(32 days)
To be determined at a later date.
Not Found
No
The description focuses on a biochemical assay and enzymatic reaction, with no mention of AI or ML terms or functionalities.
No
This device is for in vitro diagnostic use to quantify salicylate in serum, making it a diagnostic device, not a therapeutic one.
No
Explanation: The device is described as being for "IN VITRO diagnostic use" and provides a "method for salicylate determination" in serum, which indicates it is a reagent or assay kit used in a lab, not a device directly used on a patient for diagnosis.
No
The device description clearly indicates it is an "enzymatic Salicylate Assay" which is a chemical-based test, not a software application. It also mentions adaptation to "automated instruments," implying hardware components are involved.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For IN VITRO diagnostic use."
This statement is the primary indicator that the device is intended to be used outside of the body to examine specimens (like serum in this case) for diagnostic purposes. The description of the device and its function further supports this, as it describes a laboratory assay for measuring a substance in a biological sample.
N/A
Intended Use / Indications for Use
For the quantitative determination of salicylate in serum. For IN VITRO diagnostic use.
Product codes
DKJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
To be determined at a later date.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health and Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH HUMAN SERVICES USA" around the edge. In the center of the seal is a stylized image of a person with their arms outstretched.
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.
1
Page 2
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
2
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