 801.109

OR

Over-The-Counter Use

Optional Format 1-2-96)