SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 by DIAGNOSTIC CHEMICALS LTD.

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. The test can be adapted to automated instruments resulting in rapid, accurate results required by physicians.

AI/ML Overview

The provided document is a 510(k) premarket notification letter for the Salicylate-SL Assay. It confirms the device's substantial equivalence to a predicate device and allows it to be marketed. However, this document does not contain the detailed acceptance criteria or the study data that would demonstrate the device meets those criteria.

A 510(k) clearance primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical efficacy studies akin to PMA (Premarket Approval) applications. While "performance" might be mentioned in the context of the device's mechanism, the letter does not include a table of acceptance criteria or reported device performance in the way a study report would.

Therefore, for your request, I can only extract limited information based on what is provided:

1. A table of acceptance criteria and the reported device performance:

Not provided in this document. The letter refers to the device being "substantially equivalent," which implies its performance is comparable to the predicate device, but specific metrics and acceptance criteria for that equivalence are not detailed here.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not provided in this document. The letter does not detail any specific test set or study design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not provided in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not provided in this document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an in vitro diagnostic assay, not an imaging AI device that would involve human readers interpreting images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable in the typical sense for AI algorithms. This is a laboratory assay. The "algorithm" here is the enzymatic reaction and measurement. The letter mentions it "can be adapted to automated instruments," implying standalone operation as a lab test, but no separate "standalone performance study" in the context of AI is discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not explicitly stated in this document. For an in vitro diagnostic device like this, ground truth would typically be established through a reference method or validated gold standard test for salicylate concentration in serum. The document mentions "Salicylate has been traditionally measured by the 'Trinder Reaction'," suggesting this might be the comparator for method development, but it doesn't specify how ground truth was established for the specific testing of this device.

8. The sample size for the training set:

Not provided in this document.

9. How the ground truth for the training set was established:

Not provided in this document.

Summary of Device and Indications:

Device Name: Salicylate-SL Assay
Indications for Use: For the quantitative determination of salicylate in serum. For IN VITRO diagnostic use.
Mechanism: Enzymatic assay based on the action of salicylate hydroxylase on salicylate and NADH, resulting in a decrease in absorbance proportional to the amount of salicylate present. This is designed to be more rapid, specific, and simplified than the traditional Trinder Reaction and adaptable to automated instruments.
Purpose: Rapid quantitation of salicylate is necessary for effective patient management in cases of salicylate overdose (due to accidental ingestion or attempted suicidal poisoning), which can lead to central nervous system disturbances, gastrointestinal tract issues, encephalopathy, and renal failure.

To obtain the detailed information about acceptance criteria and study data, one would typically need to review the full 510(k) submission, including the specific performance data sections, which are not part of this FDA clearance letter.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 7 9 1998

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

K981872 Re : Salicylate-SL Assay Requlatory Class: II Product Code: DKJ Dated: May 25, 1998 Received: May 28, 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. ਸੇ 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 requlation 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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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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "dsmo@fdadr.cdrh.fda.gov".

Sincerely yours,

Steven Autman

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-SL Assay _____________________________________________________________________________________________________________________________________________

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 accessibility leads to its implication in a large number of accidental ingestions by children and it is a common 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.

Carol C Benson/R. Alfred Montgomery

Division of Clinical Laboratory Devices
510(k) Number K981872

Prescription Use

Regulation Number and Section

§ 862.3830 Salicylate test system.

(a)
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.(b)
Classification. Class II.