(382 days)
The IDS-iSYS Direct Renin assay is intended for the quantitative determination of Direct Renin in human EDTA plasma on the IDS iSYS Multi-Discipline Automated System. Renin measurements may aid in the diagnosis and treatment of certain types of hypertension.
The IDS-iSYS Direct Renin Control Set is used for quality control of the IDS-iSYS Direct Renin Assay on the IDS-iSYS Multi-Discipline Automated System.
The IDS-iSYS Direct Renin Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS Direct Renin Assay when performed on the IDSiSYS Multi-Discipline Automated System.
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This document is a 510(k) premarket notification for an in vitro diagnostic device, specifically assays and controls for measuring Direct Renin. Such documents review the substantial equivalence of a new device to a predicate device, and the studies cited typically focus on analytical performance rather than clinical efficacy studies often associated with AI/ML devices. Therefore, a direct mapping to the requested information about AI model performance, expert ground truth adjudication, MRMC studies, or training set details is not possible based on the provided text.
However, I can extract information related to the acceptance criteria and performance as presented for this type of diagnostic assay.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text (K123763) is a 510(k) clearance letter for the IDS iSYS Direct Renin Assay. It does not contain a table of acceptance criteria nor detailed performance data. This letter confirms that the FDA has reviewed the device and determined it to be "substantially equivalent" to legally marketed predicate devices. The full performance data and acceptance criteria would be in the original 510(k) submission, which is not provided here.
However, for in vitro diagnostic assays like this, typical acceptance criteria relate to analytical performance characteristics. While not explicitly stated with values, the Regulation Number: 21 CFR 862.1085 pertains to "Angiotensin I and renin test system." For such systems, acceptance criteria generally cover:
- Accuracy/Bias: Comparison to a reference method or predicate device.
- Precision/Reproducibility: Within-run, between-run, and total precision (CV%).
- Linearity/Measuring Range: The range over which results are proportional to the concentration.
- Limit of Detection (LoD) and Limit of Quantitation (LoQ): The lowest concentration that can be reliably detected and quantified.
- Interference: Evaluation of common endogenous and exogenous interfering substances.
- Specificity: Absence of significant cross-reactivity with related substances.
Since the FDA granted clearance based on substantial equivalence, it implies that the device's performance met the relevant acceptance criteria, demonstrating similar performance to a predicate device for these analytical characteristics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document (510(k) clearance letter) does not contain details about the sample size, data provenance, or study design (retrospective/prospective) for the test set. These details would be part of the full 510(k) submission.
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)
This type of information is not relevant for an in vitro diagnostic assay like the IDS iSYS Direct Renin Assay. The "ground truth" for such assays is established through analytical methods and scientific standards (e.g., reference methods, known concentrations of analytes, spiked samples), not through expert consensus on images or clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for an in vitro diagnostic assay. Adjudication methods are typically used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies.
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 for this in vitro diagnostic assay. MRMC studies and the concept of "human readers improving with AI assistance" are relevant to AI/ML medical devices that aid in interpretation or diagnosis by humans. This device is an automated laboratory assay for quantitative measurement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device, the IDS iSYS Direct Renin Assay, is an automated assay run on a "Multi-Discipline Automated System." Thus, its performance is inherently "standalone" in the sense that the measurement of Direct Renin concentration is performed by the instrument and reagents as an algorithm/system, without direct human cognitive input into result generation. A human interprets the final quantitative result. Performance studies for such devices evaluate the system's analytical capabilities directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For in vitro diagnostic assays, the "ground truth" for analytical performance evaluation typically involves:
- Reference Methods: Using a validated, often more complex or gold-standard, analytical method to determine true concentrations.
- Certified Reference Materials/Calibrators: Samples with precisely known concentrations of the analyte.
- Spiked Samples: Adding known amounts of the analyte to a matrix to assess recovery.
- Commutability/Traceability: Ensuring results are traceable to international reference standards if available.
The provided document does not specify the exact methods used to establish ground truth but these are the standard approaches for such devices.
8. The sample size for the training set
Not applicable in the context of AI/ML training data. For an in vitro diagnostic assay, there isn't a "training set" in the machine learning sense. The assay is developed through biochemical and engineering principles, and its performance is validated using experimental analytical studies.
9. How the ground truth for the training set was established
Not applicable for an in vitro diagnostic assay. This concept is specific to AI/ML model development.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 24, 2013
IMMUNODIAGNOSTIC SYSTEMS LTD. MICK FENTON GLOBAL RA MANAGER 10 DIDCOT WAY BOLDEN BUSINESS PARK BOLDON, TYNE & WEAR NE35 9PD UK
Re: K123763 Trade/Device Name: IDS iSYS Direct Renin Assay, IDS iSYS Direct Renin Control Set, and IDS iSYS Direct Renin Calibration Verifiers Regulation Number: 21 CFR 862.1085 Regulation Name: Angiotensin I and renin test system Regulatory Class: II Product Code: CIB Dated: November 28, 2013 Received: December 2, 2013
Dear Mr. Fenton:
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. Ilsting 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (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
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- electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carol C. Benson -S
for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
IDS iSYS Direct Renin Assay, IDS-iSYS Direct Renin Control Set, and IDS-iSYS Direct Renin Calibration Verifiers
Indications for Use (Describe)
The IDS-iSYS Direct Renin assay is intended for the quantitative determination of Direct Renin in human EDTA plasma on the IDS iSYS Multi-Discipline Automated System. Renin measurements may aid in the diagnosis and treatment of certain types of hypertension.
The IDS-iSYS Direct Renin Control Set is used for quality control of the IDS-iSYS Direct Renin Assay on the IDS-iSYS Multi-Discipline Automated System.
The IDS-iSYS Direct Renin Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS Direct Renin Assay when performed on the IDSiSYS Multi-Discipline Automated System.
Type of Use (Select one or both; as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
§ 862.1085 Angiotensin I and renin test system.
(a)
Identification. An angiotensin I and renin test system is a device intended to measure the level of angiotensin I generated by renin in plasma. Angiotensin I measurements are used in the diagnosis and treatment of certain types of hypertension.(b)
Classification. Class II.