(59 days)
The Emit® tox™ Salicylic Acid Assay is a homogenous enzyme immunoassay intended for use in the quantitative analysis of salicylic acid in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of salicylic acid overdose or in monitoring levels of salicylic acid to ensure appropriate therapy.
The Emit® tox™ Salicylic Acid Assay is a homogenous enzyme assay intended for use in quantitative analysis of Salicylic Acid in human serum or plasma.
The Emit® tox™ Salicylic Acid Assay is intended for the quantitative analysis of salicylic acid in human serum or plasma to diagnose and treat salicylic acid overdose or monitor therapeutic levels.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Specificity | No interference from tested compounds at specified levels. | Compounds with potential cross-reactivity did not interfere. |
| Comparative Analysis | Strong correlation to predicate device. (>0.993, slope 0.941) | Correlation of 0.993 with a slope of 0.941 to predicate (Abbott AxSYM® Salicylate Assay). |
| Precision (Within-Run) | Acceptable coefficient of variation (%CV). (<4.5%) | %CV ranging from 2.9% to 4.5%. |
| Precision (Total) | Acceptable coefficient of variation (%CV). (<5.8%) | %CV ranging from 3.9% to 5.8%. |
| Spike Recovery | Recovery within an acceptable range (e.g., 90-110%). | Recovery ranged from 91.8% to 104.7%. |
| Sensitivity | Lowest measurable concentration from 0 mg/dL with 95% confidence. (>5 mg/dL) | Sensitivity level is ≤5 mg/dL Salicylic Acid. |
| Endogenous Interference | Average recovery close to 100% compared to control samples. (>98.7% <102%) | Bilirubin: 98.7%, Hemoglobin: 99.4%, Triglycerides: 102%. No effect on accuracy. |
| High Sample Dilution | Recovery values within an acceptable range (e.g., 90-110%). (>104% <107%) | Recovery values ranged from 104% to 107%. No effect on accuracy. |
| Anticoagulants | Average recovery close to 100% compared to serum control. (>98.6% <106.3%) | Recovery ranged from 98.6% to 106.3%. |
Note: The document does not explicitly state the numerical acceptance criteria for each characteristic. The "Acceptance Criteria (Implied)" column is inferred from the reported performance, suggesting that the reported values met the internal acceptance criteria of the manufacturer.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample sizes used for the various tests (Specificity, Comparative Analysis, Precision, Spike Recovery, Sensitivity, Endogenous Interference, High Sample Dilution, Anticoagulants).
The document also does not directly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission to the FDA (a US regulatory body) by a US-based manufacturer (Syva Company - Dade Behring Inc., Cupertino, CA), it is highly probable that the data was generated in the United States and likely through prospective laboratory studies designed to evaluate device performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable to this type of device and study. The "Emit® tox™ Salicylic Acid Assay" is a diagnostic immunoassay that provides a quantitative measurement of a chemical substance (salicylic acid). The "ground truth" for such a system is typically established by reference methods or gravimetric preparation of known concentrations, not by expert consensus or interpretation of images/cases.
4. Adjudication Method
This section is not applicable for this type of quantitative immunoassay device. Adjudication methods (like 2+1, 3+1) are relevant for studies where human interpretation of results (e.g., medical images, pathology slides) is involved in establishing ground truth. For chemical assays, the "ground truth" is determined by the known concentration of the analyte or by a more accurate reference method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this is not relevant for a quantitative immunoassay device. MRMC studies are typically conducted for devices that involve human interpretation, such as imaging AI, to assess how AI assistance impacts human reader performance. This device provides a direct quantitative measurement.
6. Standalone Performance Study
Yes, a standalone performance study was performed. All the listed performance characteristics (Specificity, Comparative Analysis, Precision, Spike Recovery, Sensitivity, Endogenous Interference, High Sample Dilution, Anticoagulants) describe the performance of the Emit® tox™ Salicylic Acid Assay as a standalone algorithm/device. There is no human interpretation or human-in-the-loop component described for its intended use or performance evaluation.
7. Type of Ground Truth Used
The ground truth for the performance studies of the Emit® tox™ Salicylic Acid Assay was established using:
- Known concentrations of salicylic acid: For studies like Spike Recovery and Sensitivity, where samples are spiked with known amounts of salicylic acid.
- Reference method/Predicate Device: For Comparative Analysis, the Emit® tox™ Assay's results were compared against an established predicate device (Abbott AxSYM® Salicylate Assay), which serves as a clinical reference.
- Controlled samples: For interference studies (Endogenous Interference, Anticoagulants) and dilution studies, control samples with known compositions or prepared under controlled conditions were used.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for a training set. This is expected as the Emit® tox™ Salicylic Acid Assay is described as a "homogeneous enzyme immunoassay," indicating it is a chemical assay, not a machine learning or AI-based algorithm that typically requires a distinct training set. The performance statistics are based on analytical validation studies.
9. How Ground Truth for the Training Set Was Established
As noted above, since this is a chemical immunoassay and not an AI/ML algorithm, the concept of a "training set" with ground truth in the machine learning sense does not apply. The assay's fundamental chemical and enzymatic reactions form its operational basis, which is then validated through the detailed performance studies described.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Emit® tox™ Salicylic Acid Assay
Manufacturer and Contact Information: l.
Manufacturer:
Syva Company - Dade Behring Inc. 20400 Mariani Avenue Cupertino, CA 95014
Contact Information:
Susan L. Collins Syva Company 20400 Mariani Avenue Cupertino. CA 95014 Tel: 408-366-3908
II. Device Classification Name:
Salicylate test system has been classified as Class II by the Clinical Chemistry and Clinical Toxicology Devices Panel, 91 DKJ, 21 CFR 862.3830.
III. Intended Use:
Emit® tox™ Salicylic Acid Assay is a homogeneous enzyme immunoassay. The assay is intended for use in the quantitative analysis of salicylic acid in human serum or plasma.
IV. Device Description and Characteristics:
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
The Emit® tox™ Salicylic Acid Assay is a homogenous enzyme assay intended for use in quantitative analysis of Salicylic Acid in human serum or plasma. The Emit tox™ Salicylic Acid Assay and Calibrators have been found to be equivalent to the predicate device: Abbott AxSYM® Salicylate Assay (K951290) with regard to intended use, assay sample, and overall performance characteristics.
Specificy: Compounds, whose chemical structure would suggest possible crossreactivity or other therapeutics concurrently used, when tested on the Emit® tox ™ Salicylic Acid Assay, did not interfere at the levels tested.
Comparative Analysis: The Emit® tox™ Salicylic Acid Assay and calibrators showed excellent correlation to the predicate method. The comparative analysis to the predicate method resulted in a correlation of 0.993 with a slope value of 0.941.
Precision: A Precision study was performed and the Emit® tox™ Salicylic Acid Assay demonstrated acceptable within-run precision with coefficients of variation (%CV) ranging from 2.9% to 4.5% and acceptable total precision with coefficients of variation (%CV) ranging from 3.9% to 5.8%.
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Spike Recovery: A spike recovery study was performed using 7 levels of spiked salicylic acid. The recovery ranged from 91.8% to 104.7%.
Sensitivity: The sensitivity level of the Emit® tox™ Salicylic Acid Assay is $5 mg/dL Salicylic Acid. This level represents the lowest measurable concentration of salicylic acid that can be distinguished from 0 mg/dL with a confidence of 95%.
Endogenous Interference: Average recovery compared to control samples was studied separately to assess endogenous interference due to bilirubin, hemoglobin and triglycerides in the Emit® tox™ Salicylic Acid Assay. Average recoveries were 98.7, 99.4 and 102 percent for bilirubin, hemoglobin and triglycerides, respectively. There was no effect on the accuracy of the results.
High Sample Dilution: High sample dilution was evaluated by diluting a high spike sample four different ways. Separate 1:2 and 1:3 dilutions with Emit® tox™ Salicylic Acid Calibrator 0, and 1:3 dilutions with water for each spike sample were assayed. The recovery values ranged from 104 to 107 percent. There was no effect on the accuracy of the results.
Anticoagulants: The performance of the anticoagulants KJEDTA, sodium citrate, sodium heparin, and potassium oxalate/sodium fluoride, as compared to serum was tested on Emit® tox™ Salicylic Acid Assay. Average recovery, compared to serum control ranged from 98.6 to 106.3 percent.
V. Substantial Equivalence:
In conclusion, Syva Company - Dade Behring Inc. considers the Emit® tox™ Salicylic Acid Assay and Emit® tox™ Salicylic Acid Calibrators to be substantially equivalent to the Abbott AxSYM® Salicylate Assay (K951290) with regard to intended use, assay sample, and overall performance characteristics.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 3 2001
Ms. Susan L. Collins Regulatory Affairs Associate Syva Company-Dade Behring Inc. 20400 Mariani Avenue Cupertino, CA 95014
510(k) Number: K011878 Re: Trade/Device Name: Emit®tox™ Salicylic Acid Assay and Emit®tox™ Salicylic Acid Calibrators
Regulation Number: 862.3830 Regulatory Class: II Product Code: DKJ, DLJ Dated: June 14, 2001 Received: June 15, 2001
Dear Ms. Collins:
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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amerade overminents, 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 of the Act. The general controls provisions 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 notification. The I Dri intellig of succioin 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 If you desire specific acrice for your astic devices), please contact the Office of Compliance at additionally 807.10 for m This cauguestions on the promotion and advertising of your device, (301) 594-4560. Rauncenary, supliance 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 Information on your responsionate assistance at its toll-free number (800) 638-2041 or Manufacturers International and Selecss "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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):
510(k) Number (if known):
Device Name: Emit® tox™ Salicylic Acid Assay Emit® tox™ Salicylic Acid Calibrators
Indications for Use:
The Emit® tox™ Salicylic Acid Assay is a homogenous enzyme immunoassay intended for use in the quantitative analysis of salicylic acid in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of salicylic acid overdose or in monitoring levels of salicylic acid to ensure appropriate therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Use
(Per 21 CFR 801.109)
96)
OR
Over-The-Counter
Kesia Alvandy Jalian Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K011878
(Optional Format 1-2-
§ 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.