(122 days)
The Bayer ADVIA IMS Salicylate method is an in vitro diagnostic device intended to measure salicylate levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of salicylate toxicity and overdose.
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Here's a breakdown of the acceptance criteria and study details for the Salicylate method for ADVIA® IMS™, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating "equivalence" to the predicate device, the Abbott/TDx Salicylate assay. The reported device performance is compared against the predicate in terms of correlation and imprecision.
| Acceptance Criteria (Implicit) | Reported Device Performance (ADVIA IMS Salicylate) |
|---|---|
| Imprecision (Total CV%) | |
| Comparable to predicate device across various salicylate levels. | Level 4.8 mg/dL: 9.6% |
| Level 32.1 mg/dL: 2.7% | |
| Level 64.6 mg/dL: 2.5% | |
| (Predicate for reference: 7.5 mg/dL: 4.48%; 30 mg/dL: 2.95%; 60 mg/dL: 2.98%) | |
| Correlation to Predicate Device | |
| Regression equation close to Y=X (slope ~1, intercept ~0) and high correlation coefficient (R value close to 1). | Serum vs. Abbott/TDx: Y=0.997X - 1.39, R = 0.996 |
| Low Syx (standard error of the estimate). | Serum vs. Abbott/TDx: Syx = 2.88 mg/dL |
| Plasma vs. Serum Correlation | |
| Regression equation close to Y=X and high correlation coefficient (R value close to 1). | Plasma(y) vs. Serum(x): Y=0.985X + 0.00, R = 0.988 |
| Low Syx. | Plasma(y) vs. Serum(x): Syx = 2.73 mg/dL |
| Interfering Substances | |
| Minimal effect (% change) from common interfering substances. | Bilirubin (unconjugated 25 mg/dL): 0.0% change |
| Bilirubin (conjugated 25 mg/dL): 0.0% change | |
| Hemoglobin (1000 mg/dL): +6.0% change | |
| Lipids (Triglycerides 500 mg/dL): +7.0% change | |
| Analytical Range | |
| Defined and consistent with intended use. | 0 to 120 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Sizes:
- Correlation (Serum vs. Abbott/TDx): N = 47
- Correlation (Plasma vs. Serum): N = 49
- Imprecision and Interfering Substances: Specific sample size for these tests is not explicitly stated as 'N' values for individual runs but implies multiple measurements for statistical evaluation.
- Data Provenance: Not explicitly stated. It is common for these types of studies to be conducted internally by the manufacturer or a contract research organization. Given it's a diagnostic assay, the samples would likely be human serum and plasma. The country of origin and whether it's retrospective or prospective are not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of diagnostic assay, measuring specific analyte concentrations, does not typically involve human experts for establishing ground truth in the same way an image analysis algorithm would. The "ground truth" for the test set is established by:
- Reference Method Measurement: The Abbott/TDx Salicylate assay serves as the comparator (predicate device), and its measurements are used as the reference for correlation.
- Known Concentrations: For imprecision and interfering substances, samples are likely spiked with known concentrations of salicylate and/or interfering substances.
Therefore, the concept of "experts" and their qualifications as described for image analysis is not fully applicable here.
4. Adjudication Method for the Test Set
Not applicable. As explained above, the ground truth is based on quantitative measurements from a reference method or known concentrations, not subjective expert judgment requiring adjudication.
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 a standalone in-vitro diagnostic method for measuring a chemical analyte, not an AI-assisted diagnostic tool that aids human readers in interpreting complex data (like medical images).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, this study represents a standalone performance evaluation. The ADVIA IMS Salicylate method is an automated assay that provides a quantitative measurement of salicylate levels. Its performance is assessed independently against a predicate device and established analytical criteria, without a human "reading" the final output beyond interpreting the numerical result.
7. The Type of Ground Truth Used
The ground truth used is primarily:
- Reference Method Comparability: Measurements from the legally marketed predicate device (Abbott/TDx Salicylate) serve as the comparative ground truth for evaluating correlation.
- Known Concentrations: For imprecision and interference studies, samples are likely prepared with precisely known concentrations of salicylate and interfering substances.
8. The Sample Size for the Training Set
Not applicable. This is a chemical assay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The method relies on established chemical reaction principles and calibration curves rather than learning from a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The assay's analytical performance (linearity, sensitivity, specificity) is based on its chemical design and optimization, which would involve internal development and validation using various control materials and known concentrations to establish calibration and performance characteristics.
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JUL 1 1 2002
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Salicylate method for ADVIA® IMSTM
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is: HO20794
1. Intended Use
This in-vitro diagnostic method is intended to measure salicylate in human serum and plasma (lithium heparin as the anticoagulant) on ADVIA IMS. Measurements of salicylate are used in the diagnosis, monitoring and treatment of salicylate toxicity and overdose.
Predicate Device 2.
| Product Name | Reagent Part # | Calibrator Part # |
|---|---|---|
| Abbott/TDx Salicylate | 953369 | 953302 |
3. Device / Method
| Product Name | Reagent Part # | Calibrator Part # |
|---|---|---|
| Bayer ADVIA IMS Salicylate | 08319802 | 04120475 |
Imprecision (Serum)
| ADVIA IMS | |
|---|---|
| Level(mg/dL) | TotalCV(%) |
| 4.8 | 9.6 |
| 32.1 | 2.7 |
| 64.6 | 2.5 |
| Abbott/TDx | |
|---|---|
| Level(mg/dL) | TotalCV(%) |
| 7.5 | 4.48 |
| 30 | 2.95 |
| 60 | 2.98 |
Correlation (Y=ADVIA IMS, X=comparison system)
| Specimen type | ComparisonSystem (X) | N | Regression Equation | Syx(mg dL) | R | Sample Range(mg/dL) |
|---|---|---|---|---|---|---|
| Serum | Abbott/TDx | 47 | $Y=0.997X - 1.39$ | 2.88 | 0.996 | 0.5-112.2 |
| Plasma(y), Serum(x) | ADVIA IMS | 49 | $Y=0.985X + 0.00$ | 2.73 | 0.988 | 4.2-75.8 |
Interfering Substances
| InterferingSubstance | Interfering Sub.Conc. (mg/dL) | Salicylate Conc(mg/dL) | Effect(% change) |
|---|---|---|---|
| Bilirubin (unconjugated) | 25 | 29.6 | 0.0 |
| Bilirubin (conjugated) | 25 | 31.9 | 0.0 |
| Hemoglobin | 1000 | 29.7 | +6.0 |
| Lipids (Triglycerides) | 500 | 29.1 | +7.0 |
Analytical Range
Serum/Plasma: 0 to 120 mg/dL
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4. Conclusion
Performance of the ADVIA IMS Salicylate Assay on a Bayer ADVIA® IMS™ is equivalent to the performance of the Salicylate Assay on the predicate device (Abbott TDX, K844070) and is within proposed manufacturing specifications. No safety and effectiveness issues have been raised.
Kuretsch. Charles
2/28/02
Date
Date
Kenneth T. Edds Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three wavy lines below the eagle.
JUL 11 2002
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kenneth T. Edds, Ph.D. Regulatory Affairs Manager Bayer Corporation 511 Benedict Avenue Tarrytown. NY 10591-5097
Re: K020794
Trade/Device Name: Salicylate Assay for the ADVIA® IMS™ Regulation Number: 21 CFR 862.3830 Regulation Name: Salicylate test system Regulatory Class: Class II Product Code: DKJ Dated: June 19, 2002 Received: June 20, 2002
Dear Dr. Edds:
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. Iisting 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Steven Butman
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: KOZO794
Device Name: Salicylate Assay for the ADVIA® IMSTM
Indications for Use:
The Bayer ADVIA IMS Salicylate method is an in vitro diagnostic device intended to measure salicylate levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of salicylate toxicity and overdose.
Ican
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K020794
Cooger
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-CounterUse_
(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.