(88 days)
ImmunoCAP Tryptase is an in vitro semi-quantitative assay for measurement of tryptase in human serum or plasma (EDTA, lithium heparin or sodium heparin). It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings. ImmunoCAP Tryptase is to be used with the instruments Phadia 100 and Phadia 250.
ImmunoCAP Tryptase reagents are modular in concept and are available individually in different package sizes dependent on instrument system used.
The reagents needed to perform the ImmunoCAP Tryptase assay are listed below. ImmunoCAP Tryptase/ImmunoCAP Tryptase Conjugate 50 (10-9525-02/10-9522-02) ImmunoCAP Tryptase Calibrators/ImmunoCAP Tryptase Calibrator Strip (10-9526-01/10-9523-01) ImmunoCAP Tryptase Curve Control/ImmunoCAP Tryptase Curve Control Strip (10-9527-01/10-9524-01) ImmunoCAP Tryptase Anti-Tryptase (14-4518-01), ImmunoCAP Tryptase Control (10-9370-01)
The Phadia AB ImmunoCAP Tryptase assay is an in vitro semi-quantitative assay for measuring tryptase in human serum or plasma. It is intended for in vitro diagnostic use to aid in the clinical diagnosis of patients suspected of systemic mastocytosis, in conjunction with other clinical and laboratory findings. This submission is an update due to changes in raw materials for the ImmunoCAP Tryptase Conjugate and ImmunoCAP Tryptase Calibrators, but these changes do not affect the intended or indications for use.
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria in a table format. However, it indicates that the analytical and clinical performance of the updated ImmunoCAP Tryptase was "verified through studies" and concluded to be "substantially equivalent" to the currently cleared product. This implies that the performance in these studies met the thresholds established for substantial equivalence.
The performance characteristics verified include:
- Precision
- Lot-to-lot reproducibility
- Linearity
- Limit of detection
- Hook effect
- Analytical specificity
- Interference of HAMA
- Recovery
- Sample matrix compatibility
- Clinical performance
The document states that "The results showed that the clinical performance of ImmunoCAP Tryptase has not changed when used as an aid in the routine clinical diagnosis of systemic mastocytosis according to WHO criteria."
2. Sample Sizes and Data Provenance
- Test Set Sample Size: The clinical performance was verified through studies performed at two sites, including a total of 138 patients.
- Data Provenance: The document does not explicitly state the country of origin for the clinical samples. The phrase "samples with and without clinical documentation, as well as samples from healthy individuals" suggests a mix, likely from clinical settings where the studies were conducted. It is a prospective clinical evaluation, given the context of verifying performance for a device update.
- Training Set Sample Size: Not explicitly stated. The document describes an update to an existing device rather than a new algorithm development, so a distinct 'training set' for the algorithm in the sense of AI/ML models is not directly applicable here. The focus is on verifying that the material changes do not alter performance.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. This device is a semi-quantitative assay for a biomarker (tryptase), not an imaging or diagnostic AI device requiring expert adjudication of images or clinical cases for ground truth establishment. The ground truth for clinical performance would be the definitive diagnosis of systemic mastocytosis based on WHO criteria, which involves a combination of clinical, laboratory, and histopathological findings.
4. Adjudication Method for the Test Set
Not applicable. As this is not an AI/ML algorithm requiring human interpretation of outputs, there is no adjudication method in the traditional sense for a test set. Clinical diagnosis based on WHO criteria would be the reference.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a device that involves human readers interpreting diagnostic outputs. It is a laboratory assay.
6. Standalone Performance Study
Yes, a standalone performance study was done for the device. The document details the analytical performance characteristics (precision, linearity, limit of detection, etc.) and states that the updated ImmunoCAP Tryptase was compared to the currently cleared ImmunoCAP Tryptase using samples. This inherently describes a standalone performance evaluation of the updated device.
7. Type of Ground Truth Used
For the clinical performance verification, the ground truth was "routine clinical diagnosis of systemic mastocytosis according to WHO criteria." This indicates a comprehensive set of diagnostic guidelines, which would typically involve expert consensus, clinical symptoms, laboratory markers (including tryptase levels), and potentially bone marrow biopsy results.
For the analytical performance verification, the ground truth would be based on established analytical methods and reference materials to assess accuracy, precision, linearity, etc.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm that undergoes a training phase with a specific training set of data. The submission is for an update to an existing in vitro diagnostic assay due to raw material changes.
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 model for this device.
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March 2, 2018
Phadia AB % Martin Mann Sr. Regulatory Affairs Manager Phadia US Inc 4169 Commercial Ave Portage, Michigan 49002
Re: K173704
Trade/Device Name: ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip
Regulation Number: 21 CFR 866.5760 Regulation Name: Tryptase test system Regulatory Class: Class II Product Code: OYL Dated: December 1, 2017 Received: December 4, 2017
Dear Martin Mann:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kelly Oliner -S
For, Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name ImmunoCAP Tryptase
Indications for Use (Describe)
ImmunoCAP Tryptase is an in vitro semi-quantitative assay for measurement of tryptase in human serum or plasma (EDTA, lithium heparin or sodium heparin). It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings. ImmunoCAP Tryptase is to be used with the instrument Phadia 100.
ImmunoCAP Tryptase is an in vitro semi-quantitative assay for measurement of tryptase in human serum or plasma (EDTA, lithium heparin or sodium heparin). It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings. ImmunoCAP Tryptase is to be used with the instrument Phadia 250.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Traditional 510(k) Submission, Update of ImmunoCAP Tryptase A.6 510k Summary
510(k) Summary
This 510(k) Summary is prepared in accordance with the requirements of 21 CFR Part 807.92.
| Date of Summary Preparation: | February 7, 2018 |
|---|---|
| Manufacturer: | Phadia ABRapsgatan 7PP.O. Box 6460751 37 Uppsala, Sweden |
| US Distributor: | Phadia US Inc.4169 Commercial AvenuePortage, MI 49002 |
| Company Contact Person: | Martin MannSr. Regulatory Affairs ManagerPhadia US Inc.4169 Commercial AvenuePortage, MI 49002269-207-7049martin.mann@thermofisher.com |
| Device Name: | ImmunoCAP Tryptase |
| Common Name: | In vitro diagnostic test system for semi-quantitative measurement of tryptase |
| Classification:Regulation sectionClassificationClass II Special Controls GuidelineProduct nameProduct code | 21 CFR §866.5760 – Tryptase test systemClass IITryptase Test System as an Aid in theDiagnosis of Systemic MastocytosisImmunoCAP TryptaseOYL, tryptase assay system |
| Substantial Equivalence to: | ImmunoCAP Tryptase DEN120001 (K103039) |
Premarket Notification 510(k) No: K173704
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Traditional 510(k) Submission, Update of ImmunoCAP Tryptase A.6 510k Summary
Indications for use statement
ImmunoCAP Tryptase is an in vitro semi-quantitative assay for measurement of tryptase in human serum or plasma (EDTA, lithium heparin or sodium heparin). It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings. ImmunoCAP Tryptase is to be used with the instruments Phadia 100 and Phadia 250.
Device Description
Reagents
ImmunoCAP Tryptase reagents are modular in concept and are available individually in different package sizes dependent on instrument system used.
The reagents needed to perform the ImmunoCAP Tryptase assay are listed below. ImmunoCAP Tryptase/ImmunoCAP Tryptase Conjugate 50 (10-9525-02/10-9522-02) ImmunoCAP Tryptase Calibrators/ImmunoCAP Tryptase Calibrator Strip (10-9526-01/10-9523-01) ImmunoCAP Tryptase Curve Control/ImmunoCAP Tryptase Curve Control Strip (10-9527-01/10-9524-01) ImmunoCAP Tryptase Anti-Tryptase (14-4518-01), ImmunoCAP Tryptase Control (10-9370-01)
Instrument System
Phadia 100 and Phadia 250 instruments with associated software process all steps of the assay and calculate results automatically after the assay is completed.
Test Principle, ImmunoCAP Tryptase
Anti-tryptase, covalently coupled to ImmunoCAP, reacts with the tryptase in the patient sample. After washing, enzyme labeled antibodies against tryptase are added to form a complex. After incubation, unbound enzyme-anti-tryptase is washed away and the bound complex is then incubated with a developing agent. After stopping the reaction, the fluorescence of the eluate is measured. The higher the response value, the more tryptase is present in the sample. To evaluate the test results, the responses of the patient samples are transformed into concentrations with the use of a calibration curve.
Reason for Submission
This submission comprises changes in product raw material made to assay reagents ImmunoCAP Tryptase Conjugate and ImmunoCAP Tryptase Calibrators. The changes do not affect the Intended use or the Indications for use statements.
Performance Characteristics
The updated ImmunoCAP Tryptase was compared with the currently cleared ImmunoCAP Tryptase with the use of samples with and without clinical documentation, as well as samples from healthy individuals. The analytical performance characteristics of the updated ImmunoCAP Tryptase were verified through studies of precision, lot-to-lot reproducibility, linearity, limit of detection, hook, analytical specificity, interference of HAMA, recovery and sample matrix.
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Traditional 510(k) Submission, Update of ImmunoCAP Tryptase A.6 510k Summary
The clinical performance was verified through studies performed at two sites, including in total 138 patients with a suspicion of systemic mastocytosis. The results showed that the clinical performance of ImmunoCAP Tryptase has not changed when used as an aid in the routine clinical diagnosis of systemic mastocytosis according to WHO criteria.
Conclusion
The analytical and clinical data included in this 510(k) submission support that the updated ImmunoCAP Tryptase is substantially equivalent to the currently cleared product.
§ 866.5760 Tryptase test system.
(a)
Identification. A tryptase test system is a device that aids in the diagnosis of systemic mastocytosis. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings.(b)
Classification. Class II (special controls). The special control is FDA's guideline entitled “Class II Special Controls Guideline: Tryptase Test System as an Aid in the Diagnosis of Systemic Mastocytosis.” For availability of the document, see § 866.1(e).