(56 days)
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. 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. 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. The test can be adapted to automated instruments resulting in rapid, accurate results required by physicians.
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.
This document is a 510(k) clearance letter for a Salicylate Assay (ACE) device. It is a communication from the FDA to the manufacturer, indicating that the device has been deemed substantially equivalent to a legally marketed predicate device. This type of document typically does not contain detailed study results or acceptance criteria in the format requested, as it focuses on regulatory clearance rather than a scientific publication of performance data.
However, based on the provided text, I can extract the intent of the device and the type of assay it is, and infer what would typically be tested for such devices. Since the full study details are not present, I will indicate where information is "Not provided in the document" or "Inferred from device type."
Device Name: Salicylate Assay (ACE), Catalogue Number 501-71
Indications for Use: For the quantitative determination of salicylate in serum. For IN VITRO diagnostic use.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred for quantitative IVD assay) | Reported Device Performance (Not provided in this document) |
|---|---|
| Accuracy/Bias: Closeness of measured value to true value (e.g., % bias within a certain range). | Not provided in this document. |
| Precision: Reproducibility of measurements (e.g., %CV within a certain range for intra-assay, inter-assay). | Not provided in this document. |
| Linearity/Reportable Range: Range over which measurements are directly proportional to concentration (e.g., R^2 > 0.99 for a specific concentration range). | Not provided in this document. |
| Limit of Detection (LoD): Lowest concentration that can be reliably detected. | Not provided in this document. |
| Limit of Quantitation (LoQ): Lowest concentration that can be reliably quantified with acceptable accuracy and precision. | Not provided in this document. |
| Interference: Absence of significant bias from common endogenous or exogenous substances (e.g., hemolysis, lipemia, common drugs). | Not provided in this document. |
| Specificity: Ability to measure only the target analyte (salicylate) without cross-reactivity from other substances. | The document explicitly states: "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." This implies improved specificity over the traditional Trinder reaction. Specific numerical performance for specificity is not provided. |
| Method Comparison: Agreement with a reference method or predicate device (e.g., correlation coefficient > 0.95, Bland-Altman analysis). | Not provided in this document, but general substantial equivalence to a predicate device is the basis of the 510(k) clearance. |
| Stability: Performance maintained over time for reagents and controls. | Not provided in this document. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not provided in this document. Clinical performance data would typically be submitted with the 510(k) but is not part of this clearance letter.
- Data Provenance: Not provided in this document.
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 applicable/Not provided. For an in vitro diagnostic (IVD) assay like this, ground truth for performance studies is typically established by reference methods (e.g., HPLC-MS/MS, a validated predicate device, or other highly accurate laboratory methods) rather than expert interpretation of images or clinical opinions. The "experts" would be the scientists or clinical chemists performing the reference assays and validating the results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation where multiple readers assess and a consensus is reached), not for quantitative IVD assays where numerical results are compared to a reference standard.
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 is an in vitro diagnostic device for chemical analysis (salicylate in serum), not an AI-assisted diagnostic imaging device or a device involving human readers/interpreters in that sense. Therefore, an MRMC study related to human reading improvement with AI is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device, being an automated enzymatic assay, intrinsically operates in a "standalone" fashion in terms of its analytic performance. The algorithm (or enzymatic reaction and spectrophotometric measurement) produces a quantitative result. Clinical interpretation of that result by a healthcare professional is a separate step, but the device's performance itself is a standalone measurement. The document implies it can be "adapted to automated instruments," suggesting its core function is independent of continuous human intervention during the measurement process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For an in vitro diagnostic quantitative assay like this, the ground truth would most likely be established by a reference method (e.g., Gas Chromatography-Mass Spectrometry (GC-MS), High-Performance Liquid Chromatography (HPLC), or a well-established and validated predicate assay that serves as a gold standard for salicylate measurement).
8. The sample size for the training set
- Not provided in this document. As this is not an AI/machine learning device in the modern sense (it's an enzymatic chemical assay), the concept of a "training set" for an algorithm isn't directly applicable in the same way. Performance validation involves testing samples with known concentrations, but this isn't a "training set" for an AI model.
9. How the ground truth for the training set was established
- Not applicable in the context of an AI training set. For an enzymatic assay, the "ground truth" for method development and validation would be established by preparing samples with precisely known concentrations of salicylate (e.g., spiked samples) or by running patient samples in parallel with a highly accurate reference method.
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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 (770) 488-7655.
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 (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 "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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
§ 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.